Evaluation of 24-weeks of Peginterferon Alfa-2a (Pegasys) and Ribavirin Therapy in HIV-HCV Coinfected  Patients with Acute Hepatitis C

Several small uncontrolled studies using different doses and durations of conventional interferon (IFN) or PEG-IFN monotherapy or combined with ribavirin (RBV) have reported different rates of HCV viral clearance in acute HCV infection.

The aim of the current study was to evaluate the safety and tolerability of a 24-week course of PEG-IFN-2a (Pegasys) and RBV in HIV+ patients with acute HCV infection.

Patients were included in an open single arm study with a diagnosis of acute HCV infection based on elevated alanine aminotransferase (ALT), seroconversion from negative to anti HCV positive antibody status and positive qualitative and quantitative HCV RNA.

Patients who did not clear HCV RNA spontaneously after 24 weeks of follow-up were given treatment with PEG-IFN-2a (180 microgram/week) + RBV (800mg daily) for 24 weeks.

Clinical examination and ALT, HCV RNA, HIV RNA, CD4 count were performed monthly during therapy and 24 weeks after the end of PEG-IFN/RBV.

The primary efficacy end point was defined as undetectable plasma HCV RNA levels 24 weeks after treatment discontinuation (sustained virological response).

Results

A total of 18 homosexual pts were included from December 2001 to June 2004. At baseline all pts were on HAART, 17/18 (95%) pts had HIV RNA <200cps/ml, median CD4 count was 435/mm3. All pts had unprotected sex intercourse with a concomitant syphilis in 6 pts, no other risk factor for HCV was found.

HCV genotype distribution was genotype 1(n= 4), genotype 2 (n=1), genotype 3 (n=6), genotype 4 (n=7).

Two pts had spontaneous clearance of HCV RNA at week 12 and two pts refused treatment with subsequent
chronic evolution of HCV.

Fourteen pts started HCV therapy in a median delay of 24 weeks after acute HCV infection. Median HCV RNA at initiation of HCV treatment was 1332 KUI/ml (25-4373).

By October 2004, 6/14 pts (43%) achieved a negative HCV RNA within 1 month, 10/14 (71%) within 3 months, 9/13 (69%) within 6 months. Median time to reach a negative HCV RNA was 35 days [14-84].

Twenty four weeks after treatment discontinuation, a sustained virological response was obtained in 7/8 pts (87%). Follow up is on going.

Two pts discontinued treatment for intolerance. HIV RNA remained below 200 cps/ml in 17/18 pts.

Conclusion

The authors conclude, “Acute HCV hepatitis seems [to be] increasing in HIV-infected, homosexual men. These preliminary results suggest high rates of sustained virological response to PEG-IFN/RBV in HIV infected patients with acute HCV infection.”

Pitié-Salpêtrière Hospital, Paris, France.

01/26/05

Reference
S Dominguez and others. Evaluation of a 24-week pegylated interferon and ribavirin therapy in HIV patients with acute HCV. Session 5. First International Workshop on HIV and HCV Co-infection. December 2-4, 2004. Amsterdam, The Netherlands.