In patients with chronic hepatitis C virus (HCV) infection who did not achieve a sustained virologic response (SVR) with a prior direct-acting antiviral (DAA) regimen, treatment with sofosbuvir/velpatasvir/voxilaprevir improves patient-reported outcomes, according to results published in Liver International.
The study included participants with chronic HCV infection who had previously been treated with DAAs who had been randomly assigned to receive placebo treatment in the POLARIS-1 study (ClinicalTrials.gov Identifier: NCT02607735; n=147). These participants were then treated in the open-label deferred treatment sub-study with sofosbuvir 400 mg, velpatasvir 100 mg, and voxilaprevir 100 mg daily for 12 weeks.
The researchers prospectively collected patient-reported outcomes using the Short-Form-36 (SF-36), the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), the Chronic Liver Disease Questionnaire-HCV Version (CLDQ-HCV), and the Work Productivity Activity Index: Specific Health Problem (WPAI:SHP) at baseline, at treatments weeks 4 and 12, and at week 4, 12, and 24 of post-treatment follow-up.
During treatment with placebo, participants did not report any change in outcomes from baseline (P >.05), except for the Worry domain of CLDQ-HCV.
After participants initiated treatment with sofosbuvir/velpatasvir/voxilaprevir, there were significant improvements in patient reported outcomes. At treatment week 4, participants reported improvements of +2.4% to +8.1% (P <.05) for 6 out of 26 outcomes.
At treatment week 12, they reported improvements of +2.0% to +8.3% for 14 out of 26 outcomes (P <.05).
Participants who achieved SVR had similar or greater improvement in patient-reported outcomes: +2.5% to +11.9% for 24 out of 26 domains by SVR-12 (P<.05); +3.2% to +14.9% for 23 out of 26 by SVR-24 (P <.05).
After multivariate regression analysis, the researchers found that being viremic was associated with reduced patient-reported outcomes of −2.4% to −8.5% (P <.05) for all except one PRO.
“We believe that the most important implication of these data is related to the decision to treat HCV infection since it has been shown that patients treated with an interferon-free ribavirin-free DAA-based regimen achieve over 97% SVR rates, and their [patient-reported outcomes] scores also improve in a durable fashion,” the researchers wrote.
This study was funded by Gilead Sciences.
Younossi ZM, Stepanova M, Reddy KR, et al. Viral eradication is required for sustained improvement of patient-reported outcomes in patients with hepatitis C [published online June 12, 2018]. Liver Int. doi:10.1111/liv.13900