title: Quality of life of Japanese patients with chronic hepatitis C treated with ledipasvir and sofosbuvir.
abstract: The interferon (IFN)-free regimens for chronic hepatitis C (CHC) have high efficacy and superior health-related quality of life (HRQOL) in European/North American patients. The impact of these regimens on HRQOL of the Japanese CHC patients is not known.The Short Form-36 was administered before, during, and after treatment to CHC patients with genotype 1 treated with ledipasvir/sofosbuvir ± ribavirin (LDV/SOF ± RBV) for 12 weeks and genotype 2 treated with SOF + RBV for 12 weeks in clinical trials. The HRQOL data were analyzed with reference to treatment regimens and clinical factors.A total of 494 CHC patients were included (19% cirrhotic, 69% genotype 1, 52% treatment-naive; 153 received SOF + RBV, 170 received LDV/SOF + RBV, 171 received LDV/SOF). The sustained virologic response-12 rates for these regimens were 97%, 98%, and 100%, respectively. CHC patients treated with LDV/SOF, SOF + RBV, or LDV/SOF + RBV regimens had similar HRQOL scores at baseline. During treatment, more adverse events were experienced by those treated with RBV-containing regimens (46% vs 22%, P < 0.0001). The decrements in HRQOL were also significant in RBV groups: up to -3.8 points (treatment week-4), -5.2 (treatment week-12), and -3.2 (posttreatment week-12) (all P < 0.001). In contrast, RBV-free regimen (LDV/SOF) was associated with an improvement in HRQOL up to +4.1 points throughout the treatment (P < 0.01). In multivariate analysis, the use of RBV was independently associated with lower HRQOL during and after treatment (beta up to -6.4 points, P = 0.0001).Japanese CHC patients treated with RBV-containing regimens show mild HRQOL impairment. In contrast, patients treated with LDV/SOF not only showed high efficacy but also improvement of HRQOL.
authors.affiliation: Center for Liver Diseases Beatty Liver and Obesity Research Program, Department of Medicine, Inova Fairfax Hospital, VA, USA Yamanashi Prefectural Hospital Organization, Yamanashi Kohnodai Hospital, National Center for Global Health and Medicine, Chiba, Japan Center for Outcomes Research in Liver Diseases, Washington DC, USA.
authors.forename: Zobair M
authors.initials: ZM
authors.lastname: Younossi
authors.forename: Maria
authors.initials: M
authors.lastname: Stepanova
authors.forename: Masao
authors.initials: M
authors.lastname: Omata
authors.forename: Masashi
authors.initials: M
authors.lastname: Mizokami
authors.forename: Mercedes
authors.initials: M
authors.lastname: Walters
authors.forename: Sharon
authors.initials: S
authors.lastname: Hunt
mesh_terms: D000998:Antiviral Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001562:Benzimidazoles / Q000008:administration & dosage / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D005449:Fluorenes / Q000008:administration & dosage / Q000627:therapeutic use*; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000523:psychology; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D012254:Ribavirin / Q000008:administration & dosage / Q000627:therapeutic use; D000069474:Sofosbuvir / Q000008:administration & dosage / Q000627:therapeutic use*; D011795:Surveys and Questionnaires
chemical_list: D000998:Antiviral Agents; D001562:Benzimidazoles; D005449:Fluorenes; C586541:ledipasvir; D012254:Ribavirin; D000069474:Sofosbuvir