In African women, an anti-AIDS treatment regimen that includes the drug nevirapine is as effective as a treatment regimen with the more expensive drugs, lopinavir/ritonavir, according to a study by a team of international researchers published in this week's PLoS Medicine.
This finding is important as it confirms the recommendations from the World Health Organization that an increasingly common nevirapine-based treatment regimen is an affordable and effective option for the initial treatment of HIV in resource-limited settings.
The clinical trial involved 500 HIV-infected African women who had not previously taken antiretroviral treatment in seven countries (Botswana, Kenya, Malawi, South Africa, Uganda, Zambia, and Zimbabwe). The researchers, led by Shahin Lockman from the Harvard School of Public Health, randomized half of the women to receive antiretroviral therapy containing nevirapine and half to receive antiretroviral therapy containing lopinavir/ritonavir, a more expensive combination.
The researchers found that a similar number of women died in each group and each combination was as effective at controlling the level of HIV virus. In addition, similar proportions of women in both treatment groups developed serious drug-related signs and symptoms and laboratory abnormalities.
However, whereas 14% of the women in the nevirapine group stopped treatment because of adverse effects, none of the women in the lopinavir/ritonavir group stopped treatment. Furthermore, women in the nevirapine group developed more drug resistance than women in the lopinavir/ritonavir group.
The authors say: "These data support the WHO recommendation of [nevirapine-based treatment] as an initial affordable and effective HIV treatment regimen in resource limited settings, and provide reassurance regarding the efficacy of this regimen. However, these results also underscore the importance of early toxicity monitoring with nevirapine-based regimens."
They continue: "Our findings suggest that nevirapine, with careful early toxicity monitoring, remains an acceptable choice for first-line antiretroviral therapy in resource limited settings, until better tolerated and potentially more efficacious regimens become accessible."
The authors add: "Treatment failure observed in both arms also highlights the importance of access to effective second treatment options, as well as consideration of other effective, better-tolerated first-line regimens."
Funding: This project was supported in part by grants (U01AI068636, AI38838, and Statistical and Data Management Center AI68634) from the National Institute of Allergy and Infectious Diseases to the AIDS Clinical Trials Group. It also was supported in part by the General Clinical Research Center Units funded by the National Center for Research. J. Currier is supported in part by K24 AI56933. E. Dangaiso, University of Zimbabwe, Parirenyatwa, Harare, Zimbabwe CRS (Site 30313) CTU Grant #U01AI069436. F. Conradie, MD and J. Tsotsotetsi, WITS HIV Research Group, Johannesburg, South Africa (Site 11101) CTU Grant #U01 AI69463-03. KMRI/Walter Reed Project Clinical Research Center; Kericho, Kenya (Site 12501) CTU Grant #IAAY1AI8374. C. Potani and R. Mwausegha, UNC Project, Kamuzu Central Hospital, Lilongwe (Site 12001) CTU Grant #5 U01 AI069518. F. Laher and R. Hen-Boisen, Soweto, South Africa ACTG CRS (Site 12301) CTU Grant # AI69453. A. Siika, K. Wools-Kaloustian, K. Kirwa, and A. Nzioka, Moi University, Eldoret, Kenya CRS (Site 12601) CONTRACT No. AACTG. 50.5208.07, the United States Military HIV Research Program. E. Stringer, Centre for Infectious Disease Research, Kalingalinga; Lusaka, Zambia (Site 12801) CTU Grant #5U01AI069455-03 and # 3U01AI32775-13S5. E. Moko, Botswana (Site 12701) CTU Grant #5U01AI069456-03. C. Kityo and S. Rwambuya, JCRC, Kampala, Uganda (Site 12401) CTU Grant #AI-069501. F. Amod, U. Lalloo, and S. Pillay, University of Natal, Durban, South Africa (11201) CTU Grant # AI69426. SDAC (X. Sun) FSTRF (A. Nair, L.M. Smith, J. Tutko, C. Lee), Pharmaceutical Affairs Branch, SSS Ops (Y. Delph, N. Gettinger, L. Berman, L. Boone), DAIDS (B. Adedeji). These funding bodies played no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. The following companies donated study drug: Gilead (tenofovir/emtricitabine), Boehringer-Ingelheim (nevirapine), Abbott (lopinavir/ritonavir), GlaxoSmithKline (zidovudine), Bristol-Myers Squibb (didanosine). Pharmaceutical supporters provided study product but did not fund any other aspect of study conduct nor data analysis. Pharmaceutical supporters also participated as protocol team members and provided feedback (which the authors could include or exclude at their discretion) on the manuscript, but did not participate in writing the manuscript, in analyzing the data, nor in the decision to publish the manuscript. Abbott Laboratories: William C. Woodward. For Boehringer Ingelheim: Lauren Petrella. Gilead: Audrey L. Shaw, Marianne Poblenz, Sabina Pfister, Farideh Said, and Howard Jaffe. Bristol-Myers Squibb: Awny Farajallah, Kristy Grimm. GlaxoSmithKline: Navdeep Thoofer, Wendy Snowden.
Competing Interests: M. Hughes reports receiving fees as a member of the data and safety monitoring boards for Boehringer Ingelheim, Medicines Development, Pfizer, Tibotec, and Virionyx and the receipt by his department of financial support from Schering-Plough and Merck for an annual educational workshop; J. McIntyre, receiving financial support from the Abbott Speakers Bureau; M. Hosseinipour, receiving financial support from Abbott Virology for educational presentations (M. Hosseinipour has given an educational lecture at the 2009 IAS conference and the 2010 INTEREST conference for Abbott virology on the topic of antiretroviral resistance in Malawi); L. Mohapi, receiving reimbursement for travel expenses from Pfizer Laboratories (L. Mohapi received travel, accommodation and registration assistance for the XVII AIDS Conference in Mexico City, August 2008, from Pfizer); J. Mellors, serving on the scientific advisory board for Gilead Sciences, receiving consulting fees from Merck, Idenix Pharmaceuticals, Chimerix, RFS Pharmaceuticals, Panacos Pharmaceuticals, and Abbott Laboratories, receiving grant support from Merck, having stock options in RFS Pharmaceuticals, and receiving reimbursement for travel expenses from Gilead Sciences, Merck, Chimerix, Idenix Pharmaceuticals, RFS Pharmaceuticals, and Panacos Pharmaceuticals; R. Schooley, receiving consulting fees from Glaxo-SmithKline and Abbott Laboratories and reimbursement for travel expenses from Abbott Laboratories (and serves on the scientific advisory board for Gilead Sciences); and J. Currier, receiving consulting fees from GlaxoSmithKline and grant support from Merck and Tibotec. All other authors have declared that no competing interests exist.
Citation: Lockman S, Hughes M, Sawe F, Zheng Y, McIntyre J, et al. (2012) Nevirapine- Versus Lopinavir/Ritonavir-Based Initial Therapy for HIV-1 Infection among Women in Africa: A Randomized Trial. PLoS Med 9(6): e1001236. doi:10.1371/journal.pmed.1001236
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