HIV and Hepatitis.com Coverage of the
14th Annual Conference on Retroviruses
and Opportunistic Infections (14th CROI)
February 25 - 28, 2007, Los Angeles, CA
Pegylated Interferon/ribavirin Therapy Results in Low SVR Rates after Liver Transplantation in HIV-HCV Coinfected Patients

By Ronald Baker, PhD

Preliminary results of a prospective cohort study showed low sustained virological response (SVR) rates with pegylated interferon alfa-2a (Pegasys) or pegylated interferon alfa-2b (PegIntron) plus ribavirin in HIV-HCV coinfected patients following liver transplantation.

Recurrence of hepatitis C virus (HCV) is common in patients after liver transplantation, and is a major cause of graft loss and death in patients with HIV-HCV coinfection.

In the current study, presented at the 14th Conference on Retroviruses and Opportunistic
Infections last month in Los Angeles, Spanish researchers assessed the safety and efficacy of combination therapy with pegylated interferon plus ribavirin in 77 HIV-HCV coinfected liver transplant recipients.

Study Design

This prospective multi-center cohort study included 77 HIV positive patients who received 80 liver transplants in Spain since 2002. Among this group, 71 (92%) were HIV-HCV coinfected and 33 (46%) started therapy with pegylated interferon alfa-2a or alfa-2b, intended to last 48 weeks. Overall, 13 patients (17%) have died since transplantation.

Baseline Characteristics

• The median age was 39 years, 81% of liver recipients were male, and former drug use (81%) was the most common HIV risk factor.

• Among HIV-HCV coinfected patients, 12 (75%) had genotypes 1 or 4 and 4 (25%) had genotypes 2 or 3.

•The majority of patients used efavirenz (Sustiva)-based HAART regimens (56% prior to liver transplantation and 75% after liver transplantation).

• The median CD4 cell count prior to transplantation was 288 cells/mm3 and all but 1 patient had undetectable plasma HIV viral load.

• 32% received cyclosporine-based immunosuppressive therapy regimens and 68% received tacrolimus-based regimens.

• The median plasma HCV viral load before starting therapy was 1,434,000 IU/mL.

The results presented at the Retrovirus conference concerned the outcomes of an intent-to-treat analysis of first 16 evaluable patients.

Results

• Anti-HCV treatment was started a median of 7 months after liver transplantation.

• 9 patients (56%) achieved early virological response (HCV RNA decrease of at least 2 logs) at 12 weeks.

• 5 patients (31%) achieved end-of-therapy response (negative HIV RNA after completion of treatment).

• 4 patients (25%) experienced sustained virological response (undetectable serum HCV RNA 6 months after completion of therapy).

• SVR rates were 17% for genotypes 1/4 and 50% for genotypes 2/3.

• 6 patients required erythropoietin for severe anemia and 4 received granulocyte colony-stimulating factor due to severe neutropenia.

•2 patients (17%) stopped anti-HCV treatment due to toxicity and 6 (37%) due to virological non-response.

• There were 6 deaths among the 12 non-responders (50 of non-responders; 37% of all patients), all caused by liver graft loss due to recurrent HCV infection.

• 6 of the non-responders had been treated before transplantation without achieving SVR.

• In addition to the 16 patients treated with pegylated interferon plus ribavirin, 1 was treated with pegylated interferon monotherapy without SVR, and 1 experienced spontaneous HCV clearance without treatment.

Conclusion

Based on the results, the authors concluded, "The rate of sustained virological response with pegylated interferon + ribavirin was low (25%). New strategies are necessary to improve the outcome of liver transplantation in [HIV-HCV] coinfected patients."

Hosp Clin-IDIBAPS, Univ of Barcelona, Spain; Hosp Cruces, Bilbao; Hosp Univ Vall d'Hebrón, Barcelona, Spain; Hosp Univ Bellvitge, Barcelona, Spain; Hosp Gregorio Maranon, Madrid, Spain; Hosp Ramon y Cajal, Madrid, Spain; Hosp La Fe, Valencia, Spain; Hosp Univ Reina Sofia, Cordoba, Spain; Hosp Univ Virgen de la Arrixaca, Murcia, Spain.

Link to study abstract

03/27/07

Reference
J M Miro, M Montejo, L Castells, and others (the Spanish OLT in HIV-Infected Patients Working Group). Treatment of Spanish HIV-infected Patients with Recurrent Hepatitis C Virus after Liver Transplantation with Pegylated Interferon + Ribavirin: Preliminary Results of the FIPSE OLT-HIV-05 - GESIDA 45-05 Cohort Study. 14th Conference on Retroviruses and Opportunistic Infections. Los Angeles, February 25-28, 2007. Abstract 890 (poster).











































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