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Randomized Controlled Trial
. 2010 Jan;24 Suppl 1(Suppl 1):S27-36.
doi: 10.1097/01.aids.0000366080.91192.55.

Non-nucleoside reverse transcriptase inhibitor outcomes among combination antiretroviral therapy-treated adults in Botswana

C William Wester  1 , Ann Muir Thomas, Hermann Bussmann, Sikhulile Moyo, Joseph M Makhema, Tendani Gaolathe, Vladimir Novitsky, Max Essex, Victor deGruttola, Richard G Marlink
Affiliations
Randomized Controlled Trial

Non-nucleoside reverse transcriptase inhibitor outcomes among combination antiretroviral therapy-treated adults in Botswana

C William Wester et al. AIDS. 2010 Jan.

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.

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Figures

Figure 1
Figure 1
Time to Virologic Failure With Resistance by NNRTI and Sex
Figure 2
Figure 2
Time to Virologic Failure With Resistance by Baseline Plasma HIV-1 RNA
Figure 3
Figure 3
Time to First Treatment-Modifying Toxicity by NNRTI
See this image and copyright information in PMC

References

    1. Priority interventions: HIV/AIDS prevention, treatment and care in the health sector, September 2008. World Health Organization; © World Health Organization 2008. Publications of the World Health Organization can be obtained from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (TEL: +41 22 791 3264; fax: +41 22 791 4857; email: bookorders@who.int.)
    1. PAHO; 2008. Guidelines for the implementation of reliable and efficient diagnostic HIV testing, Region of the Americas. English, Spanish. Type of document: Operational guidelines, monitoring, evaluation and quality assurance. Target audience: Programme managers, laboratory managers and laboratory personnel. Implementation focus: National, district and facility. These guidelines aim to help countries expand testing and counseling services. Simple and standardized testing strategies are presented for client initiated (VCT) and provider initiated (PITC) testing in the Region of the Americas. It aims to facilitate development of appropriate national HIV testing algorithms for laboratory and non-conventional laboratory sites. Available at: LINK http://www.paho.org/English/AD/FCH/AI/LAB_GUIDE_ENG.PDF.
    1. Djomand G, et al. Virologic and immunologic outcomes and programmatic challenges of an antiretroviral treatment pilot project in Abidjan, Cote d’Ivoire. AIDS. 2003;17(Suppl 3):S5–15. - PubMed
    1. Laurent C, Diakhate N, Gueye NF, et al. The Senegalese government’s highly active antiretroviral therapy initiative: an 18-month follow-up study. AIDS. 2002;16(10):1363–70. - PubMed
    1. Weidle PJ, Malamba S, Mwebaze R, et al. Assessment of a pilot antiretroviral drug therapy programme in Uganda: patients’ response, survival, and drug resistance. Lancet. 2002;360(9326):34–40. - PubMed

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