Shorter treatment possible for HCV, phase 2 study finds

Abbreviated courses of direct-acting antivirals (DAAs) can achieve moderately high cure rates in patients with early hepatitis C virus (HCV) infection, a study reported.

Researchers conducted a single-arm, multicenter trial evaluating the treatment of early HCV (primary or re-infection) with four weeks of glecaprevir, 300 mg, and pibrentasvir, 120 mg, once daily. Early HCV was defined as new detectable HCV RNA or elevated levels of alanine aminotransferase within 24 weeks before study entry. The primary end point was sustained virologic response 12 weeks after prescribed treatment completion, while secondary end points included HCV RNA measurements. AbbVie provided the medication and partially funded the study but had no role in gathering or preparing the data or writing the manuscript.

Sixty-eight patients were screened and 45 enrolled between November 2019 and January 2023. Ninety-eight percent were male, 51% were White, and 31% were Hispanic. Median age was 36 years. Fifty-one percent had HIV infection, and 27% self-reported injecting drugs. The median time from HCV diagnosis to entry was 31 days, median baseline HCV RNA was 5.3 log₁₀ IU/mL, and median ALT level was 146 U/L. Results were published July 30 by Clinical Infectious Diseases.

In the study, 38 of 45 participants (84%; 90% CI, 74% to 91%) achieved sustained virologic response 12 weeks after finishing treatment, as did four participants who were retreated and had outcome data available.

The study authors noted that simplified approaches to treatment are critical for eliminating HCV and are particularly relevant for populations who are difficult to retain in care. They concluded that short treatment of early HCV infection was safe, well tolerated, and cured approximately 85% of participants.

Although the rate of sustained virologic response was lower than typical with six to eight weeks of treatment, most viral failures occurred in those with higher baseline HCV RNA titers, no new resistance-associated substitutions were detected, and those able to complete retreatment achieved sustained virologic response at 12 weeks.

“Treating early HCV infection allows for cure as soon as possible after diagnosis, reducing the risk of loss to follow-up associated with treatment delay and shortening the period of infectiousness, providing benefits through a treatment-as-prevention approach,” the authors wrote. “More attention to prompt provision of DAAs is warranted for vulnerable and marginalized populations at elevated risk for transmission, as incident infections represent a primary barrier to HCV elimination in the United States.”