High Dose Versus Standard Dose of Ribavirin in Patients With Chronic Hepatitis C, Genotype 3

Summary

The rate of sustained virological response (SVR) in patients with chronic hepatitis C, genotype 3, high viral load and without rapid virological response (RNA-HCV negative at week 4) is low. Standard of care of these patients include treatment with weekly peginterferon plus 800 mg/day of ribavirin (RBV). Extended treatment to 48 weeks does not provide more clinical benefit than the standard duration. The main hypothesis is that higher dose of ribavirin may be better in terms of SVR than the standard dose.

Timeline

Start

2008-11

Primary completion

2011-09

Completion

2011-12

Outcome

Missed primary endpoint

paper Intention-to-treat (ITT) analysis showed SVR rates of 64.3% (A) and 61.8% (B), with a reduction of -2.5% (-21.8% to 16.9%) (p=0.835). PMID 24360571 ↗

paper G3 patients with high viral load without RVR did not obtain a benefit from a higher dose of RBV. PMID 24360571 ↗

Publications

• Fernandez-Rodriguez CM, Morillas RM, Masnou H, Navarro JM, Barcena R, Gonzalez JM, Martin-Martin L, Poyato A, Miquel-Planas M, Jorquera F, Casanovas T, Salmeron J, Calleja JL, Sola R, Alonso S, Planas R, Romero-Gomez M. Randomized clinical trial comparing high versus standard dose of ribavirin plus peginterferon alfa-2a in hepatitis C genotype 3 and high viral load. Dargen-3 study. Gastroenterol Hepatol. 2014 Jan;37(1):1-8. doi: 10.1016/j.gastrohep.2013.10.005. Epub 2013 Dec 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Peginterferon alfa-2a	Protein / enzyme biologic	180 ug	Subcutaneous
Subject	Ribavirin	Small molecule	800 mg	Oral
Subject	Ribavirin	Small molecule	1600 mg	Oral
Background	Epo Beta	Unknown	450 iu/kg	Subcutaneous

Indications