Author: Mark Mascolini
05 February 2010
Women starting a nevirapine (NVP)-based antiretroviral combination had a higher failure rate than women starting efavirenz (EFV) in Botswana’s randomized Tsepo study, although that difference stopped short of statistical significance. Toxicity rates were higher with nevirapine than efavirenz in all study participants.
Nevirapine and efavirenz are frequent components of first-line antiretroviral therapy throughout sub-Saharan Africa. The Tsepo study is the first randomized trial to compare nevirapine with efavirenz in Botswana. This 650-person study is also comparing zidovudine/lamivudine versus zidovudine/didanosine and community-based adherence strategies versus standard strategies, but those results were not included in this analysis.
Overall rates of failure with resistance were 9.6% with nevirapine and 6.6% with efavirenz after 3 years of follow-up.
Time to virologic failure with resistance was faster with nevirapine than with efavirenz, although this difference fell short of statistical significance (risk ratio [RR] 1.54, 95% confidence interval [CI] 0.86 to 2.70, P = 0.14). Among women, the study found a stronger trend toward a higher virologic failure rate with nevirapine than efavirenz (RR 2.22, 95% CI 0.94 to 5.00, P = 0.072).
Of the 650 study participants, 139 (21%) had 176 treatment-modifying toxicities. Time to toxicity was significantly shorter in the nevirapine group than in the efavirenz group (RR 1.85, 95% CI 1.20 to 2.86, P = 0.0002).
The investigators recommend patient education on toxicity, routine safety monitoring, and consideration of the potential risk of efavirenz-related teratogenicity when starting a nonnucleoside regimen.
Source: C.W. Wester, A.M. Thomas, H. Bussmann, S. Moyo, J.M. Makhema, T. Gaolathe, V. Novitsky, M. Essex, V. deGruttola, R.G. Marlink. Non-nucleoside reverse transcriptase inhibitor outcomes among combination antiretroviral therapy-treated adults in Botswana. AIDS. 2010; 24 Suppl 1: S27-S36.
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