BARCELONA, SPAIN -- The ability of the investigative protease inhibitor telaprevir to rapidly reduce levels of hepatitis C virus hints that shorter treatment regimens may be possible, researchers reported here.
BARCELONA, SPAIN -- A dramatically shortened treatment time might be possible for patients with hepatitis C virus by adding the investigational oral drug telaprevir to standard treatment with pegylated interferon alfa-2a and ribavirin.
In a late-breaking presentation at the European Association for the Study of the Liver meeting here, John McHutchison, M.D., of Duke in Durham, N.C., said interim results of a multi-arm trial with telaprevir found:
In the experimental short-treatment group of 20 patients, Dr. McHutchison said three patients in that group dropped out before getting any treatment. Other discontinuations and failure to achieve undetectable levels left 9 patients in this group with undetectable levels of virus at 12 weeks. They discontinued all medication. They were followed for 20 weeks. Three of those patients relapsed.
"We believe that we have established proof of principle that some patients can achieve undetectable virus and remain free of virus without any treatment after q12 weeks of therapy," Dr. McHutchison said.
However, the gold standard for treatment is to maintain that level for 24 weeks -- achieving a sustained viral response. "Obviously we have to wait a bit longer to determine if we have achieved that," he said.
A co-investigator, Ira Jacobson, M.D., of Weill Cornell Medical College in New York, said, "The results of this study have elevated our hopes that we can reduce the time of treatment for this disease." He said that the current 48-week standard for genotype 1 hepatitis C is a grueling and rigorous affair for patients.
Despite the few patients in the dramatically shortened arm of the study, Patrick Marcellin, M.D., of the University of Paris, commented, "I think that you have shown that this is proof of principle, but we need to continue to evaluate these outcomes."
"We agree that the data is very encouraging," said Frank Duff, M.D., executive director for virology at Roche, Nutley, N.J., who was not involved in the trial. Roche makes pegylated interferon and ribavirin (Copegus) used in the trial.
"These are still early results," he said. "We still need to run the data and see how this pans out over the 48 weeks and that it does result in a sustained viral response. But this is all going into a very positive direction."
He noted that his company is also investigating ways of shortening the treatment period. He pointed out that patients infected with genotypes 2 and 3 of hepatitis C virus already have a shortened 24-week therapy.
In the PROVE1 trial, adverse side effects that were associated with telaprevir included rash, nausea, pruritus, diarrhea, anemia and vomiting. Dr. McHutchison noted that these are the same side effects seen with ribavirin so there maybe some interaction between the two medications.
Patrick Marcellin disclosed possible conflicts of interest with Bristol-Myers Squibb, Gilead Sciences, Inc, GlaxoSmithKline, Human Genome Sciences, Idenix Pharmaceuticals, Inc, Novartis Pharmaceuticals Corporation, Roche Pharmaceuticals, Schering-Plough Corporation, Valeant Pharmaceuticals International, and Vertex Pharmaceuticals Incorporated.
John G. McHutchison disclosed possible conflicts of interest with Anadys Pharmaceuticals, Inc, Biolex, Coley Pharmaceutical Group, Epiphany Biosciences, First Circle Medical, Inc, GlaxoSmithKline, GlobeImmune, Inc, Human Genome Sciences, Idenix Pharmaceuticals, Inc, Idera Pharmaceuticals Inc,, Intarcia Therapeutics, Inc, InterMune Inc, National Genetics Institute Inc, Novartis Pharmaceuticals Corporation, Peregrine Pharmaceuticals, Inc, Pfizer Inc, Salix Pharmaceuticals, Inc, sanofi-aventis, Schering-Plough Corporation, United Therapeutics, Valeant Pharmaceuticals International, Vertex Pharmaceuticals Incorporated, and Wyeth Pharmaceuticals.
Dr. Jacobson disclosed possible conflicts of interest with Vertex and Schering-Plough.
Dr. Duff is employed by Roche.