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Retrospective multicentre study on the effectiveness of first-line direct-acting antivirals against hepatitis C virus
Michihiro Kaya1, Kazuyo Nakamura1, Kyohei Sugiyama1
1Department of Pharmacy, Shizuoka General Hospital, Shizuoka City, Shizuoka, Japan.
Insights
Direct-acting antivirals for hepatitis C virus genotype 1, including ledipasvir/sofosbuvir, elbasvir/grazoprevir, and glecaprevir/pibrentasvir, show high effectiveness and safety. This real-world study confirms their efficacy in untreated patients in Japan.
Area of Science:
- Hepatology
- Virology
- Pharmacology
Background:
- Hepatitis C virus (HCV) genotype 1 is a significant global health concern.
- Ledipasvir/sofosbuvir, elbasvir/grazoprevir, and glecaprevir/pibrentasvir are recommended first-line treatments in Japan.
- Direct comparative studies on these regimens in real-world settings are lacking.
Purpose of the Study:
- To evaluate the real-world effectiveness and safety of ledipasvir/sofosbuvir, elbasvir/grazoprevir, and glecaprevir/pibrentasvir.
- To compare these direct-acting antiviral regimens in untreated HCV genotype 1 patients.
- To provide evidence for clinical decision-making in HCV treatment.
Main Methods:
- Retrospective multicenter study.
- Inclusion of untreated patients with persistent HCV genotype 1 infection.
- Data collected from September 2015 to January 2019 across 11 Japanese medical institutions.
- Primary endpoint: sustained virologic response (SVR) at 12 weeks.
Main Results:
- High SVR rates observed for all regimens: 98.6% (ledipasvir/sofosbuvir), 97.9% (elbasvir/grazoprevir), and 100% (glecaprevir/pibrentasvir) at 12 weeks.
- SVR rates at 24 weeks and end-of-treatment response rates were also high across all groups.
- Treatment completion rates were 98.3%, 91.7%, and 100% respectively, indicating good safety profiles.
Conclusions:
- Ledipasvir/sofosbuvir, elbasvir/grazoprevir, and glecaprevir/pibrentasvir demonstrate high effectiveness in real-world clinical practice for HCV genotype 1.
- These direct-acting antiviral regimens are safe and well-tolerated in untreated patient populations.
- The study supports the use of these agents as effective first-line treatments for HCV genotype 1 in Japan.
What Is Known And Objective:
In Japan, ledipasvir/sofosbuvir, elbasvir/grazoprevir and glecaprevir/pibrentasvir are recommended as first-line treatments for patients with untreated hepatitis C virus genotype 1. Although they have demonstrated a high efficacy in clinical trials, there are no direct comparative studies. Clarification of their effectiveness and safety in real-world clinical practice is required. Therefore, we conducted a retrospective multicentre study on the effectiveness of these direct-acting antivirals in real-world clinical practice.
Methods:
We retrospectively evaluated the clinical data of untreated patients with persistent HCV genotype 1 infection who started first-line treatment with ledipasvir/sofosbuvir, elbasvir/grazoprevir or glecaprevir/pibrentasvir between September 2015 and January 2019 at 11 medical institutions in Japan. The primary efficacy endpoint was a sustained virologic response after 12 weeks of treatment. The secondary endpoints included sustained virologic response after 24 weeks of treatment and end of treatment response. The safety endpoint was treatment completion rate.
Results And Discussion:
During the study, 420 patients (median age, 70 years; 181 males) received ledipasvir/sofosbuvir, 48 (median age 72, years; 29 males) received elbasvir/grazoprevir and 63 (median age 66, years; 35 males) received glecaprevir/pibrentasvir. For ledipasvir/sofosbuvir, elbasvir/grazoprevir and glecaprevir/pibrentasvir, the sustained virologic response after 12 weeks of treatment was 98.6%, 97.9% and 100%; the sustained virologic response after 24 weeks of treatment was 99.0%, 97.7% and 100%; the end of treatment response was 99.8%, 97.9% and 98.4%; and the treatment completion rate was 98.3%, 91.7% and 100% respectively.
What Is New And Conclusion:
In real-world clinical practice, hepatitis C virus treatment with ledipasvir/sofosbuvir, elbasvir/grazoprevir and glecaprevir/pibrentasvir was effective with safety.
