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Combination Antiretroviral Treatment for Women Previously Treated Only in Pregnancy: Week 24 Results of AIDS Clinical Trials Group Protocol A5227

Vogler, Mary A. MD*; Smeaton, Laura M. MS; Wright, Rodney L. MD, MS; Cardoso, Sandra W. MD, MSc§; Sanchez, Jorge MD, MPH; Infante, Rosa MD; Moran, Laura E. MPH; Godfrey, Catherine MD#; Demeter, Lisa M. MD**; Johnson, Victoria A. MD††

JAIDS Journal of Acquired Immune Deficiency Syndromes: April 15th, 2014 - Volume 65 - Issue 5 - p 542–550
doi: 10.1097/QAI.0000000000000072
Clinical Science

Background: Women with HIV and prior exposure to combination antiretroviral therapy (cART) solely for prevention of mother-to-child transmission (pMTCT) need to know whether they can later be treated successfully with a commonly used regimen of efavirenz (EFV) and coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF).

Methods: Nonpregnant women with plasma HIV-1 RNA of ≥500 copies per milliliter, previously cART exposed for pMTCT only, were eligible if they were off ART for ≥24 weeks before entry, were without evidence of drug resistance on standard genotyping, and were ready to start EFV plus FTC/TDF. The primary endpoint was virologic response (defined as plasma HIV RNA <400 copies/mL) at 24 weeks.

Results: Fifty-four women were enrolled between October 2007 and December 2009; 52 of 54 completed 24 weeks of follow-up. Median baseline CD4+ T-cell count was 265/mm3 and baseline plasma HIV-1 RNA was 4.6 log10 copies per milliliter. Median prior cART duration was 14 weeks, and median time elapsed from the last pMTCT dose to entry was 22 months. Virologic response at 24 weeks was observed in 42 of 52 women or 81% (exact 95% confidence interval: 68% to 90%). There were no differences in response by country, by number, or class of prior pMTCT exposures. Although confirmed virologic failure occurred in 8 women, no virologic failures were observed in women reporting perfect early adherence.

Conclusions: In this first prospective clinical trial studying combination antiretroviral retreatment in women with a history of pregnancy-limited cART, the observed virologic response to TDF/FTC and EFV at 24 weeks was 81%. Virologic failures occurred and correlated with self-reported nonadherence.

*Weill Cornell Medical College of Cornell University, New York Presbyterian Hospital, New York, NY;

Center for Biostatistics and AIDS Research, Harvard School of Public Health, Boston, MA;

Department of Obstetrics and Gynecology, Albert Einstein College of Medicine, Bronx, NY;

§STD/AIDS Clinical Research Laboratory, Instituto de Pesquisa Clinica Evandro Chagas, Fundação Oswaldo Cruz, Rio de Janeiro, Brazil;

Asociación Civil IMPACTA Salud y Educación, Lima, Perú;

Social and Scientific Systems, Inc, Silver Spring, MD;

#HIV Research Branch, Division of AIDS, National Institute of Allergy and Infectious Disease, National Institute of Health, Bethesda, MD;

**University of Rochester School of Medicine and Dentistry, Rochester, NY; and

††Birmingham Veterans Affairs Medical Center and University of Alabama at Birmingham School of Medicine, Birmingham, AL.

Correspondence to: Mary A. Vogler, MD, Weill Cornell Medical College of Cornell University, New York Presbyterian Hospital, New York, NY (e-mail: mav9046@med.cornell.edu).

Supported by Award no. U01AI068636 from the National Institute of Allergy and Infectious Diseases and supported by National Institute of Mental Health, National Institute of Dental and Craniofacial Research. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute of Allergy and Infectious Diseases or the National Institutes of Health. Supported by the Statistical and Data Management Center of the AIDS Clinical Trials Group under the National Institute of Allergy and Infectious Diseases grant no. 1 U01AI068634. UAB Virology Specialty Laboratory 54 support VSL UM1 AI068636 and UAB CFAR P30; AI27767 for laboratory support and core research facilities within UAB Center for AIDS Research/University of Alabama at Birmingham School of Medicine and Birmingham Veterans Affairs Medical Center, Birmingham Alabama; University of Alabama at Birmingham ACTG CTU grant no. U01 AI069918; Instituto de Pesquisa Clinica Evandro Chagas CRS (12101) Fiocruz Therapeutic and Prevention HIV AIDS CTU grant no. 1 U01 AI069476-01; IMPACTA Peru CTU grant no. 1U01AI069438-01; Weill Cornell Medical College ACTG CTU grant no. 5U01AI069419; University of Rochester CTU grant no. 1U01 AI069511; Bristol Myers Squibb Company, Gilead Sciences, Inc, and Merck & Co, Inc, provided study drugs.

Presented in part at the 18th CROI, ABS 752, March 2, 2011, Boston, MA.

M.A.V., MD, has served on Ad-Hoc Advisory Boards for Gilead Sciences, Merck, and Abbott Laboratories.

Received July 13, 2012

Accepted November 11, 2013

© 2014 by Lippincott Williams & Wilkins