Non-nucleoside reverse transcriptase inhibitor outcomes among combination antiretroviral therapy-treated adults in Botswana.
AIDS
; 24 Suppl 1: S27-36, 2010 Jan.
Article
en En
| MEDLINE
| ID: mdl-20023437
ABSTRACT
BACKGROUND:
National initiatives offering non-nucleoside reverse transcriptase inhibitor (NNRTI)-based combination antiretroviral therapy (cART) have expanded in sub-Saharan Africa. The Tshepo study is the first clinical trial evaluating the long-term efficacy and tolerability of efavirenz versus nevirapine-based cART among adults in Botswana.METHODS:
A 3-year randomized study (n = 650) using a 3 x 2 x 2 factorial design comparing efficacy and tolerability among (i) zidovudine/lamivudine versus zidovudine/didanosine versus stavudine/lamivudine; (ii) efavirenz versus nevirapine; and (iii) community-based supervision versus standard adherence strategies. This paper focuses on comparison (ii).RESULTS:
There was no significant difference by assigned NNRTI in time to virological failure with resistance (log-rank P = 0.14), nevirapine versus efavirenz [risk ratio (RR) 1.54, 95% CI 0.86-2.70]. Rates of virological failure with resistance were 9.6% nevirapine-treated (95% CI 6.8-13.5) versus 6.6% efavirenz-treated (95% CI 4.2-10.0) at 3 years. Women receiving nevirapine-based cART trended towards higher virological failure rates when compared with efavirenz-treated women, Holm-corrected (log-rank P = 0.072), nevirapine versus efavirenz (RR 2.22, 95% CI 0.94-5.00). A total of 139 patients had 176 treatment-modifying toxicities, with a shorter time to event in nevirapine-treated versus efavirenz-treated patients (RR 1.85, 1.20-2.86; log-rank P = 0.0002).CONCLUSION:
Tshepo-treated patients had excellent overall immunological and virological outcomes, and no significant differences were observed by randomized NNRTI comparison. Nevirapine-treated women trended towards higher virological failure with resistance compared with efavirenz-treated women. Nevirapine-treated adults had higher treatment modifying toxicity rates when compared with those receiving efavirenz. Nevirapine-based cART can continue to be offered to women in sub-Saharan Africa if patient education concerning toxicity is emphasized, routine safety monitoring chemistries are performed and the potential risk of efavirenz-related teratogenicity is considered.
Texto completo:
1
Bases de datos:
MEDLINE
Asunto principal:
Infecciones por VIH
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VIH-1
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Inhibidores de la Transcriptasa Inversa
/
Fármacos Anti-VIH
Tipo de estudio:
Clinical_trials
Límite:
Adult
/
Female
/
Humans
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Male
/
Pregnancy
País/Región como asunto:
Africa
Idioma:
En
Revista:
AIDS
Asunto de la revista:
SINDROME DA IMUNODEFICIENCIA ADQUIRIDA (AIDS)
Año:
2010
Tipo del documento:
Article
País de afiliación:
Botswana