1. 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.
- Author
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Trifan A, Stanciu C, Iliescu L, Sporea I, Baroiu L, Diculescu M, Luca MC, Miftode E, Cijevschi C, Mihai C, Sparchez ZA, Pojoga C, Streinu-Cercel A, and Gheorghe L
- Subjects
- Adult, Aged, Aged, 80 and over, Anilides therapeutic use, Cyclopropanes therapeutic use, Drug Therapy, Combination, Female, Hepatitis C, Chronic pathology, Humans, Lactams, Macrocyclic therapeutic use, Liver Cirrhosis virology, Male, Middle Aged, Proline administration & dosage, Proline therapeutic use, Retrospective Studies, Ritonavir therapeutic use, Romania, Sulfonamides therapeutic use, Time Factors, Uracil administration & dosage, Valine therapeutic use, 2-Naphthylamine administration & dosage, Anilides administration & dosage, Antiviral Agents administration & dosage, Cyclopropanes administration & dosage, Hepatitis C, Chronic drug therapy, Lactams, Macrocyclic administration & dosage, Proline analogs & derivatives, Ritonavir administration & dosage, Sulfonamides administration & dosage, Uracil analogs & derivatives, Valine administration & dosage
- Abstract
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.
- Published
- 2021
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