::: HCV News :::

Enzyme-blocking Drug Offers Hope for Hepatitis C Sufferers


By Alan Fein

(AXcess News) New York - ViroPharma, Inc. (Nasdaq: VPHM) said Sunday that data from a phase 1b trial of an enzyme-blocking drug showed a 97 percent success rate in preventing the Hepatitis C virus from replicating itself. The viral polymerase inhibitor, HCV-796, is being co-developed with Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE).

The findings were presented at the 2006 Digestive Disease Week (DDW) conference in Los Angeles, California.

Steve Villano, ViroPharma's vice president of clinical research and development called the findings of the phae 1b trial "exciting", saying that doses taken orally by patients for 14 days reduced the ALT count signifcantly in patients suffering from chronic hepatitis C who had never received any prior treatment.

"The decline in levels of ALT, an important marker of liver injury associated with hepatitis C infection, that appear to correlate with antiviral activity further support the potential benefit of longer treatment with HCV-796," said Villano.

Of the 16 patients involved in tthe phase 1b study, Seventy two percent were infected with genotype 1 HCV, which is the most common strain of Hepatitis C in the United States. Success rates of existing drug treatment of genotype 1HCV patients is one-in-five, making ViroPharma's results good news for chronic HC sufferers.

Peak antiviral response was achieved at doses of 500 mg twice daily and higher. The 500 mg, 1000 mg, and 1500 mg dose groups achieved peak mean HCV viral load reductions of 96 to 97 percent by the fourth day of a 14-day dosing period. The greatest reductions in serum ALT levels were seen in the 500 and 1000 mg dose groups.

Mild to moderate headache was the most frequently reported adverse event, unlike existing drugs which have severe side effects and can even make patients suicidal.

HCV-796 was given in combination with PEG-Interferon.

Hepatitis C is a blood-borne virus recognized as a major cause of chronic hepatitis worldwide. The World Health Organization estimates that 170 million persons worldwide are chronically infected with HCV, and three to four million persons are newly infected globally each year. According to the U.S. Centers for Disease Control and Prevention (CDC), about four million people in the U.S., or 1.8 percent of the population, are infected with HCV.

Several Interferon products are available and often given in combination with Ribavirin, but at best, its success rate is 50 percent and then in patients who are diagnosed early with the less debilitating genotypes of the virus.

If untreated, the results of Hepatitis C infection is death as the liver slowly fails. Finding a cure has become a race as more and more people throughout the world become infected with HCV. But the drug companies who developed Interferon and Ribavirin hold a monopoly and critics say they have held back the research of other companies, which they adamantly deny.

Interferon treatment in combination with Ribavirin cost over $1,000 per month just for the drugs, which are taken by hypodermic injection weekly and must be carried through for a full year.

In addition to the relatively poor treatment response in patients infected with genotype 1 HCV, the considerable side effects frequently associated with the use of Interferon can lead to discontinuation of therapy in approximately 20% of patients.

For Viropharma, a win with HCV-796 would be a big boost to the pharmaceutical company, that reported $8.2 million in earnings for the first quarter earlier this month. Analysts had expected Viropharma to report 20 cents a share in earnings instead of the 12 cents per share it earned. Viropharma said wholesalers had reduced their stocks of the antibiotic Vancocin.

Net sales of Vancocin had rose 38.8 percent to $29.2 million, though analysts were expecting Viropharma to report $40.2 million.

The company said that underlying prescription demand for Vancocin remains strong, and it therefore reiterated its forecast for net sales of the drug in 2006 of between $160 million and $170 million.

Friday, Viropharma's shares closed up 29 cents at $9.29 for a gain of 3.22 percent. Its shares had tanked when it announced its first quarter results, dropping 30 percent to $7.69 May 4th.