Real-world effectiveness of 8-week treatment with ledipasvir/sofosbuvir in chronic hepatitis C

Buggisch, Peter; Vermehren, Johannes; Mauss, Stefan; Günther, Rainer; Schott, Eckart; Pathil, Anita; Boeker, Klaus; Zimmermann, Tim; Teuber, G.; Vornkahl, Heike-Pfeiffer; Simon, Karl-Georg; Niederau, Claus; Wedemeyer, Heiner; Zeuzem, Stefan

doi:10.1016/j.jhep.2017.11.009

Cited by 54 publications

(39 citation statements)

References 16 publications

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“…80 The effect of F3 fibrosis was not confirmed in later studies. 81,82 SVR12 rates of the same order as in the clinical trials were observed in patients with or without compensated cirrhosis in real-world studies from various continents.…”

Section: Genotype 1a Pangenotypic: Glecaprevir/pibrentasvirsupporting

confidence: 66%

Direct acting antivirals treatment for hepatitis C virus infection does not increase the incidence of de novo hepatocellular carcinoma occurrence

Buonomo¹,

Scotto²,

Coppola³

et al. 2020

Medicine

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Hepatitis C virus (HCV) infection is a major cause of chronic liver disease, with approximately 71 million chronically infected individuals worldwide. Clinical care for patients with HCV-related liver disease has advanced considerably thanks to an enhanced understanding of the pathophysiology of the disease, and because of developments in diagnostic procedures and improvements in therapy and prevention. These European Association for the Study of the Liver Recommendations on Treatment of Hepatitis C describe the optimal management of patients with acute and chronic HCV infections in Anti-HCV antibodies are detectable in serum or plasma by enzyme immunoassay (EIA) in the vast majority of patients with HCV infection, but EIA results may be negative in early acute Journal of Hepatology 2018 vol. 69 j 461-511 q Clinical practice guidelines panel: Chair: Jean-Michel Pawlotsky; EASL governing board representative: Francesco Negro; Panel members:

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Section: Genotype 1a Pangenotypic: Glecaprevir/pibrentasvirsupporting

confidence: 66%

Direct acting antivirals treatment for hepatitis C virus infection does not increase the incidence of de novo hepatocellular carcinoma occurrence

Buonomo¹,

Scotto²,

Coppola³

et al. 2020

Medicine

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“…All treated persons received first‐line DAA therapy (as per National Health Service (NHS) England prescribing regulations March–August 2018) for either genotype 3a and genotype 1a and treatment efficacy reflected published results in treatment naïve noncirrhotic and cirrhotic individuals (Table B) …”

Section: Methodsmentioning

confidence: 99%

The testing of people with any risk factor for hepatitis C in community pharmacies is cost‐effective

Buchanan

Cooper

Grellier

et al. 2019

Journal of Viral Hepatitis

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New antiviral drugs with high efficacy mean the hepatitis C virus (HCV) can now be eliminated. To achieve this, it is necessary to identify undiagnosed cases of HCV. However, the costs of testing should be considered when judging the overall cost‐effectiveness of treatment. This study describes the cost‐effectiveness of a community pharmacy testing service in a population of people at risk of HCV living on the Isle of Wight (United Kingdom). Dry blood spot testing was conducted in anyone with a known risk factor for HCV in 20 community pharmacies. The outcomes and costs were entered into a Markov model. Cost and health utilities from the model were used to calculate an incremental cost‐effectiveness ratio (ICER). In 24 months, 186 tests were conducted, 13 were positive for HCV RNA and six of these (46%) received treatment during the follow‐up period. All achieved a sustained virological response at 3 months. The overall cost of the testing and treatment intervention was £242 183, and the ICER for the service was £3689 per quality‐adjusted life year (QALY) gained. If screening had been restricted to just people with a history of injecting drug use (PWID) the ICER would have been £4865 per QALY gained. The service was effective at identifying people with HCV infection, and despite the additional cost of targeted testing, its cost‐effectiveness was below the commonly accepted thresholds. In this setting, restricting targeted testing to PWID would not improve the cost‐effectiveness.

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“…[6][7][8] Moreover, largescale post-marketing studies have shown that data from clinical trials can be replicated in the realworld setting with high overall efficacy and few safety concerns. [9][10][11] Finally, there is increasing evidence that viral eradication following DAA therapy is associated with a significant decrease in liver-related morbidity and mortality, and the adverse extrahepatic sequelae of HCV infection, while being associated with an increase in health-related quality of life. [12][13][14][15] Despite these overwhelming advances, there remain challenges to eliminating HCV in some patient subgroups, including those in whom previous DAA-based therapies have failed.…”

Section: Introductionmentioning

confidence: 99%

Challenges and perspectives of direct antivirals for the treatment of hepatitis C virus infection

Vermehren

Park

Jacobson

et al. 2018

Journal of Hepatology

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Treatment of chronic hepatitis C virus infection has been revolutionised by the development of direct-acting antivirals (DAAs). All-oral, once-daily, 8- to 12-week treatment regimens are now standard of care, with viral eradication possible in >95% of patients across different populations. Despite these advances, several unresolved issues remain, including treatment of patients with hepatitis C virus genotype 3, chronic kidney disease, and those in whom DAA therapy has previously failed. Glecaprevir/pibrentasvir and sofosbuvir/velpatasvir/voxilaprevir are the most recently approved DAA regimens. Given the overwhelming success of modern DAA-based therapies, glecaprevir/pibrentasvir and sofosbuvir/velpatasvir/voxilaprevir are also likely to represent the last DAAs to be approved. Both are pangenotypic, once-daily, all-oral DAA combinations that have the potential to close the gaps in the current DAA treatment portfolio. Herein, we review the challenges associated with current DAAs and how these two regimens may be implemented in existing treatment algorithms.

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Real-world effectiveness of 8-week treatment with ledipasvir/sofosbuvir in chronic hepatitis C

Cited by 54 publications

References 16 publications

Direct acting antivirals treatment for hepatitis C virus infection does not increase the incidence of de novo hepatocellular carcinoma occurrence

Direct acting antivirals treatment for hepatitis C virus infection does not increase the incidence of de novo hepatocellular carcinoma occurrence

The testing of people with any risk factor for hepatitis C in community pharmacies is cost‐effective

Challenges and perspectives of direct antivirals for the treatment of hepatitis C virus infection

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