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Efficacy and safety of elbasvir/grazoprevir for 8 or 12 weeks for hepatitis C virus genotype 4 infection: A randomized study
- Source :
- Liver International, Liver International, Wiley-Blackwell, 2020, 40 (5), pp.1042-1051. ⟨10.1111/liv.14313⟩
- Publication Year :
- 2020
- Publisher :
- HAL CCSD, 2020.
-
Abstract
- International audience; Background & Aims Hepatitis C virus (HCV) genotype (GT) 4 infection is prevalent in sub-Saharan Africa and the Middle East, particularly in Egypt. This study evaluated the safety and efficacy of elbasvir/grazoprevir administered for 8 and 12 weeks in participants with HCV GT4 infection. Methods In this partially randomized, open-label multicentre study conducted in France (NCT03111108; Protocol MK5172-096), treatment-naive participants with GT4 infection and F0-F2 fibrosis were randomized 2:1 to elbasvir (50 mg)/grazoprevir (100 mg) for 8 or 12 weeks. Treatment-naive participants with F3-F4 fibrosis and all treatment-experienced participants (F0-F4) were assigned to elbasvir/grazoprevir for 12 weeks. The primary endpoint was sustained virologic response (SVR) 12 weeks after the end of therapy. Results One hundred and seventeen participants were enrolled. Among treatment-naive participants with F0-F2 fibrosis, SVR was achieved by 94% (50/53) and 96% (26/27) of those receiving elbasvir/grazoprevir for 8 or 12 weeks, respectively, and four participants relapsed. In the 12-week arm, 95% (35/37) achieved SVR and two participants relapsed. NS5A resistance-associated substitutions were present at baseline and virologic failure in five of the participants with relapse. Drug-related adverse events occurred in 42% (n = 22) and 50% (n = 32) of participants receiving 8 and 12 weeks of treatment, respectively. No participant discontinued treatment owing to an adverse event. Conclusion These data confirm the efficacy of elbasvir/grazoprevir administered for 12 weeks in treatment-experienced individuals with HCV GT4 infection and those with advanced fibrosis. Treatment-naive individuals with mild fibrosis can be treated effectively with an 8-week regimen.
- Subjects :
- Cyclopropanes
medicine.medical_specialty
Elbasvir
Genotype
[SDV]Life Sciences [q-bio]
Hepacivirus
Antiviral Agents
law.invention
03 medical and health sciences
0302 clinical medicine
Randomized controlled trial
law
Quinoxalines
Internal medicine
medicine
Clinical endpoint
Humans
Elbasvir, Grazoprevir
Adverse effect
Benzofurans
Sulfonamides
Hepatology
business.industry
Imidazoles
Hepatitis C
Hepatitis C, Chronic
medicine.disease
Amides
Regimen
Grazoprevir
030220 oncology & carcinogenesis
Drug Therapy, Combination
Egypt
030211 gastroenterology & hepatology
Carbamates
France
business
Subjects
Details
- Language :
- English
- ISSN :
- 14783223 and 14783231
- Database :
- OpenAIRE
- Journal :
- Liver International, Liver International, Wiley-Blackwell, 2020, 40 (5), pp.1042-1051. ⟨10.1111/liv.14313⟩
- Accession number :
- edsair.doi.dedup.....2c4661dfe96532cdabc04228e2db4487