Role of Ribavirin in the Era of Direct–Acting Antiviral Therapies of Chronic Hepatitis C

ABSTRACT

Background

The efficacy of adding ribavirin (RBV) to direct antivirals (DAAs) in HCV treatment is still debatable, with allegations of insecure profiles.

Objectives

To evaluate safety and efficacy of RBV in the era of DAAs in chronic HCV Egyptian patients.

Methods

In this cohort retrospective study, data of 847 HCV patients treated with different regimens of DAAs with or without RBV were recruited between June 2017 and September 2018. Cases were categorized into five groups: non-cirrhotic (318), compensated (196), decompensated liver cirrhosis (53), post liver transplantation (30), and 250 treatment experienced patients. All patients’ demographics and laboratory characteristics were evaluated at baseline, week_{4, 12, 24} of treatment. Ribavirin was prescribed or banned outside international guideline recommendations of HCV treatment in cases assembled from the private sector.Results: No statistically significant difference between RBV and non-RBV treated patients was documented regarding SVR₁₂ (97.2%, 97.8%) respectively in the whole cohort (p 0.509). On grouping, adding RBV was only significant in the treatment experienced patients (96.8%, 85% in RBV and non-RBV regimens respectively) (p 0.001). Adding RBV to DAA regimens was generally associated with modest adverse events particularly anemia (8.5%), and hepatic decompensation (jaundice and ascites) (0.3%). Bilirubin, INR, and platelet counts all were found to be the most independent predictors of SVR achievement by multivariate analysis (p ≤ 0.05).Conclusion: RBV may still have an augmenting role in treatment experienced patients; permitting effectual shortening of therapy particularly in patients with cirrhosis, with modest side and adverse consequences.

KEYWORDS:

• Ribavirin
• DAAs
• HCV
• SVR
• sofosbuvir

Acknowledgments

The authors are indebted to the great professor Dr Omkolsoum Alhaddad for her unlimited, sincere, and priceless inputs complying this work to be fulfilled. Also, all authors are indebted to Dr Marwa Tahoon for her valued suggestions.

Author contributions

O Alhaddad initiated the project, designed, and implemented the study for application and revised the paper. M Elsabaawy conceived and designed the study and contributed in analyzing and writing the paper. A Wahb monitored data collection, F Khalil laboratory assessment of the data, D Elsabaawy, pharmacologic data analysis, H Elshazly revised the paper, and M Rady revised and approved the paper.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.