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Results from a Cost-Effectiveness Study Demonstrate Positive Economic Impact with PEGASYS Treatment
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This is a press announcement distributed today by Roche. I attached the poster abstract for this cost-effectiveness study at DDW following the press release.
- Interim Analyses Results from a Second Study, REPEAT, for Hepatitis C Patients Who Have Failed on Peg-Intron -
Los Angeles, CA - May 23, 2006 - Roche announced today interim results from a study investigating the cost-effectiveness of treating U.S. patients who have mild chronic hepatitis C (CHC) using PEGASYS (peginterferon alpha-2a) plus COPEGUS (ribavirin). Results from the study were presented at the Annual Digestive Disease Week (DDW) conference on May 23 in Los Angeles, CA.
"Roche continues to show a commitment to people living with hepatitis C in several ways," said James A. Thommes, M.D., Senior Medical Director, Roche. "An analysis of cost effectiveness presented at DDW demonstrates favorable outcomes resulting from treatment with PEGASYS and ribavirin in patients with mild chronic hepatitis C."
Data for the cost effectiveness study were obtained from two phase III multinational, randomized, controlled trials of hepatitis C patients with genotype 1 with mild CHC who were treated with PEGASYS 180mcg plus ribavirin 1000/1200 mg/day. The overall sustained virologic response (SVR) of this group was 56 percent. The life-time disease progression to cirrhosis, hepatocellular carcinoma, and liver transplant in patients who failed to achieve an SVR was based on published data. The impact of early virologic response (EVR) at week 12 (86 percent) on the cost of treatment was included in the model.
Compared with no treatment, in HCV genotype 1 patients with mild CHC, PEGASYS plus ribavirin is a cost-effective treatment strategy in the U.S. setting. PEGASYS plus ribavirin increased quality-adjusted life expectancy (QALY) by 1.46 years yielding an incremental cost per QALY gained of $3,513.
About the REPEAT Trial
In addition to the cost-effectiveness analysis, interim results were announced at DDW from the REPEAT (REtreatment with PEgasys in pATients Not Responding to Peg-Intron Therapy) study showing that treatment with PEGASYS plus COPEGUS successfully reduced viral levels after 12 weeks of therapy in many hepatitis C patients who had previously failed treatment with Peg-Intron (peginterferon alpha-2b) plus ribavirin.
The REPEAT trial focuses on patients who failed to respond to previous therapy with Peg-Intron. The analysis presented 12-week interim efficacy and safety data from the use of either standard-dose (180mcg) or fixed-dose induction (360mcg) therapy, and further identified outcomes for patients with cirrhosis and/or advanced fibrosis. After this initial 12-week treatment period, all patients continue to be studied while completing their therapy with the standard dose of PEGASYS and COPEGUS for a total treatment duration of either 48 or 72 weeks.
Interim results showed:
- Forty-five percent of patients treated with the standard dose of PEGASYS with COPEGUS had an early virologic response (EVR), defined as having a ≥ 2 log drop in viral load or having no detectable virus after 12 weeks of treatment (n = 469).
- An EVR rate of 62 percent was achieved in the group of patients who were treated with the higher fixed-dose induction of PEGASYS with standard COPEGUS for the first 12 weeks of therapy (n = 473).
- The adverse event profiles were similar for patients taking the higher fixed-dose induction of PEGASYS with COPEGUS for 12 weeks compared to those taking the standard dose. However, more patients in the higher fixed-dose induction group had their dose of PEGASYS and ribavirin modified or were discontinued.
"The interim results from this study suggest that previous non-responders to treatment can still be re-treated with some success, particularly in those treated with the higher dose of PEGASYS with ribavirin," said Donald Jensen, M.D., professor of medicine and director of the Center for Liver Diseases at the University of Chicago. "In addition, the interim data show that the high dose of PEGASYS is generally well tolerated by patients."
About Hepatitis C
Hepatitis C, a blood-borne infectious disease of the liver, is transmitted through
body fluids, primarily blood or blood products, and by sharing needles. Hepatitis C chronically infects an estimated 2.7 million Americans and 170 million people worldwide
and is the leading cause of cirrhosis and liver cancer and the number one reason for liver transplants in the United States.
Poster at DDW
Cost-Effectiveness of First-Line Peginterferon Alfa-2a (40KD) (PEGASYS) plus Ribavirin (COPEGUS) in Patients with Mild Chronic Hepatitis C (CHC) in the US
H. B. El-Serag1; K. K. Patel2; N. Wintfeld2; J. Green2; S. D. Sullivan3
1. Houston Veterans Affairs Medical Center, Baylor College of Medicine, Houston, TX, USA.
2. Roche, Nutley, NJ, USA.
3. University of Washington, Seattle, WA, USA.
Patients with mild CHC treated with peginterferon alfa-2a (40KD) plus ribavirin attain higher sustained virological response (SVR) rates than patients with incomplete septa or cirrhosis [1]. This report utilizes these findings to assess the cost-effectiveness of treating patients with mild CHC with peginterferon alfa-2a (40KD) plus ribavirin.
Methods: Data for HCV genotype 1 patients with mild CHC [1] were obtained from two phase III multinational, randomized, controlled trials [2,3]. Mild CHC was defined as a fibrosis score of F0, F1, or F2 using the METAVIR scale. Treatment of patients with mild CHC with peginterferon alfa-2a (40KD) (180 mg/week) plus ribavirin (1000/1200 mg/day) resulted in an SVR of 56% (95% CI 50-63%) [1]. The life-time disease progression to cirrhosis, hepatocellular carcinoma, and liver transplant in patients who failed to achieve an SVR was based on published data [4]. The impact of EVR at week 12 (86%; 95% CI 80-89%) on the cost of treatment was included in the model. Quality of life weights and resource costs were based on published literature. Costs related to the treatment of adverse events were not included in the analysis. Costs (in US$ 2004) and benefits were discounted at 3%. Sensitivity analyses were performed to evaluate uncertainty in model parameters.
Results: The patient cohort had a mean age of 42 years, and METAVIR scores of F0 (27%), F1 (37%) and F2 (37%). Compared with no treatment, in HCV genotype 1 patients with mild CHC, peginterferon alfa-2a (40KD) plus ribavirin increased quality-adjusted life expectancy (QALY) by 1.46 years yielding an incremental cost per QALY gained of $3,513. Despite wide variation in model parameters in sensitivity analyses (SVR as low as 50%, 12-week response as low as 80%, time horizon as short as 20 years), the incremental cost-effectiveness ratio did not exceed $27,000 per QALY gained. The most influential variables were time horizon and discounting.
Conclusion: Compared with no treatment, for adults with mild CHC, peginterferon alfa-2a (40KD) (PEGASYS ) plus ribavirin (COPEGUS ) is a cost-effective treatment strategy in the US setting. The practice of determining the need for antiviral therapy based on histology may need reassessment in view of these findings.
1Shiffman et al. Gastroenterology 2005;128(Suppl) Abstr S1568
2Zeuzem et al. Gastroenterology 2004;127:1724
3Fried et al. NEJM 2002;347:975
4Hui et al. J Hepatol 2003;38:511
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