Abstract

Background: There is a paucity of patient-reported outcomes (PRO) data for people undergoing HCV treatment who are managed with opioid substitution therapy (OST) for addiction. Methods: Patients enrolled in phase 3 clinical trials of sofosbuvir completed 4 PRO instruments: SF-36v2, FACIT-F, CLDQ-HCV, and WPAI-HCV before, during, and post-treatment. Results: 8,450 HCV subjects were included; 4.8% (N=407) were on OST. At baseline, OST subjects had significantly (p<0.0001) lower PRO scores (by -3.5 to -15.6 on a 0-100 scale). By the end of treatment, subjects receiving IFN+RBV+SOF experienced significant decreases in PROs regardless of OST use. Subjects receiving IFN-free RBV+ regimens had significant but smaller PRO decreases, again similar in OST and non-OST. Finally, subjects treated with IFN/RBV-free regimens showed improvements in nearly all PROs during treatment, more pronounced in OST subjects. Achieving SVR-12 was associated with improvement of PROs in IFN/RBV-free-treated OST patients. In contrast, OST subjects who achieved SVR-12 with IFN+RBV+SOF did not have consistent PRO gains post-SVR. Conclusions: Receiving IFN-free regimens leads to PRO improvement during treatment and after SVR regardless of OST status. HCV subjects on OST did not experience similar PRO improvements with IFN-containing therapy, suggesting that IFN-based therapy may be less suitable for this vulnerable population.

Link to publisher’s web site