Daily Combination Therapy Better than Thrice Weekly for Previously Treated HCV Patients

Preliminary results of a study examining daily dosing of combination therapy for previously treated chronic hepatitis C patients show improved results compared to three times a week dosing.

In a study conducted from September 1997 to March 1998, 25 HCV patients who had previously relapsed or failed to respond to interferon monotherapy were given daily doses of interferon afa-2b at 3 million units plus ribavirin at 1000-1200 milligrams for twelve months.

"There is no consensus about dose and duration of combination therapy," says Zeki Karasu, M.D., lead investigator and research fellow, Oklahoma Transplantation Institute, Oklahoma City, Oklahoma. "When interferon was first approved, it was for three times a week, but later, some viral kinetic studies showed that daily use of that drug may produce better results. Based on this information, we tried daily use of these drugs in combination, and we did get better results."

After 12 weeks, 57% (12/21) showed no serum HCV (HVC-RNA negative) but 43% (9/21) remained HCV-RNA positive. Four of the 25 dropped out of the study. Of the ten relapsers to previous interferon monotherapy, 9 (90%) responded to the regimen in this study. Of the 11 previous non-responders, 3 (27%) showed HCV RNA clearance here.

The response rate for non-responding or relapsing patients is usually quite low, Dr. Karasu says. "Our results for daily use of these two drugs show much better results."

At three months, the side effects from daily dosing of combination therapy "were comparable to three times a week dosing [of combination therapy]" Dr. Karasu says. Dose reductions were necessary for 12 patients, mainly because of anemia and fatigue. And he notes the need for close patient monitoring because of the likelihood of these complications from the ribavirin component of the combination therapy.

The study is continuing, but Dr. Karasu noted that patients who respond in 3 months of treatment tend to have a sustained response. "If the patient doesn't respond after three months time, they usually don't respond after that."

Source:
Wellness Web