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 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).


CONCLUSIONS
Together with previous pharmacological and clinical studies, this prospective study suggests that these generic antiretroviral drugs can be used in developing countries.
Bourgeois
Anke
A
Institut de Recherche pour le Développement and Department of International Health, University of Montpellier (UMR 145), Montpellier, France.
Laurent
Christian
C
Mougnutou
Rose
R
Nkoué
Nathalie
N
Lactuock
Bernadette
B
Ciaffi
Laura
L
Liégeois
Florian
F
Andrieux-Meyer
Isabelle
I
Zekeng
Léopold
L
Calmy
Alexandra
A
Mpoudi-Ngolé
Eitel
E
Delaporte
Eric
E
D000328:Adult; D019380:Anti-HIV Agents / Q000494:pharmacology / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count; D002163:Cameroon; D015331:Cohort Studies; D024882:Drug Resistance, Viral; D004359:Drug Therapy, Combination; D016568:Drugs, Generic / Q000627:therapeutic use*; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D015497:HIV-1 / Q000187:drug effects / Q000302:isolation & purification; D006801:Humans; D019259:Lamivudine / Q000627:therapeutic use*; D008297:Male; D019829:Nevirapine / Q000627:therapeutic use*; D011446:Prospective Studies; D018119:Stavudine / Q000627:therapeutic use*; D016896:Treatment Outcome; D019562:Viral Load; D015215:Zidovudine / Q000627:therapeutic use*
D019380:Anti-HIV Agents; D016568:Drugs, Generic; D019259:Lamivudine; D015215:Zidovudine; D019829:Nevirapine; D018119:Stavudine