[971] IT78047 TRIAL. A RANDOMIZED, MULTICENTRE STUDY OF PEGYLATED INTERFERON ALFA 2 A PLUS TWO DIFFERENT DOSES OF RIBAVIRIN IN THE TREATMENT OF PATIENTS WITH CHRONIC HEPATITIS C AND HIV INFECTION

2nd International AIDS Society Conference on HIV Pathogenesis and Treatment

Paris, France - July 13 - 16, 2003

[TITLE:] IT78047 TRIAL. A RANDOMIZED, MULTICENTRE STUDY OF PEGYLATED INTERFERON ALFA 2 A PLUS TWO DIFFERENT DOSES OF RIBAVIRIN IN THE TREATMENT OF PATIENTS WITH CHRONIC HEPATITIS C AND HIV INFECTION

[AUTHOR(S):] J Parra-Ruiz¹, J Hernandez-Quero¹, E Perez-Guzman², R Granados-Monzon³, F Lozano-Leon⁴, M Alonso-Socas⁵ and E Jimenez-Mejias⁶ on behalf of IT78047 Study Group
¹San Cecilio Clinic Hospital, Granada Spain; ²Puerta del Mar Hospital, Cadiz, Spain; ³Dr Negrin Hospital, Las Palmas de Gran Canaria, Spain; ⁴Valme Hospital, Seville, Spain; ⁵University Hospital, Tenerife, Spain; and ⁶Virgen del Rocio Hospital, Seville, Spain

IAS Conf HIV Pathog Treat 2003 Jul 13-16;2nd: Abstract No. 971
Antiviral Therapy 2003; 8(Suppl. 1):S458

[ABSTRACT:] Pilot, multicentric, prospective and aleatorized trial of the efficacy of combination therapy with pegylated interferon alfa 2-a (pegIFNα 2a) 180 mcg weekly plus two different doses of ribavirin (RBV) 1000 mg or 800 mg daily in patients with chronic hepatitis C (liver biopsy), altered values of ALT and controlled HIV infection with or without HAART. All the 144 patients included in the study, and prior to inclusion, had quantitative assay of HCV-RNA, by PCR, and genotyping. Those who had HCV-RNA positive at 24 weeks were considered as treatment failures and were excluded. The primary efficacy endpoint was the rate of sustained virological responders, defined as the HCVRNA clearance (by PCR) 6 months after the end of treatment. Secondary endpoint was the normalization of ALT levels. Results were evaluated according to an intention-to-treat analysis. We present the results of an interim analysis at weeks 12 and 24. At week 12, 66 of 122 patients (54%) had HCV-RNA negative. At week 24, 65 of 110 (59%) patients had HCV-RNA negative. Among patients with genotype 1, 28 of 59 (47%) had HCV-RNA negative, 27 of 31 (87%) among genotype 3 and 10 of 19 (52%) among genotype 4. Withdrawal of medication was needed in 9 patients because of side effects and in 15 because of personal decision. A dose reduction of pegIFNα 2a was necessary in 32 patients (29%). RBV was reduced in 19 (17%) Combination therapy with pegIFNα 2a+RBV has a high early virological response rate with a good tolerability.

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