Trials Wrap on Interferon-Free Hepatitis C Regimen

Gilead Sciences is likely to be first to market with an oral drug for hepatitis C, after releasing persuasive data from three phase 3 studies of sofosbuvir. With regulatory filings planned this quarter, Gilead could conceivably win Food and Drug Administration approval of the nucleotide previously known as GS-7977 by early next year.

In two of the studies, Gilead studied sofosbuvir plus ribavirin (RBV) against the existing standard of care, RBV and pegylated interferon alfa-2a (peg-IFN). Patients with genotypes 2 and 3 given sofosbuvir achieved sustained virologic response (SVR) in half the time of those in the RBV/peg-IFN arm. Patients with genotypes 1, 4, 5, and 6 achieved higher rates of SVR after 12 weeks. And in a third study, sofosbuvir yielded SVR in 50 and 73 percent of patients who had failed interferon-based therapy, at weeks 12 and 16, respectively.

The allure is that sofosbuvir treats hepatitis C without the use of interferons, whose side effects lead to poor adherence with older hepatitis C treatments. According to a Fierce Biotech report, physicians are advising treatment-naive patients to wait until sofosbuvir is approved, preferring to start them on what is likely to become the new standard of care.

Gilead isn’t likely to be alone at the top of the hill for long. AbbVie, the drug-making unit of what used to be Abbott Labs, has an agent in phase 3, and several other companies are hot on their heels.

The So-So…

Eli Lilly’s stomach cancer antibody, ramucirumab, hit statistical significance with a 1.4-month overall survival (OS) benefit versus placebo. Analysts, however, generally judged the gain underwhelming.

In a trial involving patients with advanced kidney cancer, those given tivozanib had a median OS of 28.8 months. But median OS for the comparator arm, sorafenib (Nexavar), was longer — 29.3 months. The AVEO/Astellas drug did show a statistically significant improvement in progression-free survival.

Celgene’s oral PDE4 for psoriasis, apremilast, achieved PASI-75 in 33 percent of patients after 16 weeks versus 5 percent of patients given placebo. The phase 3 reductions fell below the 41 percent who reached PASI-75 in a phase 2 study.

…and the Downright Bad

The disappointing news continued at Eli Lilly, which abandoned its program to develop tabalumab as a rheumatoid arthritis treatment because of lack of efficacy. Lilly will continue to study the agent as a potential therapy for lupus.

Using darbepoetin alfa (Ara­nesp) to treat anemia has no effect on morbidity and mortality in patients with systolic heart failure. Amgen’s RED-HF study failed to meet its primary endpoint of time to death.

Hemispherx is appealing the FDA’s rejection of Ampligen, which has been in development for chronic fatigue syndrome for 20 years. Ampligen was first turned down in 2009. The FDA wants another clinical trial.

Did you hear?

Cangene is seeking approval of a botulism antitoxin vaccine, now that the FDA has blessed the anti­bioterrorism shot as effective.... Stem cell transplantation reduced mortality at day 100 in patients with leukemia and lymphoma. Now, Gamida Cell will apply for U.S. approval of StemEx.... Hopes were high that MVA85A would become the first tuberculosis vaccine in 90 years, but a study in the Lancet documented only a modest immune response, insufficient to protect against the disease.... Fecal transplants to treat C. difficile infection may not be on the fringes of medicine much longer, now that the New England Journal of Medicine has published a randomized, controlled study finding the practice far superior to antibiotic therapy.