[976] FACTORS RELATED TO OUTCOME OF TREATMENT WITH PEGYLATED INTERFERON ALPHA 2b (PEG INF) PLUS RIBAVIRIN (RBV) IN HCV/HIV-CO-INFECTED PATIENTS

2nd International AIDS Society Conference on HIV Pathogenesis and Treatment

Paris, France - July 13 - 16, 2003

[TITLE:] FACTORS RELATED TO OUTCOME OF TREATMENT WITH PEGYLATED INTERFERON ALPHA 2b (PEG INF) PLUS RIBAVIRIN (RBV) IN HCV/HIV-CO-INFECTED PATIENTS

[AUTHOR(S):] E Voigt¹, C Schulz¹, S Mauss², G Klausen³, J Goelz³, D Schranz⁴, FA Mosthaf⁵ and JK Rockstroh¹
¹University of Bonn, Germany; ²Private Practice, Duesseldorf, Germany; ³Praxiszentrum Kaiserdamm, Berlin, Germany; ⁴Private Practice, Berlin, Germany; and ⁵Private Practice, Karlsruhe, Germany

IAS Conf HIV Pathog Treat 2003 Jul 13-16;2nd: Abstract No. 976
Antiviral Therapy 2003; 8(Suppl. 1):S459

[ABSTRACT:] Background: Response rates under treatment with INF plus RBV appear to be lower in HIV/HCV-co-infected than in HCV-mono-infected patients. We analysed factors related to sustained response (SR) or nonresponse (NR) in a cohort of co-infected patients receiving peg INF plus RBV.

Methods: Within this open-label, uncontrolled, multicenter trial patients receive peg INF α 2b 1.5 µg/kg/week plus 800 mg RBV/day. HCV RNA, HIV RNA, CD4 cell count, blood count and liver enzymes are assessed at baseline and at weeks 4, 12, 24, 48, 60 and 72. 121 patients have been enrolled so far. Here we present data on 58 patients who already completed 24 weeks follow-up.

Results: 15/58 (26%) patients showed sustained response with undetectable HCV RNA at week 24 of follow up. 43/58 patients showed non-response, of whom nine experienced relapse after showing end of treatment-response. Six patients discontinued prior to week 12 and were counted for as nonresponders. With regard to treatment outcome no differences in median age (SR: 40 years, range 29–58; NR: 39 years, range 23–58) or median CD4 cell count (SR: 457×10⁶/l, range 242–986×10⁶/l; NR: 451×10⁶/l, range 150–1288) at baseline could be observed. Female participants experienced sustained response in 33% (7/21), compared with 22% (8/37) of male subjects. However, this difference was not statistically significant (P> 0.1). Sustained response rates were significantly higher in patients with HCV genotype 2/3 (50%, 9/18), compared with patients infected with HCV genotypes 1/4 (17%, 6/36, P<0.01). Patients showing an early treatment response with undetectable HCV RNA at week 12, were significantly more likely to achieve sustained response (15/25, 60%), than patients without (0/27, P<0.001).

Conclusions: Overall sustained response rates in HIV/HCV-co-infected patients treated with peg INF plus RBV are lower compared with historical data from HCV-mono-infected patients. However, several factors affect treatment outcome. Genotypes 2 and 3 favour sustained treatment response. Moreover, early response appears to be a predictive factor in co-infected as well as in HCV-mono-infected patients.

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