allAfrica.com: Africa: Daily HIV/Aids Report (Page 1 of 4)

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).

web allafrica.com	Enter your search terms	Submit search form
OR subscribers use AllAfrica's premium search engine


Use our pull-down menus to find more stories