Retrospective multicentre study on the effectiveness of first-line direct-acting antivirals against hepatitis C virus genotype-1.

Abstract

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.

• Authors: Michihiro Kaya, Kazuyo Nakamura, Kyohei Sugiyama, Ayumi Kinae, Hiromi Yamaguchi, Hirotoshi Ukita, Keiichi Odagiri, Chika Ujiie, Jun Kato, Fujito Kageyama, Mariko Nagura, Kumi Matsushita, Kaori Sugiue, Hiroki Ishida, Shinya Endo, Takaya Suzuki
• Journal: Journal of clinical pharmacy and therapeutics (J Clin Pharm Ther) Vol. 47 Issue 7 Pg. 940-947 (Jul 2022) ISSN: 1365-2710 [Electronic] England
• PMID: 35229326 (Publication Type: Journal Article, Multicenter Study)
• Copyright: © 2022 The Authors. Journal of Clinical Pharmacy and Therapeutics published by John Wiley & Sons Ltd.

Chemical References

• Antiviral Agents
• Cyclopropanes
• Sofosbuvir

Topics

• Aged
• Antiviral Agents (adverse effects)
• Cyclopropanes (therapeutic use)
• Drug Therapy, Combination
• Genotype
• Hepacivirus (genetics)
• Hepatitis C, Chronic (drug therapy)
• Humans
• Male
• Retrospective Studies
• Sofosbuvir (adverse effects)