CLINICAL RESEARCH UPDATE

by Carolyn Chu, MD, MSc, AAHIVS, AAHIVM Chief Medical Officer

July 19, 2022


Featured Literature:
Mohareb AM, Larmarange J, Kim AY, et. al. Risks and benefits of oral HIV pre-exposure prophylaxis for people with chronic hepatitis B. Lancet HIV. 2022 July 8: S2352-3018(22)00123-0. doi: 10.1016/S2352-3018(22)00123-0. PMID 35817068.  

HIV prevention among people with chronic HBV can prevent poor health outcomes associated with HIV-HBV coinfection, such as accelerated liver disease, higher hepatocellular carcinoma rates, and increased all-cause mortality. However, many initial PrEP clinical trials excluded people with HBV—therefore limited data and published evidence are available to help guide clinical decision making. Benefits of sustained tenofovir-based PrEP use in people with HBV include improved long-term HBV control with lower risk of liver-related complication, however potential challenges include lower likelihood of HBsAg loss compared with people with untreated HBV. By contrast, risks of oral PrEP discontinuation include HBV DNA reactivation, hepatitis flares, and acute liver failure although emerging data suggest tenofovir-based PrEP cessation in some people with HBV (i.e., HBeAg-negative) may be associated with higher incidence of HBsAg loss. Because real-world PrEP encompasses many scenarios – both potentially anticipated and unanticipated—including short-term and/or unmonitored PrEP use and multiple dosing options including new long-acting injectable cabotegravir, integrated systems or processes for HBV screening, monitoring, and treatment within newer PrEP programs may be helpful, especially in settings where HBV is relatively undiagnosed and/or untreated. Authors recommend all people with HBV initiating tenofovir-based PrEP undergo close follow-up and lab monitoring of HBV DNA, aminotransferases, and select HBV serologies. Indefinite use of tenofovir-inclusive PrEP should be considered in people with chronic HBV mono-infection. For people who have discontinued PrEP, authors recommend monitoring HBV DNA and aminotransferases at a minimum frequency of every 3 months for at least 1 year.

Author’s Commentary:

As authors note, uncertainty regarding PrEP safety with HBV and inconsistent antiviral use may play a role in preventing broader PrEP roll-out, despite many potential benefits in HIV prevention among people with HBV infection. Authors of this narrative review provide a useful synthesis of the benefits, risks, and key practical considerations regarding oral PrEP use in people with chronic HBV who do not meet anti-HBV treatment initiation criteria—and highlight important research priorities to address regarding PrEP use in people with chronic HBV. 

The author has no conflicts of interest to disclose.

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