Efficacy and safety of grazoprevir (MK-5172) and elbasvir (MK-8742) in patients with hepatitis C virus and HIV co-infection (C-EDGE CO-INFECTION): a non-randomised, open-label trial

Rockstroh, Jürgen K.; Nelson, Mark; Katlama, Christine; Lalezari, J.; Mallolas, Josép; Bloch, Mark; Matthews, Gail V.; Saag, Michael S.; Zamor, Philippe J.; Orkin, Chloe; Gress, Jacqueline; Klopfer, Stephanie O.; Shaughnessy, Melissa; Wahl, Janice; Nguyen, Bach Yen; Barr, Eliav; Platt, Heather; Robertson, Michael; Sulkowski, Mark S.

doi:10.1016/s2352-3018(15)00114-9

Cited by 289 publications

(269 citation statements)

References 20 publications

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“…GT-1a infected patients with HCV RNA ≤800,000 IU/ml (5.9 log 10 IU/ml) at baseline and those with HCV RNA >800,000 IU/ml (5.9 log 10 IU/ml), but without NS5A RASs at baseline should receive the FDC Grazoprevir/Elbasvir for 12 weeks without Ribavirin [B1]. These recommendations are based on the results of three phase III RCTs (C-EDGE-TN, C-EDGE-TE, C-EDGECoinfection) [61,62] and a post-hoc analysis of pooled phase II and III clinical trials data [63].…”

Section: Ritonavir-boostedmentioning

confidence: 99%

Position Paper on Treatment of Hepatitis C in Romania, 2017. Part One

Gheorghe

Sporea

Iacob

et al. 2017

JGLD

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Background & Aims: Hepatitis C Virus (HCV) infection is a common condition with endemic prevalence in some areas of the world. In Romania, the mean prevalence is about 3%. New treatments became available on the market in recent years and new drugs are in the pipeline. A re-evaluation of HCV therapy was considered mandatory. The Romanian Society of Gastroenterology and Hepatology undertook this task for the practitioners of this country.Methodology: A group of recognized experts was created who screened the available literature and the major available guidelines. A list of items requiring attention has been created. These items were discussed and rated. Decisions were taken by consensus.Recommendations: We present here the first of the two parts of our Society’s recommendations for chronic HCV infection treatment. An agreement was reached regarding the diagnostic tools, the assessment of severity and the up-dated therapy schedules.Conclusions: This Position Paper represents a guide for the assessment and the therapy of HCV infection. The recommendations are in concordance with other guidelines but are applied to the real-life conditions in this country.Abbreviations: DAAs: Direct-acting antivirals; DDIs: Drug-drug interactions; ESLD: End-stage liver disease; ESRD: End-stage renal disease; eGFR: Estimated glomerular filtration rate; EASL: European Association for the Study of the Liver; EMA: European Medicines Agency; FDA: US Food and Drug Administration; FDC: Fixed-dose combination; GT: Genotype; GRADE: Grading of Recommendations Assessment, Development and Evaluation; HCV: Hepatitis C virus; HCC: Hepatocellular carcinoma; LT: Liver transplantation; LLD: Lower limit of detection; MELD score: Mayo-Clinic End-Stage Liver Disease score; ANMDM: National Agency of Medicines and Medical Devices; PPIs: Proton pump inhibitors; PWID: People who inject drugs; RCT: Randomized controlled trial; RDT: Rapid diagnostic test; RAS: Resistance-associated substitution; SRGH: Romanian Society of Gastroenterology and Hepatology; SAE: serious adverse events; SPC: Summary of Product Characteristics; SVR: Sustained virologic response.

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Section: Ritonavir-boostedmentioning

confidence: 99%

Position Paper on Treatment of Hepatitis C in Romania, 2017. Part One

Gheorghe

Sporea

Iacob

et al. 2017

JGLD

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“…This indication was based on the C-EDGE CO-INFECTION study, which studied 218 patients with HIV/HCV coinfection who were treated with the elbasvir-grazoprevir combination [33]. Study results demonstrated an SVR rate of 96% at 12 weeks.…”

Section: Coinfection With Hivmentioning

confidence: 99%

A Brief Update on the Treatment of Hepatitis C

Austria¹,

Ninčević²,

Wu³

2017

Update on Hepatitis C

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Hepatitis C virus was discovered nearly 30 years ago, and for the first two decades, treatment was limited to agents with low response rates and substantial side effects. Since the introduction of direct-acting antivirals, there have been rapid advances made toward even higher sustained virologic responses (SVRs) and fewer side effects. This chapter provides a review of the newer agents for treatment of hepatitis C and highlights special populations, including those coinfected with HIV or hepatitis B, previously treated patients, and post-liver transplant patients.

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“…However, the new generation oral antivirals were introduced as a satisfactory treatment with better results and less side effects thanks to the option of single tablet with short-term treatments and no interferon content. Among them, one of the most recent one is elbasvir/grazoprevir combination (1,2,3). This study presents the results of two patients treated with elbasvir/grazoprevir.…”

Section: Introductionmentioning

confidence: 99%

Elbasvir/Grazoprevir Experience- A New Glance at HCV Treatment: Case Report

Çelen¹,

Kalkan²,

Tekin³

et al. 2017

vhd

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ÖZHepatitis C is a viral disease having a worldwide importance and posing a risk for liver complications. With the new treatment options, it is easy to manage with higher rates of success. Among them, one of the most recent one is elbasvir/grazoprevir option. This study presents the results of two treatment-naive patients treated with elbasvir/grazoprevir. The first case was a male non-cirrhotic patient and the second one was a female who suffered from compensated hepatic cirrhosis. Both patients received elbasvir/grazoprevir 50/100 mg in a single tablet for 12 weeks. Persistent viral response was achieved in both patients and no side effect was observed during the treatment. Elbasvir/grazoprevir combination, one of the recent treatments, was considered effective and tolerable.

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Efficacy and safety of grazoprevir (MK-5172) and elbasvir (MK-8742) in patients with hepatitis C virus and HIV co-infection (C-EDGE CO-INFECTION): a non-randomised, open-label trial

Cited by 289 publications

References 20 publications

Position Paper on Treatment of Hepatitis C in Romania, 2017. Part One

Position Paper on Treatment of Hepatitis C in Romania, 2017. Part One

A Brief Update on the Treatment of Hepatitis C

Elbasvir/Grazoprevir Experience- A New Glance at HCV Treatment: Case Report

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