Open AccessEffectiveness of 8- and 12-Week Treatment with Ombitasvir/ Paritaprevir/Ritonavir and Dasabuvir in Treatment-Naïve HCV Patients in a Real-Life Setting in Romania: the AMETHYST Study
Author(s) -
Anca Trifan,
C Stanciu,
Laura Iliescu,
Ioan Sporea,
Liliana Baroiu,
Mircea Diculescu,
M. De Luca,
Egidia Miftode,
C Cijevschi,
Mihai Craiu,
Zeno-Adrian Sparchez,
Cristina Pojoga,
Adrian Streinu-Cercel,
L. Gheorghe
Publication year - 2021
Publication title -
journal of gastrointestinal and liver diseases
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.641
H-Index - 48
eISSN - 1842-1121
pISSN - 1841-8724
DOI - 10.15403/jgld-3373
Subject(s) - ombitasvir , dasabuvir , paritaprevir , medicine , ritonavir , regimen , tolerability , ledipasvir , hepatitis c , clinical endpoint , gastroenterology , hepatitis c virus , clinical trial , immunology , viral load , adverse effect , ribavirin , human immunodeficiency virus (hiv) , virus , antiretroviral therapy
Background and Aims: The 12-week regimen of ombitasvir/paritaprevir/ritonavir and dasabuvir (OPrD) has shown high efficacy and tolerability in clinical trials for the treatment of chronic hepatitis C virus (HCV). The shorter 8-week regimen has been recently incorporated into clinical guidelines and on-label indications, but real-world evidence on its use is limited. Given this knowledge gap, the AMETHYST study aimed to evaluate the effectiveness of the 8- and 12-week regimens of OPrD in treatment-naive patients with HCV with mild to moderate liver fibrosis in Romanian clinical practice.
Methods: This was a secondary data collection study analyzing data from a 1-year Patient Support Program in HCV in Romania. Patients received OPrD treatment for 8 or 12 weeks. The effectiveness endpoint was sustained virologic response 12 weeks post-treatment (SVR12).
Results: A total of 1,835 treatment-naive patients with HCV with mild or moderate fibrosis were included in the study. Of these, 426 and 1,375 completed the 8-week and 12-week regimens, respectively. SVR12 was 98.1% in the 8-week treatment group and 98.7% in the 12-week treatment group.
Conclusion: The study provides real-world evidence that 8-week and 12-week treatment regimens of OPrD are highly effective in treatment-naive patients with HCV with mild to moderate liver fibrosis.