Replies to post #172025 on Biotech Values

[oc631]

GIFT-2—treatment-naïve and treatment-experienced GT2 with and w/o cirrhosis

It's newsworthy ABBV is running a Phase-3 study in GT2 patients. How many GT2 patients have been treated with the 2-DAA combo? What were the SVR rates? Would this study be enough for GT2 labeling in Japan?

[DewDiligence]

ABBV reports 95% SVR12 in Japanese GIFT-1 study using 2-DAA regimen:

http://finance.yahoo.com/news/abbvie-announces-top-line-results-230000601.html

AbbVie released top-line Phase 3 results for its investigational, all-oral, ribavirin-free, two direct-acting antiviral treatment with ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) [i.e. ABT450+ABT-267] in patients with genotype 1b chronic hepatitis C virus infection in Japan. The primary endpoint of the GIFT-I study was achieved, demonstrating a 95 percent (n=106/112) sustained virologic response rate at 12 weeks post treatment (SVR12) in the sub-group of previously untreated, non-cirrhotic adult GT1b Japanese patients who were eligible for therapy with interferon (IFN) and had a high viral load.

…In the GIFT-I study, the primary efficacy population comprised a sub-group of treatment-naive GT1b chronic HCV infected patient population. This sub-group consisted of treatment-naive patients without cirrhosis who were eligible for therapy with IFN with or without RBV, had a high viral load (> 100,000 IU/mL) and received at least one dose of the double-blind active study drug.

…Within the primary efficacy patient population, there were no on-treatment virologic failures and 2.8 percent of patients (n=3/109) experienced relapse. AbbVie will disclose detailed GIFT-I study results at future scientific congresses and in publications.

The GIFT-1 study is listed at http://clinicaltrials.gov/ct2/show/NCT02023099 .

ABBV has also conducted a Japanese phase-3 study in GT2 patients, called GIFT-2, for which results are expected soon: https://clinicaltrials.gov/ct2/show/NCT02023112 .

Note: The Japanese 2-DAA regimen of ABT-450/ABT-267 will result in a 50% higher royalty rate for ENTA than the 3-DAA regimen approved in the US and EU that includes ABT-333.