Vertex’s Telaprevir Passes Test in Tough-To-Treat Hepatitis C Patients
Luke Timmerman4/25/09Follow @ldtimmerman
Vertex’s telaprevir is starting to stand the test of time. The experimental drug for hepatitis C is showing today that it can cure about half of the patients who failed to respond to standard treatments. That’s about triple the cure rate for patients who tried a second round of the existing drugs.
The latest findings were reported today from a study called Prove 3, at the European Association for the Study of the Liver meeting in Copenhagen, Denmark. The study found that 51 percent of patients who took telaprevir in combination with standard drugs for six months were cured and 52 percent were cured by staying on the drug for almost a full year, researchers said. That compares with 14 percent, who were cured with a second round of the standard treatment—pegylated interferon alpha and ribavirin for almost a year.
These numbers are consistent with what Vertex reported in earlier peeks at their data, starting back in June and again in November at the American Association for the Study of Liver Disease. This study included just 115 patients, so the findings will have to be confirmed in ongoing pivotal stage trials before Vertex, which is based in Cambridge, MA and has significant operations in San Diego, can win permission from U.S. and European regulators to market the drug. But analysts are sure to get fired up in anticipation of that happening. An estimated 6 million people in the U.S. and Europe have chronic hepatitis C infections, and about 650,000 showed no improvement with the standard treatment. Telaprevir holds promise because it has shown a greater ability to cure patients of the virus, and it can cut the treatment time in half. That’s significant because standard drugs for hepatitis C cause flu-like symptoms that patients have to endure.
It means Vertex (NASDAQ: VRTX) could generate $2.6 billion in U.S. sales in 2013 when factoring in patients who failed treatment and those who are new to therapy, according to Rachel McMinn, an analyst with Cowen & Co. in San Francisco.
The cures Vertex is referring to are called sustained viral responses (SVR), measured 24 weeks after patients complete their course of therapy to make sure the virus didn’t bounce back. Telaprevir has even better results, with cure rates exceeding 60 percent for patients newly-diagnosed with hepatitis C, from other clinical trials.
“The SVR rates achieved in this difficult-to-treat population, with safety results consistent with prior telaprevir studies, add to the growing body of data supporting further development of telaprevir across the broad hepatitis C patient population,” said Freda Lewis-Hall, Vertex’s chief medical officer, in a statement.
Still, the safety profile of the drug isn’t completely benign. Adverse events in the Prove 3 trial showed patients had nausea, fatigue, headache, rash, diarrhea, and insomnia, among other effects. Rashes caused 5 percent of patients to drop out of the study. Back in November at the U.S. liver meeting, Vertex said 16 percent of patients in the Prove 3 trial dropped out of the study because of adverse events, compared with 4 percent in the control group.
Vertex is trying to build a competitive advantage in hepatitis C, which has become increasingly crowded with competitors looking to pile in with anti-viral combinations that aspire to make this disease more manageable, like HIV. Schering-Plough, with boceprevir, is the closest competitor to Vertex in the class of protease inhibitors. But Vertex is betting that it will have an edge in this tough-to-treat population that it observed in the Prove 3 study, and it is looking to buttress this case with an ongoing study of 650 patients called Realize. I described how these drugs stack up from a competitive standpoint in more detail back in September.
