Trial reportJournal of acquired immune deficiency syndromes (1999)2016
The Safety of Tenofovir-Emtricitabine for HIV Pre-Exposure Prophylaxis (PrEP) in Individuals With Active Hepatitis B.
Trial report in Journal of acquired immune deficiency syndromes (1999), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 17 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
17 citing papers in PubMed, 40 citations in OpenAlex.
- Hepatitis B status and associated factors among participants screened for simulated HIV vaccine efficacy trials in Kenya and Uganda.PloS one · 2023Trial
- HIV PrEP programmes as a framework for diagnosing and treating HBV infection in adolescents and young adults in KwaZulu-Natal, South Africa.Journal of virus eradication · 2025Article
- Tenofovir attenuates cytokine storm and bronchiolar damage in a mouse model of bleomycin-induced acute lung injury.Scientific reports · 2025Article
- What does the scale-up of long-acting HIV pre-exposure prophylaxis mean for the global hepatitis B epidemic?Journal of the International AIDS Society · 2024Article
- Article
- Low prevalence of hepatitis B virus infection in HIV-uninfected pregnant women in Cape Town, South Africa: implications for oral pre-exposure prophylaxis roll out.BMC infectious diseases · 2022Article
- Risks and benefits of oral HIV pre-exposure prophylaxis for people with chronic hepatitis B.The lancet. HIV · 2022Review
- Navigating Human Immunodeficiency Virus and Primary Care Concerns Specific to the Transgender and Gender-Nonbinary Population.Open forum infectious diseases · 2022Article
- Defining the Pre-exposure Prophylaxis Care Continuum Among Recently Incarcerated Men at High Risk for HIV Infection: Protocol for a Prospective Cohort Study.JMIR research protocols · 2022Article
- Chronic Hepatitis B Infection Among Preexposure Prophylaxis Users Enrolled in a Population-Based Program in British Columbia, Canada.Open forum infectious diseases · 2021Article
- Same-Day HIV Pre-Exposure Prophylaxis (PrEP) Initiation During Drop-in Sexually Transmitted Diseases Clinic Appointments Is a Highly Acceptable, Feasible, and Safe Model that Engages Individuals at Risk for HIV into PrEP Care.Open forum infectious diseases · 2019Article
- Next-Wave HIV Pre-Exposure Prophylaxis Implementation for Gay and Bisexual Men.AIDS patient care and STDs · 2019Review
- Identification of hepatitis B virus genotype I in Thailand.Journal of medical virology · 2019Article
- Missed opportunities of HIV pre-exposure prophylaxis in France: a retrospective analysis in the French DAT'AIDS cohort.BMC infectious diseases · 2019Article
- Patterns and clinical consequences of discontinuing HIV preexposure prophylaxis during primary care.Journal of the International AIDS Society · 2019Article
- Point-of-care screening for hepatitis B virus infection in pregnant women at an antenatal clinic: A South African experience.PloS one · 2017Observational
- The Safety of Tenofovir-Emtricitabine for HIV Pre-Exposure Prophylaxis (PrEP) in Individuals With Active Hepatitis B.Journal of acquired immune deficiency syndromes (1999) · 2016Article
Corrections and comments
- Erratum issued
Authors and funding
10 authors at 2 institutions in 1 country.
Funding
Abstract
backgroundPre-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.
methodsThe 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.
resultsOf 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.
conclusionsPrEP 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.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.