Official websites use .gov
Secure .gov websites use HTTPS
The comparative clinical effectiveness and value of simeprevir and sofosbuvir in the treatment of chronic hepatitis C infection: a technology assessment : final report
The comparative clinical effectiveness and value of simeprevir and sofosbuvir in the treatment of chronic hepatitis C infection: a technology assessment : final report
- Collection:
- Health Policy and Services Research
- Author(s):
- Tice, Jeffrey A., author
Ollendorf, Daniel A., author
Pearson, Steven D., author - Contributor(s):
- California Technology Assessment Forum, issuing body.
Institute for Clinical and Economic Review, issuing body. - Publication:
- [Boston, MA] : Institute for Clinical and Economic Review, April 15, 2014
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Comparative Effectiveness Research
Hepatitis C, Chronic -- drug therapy
Heterocyclic Compounds, 3-Ring -- therapeutic use
Sulfonamides -- therapeutic use
Uridine Monophosphate -- analogs & derivatives
Uridine Monophosphate -- therapeutic use
Antiviral Agents -- economics
Antiviral Agents -- therapeutic use
Cost-Benefit Analysis
Drug Costs
Drug Therapy, Combination
Genotype
Hepatitis C -- economics
Hepatitis C -- genetics
Heterocyclic Compounds, 3-Ring -- adverse effects
Heterocyclic Compounds, 3-Ring -- economics
Insurance Coverage
Interferon-alpha -- therapeutic use
Oligopeptides -- therapeutic use
Polyethylene Glycols -- therapeutic use
Proline -- analogs & derivatives
Proline -- therapeutic use
Protease Inhibitors -- economics
Protease Inhibitors -- therapeutic use
Randomized Controlled Trials as Topic
Ribavirin -- therapeutic use
Sulfonamides -- adverse effects
Technology Assessment, Biomedical
Treatment Outcome
Uridine Monophosphate -- adverse effects
Uridine Monophosphate -- economics
Value-Based Purchasing
Humans
United States - Genre(s):
- Technical Report
- Abstract:
- This assessment for the California Technology Assessment Forum (CTAF) evaluates the evidence on the comparative clinical effectiveness and value of two drugs recently approved by the FDA for the treatment of chronic hepatitis C: simeprevir and sofosbuvir. Chronic hepatitis C is a common infection that is a major cause of chronic liver disease, liver failure, and hepatocellular carcinoma, and it is the leading indication for liver transplantation in the Western world. Prior to 2011, the combination of pegylated interferon and ribavirin (PR) was the gold standard of therapy for the treatment of chronic hepatitis C. Approximately half of patients with genotype 1, the most prevalent type of hepatitis C in the US, could expect with PR therapy to clear the virus from their bloodstream entirely and maintain a sustained virologic response (SVR) 24 weeks after the end of treatment. PR therapy can be difficult, however, as both interferon and ribavirin can produce bothersome side effects, and in some cases, dangerous levels of anemia, neutropenia, and/or thrombocytopenia. The 2011 introduction of first generation direct-acting antiviral (DAA) protease inhibitors boceprevir (Victrelis, Merck & Co.) and telaprevir (Incivek, Vertex Pharmaceuticals, Inc.) resulted in substantially improved SVR rates in many patients when used with PR regimens. This improvement has come with new challenges, however, including significant additional side effects and drug-drug interactions as well as stringent dosing requirements and high pill burdens for patients. Novel DAA agents have been developed with the potential for simplified dosing, fewer side effects and drug-drug interactions, and in some patients, the promise of interferon- and/or ribavirin-free treatment, particularly for genotypes 2 and 3 (the other common genotypes in the US). These new agents include the recently approved second generation protease inhibitor simeprevir (Olysio, Janssen Products, LP) and polymerase inhibitor sofosbuvir (Sovaldi, Gilead Sciences, Inc.), as well as several other agents that are currently in late-stage clinical trials. Uncertainties remain with these new agents, however, as data on treatment-related side effects and their performance in particular patient populations are still emerging in the published literature. In addition, the costs of treatment are likely to increase substantially, with the two new agents expected to cost approximately $70,000 and $170,000 per course of therapy, depending on the duration of therapy. Accordingly, the California Technology Assessment Forum has chosen to review the evidence on the comparative clinical effectiveness and comparative value of new DAA agents for chronic hepatitis C in relation to the existing standard of care in multiple patient populations. This assessment will address the following questions: 1) among patients with genotype 1, are treatment regimens incorporating simeprevir and sofosbuvir equivalent or superior to the previous standard of care: pegylated interferon plus ribavirin and one of the first generation protease inhibitors telaprevir or boceprevir; 2) among patients with genotypes 2 and 3, is the combination of sofosbuvir and ribavirin equivalent or superior to the previous standard of care, pegylated interferon plus ribavirin; and 3) among interferon-ineligible or intolerant patients, is the combination of sofosbuvir plus ribavirin or sofosbuvir plus simeprevir equivalent or superior to no treatment. The purpose of this assessment is to help patients, providers, and payers address these important questions and to support dialogue needed for successful action to improve the quality and value of health care for patients with hepatitis C.
- Copyright:
- Reproduced with permission of the copyright holder. Further use of the material is subject to CC BY license. (More information)
- Extent:
- 1 online resource (1 PDF file (118 pages))
- Illustrations:
- Illustrations
- NLM Unique ID:
- 101642256 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/101642256