HCV in HIV and Pregnancy: UK Clinical Challenges and New CROI 2019 Data

Chloe Orkin Photo
Chloe Orkin, MBChB, FRCP, MD

Professor of HIV
Queen Mary, University of London
Consultant Physician
Lead for HIV Research
Barts Health NHS Trust
The Royal London Hospital
London, United Kingdom

Chloe Orkin, MBChB, FRCP, MD, has disclosed that she has participated on speaker bureaus for, received consulting fees from, and received funds for research support from Gilead Sciences, Janssen, MSD, and ViiV Healthcare.

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Released: May 9, 2019

The 2019 Conference on Retroviruses and Opportunistic Infections (CROI) held in Seattle, Washington, showcased the latest research across many relevant clinical topics. Below I summarise the clinical challenge presented by acute hepatitis C (AHC) infection in the UK and in Europe and highlight the public health implications of 2 important presentations. I also summarise one study evaluating HCV treatment during late pregnancy.

Clinical Challenge: Why Is Prompt Treatment of AHC in Patients With HIV Coinfection an Important Step in Reaching Hepatitis C Elimination Goals?
The WHO has set prevention and treatment targets that, if reached, would eliminate HCV as a public health threat by 2030. One of these targets is a 90% reduction in new HCV infections. Data from mathematical modelling studies and real-life cohorts have suggested that treating AHC with direct-acting antivirals (DAAs) reduces incident infections. However, despite several successful trials assessing DAAs in AHC/HIV coinfection, no DAAs are currently licensed for this indication, and treatment access has been limited due to high cost. The British HIV Association has set a microelimination target for HCV infection in the HIV-infected population by April 2021. Achieving this will require not only treatment for all, but also strategies to test those at high risk of reinfection and treat them early in order to limit onward transmission.

CROI 2019: AHC in European Observational Cohorts
Two important studies on treating AHC were presented at CROI 2019. The PROBE-C study, a large European cohort study evaluating spontaneous AHC clearance and DAA treatment, showed that DAA therapy was usually deferred for at least 6 months. Because of this, nearly 90% of patients (409/464) went on to develop chronic HCV infection. As newly infected individuals are known to be at high risk of transmitting the infection, this delay in treatment can undermine microelimination efforts.

A second report described a decrease in HCV incidence amongst HIV-positive men who have sex with men (MSM) following increased DAA access at 3 London clinics that collectively care for more than 6000 MSM living with HIV. During the 5-year period (2013-2018), the study identified 256 AHC diagnoses comprising 211 first infections and 45 reinfections, and the average time from diagnosis to treatment decreased from 41 to 3 months. Incidence of HCV infection peaked in 2015 in this cohort, followed by a 68% reduction in overall infections and a nearly 80% reduction in first infections in 2018 compared with the peak. Of concern, during the past 12 months, more than 40% of acute infections were reinfections. Taken together, this reduction in incidence with increased DAA access falls short of the WHO target to reduce new infections by 90% as the reinfection rate remains high and may be increasing. In addition, these data collectively highlight the ongoing need to promote and improve risk reduction strategies and design appropriate screening policies for both HIV-positive and HIV-negative MSM.

Clinical Challenge: HCV Treatment in Late Pregnancy
Although studies in pregnant women are complicated by ethical issues regarding enrollment, they are very important. Last year, a signal suggesting a potential increased risk of neural tube defects amongst infants born to women with HIV who were receiving dolutegravir at the time of conception was identified in a large African cohort. This highlighted the fact that clinical trials often lack women who wish to conceive and generally exclude pregnant women, resulting in an absence of data on novel agents in these populations. This is also a problem in HCV, where the changing epidemiology in some regions of the world is resulting in substantial increases in rates of infection among pregnant women and women of childbearing age.

Addressing the Gap: CROI 2019 Data on HCV Treatment During Pregnancy
HCV transmission rates from mother to infant range from approximately 5% to 8%. At CROI 2019, data were presented from an open-label study evaluating the safety and efficacy of ledipasvir/sofosbuvir 90/400 mg in late pregnancy in 9 HIV-negative pregnant women with viremic HCV infection. This regimen showed excellent efficacy, with all women cured of HCV infection and all infants remaining HCV negative, and no mother or infant safety concerns. Watch this space!

Your Thoughts
What are your thoughts about treatment of acute HCV infection? Would you suggest enrollment on a clinical trial for a pregnant woman with HCV infection? Please join the conversation and share your experiences in the comments box below. For more details on this and other key studies from CROI 2019, review more Conference Coverage, including CCO’s summary slidesets and audio from a series of postconference Webinars.

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