Background:
To achieve the WHO HCV elimination goal, it is critical to link patients with acute HCV to care early to prevent further transmission. Current AASLD and EASL guidelines recommend treating acute HCV without delay. Glecaprevir (GLE)/pibrentasvir (PIB) is currently approved for chronic HCV treatment. This phase 3b single-arm study examined efficacy and safety of GLE/PIB in adults with acute HCV.
Methods:
An 8-week regimen of GLE/PIB was studied in adults with acute HCV infection (Table 1) who had not previously been treated for the current infection. Efficacy endpoints included achievement of sustained virologic response at 12 weeks after the last GLE/PIB dose (SVR12), assessed in both the ITT set of all subjects receiving ≥1 GLE/PIB dose and in the modified ITT set (mITT-VF, excluding those who did not achieve SVR12 for reasons other than virologic failure). Safety endpoints included alanine aminotransferase (ALT) and total bilirubin elevations from baseline during treatment, treatment-emergent (TE) serious adverse events (TESAEs), and TEAEs leading to GLE/PIB discontinuation.
Results:
286 subjects were enrolled and treated (median age, 43.0 years; median HCV RNA, 5.37 log10 IU/mL), 14.3% had a history of illicit injection drug use within 12 months prior to treatment, and 49.7% had HIV co-infection. SVR12 was achieved by 96.2% and 100% in the ITT and mITT-VF set, respectively. None of the 286 subjects had ALT >3× upper limit of normal (ULN) that had worsened from baseline, post-nadir ALT >3× ULN + total bilirubin >2× ULN, or hepatic decompensation. One subject had a TEAE leading to GLE/PIB discontinuation that was considered unrelated to GLE/PIB. TESAEs were experienced by 10 subjects (3.5%). None were considered related to GLE/PIB.
Conclusion:
This study demonstrates that in subjects with acute HCV infection, 8-week treatment with GLE/PIB was safe and effective, resulting in high rates of SVR12. |