South Africa’s Medicines Control Council May Ban Use of Nevirapine Only for Prevention of Vertical HIV Transmission, Official Says

South Africa's Medicines Control Council yesterday during a plenary session on the final day of the South African AIDS Conference 2003 in Durban, South Africa, said that it would not ban general use of the antiretroviral drug nevirapine but might consider banning the drug to prevent mother-to-child HIV transmission, the South African Press Association reports (South African Press Association, 8/6). The MCC has said that it was considering barring the use of nevirapine to prevent mother-to-child HIV transmission unless drug maker Boehringer Ingelheim provides data proving that the drug is safe. MCC officials last week rejected the results of a 1999 Ugandan study that found that the drug is effective in preventing vertical HIV transmission, and MCC Chief Precious Matsoso gave the company 90 days to offer additional safety and efficacy information. If the drug maker fails to provide alternate data, the government says it will revoke nevirapine's temporary approval (Kaiser Daily HIV/AIDS Report, 8/6). Matsoso said that there were "glaring differences between the designs" of the Ugandan study and the South African Intrapartum Nevirapine Trial (SAINT) (South African Press Association, 8/6). Matsoso said the MCC rejected the Ugandan trial as a "pivotal study" and that the SAINT study was not "comprehensive" enough because of "problems with its design," according to U.N. IRIN/AllAfrica.com. Although the MCC is "mindful of the government's constitutional obligation to provide" the drug under a July 2002 Constitutional Court ruling, researchers and policy makers should consider "other options" in case the drug is deregistered, Matsoso said.

Scientific Grounds
Dr. James McIntyre, head of the Chris Hani Baragwanath Perinatal HIV Unit, said that differences between the nevirapine studies were "part of scientific research" and did not "rule out" the findings of either trial, according to U.N. IRIN/AllAfrica.com (U.N. IRIN/AllAfrica.com, 8/6). Matsoso acknowledged that nevirapine is "important in public programs" and that a generic version of the drug and other antiretroviral drugs have been registered "to facilitate access to treatment" (South African Press Association, 8/6). The South African Cabinet said in a statement that it was considering the implications for current HIV/AIDS programs in the country should the MCC decide to deregister nevirapine. The cabinet also said that the MCC decision on nevirapine was an "independent one, taken on scientific grounds," according the South African Press Association. The cabinet added that it has "called on those who purport to have scientific information on the efficacy of nevirapine" for mother-to-child HIV transmission prevention to offer "information to the MCC within the window period," adding, "[W]hatever approach is adopted by government will be guided by its concern for the health of both mothers and babies affected with HIV" (South African Press Association, 8/6).

Reaction
Dr. Nono Simelela, chief director of the South African Department of Health's HIV/AIDS program, said that she has been "spending sleepless nights asking what we are to do with mother-to-child transmission if we can't have nevirapine." She added, "I have 80,000 women on this program. I have to have an answer for them." U.N. Special Envoy for HIV/AIDS in Africa Stephen Lewis said, "Africa is entering a desperate and difficult period as the (HIV) infections become full-blown AIDS, and there is a sense that the worst is still to come." Lewis, who recently completed a trip to Uganda, Rwanda and Mozambique, said that some African countries are "obsessed with treatment" and have a "desperate feeling that they need to keep people alive (yet) had reached a point of no return" (Cullinan, Health-E News, 8/4). In a speech at the close of the conference yesterday, HIV/AIDS advocate Prudence Mabele called for an end to the "political game" over the use of nevirapine to prevent mother-to-child HIV transmission, asking the South African government to offer women the choice of whether to take the drug, according to U.N. IRIN/AllAfrica.com (U.N. IRIN/AllAfrica.com, 8/6). KwaZulu-Natal Health Minister Dr. Zwele Mkhize, speaking on behalf of South African Health Minister Manto Tshabalala-Msimang at the closing of the conference, said, "While we can't prejudge the decisions of the MCC, which is an independent body, the value of nevirapine to save babies' lives cannot be undermined and the program itself must not be compromised." He added that a national antiretroviral program for all people living with HIV/AIDS in the country is a "reality" and not a matter of "if, but when," according to South Africa's Star. Mkhize said, "There is no question about this. It must be placed on record that this is not an ideological issue. With the rising mortality rate from AIDS, one more death is too many" (Clarke, Star, 8/7).

AIDS Ribbon
Conference organizers have reported that a 1.49 mile-long AIDS awareness ribbon has set a Guinness World Record for the largest awareness ribbon, according to the Panafrican News Agency. The ribbon, crafted by the Mayihlome Project, is 328 yards longer than the previous record holder. Conference delegates were invited to purchase one of the 10,000 rectangles used to create the ribbon, and the funds raised will be matched by a donation from the Old Mutual Foundation. The money will be donated to Shepherd's Keep, an organization which provides shelter, medication and care for AIDS orphans in Durban (Panafrican News Agency, 8/7).

Webcasts of selected sessions of the conference are available online through kaisernetwork.org's HealthCast.