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