Journal of gastrointestinal and liver diseases : JGLD · 2021
Effectiveness 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.
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Trifan Anca, Stanciu Carol, Iliescu Laura, Sporea Ioan, Baroiu Liliana, Diculescu Mircea, Luca Mihaela-Catalina, Miftode Egidia, Cijevschi Cristina, Mihai Catalina, Sparchez Zeno-Adrian, Pojoga Cristina, Streinu-Cercel Adrian, Gheorghe Liliana
Аннотация
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.
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.