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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
The safety of tenofovir-emtricitabine for HIV pre-exposure prophylaxis (PrEP) in individuals with active hepatitis B
Journal of Acquired Immune Deficiency Syndromes, Volume 71, No. 3, Year 2016
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Description
Background: Pre-exposure prophylaxis (PrEP) with daily oral emtricitabine and tenofovir disoproxil fumarate (FTC/TDF) prevents HIV infection. The safety and feasibility of HIV PrEP in the setting of hepatitis B virus (HBV) infection were evaluated. Methods: The Iniciativa Profilaxis Pre-Exposición study randomized 2499 HIV-negative men and transgender women who have sex with men to once-daily oral FTC/TDF versus placebo. Hepatitis serologies and transaminases were obtained at screening and at the time PrEP was discontinued. HBV DNA was assessed by polymerase chain reaction, and drug resistance was assessed by population sequencing. Vaccination was offered to individuals susceptible to HBV infection. Results: Of the 2499 participants, 12 (0.5%; including 6 randomized to FTC/TDF) had chronic HBV infection. After stopping FTC/ TDF, 5 of the 6 participants in the active arm had liver function tests performed at follow-up. Liver function tests remained within normal limits at post-stop visits except for a grade 1 elevation in 1 participant at post-stop week 12 (alanine aminotransferase = 90, aspartate aminotransferase = 61). There was no evidence of hepatic flares. Polymerase chain reaction of stored samples showed that 2 participants in the active arm had evidence of acute HBV infection at enrollment. Both had evidence of grade 4 transaminase elevations with subsequent resolution. Overall, there was no evidence of TDF or FTC resistance among tested genotypes. Of 1633 eligible for vaccination, 1587 (97.2%) received at least 1 vaccine; 1383 (84.7%) completed the series. Conclusions: PrEP can be safely provided to individuals with HBV infection if there is no evidence of cirrhosis or substantial transaminase elevation. HBV vaccination rates at screening were low globally, despite recommendations for its use, yet uptake and efficacy were high when offered. Copyright © 2015 Wolters Kluwer Health, Inc. All rights reserved.
Authors & Co-Authors
Solomon, Marc M.
United States, San Francisco
Gladstone Institutes
United States, San Francisco
University of California, San Francisco
Schechter, Mauro T.
Brazil, Rio de Janeiro
Universidade Federal do Rio de Janeiro
Liu, Albert Y.
United States, San Francisco
University of California, San Francisco
United States, San Francisco
San Francisco Department of Public Health
Guanira, Juan Vicente
Peru, Lima
Investigaciones Medicas en Salud
Hance, Robert J.
United States, San Francisco
Gladstone Institutes
Chariyalertsak, Suwat
Thailand, Chaing Mai
Chiang Mai University
Mayer, Kenneth H.
United States, Boston
Fenway Community Health Center
Grant, Robert M.
United States, San Francisco
Gladstone Institutes
United States, San Francisco
University of California, San Francisco
Bekker, Linda-Gail Gail
Unknown Affiliation
Buchbinder, Susan P.
Unknown Affiliation
Casapia, Martin
Unknown Affiliation
Kállas, Èsper Georges
Unknown Affiliation
Lama, Javier R.
Unknown Affiliation
Montoya, Orlando
Unknown Affiliation
Veloso, V. G.
Unknown Affiliation
Statistics
Citations: 23
Authors: 15
Affiliations: 7
Identifiers
Doi:
10.1097/QAI.0000000000000857
ISSN:
15254135
Research Areas
Genetics And Genomics
Health System And Policy
Infectious Diseases
Study Design
Cross Sectional Study
Cohort Study
Participants Gender
Male
Female