IDSA, AASLD Hepatitis C Guidelines Offer Strategies for Incomplete Adherence

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The new guidelines for the first time offer guidance for patients who are not fully adherent to direct-acting antivirals.

The Infectious Disease Society of America and the American Association for the Study of Liver Diseases have released updated guidance on testing for, managing, and treating hepatitis C virus (HCV) infection.

The guidelines offer new strategies for physicians managing patients who are not completely adherent to direct-acting antiviral (DAA) therapy, and also reiterate the importance of universal screening in the fight to stop transmission of the virus.

In an email to Contagion, corresponding author Vincent Lo Re, MD, MSCE, of the Perelman School of Medicine at the University of Pennsylvania, and Debika Bhattacharya, MD, MSc, of the University of California Los Angeles, said they hope the updates will help further reduce the burden of HCV-related disease.

“In addition, we also believe that the guidance around incomplete treatment adherence will help providers navigate this common scenario,” they said.

DAAs have made a transformative impact on the treatment of HCV infection, but a significant number of patients do not completely adhere to their treatment plans. It is not known exactly how common incomplete adherence to DAAs is, but the guidelines refer to studies suggesting the rate is likely somewhere between 11% and 40%.

However, the guidance panel also noted that most people who miss doses quickly get back on track. One study found 61% of nonadherent episodes lasted just one or two days, which did not appear to be not long enough to affect virologic response. Longer periods of non-adherence do have the potential to affect the likelihood of a sustained virologic response (SVR), the guidelines note.

Lo Re and Bhattacharya said the importance of DAAs and the prevalence of incomplete adherence underscore the need for guidelines that address the real-world scenarios providers face. They said the path forward from incomplete adherence will vary from patient to patient.

“This is the first-time incomplete adherence has been addressed in the HCV guidance, and the update provides a detailed approach to the management of antiviral non-adherence with key considerations, including duration of incomplete adherence and patient-specific factors, like cirrhosis and HCV genotype,” they said.

The investigators also noted that people with HIV coinfection have now been factored into the simplified treatment algorithm for the first time. That decision was driven in part by a study showing people with and without HIV had similar rates of SVR at 12 weeks.

One thing that has not changed in the updated guidelines is the emphasis on universal screening for HCV. The guidance panel first recommended universal screening of adults in 2019, and the Centers for Disease Control and Prevention adopted similar guidelines the following year, adding that pregnant women should be screened with each pregnancy.

The guidance panel noted that universal HCV screening is cost-effective, as are DAAs. They added that shifts in the epidemiology of the disease have meant that incident infections now occur primarily in young adults.

“Universal screening is a crucial and necessary component of any HCV elimination strategy because it is the entry point into the HCV continuum of care,” the guidelines state.

Lo Re and Bhattacharya said the goal of the guidelines is to eliminate the disease, meaning to stop its transmission and prevent HCV-related liver complications. Given that DAAs can now cure an estimated 95% of people with chronic HCV infection who are treated, that goal is seen as achievable, they said. However, they said several hurdles remain, including the opioid epidemic, which has been tied to an increase in the incidence of acute HCV infection.

“HCV elimination has also been challenged by insufficient HCV diagnosis, linkage to care, and access to antiviral therapy,” they wrote. “Implementation of HCV test and treatment approaches as well as increased access to HCV treatment regimens will aid elimination.”

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