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COMBINATION ANTIRETROVIRAL TREATMENT FOR WOMEN PREVIOUSLY TREATED ONLY IN PREGNANCY: WEEK 24 RESULTS OF AIDS CLINICAL TRIALS GROUP PROTOCOL A5227
Acquired Immunodeficiency Syndrome
Antigens, CD4
HIV-1
Postpartum
Efavirenz
Adherence
Highly Active
Síndrome de Imunodeficiência Adquirida
Antígenos CD4
HIV-1
Autor
Afiliación
New York Presbyterian Hospital. Cornell University. Weill Cornell Medical College. New York, NY, USA.
Harvard School of Public Health. Center for Biostatistics and AIDS Research. Boston, MA, USA.
Albert Einstein College of Medicine. Department of Obstetrics and Gynecology. Bronx, NY, USA.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST e AIDS. Rio de Janeiro, RJ, Brasil.
kAsociación Civil Impacta Salud y Educación. Lima, Perú.
kAsociación Civil Impacta Salud y Educación. Lima, Perú.
Social and Scientific Systems. Inc. Silver Spring, MD, USA.
National Institute of Allergy and Infectious Disease. HIV Research Branch. Division of AIDS. Bethesda, MD, USA.
University of Rochester. School of Medicine and Dentistry. Rochester, NY, USA.
Birmingham Veterans Affairs Medical Center. Birmingham, AL, USA / University of Alabama at Birmingham. School of Medicine, Birmingham, AL, USA.
Harvard School of Public Health. Center for Biostatistics and AIDS Research. Boston, MA, USA.
Albert Einstein College of Medicine. Department of Obstetrics and Gynecology. Bronx, NY, USA.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST e AIDS. Rio de Janeiro, RJ, Brasil.
kAsociación Civil Impacta Salud y Educación. Lima, Perú.
kAsociación Civil Impacta Salud y Educación. Lima, Perú.
Social and Scientific Systems. Inc. Silver Spring, MD, USA.
National Institute of Allergy and Infectious Disease. HIV Research Branch. Division of AIDS. Bethesda, MD, USA.
University of Rochester. School of Medicine and Dentistry. Rochester, NY, USA.
Birmingham Veterans Affairs Medical Center. Birmingham, AL, USA / University of Alabama at Birmingham. School of Medicine, Birmingham, AL, USA.
Resumen en ingles
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 co-formulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF)
Methods: Non-pregnant women with plasma HIV-1 RNA of ≥ 500 copies/mL, previously cART- exposed for pMTCT only, were eligible if they were off ART for ≥ 24 weeks prior to 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: 54 women were enrolled between 10/07 and 12/09; 52/54 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/mL. 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 42/52 women or 81% (exact 95% CI: 68%–90%). There were no differences in response by country, by number or class of prior pMTCT exposures. While 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 re- treatment 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 non-adherence.
Palabras clave en ingles
Antiretroviral TherapyAcquired Immunodeficiency Syndrome
Antigens, CD4
HIV-1
Postpartum
Efavirenz
Adherence
Highly Active
DeCS
Terapia Antirretroviral de Alta AtividadeSíndrome de Imunodeficiência Adquirida
Antígenos CD4
HIV-1
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