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Telaprevir -- Benefit Assessment According to §35a Social Code Book V [Internet]

The benefit assessment of telaprevir was carried out on the basis of the approved therapeutic indication for the following research questions:

Institute for Quality and Efficiency in Health Care (IQWiG).

Version: January 12, 2012

Telaprevir for chronic hepatitis C with genotype 1: a meta-analysis

BACKGROUND/AIMS: The examination of HCV virological clearance through several randomized clinical trials of telaprevir in genotype 1 chronic hepatitis C.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2012

Safety of telaprevir for chronic hepatitis C virus infection: a meta-analysis of randomized controlled trials

BACKGROUND: Previous studies have reported telaprevir is effective for chronic hepatitis C virus infection, but the safety of a telaprevir-based regimen remains uncertain.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2012

Boceprevir and telaprevir for the treatment of chronic hepatitis C genotype 1 infection: an indirect comparison meta-analysis

BACKGROUND: The aim of this study was to examine the relative efficacy and safety of boceprevir and telaprevir, when used in combination with pegylated interferon alpha and ribavirin, using an indirect comparison meta-analysis.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2012

Efficacy and tolerability of telaprevir for chronic hepatitis virus C genotype 1 infection: a meta-analysis

BACKGROUND: Chronic hepatitis C virus (HCV) infection is one of the leading causes of hepatic cirrhosis and hepatocellular carcinoma, and HCV genotype 1 is the most prevalent genotype and is resistant to current standard therapy. We performed this meta-analysis to evaluate the efficacy and safety of telaprevir-based therapy for chronic HCV genotype 1 infection.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2012

Telaprevir versus boceprevir in chronic hepatitis C: a meta-analysis of data from phase II and III trials

BACKGROUND: Telaprevir and boceprevir are protease inhibitors now added to therapy for patients with chronic hepatitis C virus (HCV) genotype 1 infection who either are treatment naive or have a history of relapse or recurrence following a previous course of treatment with pegylated interferon + ribavirin (Peg-IFN + RBV). Because these agents are fairly new to the market, providers may have limited experience with them in the management of chronic HCV.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2013

The efficacy and safety of telaprevir-based regimens for treating chronic hepatitis C virus genotype 1 infection: a meta-analysis of randomized trials

OBJECTIVE: Previous studies have reported that telaprevir is effective for treating chronic hepatitis C virus (HCV) genotype 1 infection; however, the efficacy and safety of telaprevir-based regimens remain uncertain.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2013

The relative efficacy of boceprevir and telaprevir in the treatment of hepatitis C virus genotype 1

BACKGROUND: The licensing of direct-acting antivirals heralds a new era in the treatment of hepatitis C virus (HCV) genotype 1. We undertook a mixed treatment comparison to examine the relative efficacy among current treatments for HCV.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2013

Telaprevir for genotype 1 chronic hepatitis C: a systematic review and meta-analysis

OBJECTIVES: To assess the beneficial and harmful effects of telaprevir for patients with genotype 1 chronic hepatitis C.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2012

Treatment of chronic HCV genotype 1 infection with telaprevir: a Bayesian mixed treatment comparison of fixed-length and response-guided treatment regimens in treatment-naive and -experienced patients

BACKGROUND: Telaprevir (TVR) has been approved for response-guided-therapy (RGT) of chronic hepatitis C (HCV) genotype-1-infection in treatment-naïve and -experienced patients. In RGT-regimens patients that did not achieve extended rapid-virological-response (eRVR) within the first 4-12 weeks undergo treatment for 48-weeks, whereas in fixed-length-treatment (FLT) patients are treated for a fixed-duration regardless of their RVR.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2013

Peg-interferon plus ribavirin with or without boceprevir or telaprevir for HCV genotype 1: a meta-analysis on the role of response predictors

BACKGROUND & AIM: To compare the efficacy of pegylated-interferon (Peg-IFN) α-2a or α-2b and ribavirin given as dual therapy versus triple therapy (Peg-IFN and ribavirin plus boceprevir or telaprevir) in patients with HCV-1 chronic hepatitis naïve for anti-HCV therapy or relapsers to dual therapy in relation to the presence of constitutional, clinical and virological predictors of treatment response.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2014

Efficacy and safety of telaprevir and boceprevir in patients with hepatitis C genotype 1: a meta-analysis

WHAT IS KNOWN AND OBJECTIVE: Two NS3/4A protease inhibitors (PIs), telaprevir and boceprevir, were recently approved in the United States. The primary objective was to compare the efficacy and safety of triple therapies including either PI to dual therapy in patients with chronic hepatitis C genotype 1; the secondary objective was to conduct subgroup analyses to make comparisons based on patients' race.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2014

Efficacy of telaprevir and boceprevir in treatment-naive and treatment-experienced genotype 1 chronic hepatitis C patients: an indirect comparison using Bayesian network meta-analysis

This indirect Bayesian comparison of telaprevir versus boceprevir, combined with pegylated interferon alpha 2a or 2b and ribavirin, for genotype one chronic hepatitis C, suggested better efficacy for telaprevir, with a probability of 0.93 for patients new to treatment, and 0.98 for patients who had received treatment. These conclusions were cautious, and are likely to be reliable.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2012

Simeprevir (Galexos) (150 mg) [Internet]

Hepatitis C virus (HCV) infection is caused by an enveloped, single-stranded, linear ribonucleic acid (RNA) virus of the Flaviviridae family. Before 2011, pegylated interferon plus ribavirin (PR) was the gold standard of therapy to inhibit viral replication in patients with chronic hepatitis C (CHC). Approximately one-half of patients with genotype 1 CHC, the most prevalent type of CHC in Canada, could expect to achieve a sustained viral response (SVR) with PR therapy.

Common Drug Review - Canadian Agency for Drugs and Technologies in Health.

Version: November 2016
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Triple Therapy for Hepatitis C in Previous Non-responders: A Review of the Clinical Effectiveness and Safety [Internet]

Successful treatment of hepatitis C virus (HCV) infection is reflected by a sustained virologic response (SVR), which is the absence of detectable levels of viral genetic material in the blood 24 weeks after completion of therapy. The current standard treatment for chronic HCV infection has been a combination of peginterferon-α and ribavirin (PR) for 24 to 48 weeks, which, acting on non-specific pathways, has suboptimal SVR and significant toxicity in treated patients. Recently, new drugs that act on specific targets in the viral life cycle have been developed to directly inhibit viral production. These drugs, referred as direct-acting antiviral medications (DAA), and included protease inhibitors such as boceprevir and telaprevir, can be used alone, together with another DAA, or combined with PR. Boceprevir and telaprevir, approved by Health Canada in 2011, have demonstrated high cure rates when used together with PR, but adverse event rates and low spectrum activity (genotype 1) have been barriers to their use. In order to improve the pharmacokinetics and tolerability of DAA, a second generation of protease inhibitors such as simeprevir and sofosbuvir have been recently developed and approved for use in Canada in 2013 and 2014, respectively. Simeprevir and sofosbuvir can be used as first-line therapy for the treatment of HCV infection, or because of the high costs associated with the new DAA, in patients who had not responded to standard treatment or first generation DAA. A recent Therapeutic Review report by CADTH recommended simeprevir for treatment-naïve or -experienced patients with genotype 1 HCV, but could not make a recommendation for sofosbuvir due to a lack of evidence.

Rapid Response Report: Summary with Critical Appraisal - Canadian Agency for Drugs and Technologies in Health.

Version: December 8, 2014
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Interferon-free Regimens for Genotype 1 Chronic Hepatitis C: A Review of the Clinical Evidence and Cost-Effectiveness [Internet]

In Canada it is estimated that 242,000 Canadians have chronic hepatitis C virus (HCV) infection; however, the exact number affected is unknown as 30% to 70% of patients are unaware that they are infected. Fifteen to 25% of patients with chronic infection will develop hepatocellular carcinoma, progressive liver disease, end-stage liver disease, or will require a liver transplant over 20 to 30 years of infection. There are six major HCV genotypes, and genotype 1 accounts for approximately 60% of HCV infections in Canadians.

Rapid Response Report: Summary with Critical Appraisal - Canadian Agency for Drugs and Technologies in Health.

Version: June 25, 2014
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Direct-Acting Antiviral Agents for Chronic Hepatitis C Genotype 1 [Internet]

An estimated 250,000 Canadians have chronic hepatitis C virus (HCV) infection; however, the exact number affected is not known, as 30% to 70% of patients are unaware that they have been infected and limited population level surveillance has been carried out in Canada to document prevalent cases. While the incidence of HCV infection in the US and Canada appears to be stable or declining, liver-related morbidity and mortality are expected to increase over the coming decades, as those who are already infected age and develop progressive liver disease.

CADTH Therapeutic Review - Canadian Agency for Drugs and Technologies in Health.

Version: October 2014
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Treatment for Hepatitis C Virus Infection in Adults [Internet]

This report systematically reviews the comparative benefits and harms of current antiviral treatment regimens for chronic hepatitis C virus (HCV) infection in treatment-naïve adults.

Comparative Effectiveness Reviews - Agency for Healthcare Research and Quality (US).

Version: November 2012
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Sofosbuvir (Sovaldi): Sofosbuvir is Indicated for the Treatment of Chronic Hepatitis C Virus (CHC) Infection in Adult Patients With Compensated Liver Disease, Including Cirrhosis [Internet]

Objective: To perform a systematic review of the beneficial and harmful effects of sofosbuvir in combination with other agents for the treatment of adults with chronic hepatitis C virus (CHC) infection (genotypes 1, 2, 3, or 4).

Common Drug Review - Canadian Agency for Drugs and Technologies in Health.

Version: October 2014
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Strategies for Improving the Lives of Women Aged 40 and Above Living With HIV/AIDS [Internet]

While in its early years the HIV epidemic affected primarily the male and the young, nowadays the population living with HIV/AIDS comprises approximately 24 percent women, and its age composition has shifted towards older ages. Many women over 40 who live with HIV/AIDS also live with the medical and social conditions that accompany aging.

Technical Briefs - Agency for Healthcare Research and Quality (US).

Version: November 2016
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