Language
English
Publication Date
1-1-2023
Journal
Annals of Hepatology
DOI
10.1016/j.aohep.2023.100899
PMID
36632975
Abstract
Introduction and objectives: In clinical trials, patients with hepatitis C virus (HCV) genotype (GT)1a infection and baseline resistance-associated substitutions (RASs) at amino acid positions 28, 30, 31, or 93 receiving elbasvir/grazoprevir for 12 weeks achieved lower rates of sustained virologic response (SVR) than those without baseline RASs. SVR rates in patients with RASs were improved when elbasvir/grazoprevir treatment duration was extended from 12 to 16 weeks and administered concomitantly with ribavirin.
Materials and methods: This was a retrospective, observational analysis using electronic health record abstraction. Patients with HCV GT1a infection and RASs at positions 28, 30, 31, or 93 who were prescribed 16 weeks of elbasvir/grazoprevir and ≥ 1 prescription for ribavirin were included. SVR was defined as HCV RNA below the lower limit of quantification ≥ 70 days after end of treatment.
Results: The primary analysis included patients with baseline RASs at positions 30, 31, or 93 (n = 76); a secondary analysis included patients with RASs at positions 28, 30, 31, or 93 (n = 93). SVR was achieved by 77.6% (59/76) of patients in the primary analysis and 80.6% (75/93) of those in the secondary analysis. Of the 18 (19.4%) patients in the secondary cohort who failed to achieve SVR, 8 relapsed (4 with treatment-emergent NS5A substitutions) and 10 did not have viral sequencing to distinguish relapse from reinfection.
Conclusions: This analysis highlights the opportunities in leveraging real-world data to further understand treatment outcomes in smaller, discrete subgroups of patients with HCV infection who cannot be thoroughly evaluated in clinical trials.
Keywords
Humans, Ribavirin, Hepacivirus, Antiviral Agents, Hepatitis C, Chronic, Drug Therapy, Combination, Neoplasm Recurrence, Local, Hepatitis C, Sustained Virologic Response, RNA, Viral, Genotype, Drug Resistance, Viral, Baseline resistance, DAA, Hepatitis C virus, NS5A, treatment
Published Open-Access
yes
Recommended Citation
Hill, Deanna D; Kramer, Jennifer R; Chaffin, Kassie R; et al., "Effectiveness of Elbasvir/Grazoprevir Plus Ribavirin for Hepatitis C Virus Genotype 1A Infection and Baseline ns5a Resistance" (2023). Faculty and Staff Publications. 4576.
https://digitalcommons.library.tmc.edu/baylor_docs/4576