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

Antivir Ther. 2005;10(2):335-41.


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 Yaoundé, Cameroon. Available generic drugs were a fixed-dose combination (FDC) of zidovudine (ZDV) 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/mm3 [interquartile range (IQR) 61-223] and median viral load was 5.4 log10 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 log10 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/mm3 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.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase I
  • Comparative Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Anti-HIV Agents / pharmacology
  • Anti-HIV Agents / therapeutic use*
  • CD4 Lymphocyte Count
  • Cameroon
  • Cohort Studies
  • Drug Resistance, Viral
  • Drug Therapy, Combination
  • Drugs, Generic / therapeutic use*
  • Female
  • HIV Infections / drug therapy*
  • HIV Infections / immunology
  • HIV Infections / virology
  • HIV-1* / drug effects
  • HIV-1* / isolation & purification
  • Humans
  • Lamivudine / therapeutic use*
  • Male
  • Nevirapine / therapeutic use*
  • Prospective Studies
  • Stavudine / therapeutic use*
  • Treatment Outcome
  • Viral Load
  • Zidovudine / therapeutic use*


  • Anti-HIV Agents
  • Drugs, Generic
  • Lamivudine
  • Zidovudine
  • Nevirapine
  • Stavudine