Phase IV Study to Evaluate the Efficacy/Safety to Extend Treatment and High Dose of Ribavirin in co-Infected Patients

Summary

To compare the sustained virological response (SVR = ribonucleic acid (RNA) - hepatitis C virus (HCV) undetectable at week 24 before end the treatment) in chronic hepatitis C patients genotype 1-4 co-infected with HIV-HCV, treated with Peginterferón alfa-2a (40 KD) 180 µg/week and Ribavirin (2000 mg/day during 4 weeks, follow of 1000-1200 mg/day, according to body weight); versus Peginterferón alfa-2a (40 KD) 180 μg/week and Ribavirin (1000-1200 mg/day, according to body weight). To evaluate the impact to extend the treatment with Peginterferon alfa-2a and Ribavirin to week 72, in SVR of these patients with genotypes 1-4 without rapid virological response (RVR = RNA - HCV undetectable at 4 week).

Timeline

Start

2007-06

Primary completion

—

Completion

2010-02

Publications

• Vispo E, Labarga P, Guardiola JM, Barreiro P, Miralles C, Rubio R, Miralles P, Aguirrebengoa K, Portu J, Morello J, Rodriguez-Novoa S, Soriano V; PERICO Study Group. Preemptive erythropoietin plus high ribavirin doses to increase rapid virological responses in HIV patients treated for chronic hepatitis C. AIDS Res Hum Retroviruses. 2010 Apr;26(4):419-24. doi: 10.1089/aid.2009.0120.

Drugs

Indications