OBJECTIVES: The impact on patient HRQoL of including ribavirin (RBV) in interferon-free hepatitis C virus (HCV) treatment has not been determined. We assessed the HRQoL impact of an all-oral HCV therapy, ombitasvir/paritaprevir/ritonavir and dasabuvir (OBV/PTV/r+DSV), with and without RBV in treatment naïve, non-cirrhotic, GT1a adults at the end of 12-week treatment in Phase 3 PEARL-IV trial. METHODS: HCV patients were randomized in a 1:2 ratio to OBV/PTV/r+DSV with RBV or OBV/PTV/r+DSV without RBV and treated during a 12-week double-blind period. HRQoL was assessed using the SF-36v2 Health Survey (SF-36) which was administered to patients at baseline, during treatment, at end of treatment (EOT) and at post-treatment (PT) visits. Physical Component Summary (PCS) and Mental Component Summary (MCS) scores were calculated for the SF-36. The statistical significance of differences between treatment groups in mean change from baseline to EOT was assessed. RESULTS: The analysis included 100 patients on OBV/PTV/r+DSV with RBV and 205 on OBV/PTV/r+DSV without RBV. At EOT, mean±SD decrements from baseline PCS and MCS scores were observed in the RBV group (change of -0.6±7.19 in PCS and -2.9±10.55 in MCS) while small increases were observed in the non-RBV group (change of +0.9±7.01 in PCS and +0.3±10.09 in MCS). The difference in mean change from baseline to EOT did not reach statistical significance for either PCS (p-value=0.105) or MCS (p-value=0.063). At PT week 24, mean changes from baseline were 2.4±5.19 in PCS and 2.6±6.99 in MCS in the RBV group, and 2.2±7.00 in PCS and 2.0±10.94 in MCS in the non-RBV group. CONCLUSIONS: At the end of 12-week treatment in PEARL-IV, the addition of RBV to the interferon-free all-oral OBV/PTV/r+DSV regimen did not have a significant impact on patient HRQoL in treatment-naïve GT1a patients. After treatment, PCS and MCS scores for both treatment groups showed similar improvement over baseline.