Feb. 12, 2004 A Mount Sinai School of Medicine researcher reported results from a study with a drug combination that showed the highest hepatitis C treatment response rates ever reported in patients infected with hepatitis C and HIV virus at the 11th annual Conference on Retroviruses and Opportunistic Infections (CROI) this week.
The multinational APRICOT (AIDS PEGASYS™ Ribavirin International CO-infection Trial) study found that the drug combination of Pegasys™ (peginterferon alfa-2a) and Copegus® (ribavirin) were much more effective than the previous generation of hepatitis C therapy standard interferon and ribavirin. Efficacy was measured as the sustained virological response (SVR) rate, which is defined by the absence of detectable HCV RNA in the serum for at least six months after treatment. The study results were presented at the meeting by Dr. Douglas Dieterich, Professor of Medicine, Mount Sinai School of Medicine, New York City, and lead investigator on the APRICOT trial. The study was funded by Roche, the developers of Pegasys.
HCV and HIV are the two most prevalent blood-borne infections in the United States. Of the nearly one million people estimated to have HIV in the U.S., approximately 300,000 are believed to be co-infected with HCV. It can take 10 to 20 years following infection with hepatitis for a person to progress to end stage liver disease. However, in patients with HIV, the disease progresses far more quickly. With advances in HIV therapy prolonging the life expectancy of HIV patients, hepatitis C is now one of the leading causes of death in people with HIV.
"The results from this trial are very exciting news for the hundreds of thousands of Americans who are living with hepatitis C and HIV," said Dr. Dieterich. "They prove that, through treatment with Pegasys and Copegus, these patients can be treated successfully for their HCV -- without compromising their HIV status."
Results from the study report 40 percent overall efficacy among co-infected patients and, when analyzed by genotype, 62 percent efficacy in patients with genotypes 2 and 3, and 29 percent in those with genotype 1. Genotype 1 is typically the most difficult strain of HCV to treat. Four times more genotype 1 patients cleared the hepatitis C virus with Pegasys in combination with Copegus than with those treated with standard interferon/ribavirin combination therapy (29% vs. 7% respectively). Additionally, Pegasys monotherapy showed superior efficacy to treatment with standard interferon and ribavirin (20 percent vs. 12 percent), which is important for patients who cannot tolerate ribavirin.
The randomized, partially blinded international trial had a total of 868 HCV/HIV co-infected patients in 19 countries, and is currently, the largest study conducted among this patient population. All patients were HCV positive, had compensated liver disease, a CD4+ count greater than 100 cells/mL, and stable HIV disease, with or without antiretroviral therapy. Patients were randomized to 48 weeks of treatment with interferon three times a week plus 800 mg/day of ribavirin, 180 mcg of Pegasys once weekly plus placebo, or 180 mcg of Pegasys once weekly with 800 mg/day of Copegus. Sustained virological response (SVR) was accessed at the end of 24 weeks of treatment-free follow up (week 72).
Negative predictability ranged from 98 to 100 percent at 12 weeks. Negative predictability means that patients can determine by week 12 if they are unlikely to respond to therapy with Pegasys so decisions about the continuance of treatment can be made in that time. In addition, HIV viral levels were not negatively impacted by treatment with Pegasys and Copegus combination therapy, and no new safety concerns were reported with this study. Pegasys is a well-tolerated medication, even with the addition of full doses of ribavirin. In this study, the most commonly reported side effects were fatigue, fever and headache.
Co-authors on the study include J. Torriani, University of California, San Diego, CA; J. Rockstroh, University of Bonn, Bonn, Germany; M. Rodriguez-Torres, Fundacion de Investigacion de Diego, Santurce, Puerto Rico; E. Lissen, Virgen del Rocío University Hospital, Seville, Spain; J. González, Hospital La Paz, Madrid, Spain; A. Lazzarin, San Raffaele Vita-Salute University, Milan, Italy; G. Carosi, University of Brescia, Italy; J. Sasadeusz, Royal Melbourne Hospital, Australia; C. Katlama, Groupe Hospitalier de la Pitie Salpetriere, Paris, France; J. Montaner, University of British Columbia, Vancouver, Canada; H. Sette, Instituto de Infectologia Emilio Ribas, Sao Paulo, Brazil; F. Duff, Roche, Nutley, NJ, USA , J. DePamphilis, Roche, Nutley, NJ, USA; U. M. Schrenk, Roche, Basel; Switzerland.
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