Monotherapy with pegylated interferon produces good treatment response in HIV patients with acute HCV

Monotherapy with pegylated-interferon achieved a sustained virological response in 61% of HIV-positive patients receiving treatment for acute, sexually transmitted hepatitis C virus infection, German investigators report in the December edition of Antiviral Therapy. The investigators note that the use of the current standard of care – pegylated interferon plus ribavirin – did not improve treatment response, but did result in a higher incidence of side-effects. They therefore suggest that in patients with acute hepatitis C infection, pegylated interferon monotherapy may be a treatment option. A further interesting finding of the study was the significantly improved rate of treatment response observed in patients who took a longer duration of pegylated-interferon therapy.

There is emerging evidence that the use of antiviral therapy for acute hepatitis C infection can be successful not only in patients who are just infected with hepatitis C, but also in individuals who are also coinfected with HIV and hepatitis C. However, there is currently uncertainty about the timing, type and length of anti-hepatitis C therapy.

Investigators in Germany therefore conducted a prospective, open-label, non-randomised study involving gay men with acute hepatitis C infection. Although the mode of hepatitis C transmission was uncertain in nine men, 38 men acquired the infection through sex.

A total of 36 men were included in the investigators’ study – the other men either spontaneously cleared hepatitis C infection or declined therapy.

Patients were treated with either pegylated interferon-alpha2a (at a dose of 180mcg once weekly), or pegylated-interferon alpha2b (at a dose of 1.5mg/kg bodyweight once weekly) for 24 weeks. The study protocol was subsequently amended, however, when it was shown that the addition of ribavirin improved response to hepatitis C therapy, and a total of 23 patients were enrolled to the study and provided with a weight-dependent dose of ribavirin in addition to pegylated-interferon.

Treatment was initiated a mean of seven weeks after acute hepatitis C was detected and was continued for 24 weeks. However, therapy was continued for 48 weeks for six patients because of a poor initial response to therapy.

An end of treatment response was observed in 72% of patients, and a sustained virological response – an undetectable hepatitis C RNA 24 weeks after the completion of therapy – in 61%. An early response to treatment (an undetectable hepatitis C RNA by week eight) was significantly associated with a sustained treatment response (p

The investigators found that increasing the length of treatment to 48 weeks was significantly associated with the chances of achieving a sustained treatment response (p

A total of 300 instances of side-effects were observed in the study. Most of these were mild to moderate, although there were 16 severe or life-threatening events, including eight instances where liver function tests were five or more times the upper limit of normal.

HIV viral load fell by a modest amount during interferon therapy. CD4 cell count also fell from a mean of 416 cells/mm³ before anti-hepatitis C therapy was introduced to 356 cells/mm³ on the completion of 24 weeks treatment. However, within six months of therapy being discontinued, CD4 cell count had increased to a mean of 404 cells/mm³.

“Our data…suggest that peg-IFN monotherapy in the setting of acute hepatitis C infection may be as effective as peg-IFN/ribavirin combination therapy, and at the same time, less toxic”, conclude the investigators, adding, “future trials are needed to investigate into this matter.”