EASL: Sustained Virologic Response Equals Cure for HCV Infection

BARCELONA, Spain, April 12 -- Patients with hepatitis C virus infection who achieve a sustained virologic response to therapy should be considered cured, said investigators here today.

Only eight of 997 HCV patients who achieved the response later developed reinfection with the disease, reported Mark Swain, M.D., of the University of Calgary (Alberta), His research was selected as the opening paper of the opening session of the European Association for the Study of the Liver meeting.

In reviewing long-term outcomes from nine studies, Dr. Swain identified patients who achieved a sustained virologic response after treatment with pegylated interferon alpha-2a (40 kD) (Pegasys) as monotherapy or in combination with ribavirin (Copegus).

"I tell my patients who have had a sustained virologic remission that they can go home and get on with their lives and not to worry about hepatitis," Dr. Swain said. "I tell them that there is less than a 0.5 percent chance that the disease will ever return."

The study included three trials in which patients were treated with monotherapy and six trials in which the combination treatment was employed. Dr. Swain said the combination therapy is now considered standard of care and as many as 66% of patients infected with HCV who faithfully take their antiviral medication - usually for 48 weeks - are able to achieve the sustained virologic response.

Sustained virologic response was defined as an undetectable viral load in the blood six months following cessation of treatment.

"Although the benefits of viral eradication have been well established, the overall durability of a sustained virologic response is less well known," Dr. Swain said.

Of the patients who achieved a sustained virologic response, 163 who only had HCV infections were treated with peginterferon alfa-2a monotherapy; 741 with peginterferon alfa-2a plus ribavirin combination therapy. Ninety-three patients co-infected with HIV and HCV were treated with either monotherapy or combination therapy.

"We found that a sustained virologic response is a sustained virologic response whether it occurs in an immunosuppressed patient due to disease such as HIV or who has undergone transplantation and requires immunosuppressive drugs," Dr. Swain said.

There was no falloff in response. Of the eight patients who relapsed or were re infected, just one patient in the combined hepatitis C-HIV group was listed as a relapse. He also noted that only one of the eight cases involved a patient who had taken a full course of treatment.

Dr. Swain said that because of the way the studies were conducted it will be impossible to determine whether the patients relapsed or were re-infected. In only one case did a patient's records contain viable virus for a DNA comparison to be made. In that case, the patient appeared to become re-infected with a different strain of HCV. "We are never going to know the answer to whether these are relapses or re-infections," he said.

"This is a very important message, commented Xavier Forns, M.D., of the Hospital Clinic, Barcelona, and a member of the program committee for the conference. "This is a cure. We can cure people with this disease,"

"We made this paper Abstract 1 because we thought this was a significant finding that is important to our patients and to the clinicians."

Dr. Forns said, however, that a cure does not mean that re-infection can't occur if they continue to have risky activities.

Bristol Myers-Squibb, Canadian Institutes of Health Research, Leo Pharma, Roche and Schering. The study was supported by Roche. Dr. Forns reported no disclosures.