“Telaprevir in combination with peginterferon alfa-2a/ribavirin in HCV/HIV co-infected patients: SVR24 final study results.” Oral Presentation #54 November 11, 2012, 4:15 p.m. EST
Final results of a Phase 2 study designed to evaluate the safety and tolerability of telaprevir in combination with pegylated-interferon and ribavirin in people who are co-infected with HCV and HIV also were presented at AASLD. Data showed that 74 percent (28/38) of patients who were treated with telaprevir combination treatment achieved an HCV viral cure (SVR24) compared to 45 percent (10/22) of those who were treated with pegylated-interferon and ribavirin alone. Changes in CD4 counts were similar between the treatment groups and no HIV viral load breakthroughs were observed in either treatment group during the study. The safety and tolerability of telaprevir observed in this study was comparable to what has been observed in HCV mono-infected patients. Adverse events that occurred more frequently (≥10 percent difference) among people treated with telaprevir compared to pegylated-interferon and ribavirin alone included pruritis (itchiness), headache, nausea, rash and dizziness.
“There are many people with hepatitis C who cannot or should not wait to be treated given the severity of their disease,” said Kenneth E. Sherman, M.D., Ph.D., Director of the Division of Digestive Diseases at the University of Cincinnati College of Medicine. “People who are co-infected with hepatitis C and HIV are among those who are most in need of effective new medicines, and these new data showed that three out of four people were able to clear the hepatitis C virus with telaprevir combination treatment. We look forward to the results of the ongoing Phase 3 study.”
About INCIVEKINCIVEK ® (telaprevir) tablets is an oral medicine that acts directly on the hepatitis C virus protease, an enzyme essential for viral replication. INCIVEK has been prescribed to more than 50,000 patients in the United States. Approximately three out of four U.S. patients who are prescribed a direct-acting antiviral for the treatment of genotype 1 chronic hepatitis C (HCV) receive INCIVEK combination therapy. In Phase 3 clinical studies, 79 percent of people who had not previously been treated for HCV achieved a viral cure following treatment with INCIVEK combination therapy, compared with 46 percent of those who received pegylated-interferon and ribavirin (P/R) alone. Among people who were treated previously but did not achieve a viral cure, in the Phase 3 studies: 86 percent of relapsers achieved a viral cure with INCIVEK combination therapy compared to 22 percent with P/R alone; 59 percent of partial responders achieved a viral cure compared with 15 percent with P/R alone; and 32 percent of null responders achieved a viral cure compared with 5 percent with P/R alone. In addition, many people are eligible to complete treatment with INCIVEK combination therapy in 24 weeks – half the time required for P/R alone.