A new exploratory agent has been tested in the treatment of the hepatitis C virus infection (HCV), allowing patients to avoid the current interferon treatment that comes with harsh side effects.
A clinical trial published in the New England Journal of Medicine has defined sofosbuvir, an oral nucleotide inhibitor of HCV polymerase, as successful in the treatment of HCV infection.
The standard treatment for the HCV infection is interferon, given by injection under the fat. Troublesome side effects are also found with interferon, including:
The creation of orally administered medications have helped move forward the possibility of getting rid of interferon treatment and avoiding its harmful side effects and tedious application.
The study was open-label and researchers split 40 patients with untreated HCV, genotype 2 or 3 infection, into four groups. All groups received sofosbuvir (400 mg once a day) as well as ribavirin for the duration of 12 weeks.
Three of the groups were also given peginterferon alfa-2a for 4, 8, or 12 weeks. Another two extra groups who were also untreated previously and had HCV genotype 2 or 3, were given only sofosbuvir for 12 weeks or a combination of sofosbuvir and peginterferon afda-2a for eight weeks.
Two other groups of subjects with HCV genotype 1 infection took sofosbuvir and ribavirin for 12 weeks, including 10 people who had no reaction to earlier treatment and 25 people with no earlier treatment.
Conclusions showed that of the 40 patients who were in the randomized groups, 100% who received sofosbuvir plus ribavirin and no interferon had a sustained viral response (six months without RNA of the HCV in the blood).
The group that received sofosbuvir plus ribavirin for 12 weeks and interferon for 4, 8 or 12 weeks also showed a sustained viral response. Of the volunteers who received sofosbuvir plus peginterferon alfa-2a and ribavirin for 8 weeks, 100% had a sustained viral response, while only 60% of those who received sofobuvir by itself showing a sustained viral response.
Among the participants with HCV genotype 1 infection, 84% of those who were untreated before and 10% of those with no response to prior therapy had a sustained viral response.
Side effects that were present during the study included headache, nausea, anemia, fatigue, insomnia, and rash.
The authors believe these findings are the first step to an oral-based, short time-period treatment regimen that does not include interferon.
The current findings support a previous study conducted by Boehringer Ingelheim that found the interferon-free combination of two investigational compounds, the once-a-day protease inhibitor BI 201335 and the polymerase inhibitor BI 207127, successfully brought patients to a sustained viral response.
Written by Kelly Fitzgerald