Biotech, Hepatitis C, Drugs

Vertex Hepatitis C Drug Wipes Out Virus For Toughest-to-Treat Patients

Luke Timmerman 10/28/09

Vertex Pharmaceuticals (NASDAQ: VRTX) is vying to set a new standard of care for hepatitis C in some of the toughest patients to treat, and today it is reporting some surprisingly strong evidence that suggests the drug is working like researchers hoped it would over the long haul.

The Cambridge, MA-based biotech company offered an interim peek at results from 117 patients who took its telaprevir compound after they failed to fully respond to standard therapy. Vertex looked at “null responder” patients who didn’t respond at all to prior therapy, and found that 16 out of 28 of them, or 57 percent, achieved a clinical cure after they got telaprevir in combination with another round of standard treatment. The clinical cure, known formally as sustained viral response, is achieved when the hepatitis C virus disappears from the blood for a full 24 weeks after the course of treatment.

Telaprevir had about the same effectiveness rate for patients who partially responded to an earlier round of treatment (55 percent achieved clinical cure), while that rate shot up to 90 percent for patients who initially were helped by standard therapy, but ended up relapsing later. These results were from a study known as ‘107. Comparing separate clinical trials can be a dubious exercise because of apples-to-oranges issues, but the clinical cure rates Vertex is reporting today are higher than what it announced in April at a conference of the European Association for the Study of the Liver, in a separate study that also enrolled tough-to-treat patients, called Prove 3.

Side effects from this latest batch of results were consistent with what Vertex has seen in prior studies. Eight of the 117 patients quit taking their medication because of side effects, including four who dropped out because of rash, and one who cited anemia.

For those who are new to the Vertex story, here’s a quick refresher on why this all matters. Telaprevir is aiming to be a first-of-its-kind protease inhibitor against hepatitis C, a chronic liver disease. If it can deliver in the final stage of clinical trials, it will change the standard of treatment for the disease just as an earlier generation of antivirals did for HIV infection. The market is potentially huge, because an estimated 3.2 million people in the U.S. have hepatitis C infections, and about 650,000 have failed …Next Page »

Luke Timmerman is the National Biotechnology Editor for Xconomy. You can e-mail him at ltimmerman@xconomy.com, call 206-624-2374, or follow him on Twitter at http://twitter.com/ldtimmerman.