title: Tolerability and effectiveness of first-line regimens combining nevirapine and lamivudine plus zidovudine or stavudine in Cameroon.
abstract: We compared the tolerability and effectiveness of two major first-line regimens used in resource-limited settings, namely zidovudine-lamivudine-nevirapine and stavudine-lamivudine-nevirapine. HIV-1-infected adults in Cameroon were enrolled in a prospective cohort study between 2001 and 2003. They were eligible if they had AIDS or a CD4 cell count below 350/mm(3), a Karnofsky score over 50%, and no contraindications to antiretroviral treatment. The patients were followed up to 2 years. Of 169 patients, 85 received zidovudine-lamivudine-nevirapine and 84 stavudine-lamivudine-nevirapine. The incidence rates of treatment changes, death, drug resistance, and severe adverse effects were, respectively, 12.0 [95% confidence interval (CI) 7.2-19.9] and 10.9 (CI 6.4-18.3) per 100 person-years; 5.7 (CI 2.8-11.4) and 7.6 (CI 4.2-13.7); 2.9 (CI 1.1-7.7) and 5.0 (CI 2.4-10.6); and 41.7 (CI 30.2-57.6) and 49.1 (CI 36.1-66.6). The Kaplan-Meier curves for the likelihood of remaining on the initial regimen (p = 0.8) and for survival (p = 0.5) did not differ significantly between the groups. In Cox multivariate analysis only a lower baseline CD4 cell count was associated with death (p < 0.001). The proportion of patients with undetectable viral load and the increase in the CD4 cell count were similar in the two groups. Anemia was rare (4% vs. 6%). Five cases of severe peripheral neuropathy and one case of lipodystrophy occurred. This study suggests that the zidovudine-lamivudine-nevirapine combination is a safe first-line treatment, even in settings with few laboratory resources. In view of stavudine toxicity, these results support recommendations calling for a gradual switch from stavudine- to zidovudine-based regimens.
authors.affiliation: Institut de Recherche pour le Développement, UMR 145 (IRD/University of Montpellier 1), Montpellier, France. Christian.Laurent@mpl.ird.fr
authors.forename: Christian
authors.initials: C
authors.lastname: Laurent
authors.forename: Anke
authors.initials: A
authors.lastname: Bourgeois
authors.forename: Eitel
authors.initials: E
authors.lastname: Mpoudi-Ngolé
authors.forename: Laura
authors.initials: L
authors.lastname: Ciaffi
authors.forename: Charles
authors.initials: C
authors.lastname: Kouanfack
authors.forename: Rose
authors.initials: R
authors.lastname: Mougnutou
authors.forename: Nathalie
authors.initials: N
authors.lastname: Nkoué
authors.forename: Alexandra
authors.initials: A
authors.lastname: Calmy
authors.forename: Sinata
authors.initials: S
authors.lastname: Koulla-Shiro
authors.forename: Eric
authors.initials: E
authors.lastname: Delaporte
mesh_terms: D000328:Adult; D000740:Anemia; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count; D002163:Cameroon; D015331:Cohort Studies; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D015658:HIV Infections / Q000150:complications / Q000188:drug therapy* / Q000401:mortality; D039682:HIV-Associated Lipodystrophy Syndrome; D006801:Humans; D053208:Kaplan-Meier Estimate; D019259:Lamivudine / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D015999:Multivariate Analysis; D019829:Nevirapine / Q000009:adverse effects / Q000627:therapeutic use*; D010349:Patient Compliance; D010523:Peripheral Nervous System Diseases; D011446:Prospective Studies; D018119:Stavudine / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D019562:Viral Load; D015215:Zidovudine / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D019380:Anti-HIV Agents; D019259:Lamivudine; D015215:Zidovudine; D019829:Nevirapine; D018119:Stavudine