The news from Foster City, Calif.-based Gilead—whichwas actually announced Saturday but helped boost stock prices from around $65on Friday to as high as $74 in Monday trading—leads the pack if for no otherreason than the attention-grabbing number of 100. That would be 100 percent, asin the number of patients reportedly cured of genotype 1 chronic hepatitis Cvirus (HCV) infection, according to interim data from the ongoing Phase 2ELECTRON study examining an interferon-free, 12-week course of therapy with theinvestigational nucleotide sofosbuvir (formerly referred to as GS-7977), theNS5A inhibitor GS-5885 and ribavirin.
"This is starting to look like a home-run as wenow know Gilead at least has a 100-percent cure all-oral regimen with its ownwholly owned drug with no partnering," wrote Michael Yee, an analyst at RBCCapital Markets in San Francisco, in an investor's note. For his part, analystMatthew Roden at UBS said, "these data strongly support Gilead'sleadership position" in the race among pharmas and biotechs to releasehighly effective, low-side-effect HCV treatments.
Granted, the study was small—only 25 patients—but theinfection was undetectable four weeks after completing therapy in all of the treatment-naïvepatients, according to Gilead, and the drugs generally were well toleratedamong the study participants.
Sofosbuvir and GS-5885 are still being studied fortheir safety and efficacy. Gilead recently initiated thefirst Phase III trial (ION-I) evaluating a fixed-dose combination of sofosbuvirand GS-5885 in treatment-naïve genotype 1 patients. This four-arm study isevaluating the fixed-dose combination with and without ribavirin for 12-and24-week durations in 800 patients, 20 percent of whom have evidence ofcirrhosis.
Boehringer Ingelheim's cure percentage wasimpressive as well—as high as 85 percent—in final Phase IIb data from itsinterferon-free SOUND-C2 study. The study showed that as many as 85 percent ofgenotype 1b (GT1b) HCV patients achieved sustained virologic response 12 and 24weeks after the end of treatment with the investigational treatment regimen offaldaprevir (BI 201335) and BI 207127, in combination with ribavirin. A viralcure was achieved for 69 percent of all patients included in the study (bothGT1a and GT1b HCV infections), and includes patients with advanced liverdisease, who are more challenging to cure.
"We are looking forward to continuingdevelopment of our HCVersoprogram and are now initiating Phase III clinicaltrials investigating interferon-free HCV treatment with faldaprevir and BI207127," said Dr. Peter Piliero, vice president of clinical developmentand medical affairs at Boehringer Ingelheim. "Through HCVersoBoehringerIngelheim is striving to deliver new solutions that consider real-worldchallenges faced by patients and clinicians."
Finally, Merck announced interim results from aPhase II, multi-center, randomized, dose-ranging study assessing the safety andantiviral activity of MK-5172, an investigational, once-daily, oral NS3/4Aprotease inhibitor for the treatment of chronic HCV genotype 1 infection incombination therapy in treatment-naïve patients. The primary efficacy endpointof the study was to evaluate the complete early viral response (cEVR) of fourregimens of MK-5172 in combination with peginterferon alfa-2b and ribavirin(P/R) compared to the control arm in which patients received a four-week lead-inof P/R followed by the addition of boceprevir. The MK-5172 regimens had ratesof cEVR that ranged from 82.8 percent to 93 percent, versus the control rate of74.2 percent.
"We are excited by these interim resultsevaluating MK-5172 in combination therapy," said Dr. Eliav Barr, vice presidentof infectious disease at Merck Research Laboratories. "Our commitment tochronic hepatitis C remains steadfast. We look forward to continuing ourstudies of MK-5172, including in interferon-free regimens."
