A clinical trial last month showed that a once daily, all-oral drug combination to treat chronic hepatitis C infection (HCV)--Bristol-Myers Squibb’s daclatasvir (NS5A replication complex inhibitor) and Gilead’s sofosbuvir (nucleotide NS5B inhibitor), direct-acting viral agents--was effective in all patients. It tested that drug combination with and without ribavirin, and excluded interferon, which is notorious for causing debilitating side effects. Results of the trial were presented by Mark Sulkowski, MD, professor of medicine at Johns Hopkins University during the 48th Annual Meeting of the European Association for the Study of the Liver (International Liver Congress 2013), April 24-28, 2013, in Amsterdam, The Netherlands.
All 41 study subjects had genotype 1 chronic HCV. More than 80% had subtype 1a, which is difficult to treat. They represented HCV patients who did not respond previously to interferon-based triple therapy using pegylated interferon and ribavirin, with an approved HCV protease inhibitor, either boceprevir (Victrelis) or telaprevir (Incivek).
Twelve weeks after the treatment ended, the rates of sustained viral response (SVR) were 100% in the sofosbuvir/daclatasvir arm and 95% in the sofosbuvir/daclatasvir/ribavirin arm. SVR indicates that a patient has “cleared” the virus for at least six months after completing therapy. It is achieved when viral levels drop to nearly undetectable levels.
Of the 21 patients who completed 24 weeks of follow-up once treatment ended, all had undetectable virus, or 100% SVR in both arms. Researchers reported that the drugs were well tolerated and there were few side effects.
“These data provide proof-of-concept that the combination of two potent direct-acting antivirals with different viral targets is effective in patients who failed [pegylated interferon/ribavirin] plus a protease inhibitor,” concluded Sulkowski. “We can tell our patients who failed triple therapy they now appear to have a path forward toward a cure.”
Source: AIDSmap.com, April 29, 2013
