Thailand's Ministry of Public Health is "taking a bold step" in ensuring that the country "takes full advantage" of the World Trade Organization's Trade-Related Aspects of Intellectual Property Rights agreement by breaking the patent on Abbott Laboratories' antiretroviral drug Kaletra, a Bangkok Post editorial says (Bangkok Post, 1/31). The health ministry on Monday said that it has broken a patent on Kaletra by issuing a compulsory license to produce a lower-cost version of the drug. According to Health Minister Mongkol na Songkhla, the compulsory license was signed into law and took effect on Friday. WTO regulations allow governments to declare a "national emergency" and issue compulsory licenses without consulting the foreign patent owner. Thailand, which has 580,000 people living with HIV/AIDS, has won international recognition for its quick launch of a national drug program that treats more than 82,000 HIV-positive people. However, the government's commitment to providing universal access to care is facing increasingly high drug costs. The compulsory license could save the country as much as $24 million annually (Kaiser Daily HIV/AIDS Report, 1/30). The editorial "applaud[s] the government for using all legal methods possible to ensure Thai patients get the cheapest and best drugs available." However, the editorial says that the government also "should be careful not to unnecessarily further push away foreign investment," adding that even though the government is "not legally required to negotiate with drug companies before issuing a compulsory license doesn't mean it should not do so." The Thai government should "insist on procuring quality drugs" from World Health Organization-approved factories, especially for HIV/AIDS medications, according to the editorial. Although Thailand's Government Pharmaceutical Organization's factories do not meet WHO standards, Thai officials say their generic antiretrovirals are of high quality, the editorial says, adding that it "would be nice to remove the cloud of suspicion." According to the editorial, Thailand should import generic antiretrovirals from India until a new GPO facility that meets WHO standards is complete. This would allow the government to procure antiretrovirals with funds from the Global Fund To Fight AIDS, Tuberculosis and Malaria, which "refuses to finance Thai-produced drugs because they don't meet international standards," the editorial says. According to the editorial, the money the government saves by using drugs produced in India "could be used to expand patient education." The editorial adds that "[m]uch of the resistance to Thai generic HIV/AIDS drugs is attributed to patients who misunderstand how to take the drugs" and that there is little point in "expanding drug coverage if the drugs will prove ineffective due to incorrect usage" (Bangkok Post, 1/31).
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
Showing posts with label Antiretrovirals. Show all posts
Showing posts with label Antiretrovirals. Show all posts
May 7, 2007
April 16, 2007
Guyanese Health Ministry To Provide $450,000 For HIV/AIDS Programs Nationwide
The Guyanese Ministry of Health on Tuesday announced it will provide $450,000 to 16 nongovernmental organizations to conduct HIV/AIDS programs nationwide, the Stabroek News reports. The funding will be provided through the health ministry's HIV/AIDS prevention and control project. Health Minister Leslie Ramsammy urged the NGOs -- which include the Society Against Sexual Orientation Discrimination, Spectrum Health Net and the Art of Living Foundation -- to execute their projects in a timely and organized manner (Seales, Stabroek News, 1/25). In related news, Guyana's Government Information Agency on Tuesday announced that the number of HIV-positive people accessing antiretroviral treatment at clinics nationwide has increased since the end of 2005, the Caribbean Media Corporation reports (Caribbean Media Corporation, 1/24). Eight public health clinics in six of the country's regions by the end of 2005 were providing access to antiretrovirals, following the establishment in 2002 of the first treatment clinic in the capital, Georgetown, according to Stabroek News. In addition, GINA announced that the government plans to provide 80% of HIV-positive pregnant women in the country with treatment access through a program aimed at preventing vertical HIV transmission. GINA on Wednesday also announced that the government has provided almost 11,000 HIV-positive people with access to treatment through a clinic in the Georgetown Public Hospital Corporation. According to GINA, the government in conjunction with CDC and the President's Emergency Plan for AIDS Relief remodeled the clinic in June 2006 to increase its treatment capacity. The New Guyana Pharmaceutical Company with PEPFAR funding is producing antiretrovirals that the government makes available at no cost to all HIV-positive people in the country, GINA said, adding that Guyana plans to further expand prevention, treatment and care initiatives (Stabroek News, 1/24).
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
HIV/AIDS Advocates Protest Novartis' Case Challenge India Patent Law
Some HIV/AIDS advocacy groups are calling on pharmaceutical company Novartis to drop its legal challenge to the Indian government's patent laws, saying that if the company wins the case it could restrict access to antiretroviral drugs for millions of people worldwide, South Africa's Business Day reports. Novartis is challenging a section of India's Patents Act that aims to restrict certain kinds of patents, according to Business Day. Novartis brought a civil lawsuit against the Indian government after the country in January 2006 rejected the company's attempt to patent a new version of its leukemia drug Gleevec on the basis that the drug is a new formulation of an existing drug (Musgrave, Business Day, 1/25). According to the AP/International Herald Tribune, India's patent law, which went into effect in January 2005, allows patents for products that are new inventions developed after 1995, when India joined the World Trade Organization, or for an updated drug that exhibits improved efficacy. Although some Indian drug companies and groups say that Gleevec is a new formulation of a drug developed before 1995, Novartis says that it is an improved drug (Rabinowitz, AP/International Herald Tribune, 1/29). Decisions concerning patents on some newer HIV/AIDS drugs in India have not been announced (Business Day, 1/25). If Novartis wins the case, it could potentially set a precedent for other pharmaceutical companies seeking patent protection for drugs, including antiretrovirals, some HIV/AIDS advocates have said (AP/International Herald Tribune, 1/29). Medecins San Frontieres International Council President Christophe Fournier last month said the organization relies on reduced-cost, quality drugs produced in India to provide treatment to people living with HIV/AIDS worldwide. According to the group, antiretrovirals produced in India are used to provide treatment to more than 80% of the 80,000 people in more than 30 countries who receive treatment from the organization's projects (Business Day, 1/25). A court in Chennai, India, heard arguments in the case on Monday (AP/International Herald Tribune, 1/29). According to the New York Times, the court was asked to clarify regulations on patents for new versions of existing drugs whose original patents have expired. Novartis spokesperson John Gilardi said, "We are trying to gain clarity as to what guides India's patent laws. ... This is not about access to medicines. It is about establishing whether India is going to step up and adopt the minimum international standards required for the protection of intellectual property." Unni Karunakara, medical director of MSF's campaign to broaden access to medicines, said, "Novartis is trying to shut down the pharmacy of the developing world." A decision in the Novartis case is not expected until Feb. 15 (Gentleman, New York Times, 1/30).
Protests in India; Washington, D.C.
Hundreds of HIV/AIDS advocates on Monday protested in New Delhi, India, against the Novartis patent challenge, the AP/Herald Tribune reports. MSF, along with Oxfam International, has gathered about 250,000 signatures for a petition asking Novartis to drop the case (AP/International Herald Tribune, 1/29). Several HIV/AIDS advocacy groups in Washington, D.C., also protested on Monday, the AFP/France24 reports. David Bryden, communications director for Global AIDS Alliance, said that the advocates were attempting to deliver a golden miniature coffin to a Novartis office in the district but that they were turned away. The demonstrators chanted, "Patient rights, not patent rights" and, "Novartis greed kills people in need; Drop the case now," AFP/France 24 reports. The protest symbolizes the "fatal consequence" of Novartis' action for people who rely on India for generic drugs, Bryden said (AFP/France24, 1/29).
APM's "Marketplace" on Monday reported on the protests. The segment includes comments from Bryan Liang -- a professor at the California Western School of Law who advises pharmaceutical companies on competition, pricing and access -- and Chan Park, a patient advocate with the Lawyers Collective HIV/AIDS Unit (Levitt, "Marketplace," APM, 1/29). Audio of the segment is available online.
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
April 15, 2007
UNHCR Launches Policy To Provide Refugees With Access To Antiretroviral Treatment
The Office of the United Nations High Commissioner for Refugees has launched a new strategy aimed at ensuring HIV-positive refugees and other displaced people worldwide have access to antiretroviral treatment, care and support, IRIN News reports. The policy addresses both long-term and shorter-term antiretroviral provisions, such as post-exposure prophylaxis for sexual assault survivors and prevention of mother-to-child HIV transmission. According to the new policy, antiretroviral drugs will be planned for and included in the "earliest possible stages of an emergency response to forced displacement," IRIN reports. The strategy also outlines interventions for refugees who were receiving treatment in their home countries, those who were not on a regimen before displacement and those voluntarily returning to their home countries. In cases where repatriation is impending, refugees should be permitted and assisted to return to areas where they can access antiretrovirals, according to the policy. The policy also says that it is practical to provide access to antiretrovirals to refugees in the medium- to long-term because they often live for several years in somewhat stable environments, IRIN reports. "In certain situations ... the refugees have had difficulty accessing ARVs, and even those in urban areas sometimes failed to get treated within the national programs of the host countries," Paul Spiegel, UNHCR's senior HIV/AIDS technical officer, said, adding, "The way many of them have been accessing the drugs is innovative but has largely not been standardized." Spiegel said that UNHCR makes efforts to provide equal distribution of services to host populations. "We'd like to see refugees able to get the drugs the same way local populations do," he said, adding, "We are advocating for governments to include refugees' ARV needs in their proposals for funding" from the Global Fund To Fight AIDS, Tuberculosis and Malaria" and other agencies. According to UNHCR estimates, refugees comprise between 25,000 and 35,000 of the nearly 6.5 million people worldwide who need antiretrovirals, IRIN reports (IRIN News, 1/29).
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
Data Published In AIDS Show Viramune (nevirapine) Achieves Durable Benefit In Switch Patients
Long-term data from the Nevirapine/Efavirenz/Abacavir (NEFA) study demonstrate that patients who switched from a protease inhibitor-based regimen to a non-nucleoside reverse transcriptase inhibitor-based regimen containing Viramune (nevirapine) or efavirenz achieved comparable efficacy and safety to their previous regimen and were more likely to maintain virologic suppression after three years of follow up than patients who switched to an abacavir-containing regimen. These data were published in the 30 January issue of AIDS.
Patients may want to consider simpler regimens that can suppress the virus long term but are more tolerable and have fewer side effects than some protease inhibitor-based therapies. The findings of the NEFA study reveal that HIV-positive patients seeking effective alternatives can benefit from a switch to a treatment regimen containing a non-nucleoside reverse transcriptase inhibitor such as Viramune. said Esteban Martinez, M.D., Ph.D., professor of medicine, University of Barcelona.
The NEFA study has been the largest prospective protease inhibitor switch study conducted to date. The NEFA study was a multicentre, randomized, open-label clinical trial initially designed for 1-year follow up of 460 HIV-positive adults who had previously been treated with at least one protease inhibitor plus two nucleoside reverse transcriptase inhibitors. The follow up was extended to 3 years following recommendations from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA). Patients participating in the study were required to have maintained the amount of HIV in their blood (viral load) to less than 200 copies/mL for at least six months on their protease inhibitor-based regimen containing indinavir (n=278), nelfinavir (n=135), ritonavir (n=15), saquinavir (n=13), or indinavir or saquinavir in combination with low-dose ritonavir (n=19) prior to study entry. Patients were then randomized to replace their protease inhibitor with Viramune twice daily (n=155), efavirenz once daily (n=156) or abacavir twice daily (n=149).
An intent-to-treat (ITT) analysis of patients originally randomized to switch from their protease inhibitor to Viramune, efavirenz or abacavir showed that 93.5 percent of patients who switched to Viramune, 92.9 percent of patients who switched to efavirenz and 80.5 percent of patients who switched to abacavir achieved virologic success after three years. This analysis was conducted to control for the effects of study discontinuation and switching from study medication.
In this study, the incidence of adverse events leading to discontinuation was significantly lower in the abacavir (9%) and Viramune (19%) groups than the efavirenz (25%) group. The majority of adverse events that led to discontinuation in the abacavir and Viramune arms occurred in the first weeks of the study. The most common adverse events experienced were neuropsychiatric events in the efavirenz arm and rash in the Viramune arm. While in the Viramune group adverse events occurred within the first year, neuropsychiatric adverse events that led to late discontinuation in the efavirenz group occurred steadily through three years of follow up.
About Viramune
Viramune (nevirapine) is a product of original research done at Boehringer Ingelheim. Viramune was the first member of the non-nucleoside reverse transcriptase inhibitor (NNRTI) class of anti-HIV drugs. Viramune is indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection. This indication is based on one principal clinical trial that demonstrated prolonged suppression of HIV-RNA and several smaller supportive studies. Studies have also shown that patients switching to Viramune from a PI-based regimen demonstrate an improved lipid profile while maintaining viral suppression. The most clinically important adverse events associated with Viramune are rash and hepatic events, which have included fatal cases. Any patient can experience hepatic events; however, female gender and higher CD4 counts at initiation of therapy place patients at greater risk. Women with CD4+ cell counts >250 cells/mm3 are at the greatest risk. By application of the Viramune CD4+ guidelines the risk of hepatic events can be dramatically reduced. Viramune should not be initiated in adult females with CD4+ cell counts greater than 250 cells/mm3 or in adult males with CD4+ cell counts greater than 400 cells/mm3 unless the benefit outweighs the risk. The greatest risk of severe rash and hepatic events occurs in the first 6 weeks of therapy. It is essential that patients be monitored for these reactions at all times, and intensively during the first few months of therapy. Viramune should be discontinued and not restarted following severe hepatic, skin or hypersensitivity reactions.
Boehringer Ingelheim
Boehringer Ingelheim is committed to the research and development of novel antiretroviral agents. Apart from Viramune, Aptivus (tipranavir) is a new non-peptidic protease inhibitor, approved for combination antiretroviral treatment of HIV-1 infected adults that are highly pre-treated with virus resistant to multiple protease inhibitors. The company is involved in basic research and is committed to improving HIV therapy by providing physicians and patients with innovative antiretrovirals.
Please be advised
This release is from the Corporate Headquarters of Boehringer Ingelheim and is intended for all international markets. This being the case, please be aware that there may be some differences between countries regarding specific medical information including licensed uses. Please take account of this when referring to the material.
References:
Martinez E. et al. Three-year Follow-Up of Protease Inhibitor-based Regimen Simplification in HIV-infected Patients. AIDS 2007 21(3)
Boehringer Ingelheim GmbH
Judith von Gordon
55216 Ingelheim am Rhein
Boehringer Ingelheim GmbH
Patients may want to consider simpler regimens that can suppress the virus long term but are more tolerable and have fewer side effects than some protease inhibitor-based therapies. The findings of the NEFA study reveal that HIV-positive patients seeking effective alternatives can benefit from a switch to a treatment regimen containing a non-nucleoside reverse transcriptase inhibitor such as Viramune. said Esteban Martinez, M.D., Ph.D., professor of medicine, University of Barcelona.
The NEFA study has been the largest prospective protease inhibitor switch study conducted to date. The NEFA study was a multicentre, randomized, open-label clinical trial initially designed for 1-year follow up of 460 HIV-positive adults who had previously been treated with at least one protease inhibitor plus two nucleoside reverse transcriptase inhibitors. The follow up was extended to 3 years following recommendations from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA). Patients participating in the study were required to have maintained the amount of HIV in their blood (viral load) to less than 200 copies/mL for at least six months on their protease inhibitor-based regimen containing indinavir (n=278), nelfinavir (n=135), ritonavir (n=15), saquinavir (n=13), or indinavir or saquinavir in combination with low-dose ritonavir (n=19) prior to study entry. Patients were then randomized to replace their protease inhibitor with Viramune twice daily (n=155), efavirenz once daily (n=156) or abacavir twice daily (n=149).
An intent-to-treat (ITT) analysis of patients originally randomized to switch from their protease inhibitor to Viramune, efavirenz or abacavir showed that 93.5 percent of patients who switched to Viramune, 92.9 percent of patients who switched to efavirenz and 80.5 percent of patients who switched to abacavir achieved virologic success after three years. This analysis was conducted to control for the effects of study discontinuation and switching from study medication.
In this study, the incidence of adverse events leading to discontinuation was significantly lower in the abacavir (9%) and Viramune (19%) groups than the efavirenz (25%) group. The majority of adverse events that led to discontinuation in the abacavir and Viramune arms occurred in the first weeks of the study. The most common adverse events experienced were neuropsychiatric events in the efavirenz arm and rash in the Viramune arm. While in the Viramune group adverse events occurred within the first year, neuropsychiatric adverse events that led to late discontinuation in the efavirenz group occurred steadily through three years of follow up.
About Viramune
Viramune (nevirapine) is a product of original research done at Boehringer Ingelheim. Viramune was the first member of the non-nucleoside reverse transcriptase inhibitor (NNRTI) class of anti-HIV drugs. Viramune is indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection. This indication is based on one principal clinical trial that demonstrated prolonged suppression of HIV-RNA and several smaller supportive studies. Studies have also shown that patients switching to Viramune from a PI-based regimen demonstrate an improved lipid profile while maintaining viral suppression. The most clinically important adverse events associated with Viramune are rash and hepatic events, which have included fatal cases. Any patient can experience hepatic events; however, female gender and higher CD4 counts at initiation of therapy place patients at greater risk. Women with CD4+ cell counts >250 cells/mm3 are at the greatest risk. By application of the Viramune CD4+ guidelines the risk of hepatic events can be dramatically reduced. Viramune should not be initiated in adult females with CD4+ cell counts greater than 250 cells/mm3 or in adult males with CD4+ cell counts greater than 400 cells/mm3 unless the benefit outweighs the risk. The greatest risk of severe rash and hepatic events occurs in the first 6 weeks of therapy. It is essential that patients be monitored for these reactions at all times, and intensively during the first few months of therapy. Viramune should be discontinued and not restarted following severe hepatic, skin or hypersensitivity reactions.
Boehringer Ingelheim
Boehringer Ingelheim is committed to the research and development of novel antiretroviral agents. Apart from Viramune, Aptivus (tipranavir) is a new non-peptidic protease inhibitor, approved for combination antiretroviral treatment of HIV-1 infected adults that are highly pre-treated with virus resistant to multiple protease inhibitors. The company is involved in basic research and is committed to improving HIV therapy by providing physicians and patients with innovative antiretrovirals.
Please be advised
This release is from the Corporate Headquarters of Boehringer Ingelheim and is intended for all international markets. This being the case, please be aware that there may be some differences between countries regarding specific medical information including licensed uses. Please take account of this when referring to the material.
References:
Martinez E. et al. Three-year Follow-Up of Protease Inhibitor-based Regimen Simplification in HIV-infected Patients. AIDS 2007 21(3)
Boehringer Ingelheim GmbH
Judith von Gordon
55216 Ingelheim am Rhein
Boehringer Ingelheim GmbH
Thai Health Ministry Takes 'Bold Step' In Breaking Patent, Issuing Compulsory License For Antiretroviral Kaletra, Editorial Says
Thailand's Ministry of Public Health is "taking a bold step" in ensuring that the country "takes full advantage" of the World Trade Organization's Trade-Related Aspects of Intellectual Property Rights agreement by breaking the patent on Abbott Laboratories' antiretroviral drug Kaletra, a Bangkok Post editorial says (Bangkok Post, 1/31). The health ministry on Monday said that it has broken a patent on Kaletra by issuing a compulsory license to produce a lower-cost version of the drug. According to Health Minister Mongkol na Songkhla, the compulsory license was signed into law and took effect on Friday. WTO regulations allow governments to declare a "national emergency" and issue compulsory licenses without consulting the foreign patent owner. Thailand, which has 580,000 people living with HIV/AIDS, has won international recognition for its quick launch of a national drug program that treats more than 82,000 HIV-positive people. However, the government's commitment to providing universal access to care is facing increasingly high drug costs. The compulsory license could save the country as much as $24 million annually (Kaiser Daily HIV/AIDS Report, 1/30). The editorial "applaud[s] the government for using all legal methods possible to ensure Thai patients get the cheapest and best drugs available." However, the editorial says that the government also "should be careful not to unnecessarily further push away foreign investment," adding that even though the government is "not legally required to negotiate with drug companies before issuing a compulsory license doesn't mean it should not do so." The Thai government should "insist on procuring quality drugs" from World Health Organization-approved factories, especially for HIV/AIDS medications, according to the editorial. Although Thailand's Government Pharmaceutical Organization's factories do not meet WHO standards, Thai officials say their generic antiretrovirals are of high quality, the editorial says, adding that it "would be nice to remove the cloud of suspicion." According to the editorial, Thailand should import generic antiretrovirals from India until a new GPO facility that meets WHO standards is complete. This would allow the government to procure antiretrovirals with funds from the Global Fund To Fight AIDS, Tuberculosis and Malaria, which "refuses to finance Thai-produced drugs because they don't meet international standards," the editorial says. According to the editorial, the money the government saves by using drugs produced in India "could be used to expand patient education." The editorial adds that "[m]uch of the resistance to Thai generic HIV/AIDS drugs is attributed to patients who misunderstand how to take the drugs" and that there is little point in "expanding drug coverage if the drugs will prove ineffective due to incorrect usage" (Bangkok Post, 1/31).
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
African-American Women Who Have Received HIV Treatment Are Sought To Participate In GRACE Study
The GRACE study (Gender, Race And Clinical Experience) is now recruiting participants for the largest clinical study to date in treatment-experienced adult women with HIV to evaluate gender and race differences in response to an HIV medication. On the occasion of the seventh annual National Black HIV/AIDS Awareness Day on February 7, the study's sponsor, Tibotec Therapeutics Clinical Affairs, a division of Ortho Biotech Clinical Affairs, LLC, is seeking to raise awareness among African-American women of the trial and its importance to the treatment of HIV.
Today, women account for nearly one-third of new HIV diagnoses in the U.S., and rates of HIV infection are particularly high among women of color. African-American women, who represent only 13% of the U.S. female population, account for 64% of female AIDS cases.
"We expect GRACE will be an historic study because HIV treatment trials in treatment-experienced populations have traditionally included small numbers of women and people of color, especially in the earliest studies of new antiretroviral agents. We know that there are gender- and race-specific complications associated with HIV disease. However, we do not know a great deal about how gender and race impact the efficacy and side effects of HIV medications," said Debbie Hagins, M.D., Clinical Director of Outpatient Services, a Ryan White funded clinic in Savannah, GA, and an investigator in the GRACE study.
GRACE, a multi-center, open-label Phase IIIb trial, will compare gender differences in the efficacy, safety and tolerability of PREZISTA (darunavir) tablets administered with ritonavir and other antiretroviral agents over a 48-week treatment period. The study also will explore racial differences in treatment outcomes. Eligibility is open to men and women of all races.
PREZISTA, co-administered with 100 mg ritonavir (PREZISTA/r) and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV) infection in antiretroviral treatment-experienced adult patients, such as those with HIV-1 strains resistant to more than one protease inhibitor. PREZISTA received accelerated approval based on the 24- week analysis of HIV viral load and CD4+ cell counts from the pooled analysis of the TMC114-C213 (POWER 1) and TMC114-C202 (POWER 2) studies. Longer-term data will be required before the FDA can consider traditional approval for PREZISTA (see the full indication and important safety information below).
"As an African-American woman living with HIV for more than 20 years, I am encouraged to see studies like GRACE that are designed to learn more about HIV treatment in treatment-experienced African-Americans and women in the U.S." said Rae Lewis-Thornton, a renowned AIDS activist and Emmy Award-winning journalist. "GRACE is an example of the steps that need to be taken to address the evolving HIV epidemic in the African-American community, and those who participate in GRACE will play a very important role in advancing the understanding of HIV treatment in women and people of color."
The GRACE study will include approximately 50 sites in the United States, Mexico and Canada, and will seek to enroll approximately 420 participants, 70 percent of whom will be women. Participants must be of 18 years or older, have a viral load of 1000 copies/mL or greater and have previous intolerance or failure to prior therapy consisting of a protease inhibitor and/or non- nucleoside reverse transcriptase inhibitor-based highly active antiretroviral treatment regimen of at least 12 weeks. All participants will receive PREZISTA/r (600/100mg twice a day) with an optimized background regimen chosen by the investigator and based on resistance testing and prior treatment history.
Indication
PREZISTA, co-administered with 100 mg ritonavir (PREZISTA/r) and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV) infection in antiretroviral treatment-experienced adult patients, such as those with HIV-1 strains resistant to more than one protease inhibitor.
This indication is based on Week 24 analyses of plasma HIV RNA levels and CD4+ cell counts from two controlled trials of PREZISTA/rtv in combination with other antiretroviral drugs. Both studies were conducted in clinically advanced, treatment-experienced (NRTIs, NNRTIs, and PIs) adult patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy.
The following points should be considered when initiating therapy with PREZISTA/rtv:
-- Treatment history and, when available, genotypic or phenotypic testing should guide the use of PREZISTA/rtv.
-- The use of other active agents with PREZISTA/rtv is associated with a greater likelihood of treatment response.
-- The risks and benefits of PREZISTA/rtv have not been established in treatment-naГЇve adult patients or pediatric patients.
Important Safety Information
PREZISTA does not cure HIV infection or AIDS, and does not prevent passing HIV to others.
PREZISTA is contraindicated in patients with known hypersensitivity to any of its ingredients.
Coadministration of PREZISTA/r is contraindicated with drugs that are highly dependent on CYP3A for clearance and have a narrow therapeutic index (e.g., astemizole, terfenadine, dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, pimozide, midazolam, or triazolam) and for which elevated plasma concentrations are associated with serious and/or life- threatening events. Coadministration is not recommended with carbamazepine, phenobarbital, phenytoin, rifampin, lopinavir/ritonavir, saquinavir, lovastatin, pravastatin, simvastatin, or products containing St. John's wort (Hypericum perforatum).
Caution should be used when prescribing agents such as sildenafil, vardenafil, tadalafil, or other substrates, inhibitors, or inducers of CYP3A in patients receiving PREZISTA/rtv. This list of potential drug interactions is not complete.
PREZISTA must be co-administered with 100 mg ritonavir and food to exert its therapeutic effect. Failure to correctly administer PREZISTA with ritonavir and food will result in reduced plasma concentration of darunavir that will be insufficient to achieve the desired antiviral effect. Please refer to ritonavir prescribing information for additional information on precautionary measures.
Severe skin rash, including erythema multiforme and Stevens-Johnson Syndrome, has been reported in subjects receiving PREZISTA during the clinical development program. In some cases, fever and elevations of transaminases have also been reported. In clinical trials (n=924), rash (all grades, regardless of causality) occurred in seven percent of subjects treated with PREZISTA; discontinuation due to rash was 0.3 percent. Rashes were generally mild-to-moderate, self-limiting and maculopapular. PREZISTA should be discontinued if severe rash develops.
PREZISTA should be used with caution in patients with known sulfonamide allergy.
New-onset or exacerbations of pre-existing diabetes mellitus and hyperglycemia, and increased bleeding in hemophiliacs have been reported in patients receiving protease inhibitors. A causal relationship between protease inhibitors and these events has not been established.
PREZISTA should be used with caution in patients with hepatic impairment. There are no data regarding the use of PREZISTA in patients with varying degrees of hepatic impairment; therefore, specific dosage recommendations cannot be made.
Redistribution and/or accumulation of body fat have been observed in patients receiving ARV therapy. The causal relationship, mechanism, and long- term consequences of these events have not been established.
Immune reconstitution syndrome has been reported in patients treated with ARV therapy.
The potential for HIV-cross-resistance among protease inhibitors has not been fully explored in PREZISTA/rtv treated patients.
PREZISTA should be used during pregnancy only if the potential benefit justifies the potential risk. There are no adequate and well-controlled studies in pregnant women. The effects of PREZISTA on pregnant women or their unborn babies are not known.
In the pooled analysis of POWER 1 and 2 studies, the most frequently reported drug-related adverse events of at least moderate to severe intensity in patients receiving PREZISTA/rtv-containing regimen were headache (3.8 percent), diarrhea (2.3 percent), abdominal pain (2.3 percent), constipation (2.3 percent), and vomiting (1.5 percent).
Please see full Prescribing Information for more details.
About PREZISTA
PREZISTA was developed by Tibotec Pharmaceuticals Ltd. and is marketed in the U.S. by Tibotec Therapeutics, a division of Ortho Biotech Products, L.P.
About Tibotec Therapeutics
Tibotec Therapeutics, a division of Ortho Biotech Products, L.P., headquartered in Bridgewater, N.J., is dedicated to delivering innovative virology therapeutics that help healthcare professionals address serious unmet needs in people living with HIV.
About Tibotec Pharmaceuticals Ltd.
Tibotec Pharmaceuticals Ltd., based in Cork, Ireland, is a pharmaceutical research and development company. The Company's main research and development facilities are in Mechelen, Belgium with offices in Yardley, PA. Tibotec is dedicated to the discovery and development of innovative HIV/AIDS drugs and anti-infectives for diseases of high unmet medical need.
Tibotec Pharmaceuticals is developing a Global Access Program to facilitate access to its antiretrovirals for patients living with HIV/AIDS in developing countries. The Global Access Program includes access pricing, registration, medical education for appropriate use and voluntary licensing.
Tibotec Therapeutics
http://www.tibotectherapeutics.com
Today, women account for nearly one-third of new HIV diagnoses in the U.S., and rates of HIV infection are particularly high among women of color. African-American women, who represent only 13% of the U.S. female population, account for 64% of female AIDS cases.
"We expect GRACE will be an historic study because HIV treatment trials in treatment-experienced populations have traditionally included small numbers of women and people of color, especially in the earliest studies of new antiretroviral agents. We know that there are gender- and race-specific complications associated with HIV disease. However, we do not know a great deal about how gender and race impact the efficacy and side effects of HIV medications," said Debbie Hagins, M.D., Clinical Director of Outpatient Services, a Ryan White funded clinic in Savannah, GA, and an investigator in the GRACE study.
GRACE, a multi-center, open-label Phase IIIb trial, will compare gender differences in the efficacy, safety and tolerability of PREZISTA (darunavir) tablets administered with ritonavir and other antiretroviral agents over a 48-week treatment period. The study also will explore racial differences in treatment outcomes. Eligibility is open to men and women of all races.
PREZISTA, co-administered with 100 mg ritonavir (PREZISTA/r) and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV) infection in antiretroviral treatment-experienced adult patients, such as those with HIV-1 strains resistant to more than one protease inhibitor. PREZISTA received accelerated approval based on the 24- week analysis of HIV viral load and CD4+ cell counts from the pooled analysis of the TMC114-C213 (POWER 1) and TMC114-C202 (POWER 2) studies. Longer-term data will be required before the FDA can consider traditional approval for PREZISTA (see the full indication and important safety information below).
"As an African-American woman living with HIV for more than 20 years, I am encouraged to see studies like GRACE that are designed to learn more about HIV treatment in treatment-experienced African-Americans and women in the U.S." said Rae Lewis-Thornton, a renowned AIDS activist and Emmy Award-winning journalist. "GRACE is an example of the steps that need to be taken to address the evolving HIV epidemic in the African-American community, and those who participate in GRACE will play a very important role in advancing the understanding of HIV treatment in women and people of color."
The GRACE study will include approximately 50 sites in the United States, Mexico and Canada, and will seek to enroll approximately 420 participants, 70 percent of whom will be women. Participants must be of 18 years or older, have a viral load of 1000 copies/mL or greater and have previous intolerance or failure to prior therapy consisting of a protease inhibitor and/or non- nucleoside reverse transcriptase inhibitor-based highly active antiretroviral treatment regimen of at least 12 weeks. All participants will receive PREZISTA/r (600/100mg twice a day) with an optimized background regimen chosen by the investigator and based on resistance testing and prior treatment history.
Indication
PREZISTA, co-administered with 100 mg ritonavir (PREZISTA/r) and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV) infection in antiretroviral treatment-experienced adult patients, such as those with HIV-1 strains resistant to more than one protease inhibitor.
This indication is based on Week 24 analyses of plasma HIV RNA levels and CD4+ cell counts from two controlled trials of PREZISTA/rtv in combination with other antiretroviral drugs. Both studies were conducted in clinically advanced, treatment-experienced (NRTIs, NNRTIs, and PIs) adult patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy.
The following points should be considered when initiating therapy with PREZISTA/rtv:
-- Treatment history and, when available, genotypic or phenotypic testing should guide the use of PREZISTA/rtv.
-- The use of other active agents with PREZISTA/rtv is associated with a greater likelihood of treatment response.
-- The risks and benefits of PREZISTA/rtv have not been established in treatment-naГЇve adult patients or pediatric patients.
Important Safety Information
PREZISTA does not cure HIV infection or AIDS, and does not prevent passing HIV to others.
PREZISTA is contraindicated in patients with known hypersensitivity to any of its ingredients.
Coadministration of PREZISTA/r is contraindicated with drugs that are highly dependent on CYP3A for clearance and have a narrow therapeutic index (e.g., astemizole, terfenadine, dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, pimozide, midazolam, or triazolam) and for which elevated plasma concentrations are associated with serious and/or life- threatening events. Coadministration is not recommended with carbamazepine, phenobarbital, phenytoin, rifampin, lopinavir/ritonavir, saquinavir, lovastatin, pravastatin, simvastatin, or products containing St. John's wort (Hypericum perforatum).
Caution should be used when prescribing agents such as sildenafil, vardenafil, tadalafil, or other substrates, inhibitors, or inducers of CYP3A in patients receiving PREZISTA/rtv. This list of potential drug interactions is not complete.
PREZISTA must be co-administered with 100 mg ritonavir and food to exert its therapeutic effect. Failure to correctly administer PREZISTA with ritonavir and food will result in reduced plasma concentration of darunavir that will be insufficient to achieve the desired antiviral effect. Please refer to ritonavir prescribing information for additional information on precautionary measures.
Severe skin rash, including erythema multiforme and Stevens-Johnson Syndrome, has been reported in subjects receiving PREZISTA during the clinical development program. In some cases, fever and elevations of transaminases have also been reported. In clinical trials (n=924), rash (all grades, regardless of causality) occurred in seven percent of subjects treated with PREZISTA; discontinuation due to rash was 0.3 percent. Rashes were generally mild-to-moderate, self-limiting and maculopapular. PREZISTA should be discontinued if severe rash develops.
PREZISTA should be used with caution in patients with known sulfonamide allergy.
New-onset or exacerbations of pre-existing diabetes mellitus and hyperglycemia, and increased bleeding in hemophiliacs have been reported in patients receiving protease inhibitors. A causal relationship between protease inhibitors and these events has not been established.
PREZISTA should be used with caution in patients with hepatic impairment. There are no data regarding the use of PREZISTA in patients with varying degrees of hepatic impairment; therefore, specific dosage recommendations cannot be made.
Redistribution and/or accumulation of body fat have been observed in patients receiving ARV therapy. The causal relationship, mechanism, and long- term consequences of these events have not been established.
Immune reconstitution syndrome has been reported in patients treated with ARV therapy.
The potential for HIV-cross-resistance among protease inhibitors has not been fully explored in PREZISTA/rtv treated patients.
PREZISTA should be used during pregnancy only if the potential benefit justifies the potential risk. There are no adequate and well-controlled studies in pregnant women. The effects of PREZISTA on pregnant women or their unborn babies are not known.
In the pooled analysis of POWER 1 and 2 studies, the most frequently reported drug-related adverse events of at least moderate to severe intensity in patients receiving PREZISTA/rtv-containing regimen were headache (3.8 percent), diarrhea (2.3 percent), abdominal pain (2.3 percent), constipation (2.3 percent), and vomiting (1.5 percent).
Please see full Prescribing Information for more details.
About PREZISTA
PREZISTA was developed by Tibotec Pharmaceuticals Ltd. and is marketed in the U.S. by Tibotec Therapeutics, a division of Ortho Biotech Products, L.P.
About Tibotec Therapeutics
Tibotec Therapeutics, a division of Ortho Biotech Products, L.P., headquartered in Bridgewater, N.J., is dedicated to delivering innovative virology therapeutics that help healthcare professionals address serious unmet needs in people living with HIV.
About Tibotec Pharmaceuticals Ltd.
Tibotec Pharmaceuticals Ltd., based in Cork, Ireland, is a pharmaceutical research and development company. The Company's main research and development facilities are in Mechelen, Belgium with offices in Yardley, PA. Tibotec is dedicated to the discovery and development of innovative HIV/AIDS drugs and anti-infectives for diseases of high unmet medical need.
Tibotec Pharmaceuticals is developing a Global Access Program to facilitate access to its antiretrovirals for patients living with HIV/AIDS in developing countries. The Global Access Program includes access pricing, registration, medical education for appropriate use and voluntary licensing.
Tibotec Therapeutics
http://www.tibotectherapeutics.com
Washington County Records Four Cases Of Drug-Resistant HIV
Four men in King County, Washington, have been diagnosed with a strain of HIV that is resistant to at least two types of antiretroviral drugs, and health officials on Thursday said they are concerned the strain could spread, the Seattle Times reports. According to the Times, a third antiretroviral has limited effectiveness against the strain (King, Seattle Times, 2/2). Officials said that the same genetic strain of HIV was recorded within 15 months among the men, who were diagnosed with the drug-resistant strain as soon as they tested HIV positive. The men used methamphetamine and had multiple anonymous sexual partners, including men. None of the men was known to have had sex with any of the other three, according to officials (AP/Houston Chronicle, 2/2). Some of the men's partners have been identified, none of whom has tested positive for the resistant strain, Bob Wood, HIV/AIDS program director for the Seattle-King County Public Health Department, said. There is no information about how easily this strain might be transmitted or whether it was spread to Seattle from another city. The agency plans to distribute fliers in gay bars and bathhouses about the HIV strain, and physicians are being asked to test all newly diagnosed HIV cases for drug resistance and report them to the health department, Wood said. According to physicians, it is unlikely the drug-resistant HIV strain will cause the men to progress more rapidly to AIDS; however, once they do progress to the disease, treating them will be more difficult (Seattle Times, 2/2). Health officials as of last week had recorded 12 cases of multidrug-resistant HIV in the county, but none of the cases was as resistant to antiretrovirals as the most recent four, the AP/Chronicle reports (AP/Houston Chronicle, 2/2). About 350 to 400 new HIV cases are reported in King County annually, and about 8,000 county residents are living with the virus. Wood said the new cases should serve as an early warning because "they show there is some ongoing transmission" (Seattle Times, 2/2). Wood added, "This is mostly about behavior. Men who have sex with men need to know that drug-resistant strains can and are being transmitted and may be much less treatable" (Paulson, Seattle Post-Intelligencer, 2/2).
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
March 7, 2007
African-American Women Who Have Received HIV Treatment Are Sought To Participate In GRACE Study
The GRACE study (Gender, Race And Clinical Experience) is now recruiting participants for the largest clinical study to date in treatment-experienced adult women with HIV to evaluate gender and race differences in response to an HIV medication. On the occasion of the seventh annual National Black HIV/AIDS Awareness Day on February 7, the study's sponsor, Tibotec Therapeutics Clinical Affairs, a division of Ortho Biotech Clinical Affairs, LLC, is seeking to raise awareness among African-American women of the trial and its importance to the treatment of HIV.
Today, women account for nearly one-third of new HIV diagnoses in the U.S., and rates of HIV infection are particularly high among women of color. African-American women, who represent only 13% of the U.S. female population, account for 64% of female AIDS cases.
"We expect GRACE will be an historic study because HIV treatment trials in treatment-experienced populations have traditionally included small numbers of women and people of color, especially in the earliest studies of new antiretroviral agents. We know that there are gender- and race-specific complications associated with HIV disease. However, we do not know a great deal about how gender and race impact the efficacy and side effects of HIV medications," said Debbie Hagins, M.D., Clinical Director of Outpatient Services, a Ryan White funded clinic in Savannah, GA, and an investigator in the GRACE study.
GRACE, a multi-center, open-label Phase IIIb trial, will compare gender differences in the efficacy, safety and tolerability of PREZISTA (darunavir) tablets administered with ritonavir and other antiretroviral agents over a 48-week treatment period. The study also will explore racial differences in treatment outcomes. Eligibility is open to men and women of all races.
PREZISTA, co-administered with 100 mg ritonavir (PREZISTA/r) and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV) infection in antiretroviral treatment-experienced adult patients, such as those with HIV-1 strains resistant to more than one protease inhibitor. PREZISTA received accelerated approval based on the 24- week analysis of HIV viral load and CD4+ cell counts from the pooled analysis of the TMC114-C213 (POWER 1) and TMC114-C202 (POWER 2) studies. Longer-term data will be required before the FDA can consider traditional approval for PREZISTA (see the full indication and important safety information below).
"As an African-American woman living with HIV for more than 20 years, I am encouraged to see studies like GRACE that are designed to learn more about HIV treatment in treatment-experienced African-Americans and women in the U.S." said Rae Lewis-Thornton, a renowned AIDS activist and Emmy Award-winning journalist. "GRACE is an example of the steps that need to be taken to address the evolving HIV epidemic in the African-American community, and those who participate in GRACE will play a very important role in advancing the understanding of HIV treatment in women and people of color."
The GRACE study will include approximately 50 sites in the United States, Mexico and Canada, and will seek to enroll approximately 420 participants, 70 percent of whom will be women. Participants must be of 18 years or older, have a viral load of 1000 copies/mL or greater and have previous intolerance or failure to prior therapy consisting of a protease inhibitor and/or non- nucleoside reverse transcriptase inhibitor-based highly active antiretroviral treatment regimen of at least 12 weeks. All participants will receive PREZISTA/r (600/100mg twice a day) with an optimized background regimen chosen by the investigator and based on resistance testing and prior treatment history.
Indication
PREZISTA, co-administered with 100 mg ritonavir (PREZISTA/r) and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV) infection in antiretroviral treatment-experienced adult patients, such as those with HIV-1 strains resistant to more than one protease inhibitor.
This indication is based on Week 24 analyses of plasma HIV RNA levels and CD4+ cell counts from two controlled trials of PREZISTA/rtv in combination with other antiretroviral drugs. Both studies were conducted in clinically advanced, treatment-experienced (NRTIs, NNRTIs, and PIs) adult patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy.
The following points should be considered when initiating therapy with PREZISTA/rtv:
-- Treatment history and, when available, genotypic or phenotypic testing should guide the use of PREZISTA/rtv.
-- The use of other active agents with PREZISTA/rtv is associated with a greater likelihood of treatment response.
-- The risks and benefits of PREZISTA/rtv have not been established in treatment-naГЇve adult patients or pediatric patients.
Important Safety Information
PREZISTA does not cure HIV infection or AIDS, and does not prevent passing HIV to others.
PREZISTA is contraindicated in patients with known hypersensitivity to any of its ingredients.
Coadministration of PREZISTA/r is contraindicated with drugs that are highly dependent on CYP3A for clearance and have a narrow therapeutic index (e.g., astemizole, terfenadine, dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, pimozide, midazolam, or triazolam) and for which elevated plasma concentrations are associated with serious and/or life- threatening events. Coadministration is not recommended with carbamazepine, phenobarbital, phenytoin, rifampin, lopinavir/ritonavir, saquinavir, lovastatin, pravastatin, simvastatin, or products containing St. John's wort (Hypericum perforatum).
Caution should be used when prescribing agents such as sildenafil, vardenafil, tadalafil, or other substrates, inhibitors, or inducers of CYP3A in patients receiving PREZISTA/rtv. This list of potential drug interactions is not complete.
PREZISTA must be co-administered with 100 mg ritonavir and food to exert its therapeutic effect. Failure to correctly administer PREZISTA with ritonavir and food will result in reduced plasma concentration of darunavir that will be insufficient to achieve the desired antiviral effect. Please refer to ritonavir prescribing information for additional information on precautionary measures.
Severe skin rash, including erythema multiforme and Stevens-Johnson Syndrome, has been reported in subjects receiving PREZISTA during the clinical development program. In some cases, fever and elevations of transaminases have also been reported. In clinical trials (n=924), rash (all grades, regardless of causality) occurred in seven percent of subjects treated with PREZISTA; discontinuation due to rash was 0.3 percent. Rashes were generally mild-to-moderate, self-limiting and maculopapular. PREZISTA should be discontinued if severe rash develops.
PREZISTA should be used with caution in patients with known sulfonamide allergy.
New-onset or exacerbations of pre-existing diabetes mellitus and hyperglycemia, and increased bleeding in hemophiliacs have been reported in patients receiving protease inhibitors. A causal relationship between protease inhibitors and these events has not been established.
PREZISTA should be used with caution in patients with hepatic impairment. There are no data regarding the use of PREZISTA in patients with varying degrees of hepatic impairment; therefore, specific dosage recommendations cannot be made.
Redistribution and/or accumulation of body fat have been observed in patients receiving ARV therapy. The causal relationship, mechanism, and long- term consequences of these events have not been established.
Immune reconstitution syndrome has been reported in patients treated with ARV therapy.
The potential for HIV-cross-resistance among protease inhibitors has not been fully explored in PREZISTA/rtv treated patients.
PREZISTA should be used during pregnancy only if the potential benefit justifies the potential risk. There are no adequate and well-controlled studies in pregnant women. The effects of PREZISTA on pregnant women or their unborn babies are not known.
In the pooled analysis of POWER 1 and 2 studies, the most frequently reported drug-related adverse events of at least moderate to severe intensity in patients receiving PREZISTA/rtv-containing regimen were headache (3.8 percent), diarrhea (2.3 percent), abdominal pain (2.3 percent), constipation (2.3 percent), and vomiting (1.5 percent).
Please see full Prescribing Information for more details.
About PREZISTA
PREZISTA was developed by Tibotec Pharmaceuticals Ltd. and is marketed in the U.S. by Tibotec Therapeutics, a division of Ortho Biotech Products, L.P.
About Tibotec Therapeutics
Tibotec Therapeutics, a division of Ortho Biotech Products, L.P., headquartered in Bridgewater, N.J., is dedicated to delivering innovative virology therapeutics that help healthcare professionals address serious unmet needs in people living with HIV.
About Tibotec Pharmaceuticals Ltd.
Tibotec Pharmaceuticals Ltd., based in Cork, Ireland, is a pharmaceutical research and development company. The Company's main research and development facilities are in Mechelen, Belgium with offices in Yardley, PA. Tibotec is dedicated to the discovery and development of innovative HIV/AIDS drugs and anti-infectives for diseases of high unmet medical need.
Tibotec Pharmaceuticals is developing a Global Access Program to facilitate access to its antiretrovirals for patients living with HIV/AIDS in developing countries. The Global Access Program includes access pricing, registration, medical education for appropriate use and voluntary licensing.
Tibotec Therapeutics
http://www.tibotectherapeutics.com
Today, women account for nearly one-third of new HIV diagnoses in the U.S., and rates of HIV infection are particularly high among women of color. African-American women, who represent only 13% of the U.S. female population, account for 64% of female AIDS cases.
"We expect GRACE will be an historic study because HIV treatment trials in treatment-experienced populations have traditionally included small numbers of women and people of color, especially in the earliest studies of new antiretroviral agents. We know that there are gender- and race-specific complications associated with HIV disease. However, we do not know a great deal about how gender and race impact the efficacy and side effects of HIV medications," said Debbie Hagins, M.D., Clinical Director of Outpatient Services, a Ryan White funded clinic in Savannah, GA, and an investigator in the GRACE study.
GRACE, a multi-center, open-label Phase IIIb trial, will compare gender differences in the efficacy, safety and tolerability of PREZISTA (darunavir) tablets administered with ritonavir and other antiretroviral agents over a 48-week treatment period. The study also will explore racial differences in treatment outcomes. Eligibility is open to men and women of all races.
PREZISTA, co-administered with 100 mg ritonavir (PREZISTA/r) and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV) infection in antiretroviral treatment-experienced adult patients, such as those with HIV-1 strains resistant to more than one protease inhibitor. PREZISTA received accelerated approval based on the 24- week analysis of HIV viral load and CD4+ cell counts from the pooled analysis of the TMC114-C213 (POWER 1) and TMC114-C202 (POWER 2) studies. Longer-term data will be required before the FDA can consider traditional approval for PREZISTA (see the full indication and important safety information below).
"As an African-American woman living with HIV for more than 20 years, I am encouraged to see studies like GRACE that are designed to learn more about HIV treatment in treatment-experienced African-Americans and women in the U.S." said Rae Lewis-Thornton, a renowned AIDS activist and Emmy Award-winning journalist. "GRACE is an example of the steps that need to be taken to address the evolving HIV epidemic in the African-American community, and those who participate in GRACE will play a very important role in advancing the understanding of HIV treatment in women and people of color."
The GRACE study will include approximately 50 sites in the United States, Mexico and Canada, and will seek to enroll approximately 420 participants, 70 percent of whom will be women. Participants must be of 18 years or older, have a viral load of 1000 copies/mL or greater and have previous intolerance or failure to prior therapy consisting of a protease inhibitor and/or non- nucleoside reverse transcriptase inhibitor-based highly active antiretroviral treatment regimen of at least 12 weeks. All participants will receive PREZISTA/r (600/100mg twice a day) with an optimized background regimen chosen by the investigator and based on resistance testing and prior treatment history.
Indication
PREZISTA, co-administered with 100 mg ritonavir (PREZISTA/r) and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV) infection in antiretroviral treatment-experienced adult patients, such as those with HIV-1 strains resistant to more than one protease inhibitor.
This indication is based on Week 24 analyses of plasma HIV RNA levels and CD4+ cell counts from two controlled trials of PREZISTA/rtv in combination with other antiretroviral drugs. Both studies were conducted in clinically advanced, treatment-experienced (NRTIs, NNRTIs, and PIs) adult patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy.
The following points should be considered when initiating therapy with PREZISTA/rtv:
-- Treatment history and, when available, genotypic or phenotypic testing should guide the use of PREZISTA/rtv.
-- The use of other active agents with PREZISTA/rtv is associated with a greater likelihood of treatment response.
-- The risks and benefits of PREZISTA/rtv have not been established in treatment-naГЇve adult patients or pediatric patients.
Important Safety Information
PREZISTA does not cure HIV infection or AIDS, and does not prevent passing HIV to others.
PREZISTA is contraindicated in patients with known hypersensitivity to any of its ingredients.
Coadministration of PREZISTA/r is contraindicated with drugs that are highly dependent on CYP3A for clearance and have a narrow therapeutic index (e.g., astemizole, terfenadine, dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, pimozide, midazolam, or triazolam) and for which elevated plasma concentrations are associated with serious and/or life- threatening events. Coadministration is not recommended with carbamazepine, phenobarbital, phenytoin, rifampin, lopinavir/ritonavir, saquinavir, lovastatin, pravastatin, simvastatin, or products containing St. John's wort (Hypericum perforatum).
Caution should be used when prescribing agents such as sildenafil, vardenafil, tadalafil, or other substrates, inhibitors, or inducers of CYP3A in patients receiving PREZISTA/rtv. This list of potential drug interactions is not complete.
PREZISTA must be co-administered with 100 mg ritonavir and food to exert its therapeutic effect. Failure to correctly administer PREZISTA with ritonavir and food will result in reduced plasma concentration of darunavir that will be insufficient to achieve the desired antiviral effect. Please refer to ritonavir prescribing information for additional information on precautionary measures.
Severe skin rash, including erythema multiforme and Stevens-Johnson Syndrome, has been reported in subjects receiving PREZISTA during the clinical development program. In some cases, fever and elevations of transaminases have also been reported. In clinical trials (n=924), rash (all grades, regardless of causality) occurred in seven percent of subjects treated with PREZISTA; discontinuation due to rash was 0.3 percent. Rashes were generally mild-to-moderate, self-limiting and maculopapular. PREZISTA should be discontinued if severe rash develops.
PREZISTA should be used with caution in patients with known sulfonamide allergy.
New-onset or exacerbations of pre-existing diabetes mellitus and hyperglycemia, and increased bleeding in hemophiliacs have been reported in patients receiving protease inhibitors. A causal relationship between protease inhibitors and these events has not been established.
PREZISTA should be used with caution in patients with hepatic impairment. There are no data regarding the use of PREZISTA in patients with varying degrees of hepatic impairment; therefore, specific dosage recommendations cannot be made.
Redistribution and/or accumulation of body fat have been observed in patients receiving ARV therapy. The causal relationship, mechanism, and long- term consequences of these events have not been established.
Immune reconstitution syndrome has been reported in patients treated with ARV therapy.
The potential for HIV-cross-resistance among protease inhibitors has not been fully explored in PREZISTA/rtv treated patients.
PREZISTA should be used during pregnancy only if the potential benefit justifies the potential risk. There are no adequate and well-controlled studies in pregnant women. The effects of PREZISTA on pregnant women or their unborn babies are not known.
In the pooled analysis of POWER 1 and 2 studies, the most frequently reported drug-related adverse events of at least moderate to severe intensity in patients receiving PREZISTA/rtv-containing regimen were headache (3.8 percent), diarrhea (2.3 percent), abdominal pain (2.3 percent), constipation (2.3 percent), and vomiting (1.5 percent).
Please see full Prescribing Information for more details.
About PREZISTA
PREZISTA was developed by Tibotec Pharmaceuticals Ltd. and is marketed in the U.S. by Tibotec Therapeutics, a division of Ortho Biotech Products, L.P.
About Tibotec Therapeutics
Tibotec Therapeutics, a division of Ortho Biotech Products, L.P., headquartered in Bridgewater, N.J., is dedicated to delivering innovative virology therapeutics that help healthcare professionals address serious unmet needs in people living with HIV.
About Tibotec Pharmaceuticals Ltd.
Tibotec Pharmaceuticals Ltd., based in Cork, Ireland, is a pharmaceutical research and development company. The Company's main research and development facilities are in Mechelen, Belgium with offices in Yardley, PA. Tibotec is dedicated to the discovery and development of innovative HIV/AIDS drugs and anti-infectives for diseases of high unmet medical need.
Tibotec Pharmaceuticals is developing a Global Access Program to facilitate access to its antiretrovirals for patients living with HIV/AIDS in developing countries. The Global Access Program includes access pricing, registration, medical education for appropriate use and voluntary licensing.
Tibotec Therapeutics
http://www.tibotectherapeutics.com
March 5, 2007
Washington County Records Four Cases Of Drug-Resistant HIV
Four men in King County, Washington, have been diagnosed with a strain of HIV that is resistant to at least two types of antiretroviral drugs, and health officials on Thursday said they are concerned the strain could spread, the Seattle Times reports. According to the Times, a third antiretroviral has limited effectiveness against the strain (King, Seattle Times, 2/2). Officials said that the same genetic strain of HIV was recorded within 15 months among the men, who were diagnosed with the drug-resistant strain as soon as they tested HIV positive. The men used methamphetamine and had multiple anonymous sexual partners, including men. None of the men was known to have had sex with any of the other three, according to officials (AP/Houston Chronicle, 2/2). Some of the men's partners have been identified, none of whom has tested positive for the resistant strain, Bob Wood, HIV/AIDS program director for the Seattle-King County Public Health Department, said. There is no information about how easily this strain might be transmitted or whether it was spread to Seattle from another city. The agency plans to distribute fliers in gay bars and bathhouses about the HIV strain, and physicians are being asked to test all newly diagnosed HIV cases for drug resistance and report them to the health department, Wood said. According to physicians, it is unlikely the drug-resistant HIV strain will cause the men to progress more rapidly to AIDS; however, once they do progress to the disease, treating them will be more difficult (Seattle Times, 2/2). Health officials as of last week had recorded 12 cases of multidrug-resistant HIV in the county, but none of the cases was as resistant to antiretrovirals as the most recent four, the AP/Chronicle reports (AP/Houston Chronicle, 2/2). About 350 to 400 new HIV cases are reported in King County annually, and about 8,000 county residents are living with the virus. Wood said the new cases should serve as an early warning because "they show there is some ongoing transmission" (Seattle Times, 2/2). Wood added, "This is mostly about behavior. Men who have sex with men need to know that drug-resistant strains can and are being transmitted and may be much less treatable" (Paulson, Seattle Post-Intelligencer, 2/2).
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
March 4, 2007
World Bank To Provide Thailand With $750,000 For HIV/AIDS Treatment Programs
The World Bank plans to provide Thailand with a $750,000, three-year grant aimed at providing HIV-positive people with increased access to antiretroviral drugs, Viroj Tangcharoensathien, program director for international health policy at the country's Ministry of Public Health, said recently, Thailand's Nation reports. More than 130,000 HIV-positive people in Thailand need access to antiretrovirals, and the number is increasing annually, according to the Nation. Under the grant partnership, the bank will help address funding issues associated with the country's universal health care system, Viroj said. "We can't rely on the ministry's budget allocation alone," Viroj said, adding that the partnership will seek other resources for health services. In addition, the project will provide training for nurses and doctors in an effort to overcome the shortage of health care personnel in the country, health ministry senior adviser Suwit Wibulpol-prasert said. The collaboration is a "step forward to sustainable development in this field and improving the country's health care," Suwit said. A separate partnership between the Thailand Center of Excellence for Life Sciences and the World Health Organization will aim to standardize clinical research into tropical diseases, the Nation reports. The partnership will focus on the prevention, diagnosis and treatment of diseases such as malaria, tuberculosis and dengue fever (Nation, 2/6).
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
Abbott Offers To Lower Price Of Antiretroviral Kaletra For Thai Government Health Programs
Pharmaceutical company Abbott Laboratories on Thursday in negotiations with Thailand's Ministry of Public Health agreed in principle to lower the price of its antiretroviral drug Kaletra in response to Thailand's announcement last month that it would issue a compulsory license for the drug, the Bangkok Post reports (Treerutkuarkul, Bangkok Post, 2/9). Public Health Minister Mongkol na Songkhla last month signed the compulsory license, which allows Thailand to produce a lower-cost version of Kaletra, into law. World Trade Organization regulations allow governments to declare a "national emergency" and issue compulsory licenses without consulting the foreign patent owner. Thailand, which has 580,000 people living with HIV/AIDS, has won international recognition for its quick launch of a national drug program that treats more than 82,000 HIV-positive people. However, the government's commitment to providing universal access to care is facing increasingly high drug costs. Kaletra currently costs about $347 per patient monthly, and the lower-priced version could cost about $120 per patient monthly, according to Medecins Sans Frontieres. The compulsory license could save the country as much as $24 million annually (Kaiser Daily HIV/AIDS Report, 2/8). According to a joint statement released by the health ministry and Abbott, the two sides agreed in principle to reduce the price of Kaletra in Thailand to increase access to the drug among HIV-positive people who have developed resistance to other antiretrovirals. The lower price will apply only to Thailand's public health programs and will not apply to private hospitals, people with high incomes or foreign patients, according to the Post. Suvit Wibulpolprasert, a senior health ministry adviser on health economics, said Abbott would look into the possibility of reducing production costs to lower the price of Kaletra (Bangkok Post, 2/9). According to Xinhua News Agency, Abbott offered to lower Kaletra's cost to $167 per patient monthly, although representatives from the health ministry said that was still too high. Abbott and the ministry agreed to meet for further negotiations in one month, Xinhua reports (Xinhua News Agency, 2/9).
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
Related Editorial, Opinion Piece
The Wall Street Journal Asia on Friday published an editorial and an opinion piece on the situation. Summaries appear below.
- Wall Street Journal Asia: "By seizing patents for HIV/AIDS treatments," Thailand has "asserted that governments have the right to take intellectual property wherever and whenever they please," a Journal Asia editorial says, adding that when governments "stifle" innovation, "it's the patients who suffer most." According to the editorial, resistance to some antiretrovirals in Thailand is high, "most likely because of the reliance on faulty" Governmental Pharmaceutical Organization "generic copies." The editorial concludes that the Thai government is "toying with something ... serious" by issuing a compulsory license for Kaletra: "its citizens' lives" (Wall Street Journal Asia, 2/9).
- Roger Bate, Wall Street Journal Asia: "The only winner" in the compulsory license debate over Kaletra "will be Thailand's historically corrupt" GPO, Bate, American Enterprise Institute resident fellow, writes in a Journal Asia opinion piece. According to Bate, GPO facilities "have not passed the World Health Organization's manufacturing standards" and because there is no data on the quality of GPO-manufactured drugs, "they are at best approximate copies and should not be labeled generics." If GPO manufactures a version of Kaletra, it "would be a disaster for Thailand because the real risk to the poorest of the ill," especially HIV-positive people, is "not drug prices but bad health systems and poor training of medical professionals," Bate writes (Bate, Wall Street Journal Asia, 2/9).
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
Groups Call On G8 To Deliver On 2005 Promises Made For African Development, Including Universal Access To HIV/AIDS Treatment
Some HIV/AIDS advocacy groups last week called on finance ministers from the Group of Seven industrialized nations, meeting on Friday in Germany, to fulfill commitments made by the Group of Eight industrialized nations at its 2005 summit regarding aid to Africa, including HIV/AIDS funding, South Africa's Star reports (Pienaar, Star, 2/9). G8 leaders in July 2005 at the close of their summit in Gleneagles, Scotland, agreed to an immediate doubling of aid to Africa to $50 billion annually in order to fight poverty and disease on the continent. The final summit communique officially endorsed a debt relief plan, which canceled at least $40 billion in debt owed by the world's 18 poorest nations. The communique also included an agreement on providing universal access to HIV/AIDS treatment, according to British Prime Minister Tony Blair (Kaiser Daily HIV/AIDS Report, 1/29). According to a report from ActionAid International, Germany, Italy, Japan and the U.S. have made no attempts to meet the target of universal access to antiretrovirals by 2010, London's Guardian reports. G8 countries still need to establish a funding plan to meet the treatment access goal, the report says, adding that although 1.6 million HIV-positive people worldwide have access to antiretrovirals, 5.2 million still need access (Elliott, Guardian, 2/8). Oxfam in a statement released Thursday called on G8 nations to deliver on promises made in Gleneagles, adding that significant funding increases are needed to meet the U.N. Millennium Development Goals by 2015. According to Oxfam, development aid decreased by 2.1% in 2005. "The G8 has a choice," Max Lawson of Oxfam said, adding, "Will 2007 be yet another year of broken promises to Africa or the year they finally put their words into action?" He added, "Germany has got to take the lead on this" (Star, 2/9). According to Aditi Sharma, international HIV/AIDS coordinator of ActionAid India, G8 nations should allocate $8 billion in 2007 and $10 billion annually thereafter to achieve the goal of universal access to treatment by 2010 (De Capua, VOA News, 2/8). Germany, which this year heads the G8, has agreed to put Africa on the agenda for this year's summit in Heiligendamm, Germany (Guardian, 2/8).
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
Malaysia Could Face Increasing Number Of HIV Cases Without Amplified Control Efforts, Health Official Says
Nearly 300,000 Malaysia residents could become HIV-positive by 2015 unless increased efforts are made to reduce the spread of the virus, Ramlee Rahmat, deputy director-general for Malaysia's Ministry of Health, said on Sunday, the AP/San Jose Mercury News reports. According to the AP/Mercury News, there are about 73,000 HIV-positive people living in Malaysia, 75% of whom are injection drug users and 7% of whom are women. Rahmat said the virus is spreading quickly among IDUs, women, fishermen, truck drivers and factory workers in the country (AP/San Jose Mercury News, 2/11). In addition, the government said that transmission through heterosexual sex is increasing and noted a "worrying trend" of increasing HIV incidence among women in the country (AFP/Yahoo! News, 2/11). According to Rahmat, the government last year launched a five-year national strategic plan to reduce HIV transmission. "We are taking this very seriously," Rahmat said, adding, "If we carry out our plans effectively and the public cooperates with us, we will be successful in curbing the spread of the disease." Rahmat added that the government has increased access to drug substitution therapy and needle-exchange programs among IDUs and has provided no-cost antiretrovirals for women and children at government clinics. UNAIDS in 2006 said that Malaysia was one of several countries in the Asia-Pacific region that risked an escalating number of HIV/AIDS cases among IDUs unless efforts were made to reduce the spread of the disease. According the health ministry, three people die daily from AIDS-related illnesses. The ministry last year warned that the spread of HIV could reverse the country's development during the last 50 years, the AP/Mercury News reports (AP/San Jose Mercury News, 2/11).
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
March 3, 2007
Countries Should Find Balance Between Affordable Drugs, Development Incentives, WHO Director-General Says In Letter To Thai Health Minister
World Health Organization Director-General Margaret Chan in a letter to Thai Health Minister Mongkol na Songkhla said that although the Thai government was fully within its rights to issue a compulsory license for Abbott Laboratories antiretroviral drug Kaletra, countries should find the "right balance" between providing affordable medicines and incentives for drug companies to develop new treatments, Reuters reports (Reuters, 1/13). Mongkol last month signed the compulsory license, which allows Thailand to produce a lower-cost version of Kaletra, into law. World Trade Organization regulations allow governments to declare a "national emergency" and issue compulsory licenses without consulting the foreign patent owner. Thailand, which has 580,000 people living with HIV/AIDS, has won international recognition for its quick launch of a national drug program that treats more than 82,000 HIV-positive people. However, the government's commitment to providing universal access to care is facing increasingly high drug costs. The compulsory license could save the country as much as $24 million annually. According to a joint statement released earlier this month by the health ministry and Abbott, the two sides agreed in principle to reduce the price of Kaletra in Thailand to increase access to the drug among HIV-positive people who have developed resistance to other antiretrovirals. The lower price will apply only to Thailand's public health programs and will not apply to private hospitals, people with high incomes or foreign patients. Abbott offered to lower Kaletra's cost to $167 per patient monthly, although representatives from the health ministry said that was still too high. Abbott and the ministry agreed to meet for further negotiations in one month (Kaiser Daily HIV/AIDS Report, 2/9).
Chan's Letter, Reaction
In the letter, Chan said the Thai government was fully within its rights under WTO regulations to issue compulsory licenses. However, she added that she "firmly believe[s] that the pharmaceutical industry -- generic manufacturers and research and development companies -- are part of the solution." Countries are not required to negotiate with patent holders before issuing a license, but "prior negotiations with industry is a pragmatic approach that may ensure countries have access to high quality medicines and at affordable prices," Chan said. According to Reuters, Chan's letter in part was a response to some HIV/AIDS advocates who have criticized her for not supporting Thailand's decision during her visit to the country two weeks ago. "We expected that [Chan] would have congratulated Thailand for its efforts ... to increase public health and access to medicines for its people," a coalition of more than 400 AIDS advocates and groups wrote in a letter to Chan last week (Reuters, 2/13). In addition, Mongkol on Monday said that a Ministry of Health panel is examining drugs, including HIV/AIDS medications, that the country needs and could make or buy generic versions of while completing negotiations with pharmaceutical companies. He added that if the pharmaceutical companies reduce the cost of their drugs to a level the country is "satisfied" with, Thailand will not enforce the compulsory license. "We don't call this a threat but a negotiation for the country's benefit," he said (Wong-Anan, Reuters, 2/12). Thailand's Pharmaceutical Research and Manufacturers' Association on Thursday said it believes the government is planning to issue compulsory licenses for an additional 11 drugs, including antiretrovirals. The decision to issue compulsory licenses is "major and regrettable," the association said in a statement, adding that the health ministry's "actions risks limiting development of next-generation treatments and could lead to the proliferation of low-quality medicines." A senior health ministry official would not confirm if the government is planning to issue the licenses for the additional drugs (AFP/Nation, 2/15).
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
Indian Court Hears Arguments In Case Against Country's Patents Act
A court in Chennai, India, on Thursday heard arguments from pharmaceutical company Novartis in a case challenging a section of India's Patents Act that aims to restrict certain kinds of patents, Reuters India reports (Cage, Reuters India, 2/15). Some HIV/AIDS advocacy groups are calling on Novartis to drop its legal challenge, saying that if the company wins the case it could restrict access to antiretroviral drugs for millions of people worldwide. Novartis brought a civil lawsuit against the Indian government after the country in January 2006 rejected the company's attempt to patent a new version of its leukemia drug Gleevec on the basis that the drug is a new formulation of an existing drug. India's patent law, which went into effect in January 2005, allows patents for products that are new inventions developed after 1995, when India joined the World Trade Organization, or for an updated drug that exhibits improved efficacy. Although some Indian drug companies and groups say that Gleevec is a new formulation of a drug developed before 1995, Novartis says that it is an improved drug. Decisions concerning patents on some newer HIV/AIDS drugs in India have not been announced. If Novartis wins the case, it could potentially set a precedent for other pharmaceutical companies seeking patent protection for drugs, including antiretrovirals, some HIV/AIDS advocates have said. The court has been asked to clarify regulations on patents for new versions of existing drugs whose original patents have expired (Kaiser Daily HIV/AIDS Report, 1/30). "Internationally compatible patent laws would spur investment in biomedical [research and development] activities in India ... and help patients, the government and industry," Novartis executive Thomas Wellauer in a statement said, adding, "Only if patents are respected can research-based organizations continue making long-term, risky investments in new medicines for patients." According to Medecins Sans Frontieres, most of the roughly 9,000 pending patent applications would be affected by this ongoing case. MSF, which relies on India for about 80% of the AIDS drugs it uses to provide 80,000 people worldwide with access to treatment, in a statement said that if India is "made to change its law, many of these medicines could become patented, making them off-limits to the generic competition that has proved to bring prices down" (Reuters India, 2/15).
Waxman Letter
Rep. Henry Waxman (D-Calif.) in a letter to Novartis CEO Daniel Vasella on Wednesday called on the pharmaceutical company to reconsider its lawsuit, saying it could have a negative effect on access to affordable drugs in developing countries, the AP/Forbes reports (AP/Forbes, 2/14). Waxman, chair of the House Committee on Oversight and Government Reform, said, "I do not dispute your right to apply for a patent or appeal a denial. I am concerned, however, that your attempt to influence domestic Indian law could have a severe impact on worldwide access to medicines." He added, "Because of the profound need for affordable medicines in the developing world, I ... urge you to reconsider Novartis' challenge of public health safeguards in India's patent law" (Waxman letter, 2/13). Novartis said that defending patent laws will help patients in the long term, according to the AP/Forbes. "History has shown that patents save lives by stimulating research, which leads to innovative medicines," the company said on its Web site (AP/Forbes, 2/14).
The Waxman letter is available online. Note: you must have Adobe Acrobat to view the letter.
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
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