[973] HIV-HCV CO-INFECTION: TO TREAT OR NOT TO TREAT

2nd International AIDS Society Conference on HIV Pathogenesis and Treatment

Paris, France - July 13 - 16, 2003

[TITLE:] HIV-HCV CO-INFECTION: TO TREAT OR NOT TO TREAT

[AUTHOR(S):] S Hopkins, G Farrell, F Mulcahy and C Bergin
Dept. of Genitourinary Medicine and Infectious Diseases, St James’s Hospital, Dublin, Ireland

IAS Conf HIV Pathog Treat 2003 Jul 13-16;2nd: Abstract No. 973
Antiviral Therapy 2003; 8(Suppl. 1):S458

[ABSTRACT:] Background: The rapid decline in HIV related morbidity & mortality since the mid 1990s has been paralleled with increasing morbidity & mortality associated with hepatitis C co-infection. Studies in co-infected patients with standard interferon and ribavirin showed sustained viral response rates from 13–38%. With studies in HCV mono-infected patients suggesting SVR of 54–58% with pegylated interferon and ribavirin, safety and efficacy studies in co-infected patients are urgently required.

Methods: A prospective open label study (to n=100) was initiated in the dept. in June 2001. All suitable patients were commenced on Peg-intron (P)(1.5 mcg/kg/wk) and ribavirin (R) (1,000–1,200 mg/d). All patients were initially commenced for 24 weeks; genotype 1 and 4 were continued for a further 24 wks if a virological response had occurred at week 24. A pharmacokinetic substudy for those on antiretroviral therapy (ART) monitoring HIV viral loads (VL), CD4, intracellular levels of nucleoside reverse transcriptase inhibitors (NRTIs) and associated toxicity recruited concurrently. Statistical analysis was performed using Wilcoxen signed rank test, Fishers test and (2.

Results: Mean age was 36 yrs (24–53 yrs). 85% were men. Mode of acquisition was IDU, 60%, sexual, 12.5% and blood products, 27.5%. Of those that had a liver biopsy performed 60% had moderate fibrosis and 40% had severe fibrosis. 35% were genotype 1. 56% were on antiretroviral therapy (ART) with a mean VL of 50(96 cpm and CD4 of 503(268x10⁶/l. For those not on ART mean VL was 30,429(22,224cpm and mean CD4 was 503(268x10⁶/l. On ITT analysis, 57% had an end of treatment response (G1: 22% and Gnon1: 75%). Sustained response rates (66% cohort data) were seen in 52% (G1: 0% and Gnon1: 75%). 24% of the cohort prematurely discontinued treatment for toxicities (psychiatric 70%). There were 2 deaths on treatment (HCC & COPD). Other significant toxicities included thyroid dysfn. and retinopathy. Severe haematological side effects occurred in 16% (no discontinuations), which were managed with erythropoietin, GCSF & P-R dose reductions.

Conclusions: Successful outcomes can be achieved in HIV HCV co-infected patients with P-R. Multidisciplinary involvement is required to minimize discontinuations secondary to toxicities in this cohort.

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