Sixth International Congress Drug Therapy in HIV Infection 17-21 November, 2002 Glasgow, UK

Background: Morbidity and mortality related to HIV infection has significantly decreased due to the introduction of highly active antiretroviral therapy (HAART). However, morbidity associated with Hepatitis C (HCV) is increasingly affecting the HIV/HCV co-infected cohort. With response rates to pegylated interferon and ribavirin in the HCV mono-infected cohort approaching 50%, it is essential that clinical studies are performed to identify the safety, tolerability and efficacy of interferon and ribavirin in the co-infected cohort.

Methods: Safety, tolerability and efficacy of pegylated interferon 1.5mcg/kg/ weekly (Schering Plough) and ribavirin 1000-1200mg/d for 6-12 months was assessed in a prospective open labelled study in chronic HCV/HIV coinfected patients. All patients had a CD4 count > 200 x 10⁶/ml. Patients on HAART were also recruited to a pharmacokinetic substudy assessing clinical interactions with HAART, HIV infection and intracellular levels of nucleoside reverse transcriptase inhibitors pre and post the commencement of ribavirin. Recruitment of patients is ongoing with 40 patients enrolled to date. Intention to treat analysis (where discontinuation = failure) was used to assess efficacy. Statistical analysis was performed using SPSS 10.0.

Results: Infection was predominantly acquired through intravenous drug users (76%). Other risk groups were haemophiliacs (10%), heterosexual (10%) and homosexuals (4%). The majority were virologically stable on HAART 58%); the remainder did not require HAART as per current international guidelines. 34% patients were infected with genotype 1/4 and 66% with genotype 2/3. 85% were male and mean age was 37 years (range 24-49yrs). Median liver biopsy score was 3 (range 2-6). Intention to treat (ITT) analysis identified 4-week response rates (RR) of 35%; 12-week RR of 48%; end of treatment RR of 35%; and sustained RR of 32%. On subanalysis, ITT identified 80% RR for genotype 3/4 and 10% for genotype 1/4. The only predictor of response was genotype (2/3 compared to1/4, P<0.001). Nonpredictors of response included gender, age, baseline HCV viral load, CD4 count, HAART, normalisation of liver function tests or grade of fibrosis/ cirrhosis. Severe adverse events were seen in 28% resulting in premature discontinuations in 18% of total cohort. These were predominantly haematological (managed with erythropoeitin, G-CSF and blood products) and psychiatric. Two patients died while on study medication (hepatocellular carcinoma and chronic obstructive pulmonary disease). One patient selfdiscontinued and did not return for follow up.

Conclusions: Early response rates in genotype non-1 populations appear to be similar to the HCV mono-infected cohorts. However, rates of treatment discontinuation and severe adverse events were higher in this HCV/HIV coinfected cohort. This study provides early evidence for successful treatment of co-infected patients in specialised centres.

Presenting author: Susan Hopkins

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1 Department of GenitoUrinary Medicine & Infectious Diseases, St James’ Hospital, Dublin, Ireland

2002-11-17
PL7-3

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