Roche announced that results from the largest study conducted to date evaluating chronic hepatitis C treatment among patients co-infected with HIV and HCV were presented at the 11th Annual Conference on Retroviruses and Opportunistic Infections.
The landmark APRICOT (AIDS Pegasys Ribavirin International Co-infection Trial) study showed 40 per cent of patients treated with PegasysÒ (peginterferon alfa-2a), the most prescribed chronic hepatitis C treatment in the US and Copegus (ribavirin), achieved a sustained virological response. Sustained virological response refers to a patient's continued undetectable hepatitis C virus levels in the blood 24 weeks after finishing a course of treatment.
Approximately 30 per cent of people in the US infected with HIV are also infected with hepatitis C. HCV is a leading cause of death in HIV patients.
"People co-infected with HIV and HCV are considered to be among the most difficult to treat for chronic hepatitis C," said Dr Douglas Dieterich, co-lead investigator of the study. "The strong response rates that we have seen with Pegasys and Copegus therapy in this study are encouraging news for the 300,000 Americans estimated to be infected with HCV and HIV."
"In the APRICOT study a dramatic improvement in response rates was seen among patients treated with Pegasys combination therapy compared to those treated with Pegasys monotherapy or conventional interferon combination therapy. In addition, the side effects seen in HIV patients treated with Pegasys combination therapy were similar to those we have seen in studies among other hepatitis C patients," said Dr Francesca Torriani of the University of California, San Diego, and co-lead investigator of APRICOT.
Currently, no HCV therapies have been approved for the treatment of chronic hepatitis C in HCV/HIV co-infected patients. Roche will file for an sNDA later this year for this indication. Pegasys in combination with Copegus was approved by the FDA in December 2002, and is the market leader in HCV treatment.
HCV and HIV are the two most prevalent blood-borne infections in the United States, and HCV/HIV co-infection is increasingly recognized as a growing public health problem. In total, approximately 300,000 individuals are estimated to be co-infected in the United States. Chronic HCV affects approximately 2.7 million and HIV affects almost one million Americans.