Olivia C. Welter, Pharm.D.
The American Association for the Study of Liver Diseases and the Infectious Diseases Society of America recently released updated guidelines on the testing, treatment, and management of hepatitis C.
The updated guidance is published online at clinical infectious diseases July 23, 2023, focusing on recommendations to address non-adherence; treatment options for children under 3 years of age; Hepatitis C virus (HCV) – positive for organ donation; eligibility changes to streamline treatments; and support for vulnerable populations including treatment of incarcerated persons).
Treatment noncompliance
HCV can be treated with direct-acting antiviral drugs (DAAs). Although the treatment course is considered complete at 8 or 12 weeks, guidelines state that up to 40% of patients do not adhere to their treatment regimen.
To address this issue, the steering group developed a new treatment algorithm for patients that takes into account the timing and duration of noncompliance. The algorithm was divided into two categories: interruptions before 28 days of DAA treatment and interruptions after 28 or more days of DAA treatment.
For all patients who first failed to adhere to DAA therapy before 28 days, the panel recommended restarting the treatment course immediately. If the patient is absent for 7 days or less, no additional measures are required. If patients miss 8 or more days, they should undergo HCV RNA testing immediately after reinitiating treatment. If the test returns a negative reading, the patient should complete the entire course of medication. If positive, treatment should be extended for 4 weeks.
For patients who become noncompliant after 28 days of treatment and miss 7 or fewer days, the DAA can be restarted immediately and the full course of treatment continued. If the patient misses 8 to 20 consecutive days, treatment should be restarted immediately and HCV RNA testing should be performed.
A negative test indicates that the patient should complete the entire duration of treatment, which may be extended in some cases. A positive test indicates discontinuation of treatment and instead follows a separate set of recommendations listed in the retreatment section of the guidance document. Patients who miss treatment for 21 consecutive days or more should follow the same steps as patients who test positive for HCV RNA.
Simplified treatment eligibility
The panel’s latest recommendations for treating chronic hepatitis C virus infection expand patient eligibility, reduce clinical interventions and streamline the overall process. Minimally monitored studies indicate that HIV-coinfected patients can safely follow a simplified HCV treatment algorithm, meaning that laboratory monitoring is not required while taking DAAs.
The guidance now states that as a result of these findings, treatment-naïve HIV/HCV co-infected patients are newly eligible for simplified treatment.
In recent years, a growing body of data has shown that DAA therapy is both safe and effective in transplant patients. Therefore, the guidance document states that solid organs from HCV donors can be effectively used in HCV-negative patients. This strategy increases the number of available organs and expands transplant opportunities, ultimately reducing wait times.
Hepatitis C treatment for children and vulnerable groups
Historically, adults have been the target population for treatment of HCV and related diseases. However, recent studies have shown that DAAs can be used safely to treat HCV in children as young as 3 years old. The guidelines recommend that any child 3 years of age or older should receive DAA treatment, regardless of disease severity.
The guideline also provides recommendations for hepatitis C treatment in vulnerable populations, including people who inject drugs (PWID), men who have sex with men (MSM), and incarcerated people.
People who inject drugs should get annual HCV testing if they continue to use injection drugs. The guidance states that substance use disorder treatment programs and needle/syringe exchange programs should promote routine, opt-out HCV antibody testing and subsequent linkage to care.
MSM’s PrEP initiation appointment is an important touch point for HCV testing. Sites that offer PrEP should offer testing to their MSM patients at the first appointment and annually thereafter.
Because HCV infection rates among incarcerated people are higher than among the general population, jails and prisons should implement universal HCV opt-out testing. The guidance states that DAA treatment is available for incarcerated individuals regardless of whether treatment is initiated in the correctional system, continues established treatment, or continues after release. ■
The panel’s latest recommendations for treating chronic hepatitis C virus infection expand patient eligibility, reduce clinical interventions and streamline the overall process.