the journal Gastroenterology just published a short-term oral (ie non-interferon based) and ribavirin-free regimens for genotype 1 hepatitis c infection. important since ribavirin does have some significant adverse reactions, including anemia.
–phase 2 open-labeled study of 66 treatment-naive patients (see doi:10.1053/j.gastro.2013.10.057) with hep c, genotype 1 and RNA level >100,000, and without cirrhosis (either non-invasive FibroTest being low, or if high then a biopsy negative for cirrhosis), given daclatasvir 60mg/d (an NS5A replication complex inhibitor), asunaprevir 200mg bid (an NS3 protease inhibitor) and BMS-791325, either 75mg or 150 mg bid (a non-nucleoside NS5B inhibitor) for 12 or 24 weeks. (so, about 16 pts in each group: either shorter or longer therapy, and either 75mg or 150mg of the BMS-791325). primary endpoint of HCV-RNA level <25 IU/ml at 12 weeks after treatment (SVR12). results:
–in 64 patients HCV-RNA suppressed by week 4 of treatment. (includes 48 of 49 with genotype 1a infection, and 45 of 46 with non-CC interleukin 28B genotype — these are less responsive to interferon)
–61 pts (92%) achieved SVR12.
–no diff if 12 or 24 weeks of therapy; no diff if 75mg or 150mg of BMS-791325; no diff if genotype 1a or 1b.
–no serious adverse events, mostly headache, asthenia, and GI symptoms
so, a whirlwind of new studies have come out in the past couple of years on interferon-free and now ribavirin-free regimens, with striking successes with short-term therapy. these are really remarkable advances. (though, as with the previous blogs on this subject, they will no-doubt be a tad costly).
geoff