Daily Lymphoblastoid Interferon Successful in Genotype-1b Patients: Higher Dose Three Times a Week Proves Less Effective: this suggests daily dosing of 3 MIU of interferon is more effective than 3 MIU of interferon 3 timer per week; 3 timer per week is the standard treatment recommendation

From the 49th Annual Meeting of the AASLD, November 1998

In a study of 80 naïve patients with genotype-1b HCV infection, daily lymphoblastoid interferon gave significantly better early and sustained responses compared to higher doses three times a week. The daily dose was three million units a day, and the thrice weekly dose was six million units each time.

Dr. Raffaello Bruno of the Division of Infectious and Tropical Diseases at the University of Pavia, Italy treated all patients for one year. "We enrolled only patients with genotype-1b because it is the most difficult type of HCV to eradicate," explains Dr. Bruno. "We found that the daily dose of three million units was more effective for these patients. Seventy-eight percent of the daily dose group had a sustained response and only 23% of the thrice-weekly group had a sustained response."

At enrollment the two groups (40 patients in each) were comparable for age, sex, ALT values, risk factors, viral load, and liver histology. Patients were classified as sustained responders when they became persistently HCV RNA negative and ALT normalized during treatment and at least six months after treatment. Follow up has now continued for eight months since the end of treatment.

"I think the clinical significance of this study is that the daily dose regimen is more effective than three times weekly and is possibly more effective whether you are using interferon monotherapy or combination therapy. Of course, it's important that a clinical trial with combination therapy be run to show if the response would be similar," he says.

Side effects were comparable in the two groups and never serious enough to require therapy withdrawal, and no patients were lost to follow-up. Histological response will be evaluated after 12 months of follow-up.

One hundred percent of the group on daily therapy was initially classified as primary responders, compared to 75% of the group on thrice weekly therapy. None of the group on daily therapy was classified as non-responders, while 25% of the thrice-weekly group were non-responders.

In the daily therapy group, 77.5% had a sustained response, and 22.5% were relapsers. In the thrice-weekly group, 22.5% had a sustained response and 52.5% were relapsers.

Primary responders were classified as patients whose ALT normalized and HCV RNA became negative during treatment. Non responders were those whose ALT remained elevated and HCV RNA positive during treatment. Patients were classified as sustained responders when they became persistently HCV RNA negative and ALT normalized during treatment and at least six months after treatment. Relapsers were defined as primary responders whose ALT returned to abnormal values and HCV RNA became positive again after the end of treatment.

The findings from this study support a daily dosing schedule for the treatment of patients with chronic HCV infection. They provide corroborative evidence that HCV can have a very fast replication cycle, necessitating a dosing schedule that keeps a relatively constant level of interferon in the blood to keep the virus in check. A further study on this point–escalating doses of interferon based on patients' responses–also tried to determine which patients should be continued on the drug and which ones may not respond in the long run.

Source:
Wellness Web