Treatment of
A multinational study carried out in 2023 found sustained virologic clearance 12 weeks following treatment completion (SVR12) in 78% of patients given four weeks of G/P.2 The majority of patients were in the early phase of HCV with a median infection duration of 17 weeks. The population was mostly composed of white men who have sex with men (MSM) with concurrent HIV infection. This study was only able to enroll 23 patients due to the COVID-19 pandemic. The authors acknowledged that this study was limited in generalizability due to a small sample size and a limited portion of PWID (30%).
The PURGE-C Study
The PURGE-C study was a phase 2, open-label, single-arm, international (United States and Brazil) trial.3 Eligible participants were adults with confirmed early HCV infection. It could be a first-time infection or reinfection if there was available documented clearance of past HCV. Participants living with HIV (PWH) needed to be on antiretroviral therapy and have a suppressed HIV viral load (HIV-1 RNA
What You Need to Know
The PURGE-C trial found that a four-week regimen of glecaprevir/pibrentasvir achieved SVR12 in 84% of patients with early hepatitis C infection, indicating that shorter treatment durations may be feasible.
Initiating therapy during the early phase of HCV infection may improve outcomes and support viral clearance before chronic infection develops.
Despite promising results, the study’s small sample size and underrepresentation of persons who inject drugs highlight the need for larger, more diverse trials before routine adoption of abbreviated regimens.
Out of 68 participants screened, 45 were enrolled between November 2019 and January 2023. The median age was 36 and only one patient was female. Participants were predominantly white (51%), followed by Hispanic (31%) and Black (27%). Half of the patients also were HIV positive, and 12 patients (27%) were PWID. The median time from HCV diagnosis to starting G/P was 31 days. The majority (84%) of infections were the participant’s first HCV infection. Median baseline alanine transaminase levels were elevated to 146 U/L and the median HCV RNA was 5.3 log10 IU/mL.
Of the 45 patients with early HCV treated with four weeks of G/P, 38 (84%) achieved SVR12. Out of the seven individuals who experienced treatment failure, six had additional information available. A breakdown of the six evaluable treatment failures is available in Table 1. When looking specifically at PWH, 83% achieved SVR12. Out of the 12 PWID, 9 (75%) achieved SVR12. Most participants (73%) experienced moderate or higher AEs throughout the treatment and screening process, which were often moderate elevations in creatinine or liver inflammation markers, or occurrence of other infections not likely to be related to G/P use. No adverse effects related to the study-treatment led to premature discontinuation.
Any healthcare provider involved in the treatment of HCV has worked with patients who struggle to adhere to their medication. The PURGE-C study contributes to a small body of literature that suggests only four weeks of G/P may be sufficient to treat HCV. PURGE-C also contributes to the evidence that SVR12 rates can be appropriate when treatment is initiated in the early phase.
Only 27% of participants were PWID, again limiting generalizability to a population that is not only highly susceptible to HCV, but also may be facing the highest barriers to medication access. In clinical practice, G/P should still be given for eight weeks as currently indicated, however, if patients are only able to complete four weeks of therapy and are outside the appropriate window to resume, it may be worthwhile to check for SVR12. Otherwise, more robust data will be needed before providers can start suggesting four weeks of G/P for all patients with barriers to adherence.