A phase IIIb study of ledipasvir/sofosbuvir fixed-dose combination tablet in treatment-naïve and treatment-experienced Korean patients chronically infected with genotype 1 hepatitis C virus.

Abstract

BACKGROUND:

The standard-of-care regimen for chronic hepatitis C virus (HCV) infection in Korea, pegylated-interferon-alpha plus ribavirin, is poorly tolerated. Ledipasvir/sofosbuvir is a two-drug, fixed-dose combination tablet approved in the USA, European Union, and Japan for chronic genotype 1 HCV infection.

METHODS:

This single-arm, phase IIIb study (NCT02021656) investigated the efficacy and safety of ledipasvir/sofosbuvir fixed-dose combination tablet for 12 weeks in treatment-naïve and treatment-experienced Korean patients chronically infected with genotype 1 HCV with or without compensated cirrhosis.

RESULTS:

The proportion of patients with sustained virologic response 12 weeks after treatment discontinuation (SVR12) was 99 % (92/93), with rates of 100 % (46/46) and 98 % (46/47) in treatment-naïve and treatment-experienced patients, respectively. There were no on-treatment failures. One patient relapsed after the end of treatment. The most common treatment-emergent adverse events were headache (8 %, 7/93) and fatigue (6 %, 6/93). There were no grade 3 or 4 adverse events, seven grade 3 laboratory abnormalities, and one premature discontinuation of study treatment (due to nonserious mouth ulceration). None of the three reported serious adverse events were related to treatment.

CONCLUSIONS:

These data suggest that 12 weeks of ledipasvir/sofosbuvir is effective and well tolerated in treatment-naïve and treatment-experienced Korean patients with chronic genotype 1 HCV infection.

• Authors: Young-Suk Lim, Sang Hoon Ahn, Kwan Sik Lee, Seung Woon Paik, Youn-Jae Lee, Sook-Hyang Jeong, Ju-Hyun Kim, Seung Kew Yoon, Hyung Joon Yim, Won Young Tak, Sang-Young Han, Jenny C Yang, Hongmei Mo, Kimberly L Garrison, Bing Gao, Steven J Knox, Phillip S Pang, Yoon Jun Kim, Kwan-Soo Byun, Young Seok Kim, Jeong Heo, Kwang-Hyub Han
• Journal: Hepatology international (Hepatol Int) Vol. 10 Issue 6 Pg. 947-955 (Nov 2016) ISSN: 1936-0541 [Electronic] United States
• PMID: 27198664 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study)

Chemical References

• Antiviral Agents
• Benzimidazoles
• Fluorenes
• Tablets
• ledipasvir, sofosbuvir drug combination
• Uridine Monophosphate
• Sofosbuvir

Topics

• Adult
• Aged
• Antiviral Agents (administration & dosage, adverse effects)
• Benzimidazoles (administration & dosage, adverse effects)
• Drug Administration Schedule
• Female
• Fluorenes (administration & dosage, adverse effects)
• Genotype
• Hepacivirus (genetics)
• Hepatitis C, Chronic (drug therapy)
• Humans
• Male
• Middle Aged
• Republic of Korea
• Sofosbuvir
• Sustained Virologic Response
• Tablets
• Treatment Outcome
• Uridine Monophosphate (administration & dosage, adverse effects, analogs & derivatives)
• Young Adult