Long-term efficacy and tolerance of efavirenz- and nevirapine-containing regimens in adult HIV type 1 Senegalese patients.
Owing to their low toxicity, low price, and ease of use, efavirenz (EFV) and nevirapine (NVP) are frequently used as part of antiretroviral regimens for AIDS treatment. Several clinical trials have already studied their efficacy and tolerance. However, long-term observations of the effects of these drugs in patients are limited. We used data from a prospective Senegalese cohort to analyze long-term tolerance and efficacy of these two drugs in a low-resources setting. Patients were included if they started their therapy with EFV or NVP. They were censored after treatment discontinuation. The primary endpoint was the time to treatment discontinuation. Secondary endpoints included time to death, time to disease progression, occurrence of severe adverse effects, CD4 cell recovery, and virological response. Confounding factors were controlled using marginal structural models. The median follow-up time in both EFV and NVP arms was 48 months. The hazard ratio (HR) of drug discontinuation in the EFV arm vs. the NVP arm was 0.84 (0.34; 1.87). There was a borderline difference in virological response [HR 1.38 (0.999; 1.89)] but no differences in time to death [HR 1.15 (0.41; 3.24)], time to AIDS progression [HR 1.25 (0.61; 2.58)], or time to increase in CD4 cell count above 500 cells/mm3. Adverse effects were different between NVP and EFV, but long-term tolerance was good for both. This analysis provided further information on long-term tolerance and efficacy of EFV and NVP in a resource-limited setting.
de Beaudrap
Pierre
P
Hospices Civils de Lyon, Service de Biostatistique, Lyon, F-69424, France. pierre.debeaudrap@ird.fr
Etard
Jean-François
JF
Guèye
Fatou Ngom
FN
Guèye
Mandoumbe
M
Landman
Roland
R
Girard
Pierre-Marie
PM
Sow
Papa Salif
PS
Ndoye
Ibrahima
I
Delaporte
Eric
E
D000328:Adult; D000480:Alkynes; D019380:Anti-HIV Agents / Q000009:adverse effects / Q000627:therapeutic use*; D048588:Benzoxazines / Q000009:adverse effects / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count; D015331:Cohort Studies; D003521:Cyclopropanes; D004361:Drug Tolerance; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000401:mortality; D015497:HIV-1 / Q000187:drug effects*; D006801:Humans; D016015:Logistic Models; D008297:Male; D019829:Nevirapine / Q000009:adverse effects / Q000627:therapeutic use*; D018579:Patient Selection; D016012:Poisson Distribution; D016016:Proportional Hazards Models; D018894:Reverse Transcriptase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D012675:Senegal / Q000453:epidemiology; D013997:Time Factors; D016896:Treatment Outcome; D019562:Viral Load
D000480:Alkynes; D019380:Anti-HIV Agents; D048588:Benzoxazines; D003521:Cyclopropanes; D018894:Reverse Transcriptase Inhibitors; D019829:Nevirapine; C098320:efavirenz