A new study (Hepatology 2015; 61: 1127-35) shows that an all-oral 12 week treatment of daclatasvir (DCV) with sofosbuvir (SOF) is effective in the difficult-to-treat Hepatitis C virus (HCV) genotype 3 patients. In this study, the “Ally-3” phase III study, 101 treatment-naïve and 51 treatment experienced patients were treated with a daily regimen of DCV 60 mg and SOF 400 mg.
- SVR12 was 90% in treatment-naïve, and 86% among in treatment experienced.
- Among patients without cirrhosis, the SVR12 was 96%, compared with 63% of those with cirrhosis (based on FibroTest scores)
Related blog posts:
- A New Villain for Hepatitis C | gutsandgrowth
- Understanding HCV Treatment Failures with Sofusbuvir …
Bottomline: This new regimen is a promising addition to the new crop of HCV drugs which will be affordable when?
A second study (Hepatology 2015; 61: 1174-82) examined the minimum target pricing for direct-acting antivirals (DAA) for HCV. Using data on manufacturing costs, derived in large part from experience with HIV antivirals, the authors calculate that a minimum cost for a 12-week course of combination DAA could be US $171-360 per person without genotyping and the drug costs alone from US $122-192 per person. Of course, these costs are completely theoretical and complete fantasy, at least until 2027 when some of the patents expire.
Related post: HCV Treatments: “Sticker Shock” or “Low Value …
Briefly noted: Hepatology 2015; 61: 1261-68. N=986 Koreans with HBsAg carrier status and 40 years of age or older. FIB-4 is highly predictive of hepatocellular carcinoma (HCC) risk in those with chronic hepatitis B. FIB-4 was defined based on age x AST , PLTS, and ALT. Since a high FIB-4 reflects liver fibrosis, it is not unexpected that high levels were associated with HCC. A FIB-4 >/= 2.4 showed an adjusted Hazard Ratio of 21.34.