Effectiveness and safety of a generic fixed-dose combination of nevirapine, stavudine, and lamivudine in HIV-1-infected adults in Cameroon: open-label multicentre trial

• Published in: The Lancet (British edition) 2004-07, Vol.364 (9428), p.29-34
• Main Authors: Laurent, Christian, Kouanfack, Charles, Koulla-Shiro, Sinata, Nkoué, Nathalie, Bourgeois, Anke, Calmy, Alexandra, Lactuock, Bernadette, Nzeusseu, Viviane, Mougnutou, Rose, Peytavin, Gilles, Liégeois, Florian, Nerrienet, Eric, Tardy, Michèle, Peeters, Martine, Andrieux-Meyer, Isabelle, Zekeng, Léopold, Kazatchkine, Michel, Mpoudi-Ngolé, Eitel, Delaporte, Eric
• Format: Article
• Language: English
• Subjects: Acquired immune deficiency syndrome; Acquired Immunodeficiency Syndrome - complications; Acquired Immunodeficiency Syndrome - drug therapy; Adult; AIDS; Anti-Retroviral Agents - administration & dosage; Anti-Retroviral Agents - adverse effects; Antibiotics. Antiinfectious agents. Antiparasitic agents; Antiretroviral agents; Antiviral agents; Biological and medical sciences; Cameroon; CD4 Lymphocyte Count; Developing Countries; Disease control; Disease Progression; Drug Combinations; Drugs, Generic - administration & dosage; Drugs, Generic - adverse effects; Female; Generic drugs; HIV Infections - drug therapy; HIV Infections - immunology; HIV Infections - virology; HIV-1 - isolation & purification; Human viral diseases; Humans; Infectious diseases; Lamivudine - administration & dosage; Lamivudine - adverse effects; LDCs; Male; Medical sciences; Mutation; Nevirapine - administration & dosage; Nevirapine - adverse effects; Pharmacology. Drug treatments; Public health; Reverse Transcriptase Inhibitors - administration & dosage; Side effects; Stavudine - administration & dosage; Stavudine - adverse effects; Viral diseases; Viral diseases of the lymphoid tissue and the blood. Aids; Viral Load
• ISSN: 0140-6736; 1474-547X
• DOI: 10.1016/S0140-6736(04)16586-0

Generic fixed-dose combinations have been prequalified by WHO to treat HIV-infected patients in resource-limited countries. Despite their widespread use they are, however, not yet recommended by some of the major donor agencies owing to scarcity of clinical data on effectiveness, safety, and quality. We aimed to assess these issues for one of the most frequently prescribed treatments in Africa, a generic fixed-dose combination of nevirapine, stavudine, and lamivudine. 60 patients were followed in an open-label, 24-week multicentre trial in Cameroon. All patients received one tablet of the fixed-dose combination drug twice daily. The primary outcome measure was the proportion of patients with viral load less than 400 copies per mL at the end of the study period, in an intention-to-treat analysis. At baseline, 92% of patients (n=55) had AIDS; median CD4 count was 118 cells per μL (IQR 78–167) and median plasma HIV-1 RNA was 104 736 copies per mL (40 804–243 787). The proportion of patients with undetectable viral load (