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CURATOR
A pinboard by
Amirah Azzeri

PhD student, University of Malaya

PINBOARD SUMMARY

This study will focus on economic evaluation of current and future of hepatitis C treatment

Hepatitis C virus (HCV) causes important clinical and economic implications in many countries worldwide. The disease burden related to chronic hepatitis C is expected to increase with time as the HCV-infected population ages and progress to more severe stages of liver disease. This scenario is associated with high costs of clinical management of various stages of liver disease including end stage liver disease and hepatocellular carcinoma. The development of novel direct acting antiviral (DAA) drugs, which achieves high cure rates for all the main genotypes of hepatitis C virus has changed the epidemiology and prognosis of this disease. Treatment with DAA is of shorter duration compared to the previous standard treatment with interferon-based regimens with higher sustained virologic rate (SVR) and fewer side effects. Clinical guidelines of most countries globally now recommends the use of DAA as standard treatment. Additionally, patients with more severe stages of liver disease and comorbidities are eligible for treatment with DAA and are able to achieve SVR, unlike with interferon-based treatment. Due to these advantages, DAA drugs are currently marketed at high prices, which are considered extremely expensive for many countries, including Malaysia. DAA innovator drugs are available at tiered pricing for various markets, and procurement prices negotiated may depend on a specific country’s economic status as well as the local HCV disease burden. The main objective of this study is to determine the cost-effectiveness of DAA regimens for patients with chronic HCV infection in Malaysia. Conducting cost-effectiveness analysis of DAA in Malaysia will require local data on Malaysia’s healthcare cost and quality adjusted life years for hepatitis C treatment that will be determined in this study. Cost effectiveness analysis will be useful for health policy to access the appropriateness of using DAA as the main stay of treatment to all diagnosed and eligible hepatitis C-infected patients, given scarce healthcare resources in this country.

3 ITEMS PINNED

Sofosbuvir-velpatasvir with ribavirin for 24 weeks in HCV patients previously treated with a direct-acting antiviral regimen.

Abstract: The optimal retreatment strategy for patients chronically infected with hepatitis C virus (HCV) who experience virologic failure after treatment with direct-acting antiviral (DAA)-based therapies remains unclear. In this multicenter, open-label, phase 2 study, we evaluated the efficacy and safety of a fixed-dose combination of sofosbuvir-velpatasvir (400 mg/100 mg) plus weight-adjusted ribavirin administered for 24 weeks in patients who did not achieve sustained virologic response (SVR) after prior treatment with DAA regimens that included the nucleotide analogue NS5B inhibitor sofosbuvir plus the NS5A inhibitor velpatasvir with or without the NS3/4A protease inhibitor voxilaprevir. The primary efficacy endpoint was the proportion of patients achieving SVR at 12 weeks after the cessation of treatment. In total, 63 of 69 (91%; 95% confidence interval [CI], 82-97%) patients achieved SVR12, including 36 of 37 (97%; 95% CI, 86-100%) patients with HCV genotype 1 infection, 13 of 14 (93%; 95% CI, 66-100%) patients with genotype 2 infection, and 14 of 18 (78%; 95% CI, 52-94%) patients with genotype 3 infection. Most adverse events were of mild or moderate severity. The most frequently reported adverse events were fatigue, nausea, headache, insomnia, and rash. One patient (1%) with genotype 1a infection discontinued all treatment due to an adverse event (irritability).Retreatment of patients who previously failed DAA-based therapies with sofosbuvir-velpatasvir plus ribavirin for 24 weeks was well tolerated and effective, particularly those with HCV genotype 1 or 2 infection. This article is protected by copyright. All rights reserved.

Pub.: 13 May '17, Pinned: 31 Jul '17

Bridging the data gaps in the epidemiology of hepatitis C virus infection in Malaysia using multi-parameter evidence synthesis.

Abstract: Collecting adequate information on key epidemiological indicators is a prerequisite to informing a public health response to reduce the impact of hepatitis C virus (HCV) infection in Malaysia. Our goal was to overcome the acute data shortage typical of low/middle income countries using statistical modelling to estimate the national HCV prevalence and the distribution over transmission pathways as of the end of 2009.Multi-parameter evidence synthesis methods were applied to combine all available relevant data sources - both direct and indirect - that inform the epidemiological parameters of interest.An estimated 454,000 (95% credible interval [CrI]: 392,000 to 535,000) HCV antibody-positive individuals were living in Malaysia in 2009; this represents 2.5% (95% CrI: 2.2-3.0%) of the population aged 15-64 years. Among males of Malay ethnicity, for 77% (95% CrI: 69-85%) the route of probable transmission was active or a previous history of injecting drugs. The corresponding proportions were smaller for male Chinese and Indian/other ethnic groups (40% and 71%, respectively). The estimated prevalence in females of all ethnicities was 1% (95% CrI: 0.6 to 1.4%); 92% (95% CrI: 88 to 95%) of infections were attributable to non-drug injecting routes of transmission.The prevalent number of persons living with HCV infection in Malaysia is estimated to be very high. Low/middle income countries often lack a comprehensive evidence base; however, evidence synthesis methods can assist in filling the data gaps required for the development of effective policy to address the future public health and economic burden due to HCV.

Pub.: 08 Nov '14, Pinned: 31 Jul '17

Projections of the current and future disease burden of hepatitis C virus infection in Malaysia.

Abstract: The prevalence of hepatitis C virus (HCV) infection in Malaysia has been estimated at 2.5% of the adult population. Our objective, satisfying one of the directives of the WHO Framework for Global Action on Viral Hepatitis, was to forecast the HCV disease burden in Malaysia using modelling methods.An age-structured multi-state Markov model was developed to simulate the natural history of HCV infection. We tested three historical incidence scenarios that would give rise to the estimated prevalence in 2009, and calculated the incidence of cirrhosis, end-stage liver disease, and death, and disability-adjusted life-years (DALYs) under each scenario, to the year 2039. In the baseline scenario, current antiviral treatment levels were extended from 2014 to the end of the simulation period. To estimate the disease burden averted under current sustained virological response rates and treatment levels, the baseline scenario was compared to a counterfactual scenario in which no past or future treatment is assumed.In the baseline scenario, the projected disease burden for the year 2039 is 94,900 DALYs/year (95% credible interval (CrI): 77,100 to 124,500), with 2,002 (95% CrI: 1340 to 3040) and 540 (95% CrI: 251 to 1,030) individuals predicted to develop decompensated cirrhosis and hepatocellular carcinoma, respectively, in that year. Although current treatment practice is estimated to avert a cumulative total of 2,200 deaths from DC or HCC, a cumulative total of 63,900 HCV-related deaths is projected by 2039.The HCV-related disease burden is already high and is forecast to rise steeply over the coming decades under current levels of antiviral treatment. Increased governmental resources to improve HCV screening and treatment rates and to reduce transmission are essential to address the high projected HCV disease burden in Malaysia.

Pub.: 05 Jun '15, Pinned: 31 Jul '17