South African Health Minister, HIV/AIDS Experts Agree More Research Needed on Safety of Single-Dose Nevirapine
Further research is needed on claims from South Africa's Medicines Control Council that single-dose nevirapine, which is used to prevent mother-to-child HIV transmission, increases the risk of drug resistance, the country's Ministry of Health said on Thursday, the SAPA/Business Day reports (SAPA/Business Day, 8/12). MCC during the XV International AIDS Conference last month said that the government would stop recommending the use of nevirapine as a monotherapy because of reports that it increased the risk of developing drug-resistant HIV strains by up to 50%. 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 (Kaiser Daily HIV/AIDS Report, 7/14).
Nevirapine Monotherapy to Continue
Health Minister Manto Tshabalala-Msimang on Thursday met with scientists from MCC, the Chris Hani-Baragwanath Hospital, the National Institute of Communicable Diseases, the Medical Research Council and the essential drugs listing committee to discuss the issue. The meeting is expected to be followed by a closed meeting of Tshabalala-Msimang and other government health officials (South African Press Association, 8/12). Meeting attendees agreed on the need for further research as well as coordination between researchers and representatives of the health department, MCC and MRC, according to Tshabalala-Msimang spokesperson Sibani Mngadi. Groups should make recommendations to Tshabalala-Msimang that "seek to meet the primary objective of the program to reduce the risk of mother-to-child transmission, which is to have healthy babies who are HIV-negative at 24 months," Mndagi said (SAPA/Business Day, 8/12). However, the use of single-dose nevirapine will continue until a final decision is made, Mngadi said (South African Press Association, 8/12).
MCC Recalls Generic Combination Drug
MCC has ordered a recall of Cipla-Medpro's generic antiretroviral drug Duovir, which is a combination of zidovudine and lamivudine, following the World Health Organization's removal of the drug from its list of approved HIV treatments, Xinhua News/China View reports (Xinhua News/China View, 8/12). Dr. Lembit Rago, WHO's coordinator for quality assurance and safety of medicines, in June said that Indian pharmaceutical company Cipla's versions of lamivudine and zidovudine were removed from the list because of problems detected during a routine inspection of an independent laboratory that Cipla had hired to conduct bioequivalence studies of the drugs. The bioequivalency tests, which were conducted among volunteers whose blood had been tested after receiving treatment with the two drugs, determine whether the blood concentration of the generic drug is similar to the patented version. Although the drugs were removed from the list of approved treatments because of Cipla's poor documentation, they still may be bioequivalent to the patented drugs (Kaiser Daily HIV/AIDS Report, 6/16).
New Bioequivalency Tests Begin
Cipla-Medpro, the third-largest generic drug manufacturer in South Africa, on Thursday confirmed that it had suspended sales and quarantined the product. MCC has given the company 30 days to conduct new bioequivalency tests and submit results, according to Cipla-Medpro Medical Director Nic de Jongh (Xinhua News/China View, 8/12). The South African AIDS treatment advocacy group Treatment Action Campaign and Medecins Sans Frontieres-South Africa on Wednesday issued a statement saying that MCC's decision was "rational, reasonable and in the public interest" and called on Cipla to submit documentation of bioequivalence as soon as possible (TAC/MSF release, 8/11). Cipla-Medpro, which is a joint venture between Cipla and South African generic drug manufacturer Medpro Pharmaceutica, said it already has started the testing and expects results soon (Xinhua News/China View, 8/12).