South Africa to Stop Recommending Nevirapine for Use by Itself for Mother-to-Child HIV Transmission, Medicines Control Council Says

South Africa's Medicines Control Council on Tuesday said that the government would stop recommending that the antiretroviral drug nevirapine be administered alone to reduce mother-to-child HIV transmission because its use significantly increases the chance of drug resistance, Reuters reports (Quinn, Reuters, 7/13). Although the regimen has become increasingly common in clinics throughout Africa, MCC recommended against administering a single dose of nevirapine to a pregnant woman before childbirth and also said that the drug is more effective when used in combination with other antiretrovirals, the New York Times reports (LaFraniere, New York Times, 7/14). According to an MCC statement, "using nevirapine as a monotherapy for this purpose show[s] significant resistance of up to 50 percent," Reuters reports (Reuters, 7/13). The once-controversial drug had pitted AIDS advocates against a government reluctant to distribute nevirapine. However, since the AIDS advocacy group Treatment Action Campaign won a lawsuit against the government that forced provision of nevirapine, there has been little evidence of dangerous side effects from the drug, as the government had once claimed. Without nevirapine -- which is taken by women during labor and administered to infants following birth -- about 25% of infants born to HIV-positive women contract the disease from their mothers; however, with the now-routine administration of the drug, the incidence of mother-to-child HIV transmission is about 8%, according to doctors. Caesarean-section deliveries and bottle feeding -- as opposed to breastfeeding, which can transmit HIV to infants -- also help to reduce the risk of vertical HIV transmission (Kaiser Daily HIV/AIDS Report, 6/9).

Recommendations
MCC now recommends administering nevirapine in combination with zidovudine, the Times reports (New York Times, 7/14). MCC said it "believes that the risk-benefit profile of nevirapine monotherapy has changed and therefore no longer recommends its use for the prevention of mother-to-child transmission of HIV." Kevin McKenna, a spokesperson for German pharmaceutical company Boehringer Ingelheim -- which holds the patent to nevirapine -- said that the company does not object to using the drug as a combination treatment, but he added that he is concerned that MCC could withdraw the use of nevirapine altogether. McKenna said, "We will be taking it up with MCC very shortly." TAC Secretary Mark Heywood said, "We think that it would be wrong of the government to simply withdraw nevirapine. What the government needs to do is to introduce, as soon as possible, access to double-drug regimens or triple-drug regimens for pregnant women" (Reuters, 7/13). Nathan Geffen, national manager of TAC, said, "We think the change in protocol ... is something we should welcome," adding, "But in the meanwhile, they must continue with their programs" (McDonough, VOA News, 7/13).

Reaction
Public health experts and HIV/AIDS advocates attending the XV International AIDS Conference in Bangkok, Thailand, said that MCC's decision represents another example of the government's "reluctance to confront the AIDS epidemic head-on," according to the Times. Joep Lange, International AIDS Society president and co-chair of the AIDS conference, said that MCC's decision sends a "totally wrong message," adding, "We know that in many settings the single dose of nevirapine ... is better than nothing" (New York Times, 7/14). Harvard University AIDS Institute Executive Director Richard Marlink, who serves as scientific director for the Elizabeth Glaser Pediatric AIDS Foundation, said that South Africa's decision could influence other countries in Africa. "In those rural places, women coming into labor probably will not use it now. We're saving a whole lot of lives with a simple dose," he said, adding, "Yes, you should add [zidovudine] or other drugs -- if you have it. But how many places have it?" Dr. Glenda Gray, co-director of the HIV Perinatal Research Unit at Chris Hani Baragwanath Hospital in Soweto, said that nevirapine is the "backbone" of most mother-to-child HIV transmission prevention programs, the Boston Globe reports. She added, "We mustn't jeopardize children's lives by not using nevirapine when we have no other option. I don't think women should be without any intervention while we're looking for that magic bullet." Timothy Farley, coordinator of sexually transmitted diseases and reproductive-tract infections for the World Health Organization, said that one dose of nevirapine "is very practical and very easy to deliver." He added that doctors and health workers should use a combination of nevirapine and zidovudine "when feasible" (Boston Globe, 7/14).

Ministry of Health
The South African Ministry of Health on Tuesday said it would not curb the use of nevirapine despite the MCC regulation, the Washington Post reports. However, the ministry said that it must review the program because of the MCC decision, ministry spokesperson Sibani Mngadi said. Mngadi said that significantly cutting the program or canceling the program was not an option, according to the Post. "We are not going to stop our efforts to stop mother-to-child transmission," Mngadi said (Timberg, Washington Post, 7/14).

Dr Allen Rosenfield, Dean of the Columbia University's Mailman School of Public Health and a member of the Kaiser Family Foundation Board, talks with Kaiser's Jackie Judd about the latest efforts to treat pregnant women in the developing world who are HIV positive.

Back to other news for July 14, 2004