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Starting Antiretroviral Therapy Immediately in Africa

March 23, 2015

While the national treatment guidelines of several countries (including Spain, France, U.S. and Brazil) recommend antiretroviral therapy initiation irrespective of CD4 cell count or clinical stage, many countries and the World Health Organization (WHO) recommend deferring antiretroviral therapy until CD4+ cell counts reach lower levels. Because of this, we believe that the most important presentation at CROI was of the results from the Temprano ANRS 12136 Trial.

The study, conducted in Côte d'Ivoire, West Africa, randomized 2,076 treatment-naive individuals with a CD4+ cell count below 800 cells to receive either:

  • Immediate antiretroviral therapy with or without six months of isoniazid tuberculosis preventive therapy.
  • Deferred antiretroviral therapy with or without six months of isoniazid preventive therapy.

The participants were started on one of three treatment regimens:

  • efavirenz (Sustiva, Stocrin).
  • lopinavir/ritonavir (Kaletra).
  • zidovudine (AZT, Retrovir) with tenofovir/emtricitabine (Truvada).

About 35% of the participants had a positive QuantiFERON test [a registered trademark test for tuberculosis] at screening. Most participants in the deferred arm would start antiretroviral therapy at a CD4+ cell count threshold of 350 cells/mL. By a median follow-up of 30 months, 58% of the participants in the deferred arm started antiretroviral therapy. The main study endpoints were clinical: all-cause mortality, any AIDS-defining event, severe bacterial infections, or non-AIDS cancer.

The results are critically important: Immediate antiretroviral therapy and isoniazid preventive therapy independently reduced the rate of main endpoints, 44% (P = .0002) and 35% (P = .005), respectively. The main finding was that a subanalysis including only participants with baseline CD4 ≥500 cells/mL reproduced the same efficacy, with reductions in the endpoints of 44% (P = .03) and 39% (P = .056), respectively. Therefore, the first randomized study to show clinical benefit in initiating antiretroviral therapy in participants with a CD4 count >500 cells/mL finally comes from ... Africa! These data will be reported to the WHO and Côte d'Ivoire government and we believe will almost certainly change global treatment guidelines. Of note, immediate antiretroviral therapy does not only benefit individual health or just prevent HIV transmission, but also prevents tuberculosis.

Which other studies presented at CROI 2015 will have lasting impact? Read more of Llibre and Young's top picks.

Josep M. Llibre, M.D., is in the HIV Unit of the "Lluita contra la SIDA" Foundation at University Hospital Germans Trias i Pujol, Universitat Autònoma de Barcelona, Badalona, Spain. Llibre has received funding for research or payment for conferences or participation on advisory boards from Abbott, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, Janssen-Cilag, Merck Sharp & Dohme, and ViiV Healthcare.

Benjamin Young, M.D., Ph.D., is senior vice president and chief medical officer of the International Association of Providers of AIDS Care based in Washington, D.C., and an adjunct professor at the Josef Korbel School of International Studies at the University of Denver. Young has received consulting or speaking fees from Bristol-Myers Squibb, Gilead Sciences, Merck & Co., and ViiV Healthcare. He has received research funding from Bristol-Myers Squibb Company, Gilead Sciences, Merck & Co., and ViiV Healthcare.

Copyright © 2015 Remedy Health Media, LLC. All rights reserved.

This article was provided by TheBodyPRO. It is a part of the publication The 22nd Conference on Retroviruses and Opportunistic Infections (CROI 2015).

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