Kaisernetwork.org (Washington, DC)
28 March 2008
Politics and Policy
FDA To Review Safety of GSK, BMS Antiretrovirals Abacavir, Didanosine
[Mar 28, 2008]
FDA on Thursday announced that it will review the safety of GlaxoSmithKline's antiretroviral drug abacavir and Bristol-Myers Squibb's antiretroviral didanosine, Reuters reports (Richwine, Reuters, 3/27). The agency said that data pooled from a recent study conducted among more than 33,000 HIV-positive people found that the antiretrovirals were linked to an increased risk of heart attack among some of the participants (AP/Wall Street Journal, 3/27).
Didanosine is a generic version of BMS's VIDEX, which was FDA-approved in December 2004. The drug is used in combination with other antiretrovirals for the treatment of HIV-1 infection. Abacavir is a second-line antiretroviral used to treat people living with HIV/AIDS who have developed resistance to first-line drugs (Kaiser Daily HIV/AIDS Report, 2/6). Abacavir is sold under the brand name Ziagen. GSK and BMS said their own evaluations have not found an increased risk of heart attack.
According to FDA, people taking either drug "had a greater chance of developing a heart attack than patients taking other medications." However, the risk did not increase over time and seemed to diminish after people stopped taking the drugs, the agency said. "The effect was not seen six months after stopping the drugs," FDA said. In a notice on its Web site, FDA said it is still evaluating the data and that the review "may result in the need to revise labeling for the products." The agency added that the current analysis of the study is incomplete, noting that researchers have not evaluated the risk of heart attack associated with Gilead Sciences' Viread and Emtriva. "Until this evaluation is complete, health care providers should evaluate the potential risks and benefits" of antiretrovirals their patients are taking, the agency said.
Marc Meachem, a GSK spokesperson, said the company has analyzed its own databases and "did not see any sign of an increased risk of heart attack." BMS spokesperson Sonia Choi said that the company has not "seen an increase of cardiovascular events in our studies of VIDEX or in our (company) safety database." FDA said that the results from analyses by GSK and BMS are inconclusive, according to Reuters. Mark Schoenebaum, an analyst for Bear Stearns, said in a research note that he believes safety concerns with GSK's abacavir "will drive increased switching to Gilead-based regimens" (Reuters, 3/27).
Link to this story.
Global Challenges
Number of HIV Cases in Asia Could Increase by 8M Unless Increased Action Is Taken To Address Virus, Report Says
[Mar 28, 2008]
The number of HIV cases in Asia could increase by more than 150%, or eight million cases, by 2020 unless more is done to prevent the spread of the virus, according to a report released Wednesday by the United Nations Commission on AIDS in Asia and the Pacific, Reuters reports. According to the report, about five million people are living with HIV/AIDS in Asia, and 440,000 people in the region are dying annually of AIDS-related causes. The report also found that the number of annual AIDS-related deaths could increase to 500,000 by 2020 without a bolstered response to the disease (Krauskopf, Reuters, 3/26).
The 238-page report was based in part on online responses from hundreds of representatives from community groups that are involved in HIV/AIDS-related work in Asia. The report found that Southeast Asia has the highest HIV prevalence in the region and that Indonesia has the fastest rate of growth (AFP/Google.com, 3/26). In addition, the report found that AIDS-related illnesses are the most likely cause of death and lost work days among people ages 15 to 44 (Reuters, 3/26). According to the report, the epidemic in Asia is characterized by high-risk behavior among commercial sex workers and their customers, injection drug users and men who have sex with men (Kyodo News, 3/26). The report noted that by 2020, the increase in the number of cases could be kept at three million if a response is adopted immediately. The commission recommended a minimum annual investment of 30 cents to 50 cents per capita on focused prevention programs (Reuters, 3/26). It added that an annual budget of $1 billion for prevention programs among high-risk populations could reduce new cases by 60%. According to the report, about $1.2 billion was available for overall HIV/AIDS programs in Asia in 2007, while the amount needed for an adequate response to the disease was about $6.4 billion (AFP/Google.com, 3/26).
Chakravarthi Rangarajan, chair of the commission, said that heads of governments should become directly involved in HIV prevention efforts to show leadership on the issue, which generally has been lacking. He added that prevention programs should promote the extensive use of condoms. The commission added that efforts to develop policies to fight the spread of HIV should involve the communities most affected by the disease and that governments need to change or abolish laws that incite HIV-related discrimination (Reuters, 3/26). The programs also should focus on protecting the wives of men who frequent commercial sex workers, as well as on providing sex education in schools and colleges, the report said (AFP/Google.com, 3/26).
Comments
UNAIDS Executive Director Peter Piot said the report "shows clearly that the response to the epidemic has to be tailored to Asian realities. ... There is not one Asian reality, there are many. The time is gone that with a blueprint for the whole world, we can stop this epidemic" (Reuters, 3/26). Rangarajan said, "The costs of inaction are simply too high," adding, "Without concerted and evidence-based responses, Asia can expect an economic (annual) loss of $2 billion" by 2020 (AFP/Google.com, 3/26).
U.N. Secretary General Ban Ki-moon in a statement said, "By implementing the recommendations of the commission, Asian countries can avert massive increases in infections and death, prevent economic losses and save millions of people from poverty." He added, "Such leadership is critical in Asia today" (Kyodo News, 3/26). Ban said, "We will never see equitable progress if some parts of the population are still denied basic health and human rights" (AFP/Google.com, 3/26).
Link to this story.
Globe and Mail Examines African Governments' Efforts To Increase Male Circumcision To Curb Spread of HIV
[Mar 28, 2008]
Toronto's Globe and Mail on Thursday examined the efforts of several African governments to provide male circumcision as a way of curbing the spread of HIV. According to the Globe and Mail, male circumcision could prevent "millions" of new HIV cases in Africa, where about 50% of men currently are not circumcised. Several African governments in response to recent studies about the procedure have implemented or are planning circumcision programs.
Swaziland hopes to offer the procedure to 200,000 men over the next five years; however, a shortage of doctors has complicated the government's efforts. The Family Life Association of Swaziland has "hundreds" of men on its waiting list for the procedure, and the clinic's one doctor performs about 10 circumcisions daily, the Globe and Mail reports. FLAS also has offered "Circumcision Saturdays" at clinics throughout the country. The procedure costs about $82 in the country, and the President's Emergency Plan for AIDS Relief is providing funds so the procedure can be offered at no cost.
Rwanda earlier this year also launched a campaign to increase male circumcision. The campaign is focusing on providing the procedure to military personnel, police officers and students. The country's Ministry of Health also is increasing efforts to circumcise infants. In addition, Kenya has decided to offer circumcision to all men in the country, and public health officials are examining ways to implement a safe and cost-effective program that recognizes cultural issues. Private urologists across Eastern and Southern Africa have reported an increase in the number of men requesting the procedure.
Be the first to Write a Comment!
AllAfrica aggregates and indexes content from over 125 African news organizations, plus more than 200 other sources, who are responsible for their own reporting and views. Articles and commentaries that identify allAfrica.com as the publisher are produced or commissioned by AllAfrica.
