Field assessment of generic antiretroviral drugs: a prospective cohort study in Cameroon.

Objective: To assess the effectiveness of generic anti-retroviral drugs in terms of survival and virological and immunological responses as well as their tolerability and the emergence of viral resistance. Methods: A total of 109 HIV-1 infected patients were enrolled in a prospective cohort study in Younde Cameroon. Available generic drugs were a fixed-dose combination (FDC) of zidovudine (SDV) and lamivudine (3TC) an FDC of 3TC stavudine (d4T) and nevirapine (NVP) and individual formulations of ZDV 3TC and NVP. Results: At baseline the median CD4 cell count was 150/mm(3) [interquartile range (IQR) 61- 223] and median viral load was 5.4 log(-10) copies/ml (IQR 4.8-5.6); 78% of patients received ZDV/3TC/NVP and 22% received 3TC/d4T/NVP. Median follow-up was 16 months (IQR 11-23). The survival probability was high (0.92 at 12 months); plasma viral load declined by a median of 3.3 log(-10) copies/ml and 86.9% of the intention-to-treat population had viral load <400 copies/ml at 12 months; CD4 count had increased by a median of 106 cells/mm(3) at 12 months; drug resistance rarely emerged (incidence rate 3.2 per 100 person-years); and the treatments were reasonably well-tolerated (incidence rate of severe adverse effects 7.8 per 100 person-years). Conclusion: Together with previous pharmacological and clinical studies this prospective study suggests that these generic antiretroviral drugs can be used in developing countries. (authors)