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VP17 Hepatitis C Virus Treatment: A Meta-Analysis Of Long-Term Efficacy
- Chiara Inserra, Sophia Campbell Davies, Mariagrazia Piacenza, Angelo Bignamini, Paola Minghetti, Grazia Zerega
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- Journal:
- International Journal of Technology Assessment in Health Care / Volume 34 / Issue S1 / 2018
- Published online by Cambridge University Press:
- 03 January 2019, pp. 162-163
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Introduction:
The efficacy of second generation direct-acting antiviral agents (DAAs-2), in terms of sustained viral response (SVR) 12 weeks after the end of treatment (EOT), has widely been proven; however, long-term efficacy is still controversial due to the low number of available studies with a small number of patients. The objective of this study is to conduct a systematic review and, if possible, a meta-analysis of existing clinical evidence of the long-term efficacy (SVR longer than 12 weeks after EOT) of DAAs-2 for hepatitis C virus (HCV) treatment.
Methods:A systematic review was performed with the use of CENTRAL, MEDLINE, Embase, Pubmed and SBBL-CILEA/METACRAWLER databases. Trials were initially screened by the title; secondly, full papers and abstracts were analysed. The meta-analysis included randomised controlled trials (RCTs) with adult patients affected by HCV, treated with DAAs-2 and assessed for longer than 12 weeks after EOT. Study quality assessment was undertaken using the Jadad scale. Heterogeneity analysis of the studies was conducted with chi-square and I2. The statistical analysis of the efficacy rate was performed using the meta package with the R software. The effect estimate was expressed in risk ratio (RR) with 95% confidence interval (CI 95%) and pooled using a random effects model.
Results:Of the 106 identified studies, 11 high quality RCTs were included for meta-analysis (25 were duplicate publications, 70 did not meet the inclusion criteria). Considered genotypes were 1 (n = 9), 2 (n = 1), 3 (n = 1). Meta-analysis included 3,720 patients (2,698 treated with DAAs-2; 1,022 treated with placebo or a first generation DAA±Ribavirin±Pegylated interferon). Heterogeneity between studies was high (p<0.001; I2 = 90.2%); however, it was absorbed by the model (τ2 = 0,08). Long-term efficacy was expressed as SVR 24 weeks after EOT, since longer timescales were not available. According to the pooled RR, the incidence of efficacy was 1.5 (CI 95%: 1.24−1.83, p < 0.001).
Conclusions:The meta-analysis demonstrated that DAAs-2 for HCV treatment have long-term efficacy at SVR 24 weeks after the EOT; however, the number of studies is mostly based on genotype 1. More RCTs are required to confirm long-term efficacy at more than six months after EOT for all treated genotypes.
OP61 Cost-Utility Analyses Of Biologics For Refractory Ulcerative Colitis
- Sophia Campbell Davies, Chiara Inserra, Gaetana Muserra, Mariagrazia Piacenza, Sandro Ardizzone, Tommaso Saporito
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- Journal:
- International Journal of Technology Assessment in Health Care / Volume 33 / Issue S1 / 2017
- Published online by Cambridge University Press:
- 12 January 2018, p. 27
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INTRODUCTION:
Although many biologics (Bs) have been approved for the treatment of moderate-to-severe Ulcerative Colitis (UC) in patients who have responded inadequately to conventional therapy, the selection of Bs is controversial due to the lack of head-to-head trials. Indirect economic comparisons of these costly drugs are available from National Healthcare perspectives that are not the Italian ones. Therefore, the objective is to evaluate cost-utility of Bs for the treatment of refractory moderate-to-severe UC both in Italy and in the Lombardy Region.
METHODS:A Markov model (considering three transition states: remission, clinical response, relapse) was constructed using the software R 3.3.1 markovchain-package to evaluate incremental cost-utility ratios (ICUR) of adalimumab (ADA), infliximab (IFX), infliximab biosimilar (IFX-B), golimumab (GOL) and vedolizumab (VED) treatments of patients over a 10-year time horizon from the perspective of the Italian (N) and Lombardy Region (R) healthcare system. Clinical parameters were derived from clinical trials. Costs (actualized by – 1.5 percent) were obtained from the National database and Regional public tender. Utility was expressed as QALY (Quality-Adjusted Life Years).
RESULTS:Costs per treatment were different from a N and R perspective (ADA -55 percent; IFX -16.7 percent; IFX-B -29.6 percent; GOL -9.6 percent; VED -10 percent). Direct healthcare costs (treatment cost, visits, laboratory tests, hospital admissions) were calculated over 10 years of treatment per patient: ADA (N: EUR114,227, R: EUR68,314, -40.2 percent), IFX (N: EUR130,595, R: EUR103,081, -21 percent), IFX-B (N: EUR110,438, R: EUR78,852, -28.6 percent), GOL (N: EUR118,602, R: EUR96,922, -18.3 percent), VED (N: EUR113,852, R: EUR102,932, -9.6 percent) with associated QALY respectively of 6.68, 6.66, 6.66, 6.70, 7.02. From a N perspective, IFX-B was dominating compared to all other treatments. The ICUR of VED/IFX-B was EUR9,483 for 10 years (willingness to pay EUR948/QALY). From a R perspective, ADA was dominating compared to all other treatments. The ICUR of VED/ADA was EUR101,818 for 10 years (Willingness to Pay, WTP EUR10,182/QALY).
CONCLUSIONS:National and Regional cost-utility analyses produced different results. As Regional price discounts can occur, local analysis is needed to estimate the economic impact of therapies to ensure optimal choice.