AEGiS-13IAC: Ttreatment of hepatitis C with recombinant alpha 2a interferon (RIFNA2A) in HIV seropositives in the HAART era.

13th International AIDS Conference

Durban, South Africa - July 9-July 14, 2000

Ttreatment of hepatitis C with recombinant alpha 2a interferon (RIFNA2A) in HIV seropositives in the HAART era.

Int Conf AIDS 2000 Jul 9-14; 13:(abstract no. ThOrB659)

Zaltron S, Carosi G, Puoti M, Zaltron S, Zanini B, Putzolu V, Delle Foglie P, Quinzan P, Costa P, Marino R, Andreoni M, Stagni G
S.Zaltron, Clinica di Malattie Infettive, Spedali Civili, P.zza Spedali 1, 25123 Brescia, Italy, Tel.: +39 030 399 5671, Fax: +39 030 303 061, E-mail: puoti_brambilla@iol.it

Aims: To assess: efficacy , tolerability, effect on HIV infection of rIFN2a treatment in HIV-HCV coinfected patients. Design: Multicentre, open, randomised, controlled trial aimed to compare rIFNa2a 6 MIU s.c. TW for 12 months with no treatment.

METHODS: Inclusion criteria were: chronic hepatitis C as the only cause of liver damage, no contraindication to rIFNa2a, compensated liver disease and CD4> 300/mmc in the last 6 m. Patients were monitored monthly with biochemistry, complete blood counts and thrimestrally with Amplicor HCV 2.0, thyroid hormones, HIVRNA and CD4. rIFNa2a was stopped in the presence of WHO class IV and dose was halved in the presence of WHO class III adverse events. Primary response (PR) was defined as ALT normalisation in the presence of undetectable HCVRNA after 3 and 6 m.

RESULTS: Eighty two patients '84% males, 84% previously IDU,aged 34±5 years with CD4 cells 570±271/mmc (M±SD)' were randomised from January 1998 to January 2000: 41 to treatment and 41 to no treatment. Three were cirrhotics, 53% were infected by HCV genotype 1 or 4, 63% had HCVRNA>1 million copies/ml. Fifty seven patients (30 treated) completed the third month and 43 (24 treated) the sixth month of the study. Fifty per cent of the patients were treated with HAART in both groups. PR was observed at three and six months in 37% and 33% of treated patients and in none of untreated patients (p>0.01). One patients in the treated group developed abdominal NHL and died. Two patients in the treated group showed HIVRNA increase greater than 0.5 log copies/ml. Mean CD4 cells counts were similar in the two groups at all time points. PR was associated with with CD4 cells >500 (60% vs. 0 p>0.01) and infection by HCV genotype 3 or 2 (54% vs 23%; OR 3.8 95% CI 0.6-25).

CONCLUSIONS: rIFNa2a treatment does not seem to interfere with natural history or management of HIV infection. However primary response rate seem to be related to CD4 depletion.

Keywords: AEGIS, Interferon-alpha, Hepatitis C, Antiretroviral Therapy, Highly Active, HIV Seropositivity, Hepatitis C, Chronic, Hepacivirus, HIV Infections, CD4 Lymphocyte Count, Hepatitis C Antibodies, Antigens, CD4, Human, Male, immunology
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ThOrB659