Olivia C. Welter, PharmD
The American Association for the Study of Liver Diseases and the Infectious Diseases Society of America recently released updated guidance on testing, treating, and managing hepatitis C.
The updated guidance, published online in Clinical Infectious Disease on July 23, 2023, is focused on recommendations for addressing nonadherence; treatment options for children as young as 3 years old; hepatitis C virus (HCV)–positive organ donation; eligibility changes for a simplified treatment approach; and therapy in vulnerable populations, including incarcerated persons.
Treatment nonadherence
HCV can be treated with direct acting antivirals (DAA). Though the course of therapy is considered to be complete at 8 or 12 weeks, the guidance specifies that up to 40% of patients do not adhere to their treatment regimen.
To address this, the guidance panel developed a new treatment algorithm for patients that considers the timing and duration of nonadherence. The algorithm is broken down into two categories: interruptions prior to receiving 28 days of DAA therapy and interruptions after receiving 28 or more days of DAA therapy.
For all patients who are first nonadherent to their DAA therapy before 28 days, the panel recommends immediately restarting the course of treatment. If a patient misses 7 or fewer days, no other action is needed. If a patient misses 8 or more days, they should immediately receive an HCV RNA test after restarting therapy. If the test returns a negative reading, the patient should complete the medication for the full duration. If positive, the treatment should be extended by 4 weeks.
For patients whose nonadherence occurs after 28 days of treatment and who miss 7 or fewer days, they can immediately restart DAA and continue for the full duration. If a patient misses 8 to 20 consecutive days, they should immediately restart therapy and receive an HCV RNA test.
A negative test indicates that a patient should complete the full duration of therapy, which can be extended in certain circumstances. A positive test indicates stopping treatment and instead following a separate set of recommendations that is laid out in the retreatment section of the guidance document. Patients who miss 21 consecutive days of therapy or more should follow the same steps as a patient with a positive HCV RNA test.
Simplified treatment eligibility
The panel’s updated recommendations for treating chronic HCV infection expands patient eligibility, reduces clinician intervention, and simplifies the process overall. Studies on minimal monitoring have shown that patients who are coinfected with HIV can safely follow a simplified HCV treatment algorithm, meaning no laboratory monitoring is needed while taking DAAs.
The guidance now states that patients who are treatment-naïve and HIV/HCV coinfected are newly eligible for simplified treatment because of these findings.
In recent years, more data have been published that show DAA therapy is both safe and effective in transplant patients. Because of this, the guidance document notes that solid organs from donors with HCV can be used effectively in patients who are HCV-negative. This strategy increases the pool of available organs and expands access to transplantation, ultimately reducing wait-list times.
HCV treatment in children and vulnerable populations
Historically, adults have been the target population for treating HCV and related diseases. However, recent studies have shown that children as young as 3 years old can safely use DAAs to treat HCV. The guidance recommends that any child 3 years or older should be treated with DAAs regardless of disease severity.
The guidance also offers recommendations on HCV treatment among vulnerable populations, including people who inject drugs (PWID), men who have sex with men (MSM), and incarcerated people.
PWID should receive annual HCV testing if injectable drug use is ongoing. The guidance notes that substance use disorder treatment programs and needle/syringe exchange programs should facilitate routine, opt-out HCV antibody testing, and subsequent linkage to care.
Initiation appointments for PrEP for MSM are an important touchpoint for testing for HCV. Sites that prescribe PrEP should offer testing at initiation appointments and annually thereafter for their MSM patients.
Because incarcerated people have a higher prevalence of HCV than the general population, jails and prisons should implement universal opt-out testing for HCV. The guidance states that DAA treatment is feasible for incarcerated peeople whether the therapy is initiated in the correctional system, a continuation of established treatment, or a continuation of treatment upon release. ■
The panel’s updated recommendations for treating chronic HCV infection expands patient eligibility, reduces clinician intervention, and simplifies the process overall.