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Keeping up with changes in HCV guidance: An update on the latest recommendations

Debika Bhattacharya, MD, MSc
Vincent Lo Re, MD, MSCE, FIDSA
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Hepatitis C virus illustrationThe landscape of the hepatitis C virus epidemic is always changing, and clinicians rely on timely, evidence-based guidance to navigate the evolving terrain, which now includes the effects of the COVID-19 pandemic. Debika Bhattacharya, MD, MSc, and Vincent Lo Re III, MD, MSCE, FIDSA — two co-chairs of the HCV Guidance Panel, a collaborative effort of IDSA and the American Association for the Study of Liver Diseases — recently answered questions from Science Speaks about the panel’s new article in Clinical Infectious Diseases, which highlights recent updates to the guidance since the panel’s previous journal publication in 2020. The panel provides rapid updates and recommendations through a web-based platform.

This update includes an ongoing emphasis on universal screening for HCV, which the guidance panel first called for in 2019. How has the implementation of universal screening progressed since then?

In 2020, the U.S. Preventive Services Task Force also called for implementation of universal screening — a welcome recommendation from an influential policymaking group. However, messaging and uptake was understandably waylaid by the COVID-19 pandemic, which occurred at the same time. Indeed, U.S. data from the early pandemic supports this, wherein HCV RNA testing remained at 39% below baseline in July 2020. Decreases in HCV testing translate into decreases in treatment; in the same study, there was a contemporaneous decline in the number of HCV treatments dispensed. This is the reason we wanted to highlight the importance of universal HCV screening with this update — to make sure that this recommendation was again underscored so that we can increase HCV screening rates to above and beyond pre-pandemic levels.

People with HIV are now included in the guidance’s simplified HCV treatment algorithm. What prompted this update and how do you see it impacting treatment in this population?

There were several reasons the guidance panel now includes people with HIV in the simplified HCV treatment algorithm, but the most important were the findings of the AIDS Clinical Trials Group MINMON study and the evolution towards integrase strand transfer inhibitor–based regimens as primary antiretroviral therapy regimens for HIV. The ACTG MINMON study evaluated a simplified treatment regimen, much like the algorithm in the HCV guidance, with minimal monitoring on therapy and dispensation of the entire course of medication at treatment initiation. In this study, 42% (166/399) of participants were people with HIV, and the overall sustained virological response rate at 12 weeks was 95%, with no difference in sustained virological response rates between those with and without HIV. This study suggested that this simplified approach could also be utilized in those with HIV. Finally, with the increasing use of integrase strand transfer inhibitor-based regimens, the likelihood of significant drug-drug interactions with HCV protease inhibitors, in particular, are minimized. Complex potential drug-drug interactions were a significant concern with older HIV and HCV regimens. We hope that these expanded inclusion criteria will improve access to HCV therapy for those with HIV.

How does the updated guidance address the management of incomplete treatment adherence?

Incomplete adherence is common, occurring in 11%-40% of individuals on treatment. Acknowledging that there is limited data on the optimal management of incomplete adherence, the guidance panel utilized existing observational data and the experience and opinion of the members of the panel. The panel considered the timing and duration of nonadherence as well as patient factors (HCV genotype and presence of cirrhosis) in recommending whether to continue with the original number of doses or to extend therapy. In general, those with harder to treat conditions (HCV genotype 3 and/or cirrhosis) are recommended to extend therapy by an additional 4 weeks if more than 8 days of therapy are missed and HCV RNA is undetectable when assessed at the time of incomplete adherence.

What does the guidance recommend regarding treatment for individuals with HCV residing in correctional settings like jails or prisons, and how does the guidance address the issues of cost and feasibility?

Recent cross-sectional surveys suggest that the HCV seroprevalence among incarcerated populations in the U.S. may be as high as 34.6%, which greatly exceeds the 1.7% HCV seroprevalence in the general population. Given the high HCV prevalence among persons in the U.S. correctional system, the success of the U.S. HCV elimination effort depends on identifying HCV-infected individuals in jails and prisons, linking these persons to medical care for HCV management and providing access to antiviral treatment. The HCV guidance recommends that jails and prisons should implement opt-out HCV testing consisting of HCV antibody testing followed by confirmatory HCV RNA testing if antibody-positive. Universal opt-out testing of incarcerated persons for chronic HCV is highly cost-effective and has been shown to reduce ongoing HCV transmission and the incidence of advanced liver disease.

Treatment for chronic HCV infection is feasible within jail and prison settings and would aid the HCV elimination effort. The HCV guidance recommends that chronically infected persons residing in jails should receive counseling about HCV infection and be provided linkage to follow-up community health care for evaluation of liver disease and treatment upon release. The guidance also recommends that those whose jail sentence is sufficiently long to complete a recommended course of HCV therapy should receive that treatment while incarcerated. Chronically infected individuals in prison should receive HCV therapy according to IDSA and the American Association for the Study of Liver Diseases guidance while incarcerated. Jails and prisons should facilitate continuation of HCV therapy for persons on HCV treatment at the time of incarceration. HCV treatment in correctional settings is cost-effective because HCV antivirals halt progression of HCV-related liver disease and decrease the risk of cirrhosis, hepatic decompensation and hepatocellular carcinoma, offsetting future health care costs from liver and non-liver complications.

The guidance includes management and treatment recommendations in the transplantation setting. What have we learned about the use of direct-acting antiviral treatment in these patients?

Clinical trial and real-world data have provided robust evidence supporting both the safety and efficacy of HCV direct-acting antiviral treatment in patients who have undergone solid organ transplantation. Investigators who conducted a real-world observational study evaluating the efficacy and safety of direct-acting antiviral treatment in liver, kidney, or dual liver and kidney transplant recipients reported a cure rate of 94% among participants treated with combination ledipasvir/sofosbuvir. Adverse events, including acute cellular rejection, were rare. In addition, a trial evaluating a 12-week course of once daily glecaprevir/pibrentasvir HCV treatment among patients without cirrhosis who had undergone liver or kidney transplantation experienced a cure rate of 98%. No treatment-related serious adverse events were reported.

Read the guidance panel's new article, "Hepatitis C Guidance 2023 Update: AASLD-IDSA Recommendations for Testing, Managing, and Treating Hepatitis C Virus Infection," on the CID website. 



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