Eight-Week Hepatitis C Treatment with New Direct Acting Antivirals Has a Better Safety Profile While Being Effective in the Treatment-Naïve Geriatric Population Without Liver Cirrhosis and Hepatitis C Virus-RNA < 6 Million IU/mL.
Dig Dis Sci
; 63(12): 3480-3486, 2018 12.
Article
in En
| MEDLINE
| ID: mdl-30259281
ABSTRACT
AIM:
Results of recent studies have confirmed the efficacy of an 8-week course of ledipasvir/sofosbuvir (LDV/SOF) in patients who are non-cirrhotics, native to treatment, are infected with hepatitis C (HCV) genotype 1, and have HCV viral load < 6 million IU/mL. However, there are limited data on a shortened treatment course in patients who are over the age of 65.METHODS:
A retrospective study was performed to examine the safety, tolerability, and sustained viral response rates (SVR) of the 8-week LDV/SOF therapy compared to the 12-week LDV/SOF therapy among non-cirrhotic, treatment-naïve, genotype 1 HCV patients with viral load < 6 million IU/mL who are 65 years of age or older.RESULTS:
A total of 454 patients were identified of which 182 non-cirrhotic, genotype 1 HCV-RNA < 6 million IU/mL patients received the 8-week LDV/SOF treatment and 272 received the 12-week LDV/SOF treatment. Mean [± standard deviation (SD)] aspartate aminotransferase to platelet ratio index score for the entire cohort was 0.45 ± 0.03. The mean (± SD) age for the 8-week treatment was 69.7 (± 7) years, 54.7% male and 45.3% female. The mean (± SD) age of the 12-week treatment was 71.7 (± 3) years, 56.4% male and 43.6% female. Overall, SVR-12 for the 8-week regimen was 93% and SVR-12 for the 12-week regimen was 95%. For the 182 treated with the 8-week LDV/SOF treatment, there were no serious adverse events requiring hospitalization or signs of liver failure requiring transplantation. Overall, the 8-week treatment patient cohort experienced less fatigue, headache, dry mouth, and diarrhea. This finding was statistically significant with a P value < 0.001.CONCLUSION:
Eight-week LDV/SOF therapy in treatment-naive, non-cirrhotic, genotype 1 HCV patients with RNA < 6 million IU/mL was found safe, better tolerated, effective, and required less upfront cost when compared with the 12-week LDV/SOF treatment regimen in properly selected geriatric population.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Uridine Monophosphate
/
Benzimidazoles
/
Hepatitis C
/
Hepacivirus
/
Fluorenes
Type of study:
Diagnostic_studies
/
Observational_studies
/
Prognostic_studies
/
Risk_factors_studies
Limits:
Aged
/
Female
/
Humans
/
Male
/
Middle aged
Country/Region as subject:
America do norte
Language:
En
Journal:
Dig Dis Sci
Year:
2018
Document type:
Article
Affiliation country:
Estados Unidos