May 13, 2011 |
The Food and Drug Administration on Friday approved marketing of the Merck drug boceprevir, the first new drug for hepatitis C in 20 years. The agency is still considering approval of a similar drug, telaprevir, and is expected to approve it soon as well. Both drugs are members of a new class of hepatitis drugs called protease inhibitors, which block a key enzyme required by the virus to replicate. They are expected to convert hepatitis C from a debilitating disease into a manageable condition for the majority of people infected with the virus.
April 29, 2011 |
Two new drugs to treat hepatitis C got strong – that is, unanimous – backing this week from an advisory panel to the FDA. Both are meant to be given in combination with standard therapy and, together, offer new options for people with the virus. One drug, boceprevir , manufactured by Merck, has been shown in clinical trials to roughly double the number of patients who suppress the hepatitis C virus to undetectable levels — a “viral cure” — when compared to those who undergo regular therapy alone. The other drug, telaprevir , developed by Vertex, has achieved a 75% cure rate when administered to previously untreated patients as part of combination therapy. The panel’s decisions don’t guarantee FDA approval, but the FDA tends to follow the panel’s recommendations.
March 31, 2011 |
Two experimental drugs promise to transform hepatitis C from a debilitating liver disease into a manageable condition for a majority of patients, researchers said Wednesday. The new drugs work by blocking a key enzyme that the hepatitis C virus needs to make copies of itself and spread. They promise to revolutionize treatment for patients in much the same way as protease inhibitors did for HIV patients in 1995, experts said. The two drugs, called boceprevir and telaprevir, nearly doubled the number of patients who achieve what is known as a sustained viral suppression — in effect, a cure — among those with new hepatitis C infections.
August 9, 2010
An experimental antiviral agent called boceprevir doubled the cure rate for hepatitis C in a small phase 2 clinical trial designed to show efficacy, researchers reported Sunday. The drug will now be submitted to the larger Phase 3 trial required for approval of the drug by the Food and Drug Administration. Hepatitis C is a chronic viral infection that affects an estimated 170 million people worldwide, leading eventually to cirrhosis and liver cancer if not controlled. The standard treatment now is a 48-week regimen of pegylated interferon, which boosts the immune system, and the antiviral agent ribavirin, which is a general-purpose antiviral agent.
January 12, 2010 |
Hepatitis B and C remain serious threats to public health, but many healthcare providers fail to screen at-risk patients and don't know how to treat those infected with the viral diseases, which can cause liver failure and cancer, according to a report released Monday by the National Academy of Sciences. The long-awaited assessment calls for a campaign to educate the public, doctors and lawmakers about the diseases, an approach similar to HIV/AIDS outreach. Researchers found that even though chronic viral hepatitis infections are three to five times more frequent than HIV in the United States, many doctors and nurses do not understand the extent of the problem.
December 4, 2009 |
An experimental antiviral drug that works by a different mechanism than existing drugs has been shown to suppress hepatitis C in chimpanzees and is already being tested in human clinical trials, researchers reported Thursday. The new agent is a so-called antisense drug that binds to RNA required by the virus for replication, preventing the virus from proliferating in the liver. Preliminary tests suggest that the drug, called SPC3649, has no toxic side effects, does not allow development of resistance -- which plagues other hepatitis drugs -- and has lasting effects after treatment has stopped.
August 17, 2009 |
By her own admission, Kristen Diane Parker cruised for empty operating rooms at the Denver hospital where she worked. The surgical technician would slip into the rooms and steal syringes of fentanyl, a powerful painkiller, replacing them with syringes she'd filled with saline, she later confessed to investigators. Parker, who has hepatitis C, had allegedly used those decoy syringes -- the source of transmission, authorities believe, for at least 23 Coloradans now infected with the liver-damaging disease.
August 12, 2009 |
The California State Athletic Commission has faxed a letter of apology to the promoters of a mixed martial arts card on which a fighter with a positive test for hepatitis C was allowed to compete. The commission also said it had been told, but had no documentation as of Tuesday, that the test had been a false positive and the fighter did not have hepatitis C. Al Joslin and Shelly Matlock, owners of PureCombat Promotions, which held a March 7 MMA card in Tulare, said they received the letter Sunday.
August 8, 2009 |
The promoter of a mixed martial arts card March 7 in Tulare, Calif., confirmed Friday that one of the competitors was allowed to fight despite testing positive for Hepatitis C and having no test results on file for HIV. Al Joslin, who has promoted nine cards in California, said he learned of the situation about a week ago, when he was leaked a copy of a memo from the California State Athletic Commission. The commission is responsible for medical clearance of all MMA and boxing shows in the state.