Potentially Material News: Friday Night, Gilead Won FDA Nod For Next Gen Hep C “Category Killer” — Merck’s Victrelis® To Fade Now

And so, the end for Merck’s Victrelis® (and Vertex’s Incivek®, too) draws nigh. Both required interferon supplements, for full efficacy. Not so with Gilead’s sofosbuvir — now to be sold under the branded name Sovaldi®. This is an all oral regime, and shows much better cure rates — without the flu-like symptoms of an injected interferon co-hort.

Do go read all of this link — it’s the Friday evening Wall Street Journal item — while we were off the grid — for the passing of Mr. President Mandela:

. . . .The drug, Sovaldi, is the first pill approved to treat some types of hepatitis C without interferon, an injected drug that can cause flulike symptoms.

The hepatitis C virus is most often transmitted through the sharing of needles and other equipment used to inject drugs. More than three million Americans and about 170 million world-wide are infected with the disease, which if untreated can lead to liver damage and death. The disease is the leading cause of liver transplants in many countries.

The current treatment regimen of three drugs can require close to a year of injections which often cause side effects, and which don’t work in a large number of patients, according to liver doctors.

In clinical testing, Sovaldi was shown to cure about 90 % of patients when taken in combination with at least one other drug for 12 or 24 weeks, depending on the form of the disease they had. “It’s a monstrous advance,” said Douglas Dieterich, a liver specialist at Mount Sinai’s Icahn School of Medicine in New York City who participated in the Sovaldi clinical testing. . . .

More background here — and there are more candidates lining up behind Gilead’s now, but Gilead clearly has the lead — for perhaps the next six to 12 months. This is in many ways, the beginning of the end of the global burden of Hep C, not unlike the end of polio — in the early 1950s. A heady time in life science, indeed.

[An only tangentially related auto-immune disorder “science movie” plug: I saw “Dallas Buyers’ Club” over the weekend — DO GO SEE IT. The story of life saving science advancing — despite entrenched financial and regulatory interests (to say nothing of odious prejudices) is truly fascinating. And it is a great relationship movie, to boot — even if it takes some liberties with the actual Dallas facts. Go see it.]


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