Subgroup differences in response to 8 weeks of ledipasvir/sofosbuvir for chronic hepatitis C

Thomas R O'Brien; Krystle A Lang Kuhs; Ruth M Pfeiffer

doi:10.1093/ofid/ofu110

Subgroup differences in response to 8 weeks of ledipasvir/sofosbuvir for chronic hepatitis C

Open Forum Infect Dis. 2014 Dec 13;1(3):ofu110. doi: 10.1093/ofid/ofu110. eCollection 2014 Dec.

Authors

Thomas R O'Brien¹, Krystle A Lang Kuhs¹, Ruth M Pfeiffer²

Affiliations

¹ Infections and Immunoepidemiology Branch .
² Biostatistics Branch, Division of Cancer Epidemiology and Genetics , National Cancer Institute , Bethesda, Maryland.

Abstract

Treatment of hepatitis C virus (HCV) infection with ledipasvir/sofosbuvir promises tremendous benefits, but high cost may impede implementation of this regimen. Subgroups with excellent response to 8 weeks of treatment might respond to a shorter course. In ION-3, 423 previously untreated HCV genotype 1-infected patients without cirrhosis had outcome data after receiving ledipasvir/sofosbuvir for 8 weeks. After reanalyzing published ION-3 data, we found that sustained virologic response (SVR) rates varied significantly by gender (P = .002) and rs12979860 genotype (P trend = .03), exceeding 98% in women and rs12979860-CC individuals. The very high SVR rates in these subgroups suggest that these factors might be considered in selecting patients to receive 8 weeks of ledipasvir/sofosbuvir and support shorter trials of this regimen in selected patients.

Keywords: IFNL4; clinical trial; cost-effectiveness; direct-acting antiviral agents; gender; hepatitis C virus.