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Hepatitis C, disease and its management: a cost-effectiveness analysis of the new generation oral protease inhibitors.

ABSTRACT: Hepatitis C, caused by a single-stranded RNA virus, has become a global health problem. Infecting millions of individuals in the United States alone, chronic HCV infection can lead to devastating medical problems including cirrhosis and hepatocellular carcinoma. These problems create millions of dollars in health-care costs for treatment and management. This study determines the cost-effectiveness of hepatitis C treatment with the new generation of oral protease inhibitors.A Markov model was constructed to simulate the progression of genotype-1 chronic hepatitis C disease in a cohort of 50-year-old patients. A decision tree, along with the Markov model, was then used to determine duration of disease, treatment success, progression of disease and mortality. At the end of each stage in the model, the cost and quality-adjusted life years (QALY) were summed for each individual. These were then used to calculate the overall cost-effectiveness ratio (CER) using QALY as the unit of effectiveness. Four treatment options were modelled: sofosbuvir with pegylated interferon-? and ribavirin (SOF/PEG-IFN+RBV), sofosbuvir with ribavirin (SOF/RBV), simeprevir with pegylated interferon-? and ribavirin (SMV/PEG-IFN+RBV) and simeprevir with sofosbuvir (SMV/SOF).SOF/PEG-IFN+RBV yielded a CER ratio of $6,796.22/QALY, SMV/PEG-IFN+RBV of $7,642.60/QALY and SMV/SOF of $8,959.11/QALY. SOF/RBV had a higher CER of $16,295.30/QALY. It is important to note however that SMV/SOF had the highest QALY at 19.08.After consideration of quality of life, treatment regimens and treatment side effects, the SMV/SOF regimen yields acceptable cost-effectiveness ratios with high QALY.

SUBMITTER: Arshad M

PROVIDER: S-EPMC5323075 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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Hepatitis C, disease and its management: a cost-effectiveness analysis of the new generation oral protease inhibitors.

Arshad Mahreen M Wei Feifei F Nelsen David A DA

Antiviral therapy 20150826 8

<h4>Background</h4>Hepatitis C, caused by a single-stranded RNA virus, has become a global health problem. Infecting millions of individuals in the United States alone, chronic HCV infection can lead to devastating medical problems including cirrhosis and hepatocellular carcinoma. These problems create millions of dollars in health-care costs for treatment and management. This study determines the cost-effectiveness of hepatitis C treatment with the new generation of oral protease inhibitors.<h4 ...[more]

PMID: 26555064

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Project description:BACKGROUND:Chronic hepatitis C virus is difficult to treat and affects approximately 3 million Americans. Protease inhibitors increase the effectiveness of standard therapy, but they are costly. A genetic assay may identify patients most likely to benefit from this treatment advance. OBJECTIVE:To assess the cost-effectiveness of new protease inhibitors and an interleukin (IL)-28B genotyping assay for treating chronic hepatitis C virus. DESIGN:Decision-analytic Markov model. DATA SOURCES:Published literature and expert opinion. TARGET POPULATION:Treatment-naive patients with chronic, genotype 1 hepatitis C virus monoinfection. TIME HORIZON:Lifetime. PERSPECTIVE:Societal. INTERVENTION:Strategies are defined by the use of IL-28B genotyping and type of treatment (standard therapy [pegylated interferon with ribavirin]; triple therapy [standard therapy and a protease inhibitor]). Interleukin-28B-guided triple therapy stratifies patients with CC genotypes to standard therapy and those with non-CC types to triple therapy. OUTCOME MEASURES:Discounted costs (in 2010 U.S. dollars) and quality-adjusted life-years (QALYs); incremental cost-effectiveness ratios. RESULTS OF BASE-CASE ANALYSIS:For patients with mild and advanced fibrosis, universal triple therapy reduced the lifetime risk for hepatocellular carcinoma by 38% and 28%, respectively, and increased quality-adjusted life expectancy by 3% and 8%, respectively, compared with standard therapy. Gains from IL-28B-guided triple therapy were smaller. If the protease inhibitor costs $1100 per week, universal triple therapy costs $102,600 per QALY (mild fibrosis) or $51,500 per QALY (advanced fibrosis) compared with IL-28B-guided triple therapy and $70,100 per QALY (mild fibrosis) and $36,300 per QALY (advanced fibrosis) compared with standard therapy. RESULTS OF SENSITIVITY ANALYSIS:Results were sensitive to the cost of protease inhibitors and treatment adherence rates. LIMITATION:Data on the long-term comparative effectiveness of the new protease inhibitors are lacking. CONCLUSION:Both universal triple therapy and IL-28B-guided triple therapy are cost-effective when the least-expensive protease inhibitor are used for patients with advanced fibrosis. PRIMARY FUNDING SOURCE:Stanford University.

Project description:AimTo evaluates the effectiveness and safety of the first generation, NS3/4A protease inhibitors (PIs) in clinical practice against chronic C virus, especially in patients with advanced fibrosis.MethodsProspective study and non-experimental analysis of a multicentre cohort of 38 Spanish hospitals that includes patients with chronic hepatitis C genotype 1, treatment-naïve (TN) or treatment-experienced (TE), who underwent triple therapy with the first generation NS3/4A protease inhibitors, boceprevir (BOC) and telaprevir (TVR), in combination with pegylated interferon and ribavirin. The patients were treatment in routine practice settings. Data on the study population and on adverse clinical and virologic effects were compiled during the treatment period and during follow up.ResultsOne thousand and fifty seven patients were included, 405 (38%) were treated with BOC and 652 (62%) with TVR. Of this total, 30% (n = 319) were TN and the remaining were TE: 28% (n = 298) relapsers, 12% (n = 123) partial responders (PR), 25% (n = 260) null-responders (NR) and for 5% (n = 57) with prior response unknown. The rate of sustained virologic response (SVR) by intention-to-treatment (ITT) was greater in those treated with TVR (65%) than in those treated with BOC (52%) (P < 0.0001), whereas by modified intention-to-treatment (mITT) no were found significant differences. By degree of fibrosis, 56% of patients were F4 and the highest SVR rates were recorded in the non-F4 patients, both TN and TE. In the analysis by groups, the TN patients treated with TVR by ITT showed a higher SVR (P = 0.005). However, by mITT there were no significant differences between BOC and TVR. In the multivariate analysis by mITT, the significant SVR factors were relapsers, IL28B CC and non-F4; the type of treatment (BOC or TVR) was not significant. The lowest SVR values were presented by the F4-NR patients, treated with BOC (46%) or with TVR (45%). 28% of the patients interrupted the treatment, mainly by non-viral response (51%): this outcome was more frequent in the TE than in the TN patients (57% vs 40%, P = 0.01). With respect to severe haematological disorders, neutropaenia was more likely to affect the patients treated with BOC (33% vs 20%, P ≤ 0.0001), and thrombocytopaenia and anaemia, the F4 patients (P = 0.000, P = 0.025, respectively).ConclusionIn a real clinical practice setting with a high proportion of patients with advanced fibrosis, effectiveness of first-generation PIs was high except for NR patients, with similar SVR rates being achieved by BOC and TVR.

Project description:UnlabelledRecently approved, interferon-free medication regimens for treating hepatitis C are highly effective, but extremely costly. We aimed to identify cost-effective strategies for managing treatment-naïve U.S. veterans with new hepatitis C medication regimens. We developed a Markov model with 1-year cycle length for a cohort of 60-year-old veterans with untreated genotype 1 hepatitis C seeking treatment in a typical year. We compared using sofosbuvir/ledipasvir or ombitasvir/ritonavir/paritaprevir/dasabuvir to treat: (1) any patient seeking treatment; (2) only patients with advanced fibrosis or cirrhosis; or (3) patients with advanced disease first and healthier patients 1 year later. The previous standard of care, sofosbuvir/simeprevir or sofosbuvir/pegylated interferon/ribavirin, was included for comparison. Patients could develop progressive fibrosis, cirrhosis, or hepatocellular carcinoma, undergo transplantation, or die. Complications were less likely after sustained virological response. We calculated the incremental cost per quality-adjusted life year (QALY) and varied model inputs in one-way and probabilistic sensitivity analyses. We used the Veterans Health Administration perspective with a lifetime time horizon and 3% annual discounting. Treating any patient with ombitasvir-based therapy was the preferred strategy ($35,560; 14.0 QALYs). All other strategies were dominated (greater costs/QALY gained than more effective strategies). Varying treatment efficacy, price, and/or duration changed the preferred strategy. In probabilistic sensitivity analysis, treating any patient with ombitasvir-based therapy was cost-effective in 70% of iterations at a $50,000/QALY threshold and 65% of iterations at a $100,000/QALY threshold.ConclusionManaging any treatment-naïve genotype 1 hepatitis C patient with ombitasvir-based therapy is the most economically efficient strategy, although price and efficacy can impact cost-effectiveness. It is economically unfavorable to restrict treatment to patients with advanced disease or use a staged treatment strategy. (Hepatology 2016;63:428-436).

Dataset Information

Hepatitis C, disease and its management: a cost-effectiveness analysis of the new generation oral protease inhibitors.

Publications

Hepatitis C, disease and its management: a cost-effectiveness analysis of the new generation oral protease inhibitors.

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