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.

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.

• Authors: Anca Trifan, Carol Stanciu, Laura Iliescu, Ioan Sporea, Liliana Baroiu, Mircea Diculescu, Mihaela-Catalina Luca, Egidia Miftode, Cristina Cijevschi, Catalina Mihai, Zeno-Adrian Sparchez, Cristina Pojoga, Adrian Streinu-Cercel, Liliana Gheorghe
• Journal: Journal of gastrointestinal and liver diseases : JGLD (J Gastrointestin Liver Dis) Vol. 30 Issue 1 Pg. 88-93 (Mar 13 2021) ISSN: 1842-1121 [Electronic] Romania
• PMID: 33723561 (Publication Type: Journal Article)

Chemical References

• Anilides
• Antiviral Agents
• Cyclopropanes
• Lactams, Macrocyclic
• Sulfonamides
• ombitasvir
• Uracil
• Proline
• 2-Naphthylamine
• dasabuvir
• Valine
• Ritonavir
• paritaprevir

Topics

• 2-Naphthylamine (administration & dosage)
• Adult
• Aged
• Aged, 80 and over
• Anilides (administration & dosage, therapeutic use)
• Antiviral Agents (administration & dosage)
• Cyclopropanes (administration & dosage, therapeutic use)
• Drug Therapy, Combination
• Female
• Hepatitis C, Chronic (drug therapy, pathology)
• Humans
• Lactams, Macrocyclic (administration & dosage, therapeutic use)
• Liver Cirrhosis (virology)
• Male
• Middle Aged
• Proline (administration & dosage, analogs & derivatives, therapeutic use)
• Retrospective Studies
• Ritonavir (administration & dosage, therapeutic use)
• Romania
• Sulfonamides (administration & dosage, therapeutic use)
• Time Factors
• Uracil (administration & dosage, analogs & derivatives)
• Valine (administration & dosage, therapeutic use)