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Last Update:  July 12, 2017
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General Reports
               

     Journal Papers, Abstracts, and Commentaries
 
  Efficient hepatitis C virus genotype 1b Core-NS5A recombinants permit efficacy testing of protease and NS5A inhibitors
Pham LV, Ramirez S, Carlsen TH,  et al
Antimicrob Agents Chemother. 2017 Mar 27
Abstract

Tracking HCV protease population diversity during transmission and susceptibility of founder populations to antiviral therapy.
Khera T, Todt D, Vercauteren K, McClure CP,
Antiviral Res. 2017 Jan 3;139:129-137. .
Abstract

Daclatasvir and asunaprevir treatment in patients with severe liver fibrosis by HCV genotype 1b infection: Real world data.
Ishigami M, Hayashi K, Honda T, et al
J Gastroenterol Hepatol
. 2017 Mar 4.
Abstract


Preclinical characterization of the novel HCV NS3 protease inhibitor GS-9256.
Yang H, Yang C, Wang Y, Rhodes G, et al
Antivir Ther. 2017 Jan 20.
Abstract

Structure-activity relationships of 4-hydroxy-4-biaryl-proline acylsulfonamide tripeptides: A series of potent NS3 protease inhibitors for the treatment of hepatitis C virus.
Wang AX, Chen J, Zhao Q,  et al
Bioorg Med Chem Lett. 2016 Dec 9. .
Abstract

Network meta-analysis of first- and second-generation protease inhibitors for chronic hepatitis C genotype 1: efficacy based on RVR and SVR 24.
Borba HH, Wiens A, Steimbach LM,
Eur J Clin Pharmacol. 2016 Oct 19
Abstract

FULL-TEXT ARTICLE
Outcomes and Costs of Treating Hepatitis C Patients in the Era of First Generation Protease Inhibitors - Results from the PAN Study.
Stahmeyer JT, Rossol S, Bert F,  et al
PLoS One. 2016 Jul 28;11.

Paper

FULL-TEXT ARTICLE
Investigation of NS3 Protease Resistance-Associated Variants and Phenotypes for the Prediction of Treatment Response to HCV Triple Therapy.
Dietz J, Rupp D, Susser S, Vermehren J,  et al
PLoS One
. 2016 Jun 9;11(6):e0156731.

Paper

FULL-TEXT ARTICLE
Effects of Smoking on Pegylated Interferon alpha 2a and First Generation Protease Inhibitor-based Antiviral Therapy in Naïve Patients Infected with Hepatitis C Virus Genotype 1.
Zimmermann T, Hueppe D, Mauss S, et al
J Gastrointestin Liver Dis
. 2016 Mar;25(1):15-24.
Paper

Protease inhibitors to treat hepatitis C in the Swiss HIV Cohort Study: high efficacy but low treatment uptake.
Schaerer V, Haubitz S, Kovari H,  et al
HIV Med
. 2015 Jul 2. .
Abstract

Ritonavir-boosted protease inhibitor based therapy: a new strategy in chronic hepatitis C therapy.
Brayer SW, Reddy KR.
Expert Rev Gastroenterol Hepatol. 2015 Apr 6:1-12
Abstract

Patients treated with first-generation HCV protease inhibitors exhibits high ribavirin concentrations.
Bodeau S, Nguyen-Khac E,  et al
Clin Pharmacol
. 2014 Dec 23
Abstract

FULL-TEXT ARTICLE
Nationwide experience of treatment with protease inhibitors in chronic hepatitis C patients in Denmark: identification of viral resistance mutations.
Sølund C, Krarup H, Ramirez S,  et al
PLoS One
. 2014 Dec 1;9(12):e113034
Paper

Cost-Effectiveness of IL28Β Genotype-Guided Protease Inhibitor Triple Therapy versus Standard of Care Treatment in Patients with Hepatitis C Genotypes 2 or 3 Infection.
Bock JA, Fairley KJ, Smith RE, et al
Public Health Genomics
. 2014 Sep 18.
Abstract

Protease inhibitor-based triple therapy is highly effective for hepatitis C recurrence after liver transplant: a multicenter experience.
Faisal N, Yoshida EM, Bilodeau M,  et al
Ann Hepatol
. 2014 Sep-Oct 2014;
Abstract

Treatment of HCV infection with the novel NS3/4A protease inhibitors.
De Luca A, Bianco C, Rossetti B.
Curr Opin Pharmacol
.
2014 Aug 9;18C:9-17
Abstract

Detection of a Sexually Transmitted HCV Protease Inhibitor-Resistance Variant in a HIV-infected Homosexual Man.
Franco S, Tural C, Nevot M, Moltó J,  et al
Gastroenterology
. 2014 May 21.

Abstract

Resistance to hepatitis C virus protease inhibitors.
Kieffer TL, George S.

Abstract

Drug interactions and protease inhibitors used in the treatment of hepatitis C: How to manage?
Talavera Pons S, Lamblin G, et al  
Eur J Clin Pharmacol
. 2014 May 10.
Abstract

FULL-TEXT ARTICLE
Hepatitis C virus protease inhibitor-resistance mutations: Our experience and review.
Wu S, Kanda T, Nakamoto S, Imazeki F, Yokosuka O.
World J Gastroenterol. 2013 Dec 21;19(47):8940-8948
Paper

Hepatitis C virus NS3 inhibitors: current and future perspectives.
Salam KA, Akimitsu N.
Biomed Res Int. 2013;2013:467869..
Abstract

Triple therapy with first-generation Protease Inhibitors for patients with genotype 1 chronic hepatitis C: Recommendations of the Italian Association for the Study of the Liver (AISF).
Italian Association for the Study of the Liver (AISF), Coco B, Caraceni P, Aghemo A, et al
Dig Liver Dis. 2013 Oct 8.
Abstract

Cost-Effectiveness Analysis of Triple Therapy with Protease Inhibitors in Treatment-Naive Hepatitis C Patients.
Blázquez-Pérez A, San Miguel R, Mar J.
Pharmacoeconomics. 2013 Sep 3
Abstract

Protease Inhibitors for Hepatitis C: Economic Implications.
Turner SJ, Brown J, Paladino JA.
Pharmacoeconomics. 2013 Jul 10.
Abstract

A Survey of Hepatitis C Treatment Clinical Practice Patterns Using the Newly Approved Protease Inhibitors.
Chen EY, Lee WM, Hynan LS, Singal AG.
J Clin Gastroenterol
. 2013 Mar .

Abstract

Asunaprevir
 

     Journal Papers, Abstracts, and Commentaries

 

Asunaprevir: An HCV Protease Inhibitor With Preferential Liver Distribution.
Eley T, Garimella T, Li W, Bertz RJ.
Clin Pharmacol Drug Dev. 2017 Mar;6(2):195-200.

Abstract

Daclatasvir and asunaprevir for genotype 1b chronic hepatitis C patients with chronic kidney disease.
Kondo C, Atsukawa M, Tsubota A, et al
Hepatol Res. 2017 Feb 22
Abstract

The efficacy and safety of dual oral therapy with daclatasvir and asunaprevir for genotype 1b in Japanese real-life settings.
Sezaki H, Suzuki F, Hosaka T, Akuta N, et al
Liver Int
.
2017 Feb 8.

Abstract

Favorable efficacy of daclatasvir plus asunaprevir in treatment of elderly Japanese patients infected with HCV genotype 1b aged 70 and older.
Akuta N, Sezaki H, Suzuki F, et al
J Med Virol. 2017 Jan;89(1):91-98.
Abstract

Real-World Experience With Daclatasvir Plus Sofosbuvir ± Ribavirin for Post-Liver Transplant HCV Recurrence and Severe Liver Disease
Herzer K, Welzel TM, Spengler U, et al
Transpl Int. 2016 Dec 24
Abstract

Asunaprevir/Daclatasvir and Sofosbuvir/Ledipasvir for Recurrent Hepatitis C following Living Donor Liver Transplantation.
Omichi K, Akamatsu N, Mori K,
Hepatol Res. 2016 Nov 22
Abstract

Safety and efficacy of dual therapy with daclatasvir and asunaprevir for older patients with chronic hepatitis C.
Morio R, Imamura M, Kawakami Y,  et al
J Gastroenterol. 2016 Sep 8
Abstract

Safety and efficacy of dual direct-acting antiviral therapy (daclatasvir and asunaprevir) for chronic hepatitis C virus genotype 1 infection in patients on hemodialysis.
Toyoda H, Kumada T, Tada T, et al
J Gastroenterol
. 2016 Feb 12.

Abstract

Improvement of renal dysfunction in a patient with HCV-related liver cirrhosis by daclatasvir and asunaprevir combination therapy: A case report.
Tsuge M, Hiramatsu A, Shinohara F, et al
Hepatol Res
. 2015 Nov 27
Abstract

Comparison of Daclatasvir and Asunaprevir for Chronic HCV 1b Infection with Telaprevir and Simeprevir plus Peginterferon and Ribavirin, with a Focus on the Prevention of Occurrence and Recurrence of Hepatocellular Carcinoma.
Sugimoto K, Kim SR, Kim SK, et al
Oncology. 2015 Nov;89 Suppl 2:42-46
Abstract

Combination therapies with daclatasvir and asunaprevir on NS3-D168 mutated HCV in human hepatocyte chimeric mice.
Kan H, Hiraga N, Imamura M, et al
Antivir Ther. 2015 Nov 12.
Abstract

Asunaprevir (BMS-650032) for the treatment of hepatitis C virus.
Akamatsu N, Sugawara Y, Kokudo N.
Expert Rev Anti Infect Ther. 2015 Sep 28:1-11
Abstract

Asunaprevir for hepatitis C: a safety evaluation.
Gentile I, Zappulo E, Buonomo AR, et al
Expert Opin Drug Saf. 2015 Sep 2:1-16.
Abstract

Relationships between serum asunaprevir concentration and alanine aminotransferase elevation during daclatasvir plus asunaprevir for chronic HCV genotype 1b infection.
Akuta N, Sezaki H, Suzuki F,  et al
J Med Virol
. 2015 Aug 20.

Abstract

Decreased tacrolimus concentration following a temporal increase during interferon-free therapy with asunaprevir and daclatasvir in patients with recurrent hepatitis C after liver transplantation.
Ueda Y, Uemoto S. 
Transpl Int
. 2015 Aug 13
Abstract

Asunaprevir: A Review of Preclinical and Clinical Pharmacokinetics and Drug-Drug Interactions.
Eley T, Garimella T, Li W, Bertz RJ.
Clin Pharmacokinet. 2015 Jul 16.
Abstract

Preclinical Pharmacokinetics and In Vitro Metabolism of Asunaprevir (BMS-650032), a Potent Hepatitis C Virus NS3 Protease Inhibitor.
Mosure KW, Knipe JO, Browning M,  et al
J Pharm Sci. 2015 Jan 28
Abstract

Asunaprevir-containing regimens for the treatment of hepatitis C virus infection.
Yang SS, Kao JH.
Expert Rev Gastroenterol Hepatol. 2015 Jan;9(1):9-20.
Abstract

The Pharmacokinetics of Daclatasvir and Asunaprevir Administered in Combination in Studies in Healthy Subjects and Patients Infected with Hepatitis C Virus.
Eley T, Sevinsky H, Huang SP, et al

Clin Drug Investig
. 2014 Aug 13
Abstract

Asunaprevir-containing regimens for the treatment of hepatitis C virus infection.
Yang SS, Kao JH.
Expert Rev Gastroenterol Hepatol. 2014 Aug 31:1-12
Abstract

Asunaprevir, a protease inhibitor for the treatment of hepatitis C infection.
Gentile I, Buonomo AR, Zappulo E,  et al
Ther Clin Risk Manag. 2014 Jun 26;10:493-504
Paper

The effect of hepatic impairment on the pharmacokinetics of asunaprevir, an HCV NS3 protease inhibitor.
Eley T, He B, Chang I,  et al
Antivir Ther. 2014 Apr 7.
Abstract

Single and Multiple Ascending Dose Studies of the NS3 Protease Inhibitor, Asunaprevir, in Subjects With or Without Chronic Hepatitis C.
Pasquinelli C, McPhee F, Eley T, et al
Antimicrob Agents Chemother. 2012 Jan 30.
Abstract


Boceprevir
 

     Journal Papers, Abstracts, and Commentaries

 
Boceprevir-based triple therapy to rescue HCV genotype 1/HBV dually infected patients refractory to peginterferon plus ribavirin combination therapy in Taiwan.
Hsieh MH, Yeh ML, Su TH,  et al
J Formos Med Assoc. 2017 Jul 7
Abstract

Exploring resistance pathways for first-generation NS3/4A protease inhibitors boceprevir and telaprevir using Bayesian network learning.
Cuypers L, Libin P, Schrooten Y, et al
Infect Genet Evol
. 2017 May 9.
Abstract

Efficacy and safety profile of boceprevir- or telaprevir-based triple therapy or dual peginterferon alfa-2a or alfa-2b plus ribavirin therapy in chronic hepatitis C: the real-world PegBase observational study.
Mangia A, Foster GR, Berg CP, et al 
Ann Gastroenterol
. 2017;30(3):327-343.
Abstract

Aplastic Anemia and Severe Myelosuppression with Boceprevir or Simeprevir-Containing Hepatitis C Virus Treatment.
Senín A, Broquetas T, Cañete N, et a|
 ,l Ann Hepatol
. 2017 Feb 15;16(2):312-317.
Abstract

Rapid virological response of telaprevir and boceprevir in a Brazilian cohort of HCV genotype 1 patients: a multicenter longitudinal study.
Borba HH, Wiens A, Steimbach LM,
Ther Clin Risk Manag
. 2017 Jan 10;
Abstract

Boceprevir or telaprevir in hepatitis C virus chronic infection: The Italian real life experience.
Cleo Study Group, Ascione A, et al

i LE,World J Hepatol. 2016 Aug 8;
Abstract

Efficacy and safety of boceprevir-based triple therapy in HCV cirrhotic patients awaiting liver transplantation (ANRS HC29 BOCEPRETRANSPLANT).
Fontaine H, Maynard M, Bouix C,. et al
Clin Res Hepatol Gastroentero
l
. 2016 Aug 20
.
Abstract

Optimisation of triple therapy for patients with chronic hepatitis C: a systematic review.
Pecoraro V, Cariani E, Villa E, Trenti T.
Eur J Clin Invest. 2016 Aug;46(8):737-48.
Abstract

Addition of boceprevir to PEG-interferon/ribavirin in HIV-HCV-Genotype-1-coinfected, treatment-experienced patients: efficacy, safety, and pharmacokinetics data from the ANRS HC27 study.
Poizot-Martin I, Bellissant E, et al
HIV Clin Trials. 2016 Mar;17(2):63-71
Abstract

FULL-TEXT ARTICLE
Boceprevir plus peginterferon/ribavirin for treatment of chronic hepatitis C in Russia
Isakov V, Nikitin I, Chulanov V, Ogurtsov P, et al
World J Hepatol. 2016 Feb 28;8(6):331-
Paper

FULL-TEXT ARTICLE
Impact of IL28B, APOH and ITPA Polymorphisms on Efficacy and Safety of TVR- or BOC-Based Triple Therapy in Treatment-Experienced HCV-1 Patients with Compensated Cirrhosis from the ANRS CO20-CUPIC Study
About F, Oudot-Mellakh T, Niay J,  et al
PLoS One
. 2015 Dec 15;10(12):e0145105.

Paper

FULL-TEXT ARTICLE
Boceprevir for chronic HCV genotype 1 infection in treatment-experienced patients with severe fibrosis or cirrhosis: The Greek real-life experience.
Manolakopoulos S, Kranidioti H, Goulis J, et al
Ann Gastroenterol. 2015 Oct-Dec;28(4):481-6.
Paper

FULL-TEXT ARTICLE
Boceprevir-Based Triple Antiviral Therapy for Chronic Hepatitis C Virus Infection in Kidney-Transplant Candidates
Mehawej M, Rostaing L, Alric L, et al
J Transplant
.
2015;2015:159795
Paper

IL28B genotype predicts response to chronic hepatitis C triple therapy with telaprevir or boceprevir in treatment naïve and treatment-experienced patients other than prior partial- and null-responders.
Calisti G, Tavares A, Macartney MJ,  et al
Springerplus. 2015 Jul 16;4:357.
Abstract

Molecular principles behind Boceprevir resistance due to mutations in hepatitis C NS3/4A protease.
Nagpal N, Goyal S, Wahi D, et al
Gene
. 2015 Jun 5. pii: S0378-1119(15)00716-
Abstract

Lead-in period and week 8 as predictive tools for response to boceprevir therapy: a retrospective study of Spanish real clinical practice
Crespo J, Berenguer M, Pérez F, Fernández I,  et al
Gastroenterol Hepatol. 2015 May 11
Abstract

Treatment Patterns, Health Care Resource Utilization, and Costs in U.S. Patients Diagnosed with Chronic Hepatitis C Infection Who Received Telaprevir or Boceprevir.
Le TK, Kalsekar A, Macaulay D, et al
J Manag Care Spec Pharm
. 2015 Apr;21(4):308-318.
Abstract

Intracellular accumulation of boceprevir according to plasma concentrations and pharmacogenetics.
Cusato J, Allegra S, De Nicolò A,  et al
Int J Antimicrob Agents. 2015 Mar 14
Abstract

FULL-TEXT ARTICLE
First-generation protease inhibitor-triple therapy: SVR 24, safety, and predictors of response in a large single center cohort.
Werner CR, Franz C, Egetemeyr DP,  et al
Virol J
. 2015 Mar 3;12(1):37.
Paper

Telaprevir- and Boceprevir-Based Triple Therapy for Hepatitis C in Liver Transplant Recipients With Advanced Recurrent Disease: A Multicenter Study.
Verna EC, Saxena V, Burton JR Jr,  et al
Transplantation
. 2015 Feb 24.

Abstract

A Phase I study to assess the safety, tolerability and pharmacokinetic profile of boceprevir and sildenafil when dosed separately and together, in healthy male volunteers.
Mora-Peris B, Else L, Goldmeier D, et al
J Antimicrob Chemother
. 2015 Feb 17.
Abstract

Pharmacokinetic interaction between HCV protease inhibitor boceprevir and methadone or buprenorphine in subjects on stable maintenance therapy.
Hulskotte EG, Bruce RD, Feng HP,  et al
Eur J Clin Pharmaco
l
. 2015 Feb 11.
Abstract

Virological outcomes and treatment algorithms utilisation in observational study of patients with chronic hepatitis C treated with boceprevir or telaprevir.
Sterling RK, Kuo A, Rustgi VK,  et al
Aliment Pharmacol Ther. 2015 Jan 28
Abstract

Early virological assessment during telaprevir- or boceprevir-based triple therapy in hepatitis C cirrhotic patients who failed a previous interferon based regimen - The ANRS CO20-CUPIC study.
Bailly F, Virlogeux V, Dufour C,  et al
Clin Res Hepatol Gastroenterol. 2015 Jan 27. pii: S2210-7401(15)00002-9

Abstract

Long-term follow-up of patients receiving boceprevir for treatment of chronic hepatitis C.
Howe AY, Long J, Nickle D, et al
Antiviral Res
. 2015 Jan;113:71-8
Abstract

Boceprevir and telaprevir for chronic genotype 1 hepatitis C virus infection. A systematic review and meta-analysis.
Manzano-Robleda MD, Ornelas-Arroyo V,   et al
Ann Hepatol
. 2015 J
an-Feb 2015;14(1):46-57.Z
Abstract

Virologic response and haematologic toxicity of boceprevir- and telaprevir-containing regimens in actual clinical settings.
Butt AA, Yan P, Shaikh OS,  et al
J Viral Hepat
. 2014 Dec 18.
Abstract

FULL-TEXT ARTICLE
Boceprevir is highly effective in treatment-experienced hepatitis C virus-positive genotype-1 menopausal women.
Bernabucci V, Ciancio A, Petta S, et al
World J Gastroenterol
. 2014 Nov 28;20(44):16726-33.
Paper

Drug-drug interactions of telaprevir and boceprevir in HCV-monoinfected and HIV/HCV-coinfected patients can modify the adherence.
Gonzalez-Colominas E, Broquetas T, et al
Liver Int. 2014 Nov 10.

Abstract

Undetectable HCV-RNA at treatment-week 8 results in high-sustained virological response in HCV G1 treatment-experienced patients with advanced liver disease: the International Italian/Spanish Boceprevir/Peginterferon/Ribavirin Name Patients Program.
Bruno S, Bollani S, Zignego AL,  et al
J Viral Hepat
. 2014 Oct 14.
Abstract

Drug-drug Interaction with Telaprevir or Boceprevir in Liver Transplant Patients: About Four Cases
Delaborde L, Logerot S, Fonrose X.
Therapie
. 2014 Oct 17
Abstract

Safety Profile of Boceprevir and Telaprevir in Chronic Hepatitis C: Real-World Experience From HCV-TARGET.
Gordon SC, Muir AJ, Lim JK,  et al
J Hepatol. 2014 Sep 9. pii: S0168-8278(14)00647-3
Abstract

Treatment of chronic hepatitis with boceprevir leads to remission of porphyria cutanea tarda.
Aguilera P, Laguno M, To-Figueras J.
Br J Dermatol
. 2014 Aug 25.
Abstract

Lack of Clinically Significant Pharmacokinetic Interaction Between the Thrombopoietin Receptor Agonist Eltrombopag and Hepatitis C Virus Protease Inhibitors Boceprevir and Telaprevir.
Wire MB, Fang L, Hussaini A, et al.
Antimicrob Agents Chemother
. 2014 Aug 25.
Abstract

FULL-TEXT ARTICLE
Prediction of treatment week eight response & sustained virologic response in patients treated with boceprevir plus peginterferon alfa and ribavirin.
Thompson A, Devine S, Kattan M, Muir A.

PLoS One
. 2014 Aug 1;9(8):e103370
Paper

Hepatitis C virus NS3 protease genotyping and drug concentration determination during triple therapy with telaprevir or boceprevir for chronic infection with genotype 1 viruses, southeastern France.
Aherfi S, Solas C, Motte A,  et al
J Med Virol. 2014 Jul 23.
Abstract

Effects of boceprevir and telaprevir on the pharmacokinetics of dolutegravir.
Johnson M, Borland J, Chen S, et al
Br J Clin Pharmacol. 2014 May 16
Abstract

Acute pancreatitis associated with boceprevir: a case report.
Bilar JM, de Carvalho-Filho RJ, Mota CF, et al
Braz J Infect Di
s. 2014 May 12.
Abstract

Safety & Efficacy of Boceprevir/Peginterferon/Ribavirin for HCV G1 Compensated Cirrhotics: Meta-Analysis of 5 Trials.
Vierling JM, Zeuzem S, Poordad F, et al
J Hepatol. 2014 Apr 17.
Abstract

The cost-effectiveness of boceprevir for hepatitis C.
Neoh CF, Kong DC.
Expert Rev Pharmacoecon Outcomes Res
. 2014 Apr 8
Abstract

Effectiveness of Telaprevir or Boceprevir in Treatment-experienced Patients with HCV Genotype 1 Infection and Cirrhosis.
Hezode C, Fontaine H, Dorival C, et al
Gastroenterology. 2014 Apr 3.
Abstract

Telaprevir or boceprevir triple therapy in patients with chronic hepatitis C and varying severity of cirrhosis.
Saxena V, Manos MM, Yee HS, et al
Aliment Pharmacol Ther. 2014 Mar 24

Abstract

Telaprevir or Boceprevir Based Therapy for Chronic Hepatitis C Infection: Development of Resistance Associated Variants in Treatment Failure.
Macartney MJ, Irish D, Bridge SH, Garcia-Diaz A,  et al
Antiviral Res. 2014 Mar 1.
Abstract

How to optimize current therapy of HCV genotype 1 infection with boceprevir.
Bourlière M, Adhoute X, Wendt A,  et al
Liver Int. 2014 Feb;34 Suppl 1:4-10
Abstract

Liver transplantation in a child with multifocal hepatocellular carcinoma hepatitis C and management of post-transplant viral recurrence using boceprevir.
Malik S, Dekio F, Wen JW.
Pediatr Transplant. 2014 Jan 11
Abstract

Boceprevir for Chronic HCV Genotype 1 Infection in Patients with Prior Treatment Failure to Peginterferon/Ribavirin, including Prior Null Response.
Vierling JM, Davis M, Flamm S,  et al
J Hepatol
.
2013 Dec 19.
Abstract

Similar Effectiveness of Boceprevir and Telaprevir Treatment Regimens for Hepatitis C Virus Infection, Based on a Nationwide Study of Veterans.
Ioannou GN, Beste LA, Green PK.
Clin Gastroenterol Hepatol
. 2013 Dec 17
Abstract

The Effects of Boceprevir and Telaprevir on the  Pharmacokinetics of Maraviroc: An Open Label, Fixed -Sequence Study in Healthy Volunteers.
Vourvahis M, Plotka A, Kantaridis C,  et al
J Acquir Immune Defic Syndr. 2013 Dec 16.
Abstract

First case of Drug Rash Eosinophilia and Systemic Symptoms due to Boceprevir.
Samain A, Duval-Modeste AB, Joly P, et al
J Hepatol
. 2013 Dec 12
Abstract

Hepatitis C virus NS3 inhibitors: current and future perspectives.
Salam KA, Akimitsu N.
Biomed Res Int. 2013;2013:467869..
Abstract

A Modified Ribavirin-free Interferon Therapy With Boceprevir in Post-Liver Transplant Recurrent Hepatitis C.
Maticic M, Luznik Z, Stepec S, Popovic P,
J Clin Gastroenterol. 2013 Nov 21.
Abstract

Efficacy and safety of telaprevir and boceprevir in patients with hepatitis C genotype 1: a meta-analysis.
Park C, Jiang S, Lawson KA.
J Clin Pharm Ther
. 2013 Nov 16
Abstract

Seizures in Patients with Chronic Hepatitis C Treated with NS3/4A Protease Inhibitors: Does Pharmacological Interaction Play a Role?
Milazzo L, Falvella FS, Magni C, et al
Pharmacology
. 2013 Oct 31;92(5-6):235-237
z
Abstract

Boceprevir Plus Peginterferon α-2b/Ribavirin in Chronic Hepatitis C Genotype 1: Impact of Baseline Viral Load on Sustained Virologic Response.
Gordon SC, Reddy KR, Jacobson IM,  et al
J Clin Gastroenterol
. 2013 Oct 30
Abstract

The pharmacokinetic evaluation of boceprevir for treatment of Hepatitis C virus.
Shankar H, Bichoupan K, Dieterich DT.
Expert Opin Drug Metab Toxicol. 2013 Oct 1
Abstract
 

The discovery and development of boceprevir.
Rotella DP.
Expert Opin Drug Discov. 2013 Sep 30.
Abstract

Cost-effectiveness of boceprevir in patients previously treated for chronic hepatitis C genotype 1 infection in the United States.
Chhatwal J, Ferrante SA, Brass C,. et al
Value Health
. 2013 Sep-Oct;16(6):973-86.
Abstract

Reply to: Renal impairment is frequent in chronic hepatitis C patients under triple therapy with telaprevir or boceprevir.
Véronique LR, Paul C, Chanlina V, Marie E.
Hepatology
. 2013 Sep 3
Abstract

Pretreatment resistance to hepatitis C virus protease inhibitors boceprevir/telaprevir in hepatitis C virus subgenotype 1a-infected patients from Manitoba.
Andonov A, Kadkhoda K, Osiowy C, Kaita K.
Can J Gastroenterol. 2013 Jul;27(7):414-6.
Abstract

Analysis of boceprevir resistance associated amino acid variants (RAVs) in two phase 3 boceprevir clinical studies.
Barnard RJ, Howe JA, Ogert RA,  et al
Virology. 2013 Jul 19.
Abstract

Development of boceprevir: a first-in-class direct antiviral treatment for chronic hepatitis C infection.
Hazuda DJ, Burroughs M, Howe AY, et al
Ann N Y Acad Sci
. 2013 Jul;1291(1):69-76
Abstract

Renal impairment is frequent in chronic hepatitis C patients under triple therapy with telaprevir or boceprevir.
Mauss S, Hueppe D, Alshuth U.
Hepatology. 2013 Jun 28.
Abstract

Cost-effectiveness of boceprevir or telaprevir for previously treated patients with genotype 1 chronic hepatitis C.
Cammà C, Petta S, Cabibbo G, et al
J Hepatol. 2013 May 23.
Abstract

A Multiplex LC-MS/MS Assay for the Simultaneous Therapeutic Drug Monitoring of Ribavirin, Boceprevir and Telaprevir.
Aouri M, Moradpour D, Cavassini M, et al
Antimicrob Agents Chemother
. 2013 Apr 29.
Abstract

FULL-TEXT PDF ARTICLE
Boceprevir for previously untreated patients with chronic hepatitis C Genotype 1 infection: a US-based cost-effectiveness modeling study
Ferrante SA, Chhatwal J, Brass CA,  et al
BMC Infect Dis
. 2013 Apr 27;13(1):190
Paper

A Small Percentage of Patients with Hepatitis C Receive Triple Therapy with Boceprevir or Telaprevir.
Chen EY, Sclair SN, Czul F, et al
Clin Gastroenterol Hepatol. 2013 Apr 16.
Abstract

Pharmacokinetic Evaluation of the Interaction Between the HCV Protease Inhibitor Boceprevir and the HMG-CoA Reductase Inhibitors Atorvastatin and Pravastatin.
Hulskotte E, Feng HP, Xuan F, et al
Antimicrob Agents Chemother. 2013 Mar
Abstract

Boceprevir-based tritherapy of HCV-infected Belgian liver-transplanted patients: Preliminary experience.
Degré D, Colle I, Van Vlierberghe H, Moreno C.
Liver Transpl. 2013 Mar 14.
Abstract

Telaprevir Versus Boceprevir in Chronic Hepatitis C: A Meta-Analysis of Data From Phase II and III Trials.
Sitole M, Silva M, Spooner L,  et al
Clin Ther. 2013 Jan 29
Abstract

Optimal treatment with boceprevir for chronic HCV infection.
Maasoumy B, Manns MP.
Liver Int. 2013 Feb;33 Suppl 1:14-22.
Abstract

Serious neuropsychiatric adverse effects in a hepatitis C virus/hepatitis B virus/HIV-coinfected patient receiving bosentan and telaprevir.
Lê MP, Gervais A, Le Beller C, et al
J Antimicrob Chemother. 2013 Jan 20.
.
Abstract

In Vitro Assessment of Drug-drug Interaction Potential of Boceprevir Associated with Drug Metabolizing Enzymes and Transporters.
Chu X, Cai X, Cui D,  et al
Drug Metab Dispos. 2013 Jan 4.
Abstract

Pharmacokinetic Interactions Between the Hepatitis C Virus Protease Inhibitor Boceprevir and Ritonavir-Boosted HIV-1 Protease Inhibitors Atazanavir, Darunavir, and Lopinavir.
Hulskotte EG, Feng HP, Xuan F, et al
Clin Infect Dis. 2012 Dec 14.
Abstract

Boceprevir: a review of its use in the management of chronic hepatitis C genotype 1 infection.
Garnock-Jones KP.
Drugs. 2012 Dec 24;72(18):2431-56.

Abstract

Boceprevir: A recently approved protease inhibitor for hepatitis C virus infection.
Lam JT, Jacob S.
Am J Health Syst Pharm. 2012 Dec 15;69(24):2135-9.

Abstract

Boceprevir in combination with HIV protease inhibitors in patients with advanced fibrosis-altered drug-drug interactions?
Schwarze-Zander C, Boesecke C,  et al
J Int AIDS Soc. 2012 Nov 11;15(6):18418.
Abstract

Boceprevir and personalized medicine in hepatitis C virus infection.
Habersetzer F, Leboeuf C, Doffoël M, Baumert TF.
Pharmgenomics Pers Med. 2012;5:125-37

Abstract

Stereoselective Addition of 2-phenyloxazol-4-yl trifluoromethanesulfonate to N-Sulfinyl Imines: Application to the Synthesis of the HCV Protease Inhibitor Boceprevir.
Morris WJ, Muppalla KK, Cowden C, Ball RG.
J Org Chem. 2012 Dec 6

Abstract

The first wave: HCV NS3 protease inhibitors telaprevir and boceprevir.
Marks KM, Jacobson IM.
Antivir Ther
. 2012;17(6 Pt B):1119-31.
Abstract

Pharmacokinetic Interactions Between the HCV Protease Inhibitor Boceprevir and Ritonavir-Boosted HIV-1 Protease Inhibitors Atazanavir, Darunavir, and Lopinavir.
Hulskotte EG, Feng HP, Xuan F, et al
Clin Infect Dis. 2012 Nov 15.
Abstract

The Relative Efficacy of Boceprevir and Telaprevir in the Treatment of HCV Genotype 1.
Schmitz S, O'Leary A, Walsh C, Bergin C, Norris S.
Clin Infect Dis. 2012 Oct 16.
Abstract

Pharmacokinetic Interaction between Boceprevir and Etravirine in HIV/HCV Seronegative Volunteers.
Hammond KP, Wolfe P, Burton JR Jr, :

J Acquir Immune Defic Syndr
. 2012 Oct 15
Abstract

Boceprevir: A Protease Inhibitor for the Treatment of Hepatitis C.
Chang MH, Gordon LA, Fung HB.
Clin Ther. 2012 Sep 10.
Abstract

Practical Management of Boceprevir and Immunosuppressive Therapy in Liver Transplant Recipient Recurrence
Coilly A, Furlan V, Roche B,  et al
Antimicrob Agents Chemother.2012 Aug 29
Abstract

Triple therapy with boceprevir or telaprevir for treatment naïve HCV patients.
Esteban R, Buti M.
Best Pract Res Clin Gastroenterol.
Abstract

Triple therapy with boceprevir or telaprevir for prior HCV non-responders.
Asselah T.
Best Pract Res Clin Gastroenterol. 2012 Aug;26(4):455-62
Abstract

The first wave: HCV NS3 protease inhibitors telaprevir and boceprevir.
Marks KM, Jacobson IM.
Antivir Ther. 2012;17(6 Pt B):1119-31.
Abstract

Factors that Predict Response of Patients with HCV Infection to Boceprevir.
Poordad F, Bronowicki JP, Gordon SC,  et al

Gastroenterology. 2012 May 21
Abstract

Review of boceprevir and telaprevir for the treatment of chronic hepatitis C.
Wilby KJ, Partovi N, Ford JA, Greanya E, Yoshida EM.

Can J Gastroenterol
. 2012 Apr;26(4):205-10.
Abstract

Boceprevir: an oral protease inhibitor for the treatment of chronic HCV infection.
Trembling PM, Tanwar S, Dusheiko GM.
Expert Rev Anti Infect Ther
. 2012 Mar;10(3):269-79.
Abstract

A review of drug interactions with boceprevir and telaprevir: implications for HIV and transplant patients.
Wilby KJ, Greanya ED, Ford JA,, et al

Ann Hepatol
. 2012 Mar;11(2):179-85.
Abstract

Expert opinion on boceprevir- and telaprevir-based triple therapies of chronic hepatitis C.
Sarrazin C, Berg T, Cornberg M,  et al
Z Gastroenterol. 2012 Jan;50(1):57-72.
Abstract

Triple therapy for HCV genotype 1 infection: telaprevir or boceprevir?
Shiffman ML, Esteban R.
Liver Int. 2012 Feb;32 Suppl 1:54-60.
Abstract

Phase III results of Boceprevir in treatment naïve patients with chronic hepatitis C genotype 1
Manns MP, Markova AA, Serrano BC, Cornberg M.
Liver Int. 2012 Feb;32 Suppl 1:27-31.
Abstract

Specific Detection of Naturally Occurring Telaprevir and Boceprevir (Protease Inhibitors) HCV Resistant Mutants among Treatment Naive Infected Individuals.
Fonseca-Coronado S, Escobar-Gutiérrez A, Ruiz-Tovar K, et al
J Clin Microbiol. 2011 Nov 23.
Abstract

Formulary management of the protease inhibitors boceprevir and telaprevir for chronic hepatitis C virus.
Tungol A, Rademacher K, Schafer JA.
J Manag Care Pharm. 2011 Nov;17(9):685-94.
Abstract

Analysis of long-term persistence of resistance mutations within the hepatitis C virus NS3 protease after treatment with telaprevir or boceprevir.
Susser S, Vermehren J, Forestier N, et al
J Clin Virol. 2011 Sep 14.
Abstract

Boceprevir: A Protease Inhibitor for the Treatment of Chronic Hepatitis C (September).
Foote BC, Spooner LM, Belliveau PP.
Ann Pharmacother. 2011 Aug 9
Abstract

A sprint to increase response to HCV treatment: expectancies but caution.
Asselah T.

J Hepatol
. 2011 Jun 30
Abstract

Efficacy of boceprevir, an NS3 protease inhibitor, in combination with peginterferon alfa-2b
and ribavirin in treatment-naive patients with genotype 1 hepatitis C infection (SPRINT-1):
an open-label, randomised, multicentre phase 2 trial.
Kwo PY, Lawitz EJ, McCone J,. et al
Lancet. 2010 Aug 28;376(9742):705-16
Abstract

Highly sensitive determination of HCV protease inhibitors boceprevir (SCH 503034) and
telaprevir (VX 950) in human plasma by LC-MS/MS.
Farnik H, El-Duweik J, Welsch C,
J Chromatogr B Analyt Technol Biomed Life Sci
. 2009 Dec 1;877(31):4001
Abstract


Danoprevir(ITMN-191/R722)
 

     Journal Papers, Abstracts, and Commentaries

 
Ritonavir-boosted danoprevir plus peginterferon alfa-2a and ribavirin in Asian chronic hepatitis C patients with or without cirrhosis.
Kao JH, Tung SY, Lee Y, et a;
J Gastroenterol Hepatol. 2016 Oct;31(10):1757-1765
Abstract

Effect of D168V mutation in NS3/4A HCV protease on susceptibilities of faldaprevir and danoprevir.
Meeprasert A, Hannongbua S, Kungwan N, Rungrotmongkol T.
Mol Biosyst
. 2016 Oct 12.
Abstract

Modelling the interaction between danoprevir and mericitabine in the treatment of chronic HCV infection.
Canini L, Guedj J, Chatterjee A, Lemenuel-Diot A, et al
Antivir Ther.
2015 Nov 10
Abstract

Boceprevir and telaprevir for chronic genotype 1 hepatitis C virus infection. A systematic review and meta-analysis.
Manzano-Robleda MD, Ornelas-Arroyo V,   et al
Ann Hepatol. 2015 Jan-Feb 2015;14(1):46-57.Z
Abstract

Characterization of the Transmembrane Transport and Absolute Bioavailability of the HCV Protease Inhibitor Danoprevir.
Brennan BJ, Poirier A, Moreira S,  et al
Clin Pharmacokinet. 2014 Dec 9.
Abstract

A pharmacokinetic/viral kinetic model to evaluate the treatment effectiveness of danoprevir against chronic HCV.
Canini L, Chatterjee A, Guedj J,  e
t al 
Antivir Ther
. 2014 Oct 16
Abstract

Randomised study of danoprevir/ritonavir-based therapy for HCV genotype 1 patients with prior partial or null responses to peginterferon/ribavirin.
Feld JJ, Jacobson IM, Jensen DM,  et al
J Hepatol
. 2014 Sep 16. pii: S0168-8278(14)00667-

Abstract

Identification of the NS5B S282T Resistant Variant and Two Novel Amino Acid Substitutions That Affect Replication Capacity in Hepatitis C Virus-Infected Patients
Treated with Mericitabine and Danoprevir.
Tong X, Li L, Haines K, Najera I. et al
Antimicrob Agents Chemother. 2014 Jun;58(6):3105-3114
Abstract

Efficacy and Safety of Danoprevir-Ritonavir plus Peginterferon Alfa-2a-Ribavirin in Hepatitis C Virus Genotype 1 Prior Null Responders.
Gane EJ, Rouzier R, Wiercinska-Drapalo A,  et al
Antimicrob Agents Chemother. 2014 Feb;58(2):1136-45.
Abstract
Efficacy and Safety of Danoprevir/Ritonavir plus Peginterferon Alfa-2a/Ribavirin in HCV Genotype 1 Prior Null Responders.
Gane EJ, Rouzier R, Wiercinska-Drapalo A, et al
Antimicrob Agents Chemother. 2013 Dec 2
Abstract

A randomised study of the effect of danoprevir/ritonavir or ritonavir on substrates of cytochrome P450 (CYP) 3A and 2C9 in chronic hepatitis C patients using a drug cocktail.
Morcos PN, Chang L, Kulkarni R, et al
Eur J Clin Pharmacol. 2013 Nov;69(11):1939-1949
Abstract

Randomized controlled trial of danoprevir plus peginterferon alfa-2a and ribavirin in treatment-naïve patients with hepatitis C virus genotype 1 infection.
Marcellin P, Cooper C, Balart L, et al
Gastroenterology. 2013 Oct;145(4):790-800.e3.
Abstract

FULL-TEXT ARTICLE
Characterization of hepatitis C virus (HCV) quasispecies dynamics upon short-term dual therapy with the HCV NS5B nucleoside polymerase inhibitor mericitabine
and the NS3/4 protease inhibitor danoprevir.

Le Pogam S, Yan JM, Chhabra M,  et al
Antimicrob Agents Chemother
. 2012 Nov;56(11):5494-502.
Paper'

Effect of Ritonavir-Boosted Danoprevir, a Potent Hepatitis C Virus Protease Inhibitor, on the Pharmacokinetics of Methadone in Healthy Subjects Undergoing Methadone Maintenance Therapy.
Moreira SA, Morcos PN, Navarro MT,  et al
Pharmacotherapy. 2013 Aug 14
Abstract

Discovery of Danoprevir (ITMN-191/R7227), a Highly Selective and Potent Inhibitor of Hepatitis C Virus (HCV) NS3/4A Protease.
Jiang Y, Andrews SW, Condroski KR, et al
J Med Chem. 2013 May 28
Abstract

Evaluating the Role of Macrocycles in the Susceptibility of Hepatitis C Virus NS3/4A Protease Inhibitors to Drug Resistance.
Ali A, Aydin C, Gildemeister R,  et al
ACS Chem Biol. 2013 May 1.
Abstract

FULL-TEXT ARTICLE
Analysis of hepatitis C virus decline during treatment with the protease inhibitor danoprevir using a multiscale model.
Rong L, Guedj J, Dahari H,  et al
PLoS Comput Biol. 2013;9(3):e1002959
Paper

Impact of low-dose ritonavir on danoprevir pharmacokinetics: results of computer-based simulations and a clinical drug-drug interaction study.
Reddy MB, Chen Y, Haznedar JO,  et al
Clin Pharmacokinet. 2012 Jul 1;51(7):457-65.
Abstract
 
Sustained virological response after 14-day treatment with danoprevir and 48-week treatment with pegylated interferon-α2a (40 KD) plus ribavirin.
Larrey D, Carenco C, Guyader D,  et al
Antivir Ther. 2012;17(5):927-32
Abstract

Simeprevir (TMC435)
 

     Books and Documents
 
  iNTERNET DOCUMENT
Triple Therapy for Hepatitis C in Previous Non-responders: A Review of the Clinical Effectiveness and Safety
Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2014 Dec 08..
Document

     Journal Papers, Abstracts, and Commentaries
 

 
FULL-TEXT ARTICLE
Virology analysis in HCV genotype 1-infected patients treated with the combination of simeprevir and TMC647055/ritonavir, with and without ribavirin, and JNJ-56914845
Vijgen L, Thys K, Vandebosch A,et al  
Virol J. 2017 May 31;14(1):101
Paper

Curing Chronic Hepatitis C: A Cost Comparison of the Combination Simeprevir Plus Sofosbuvir vs. Protease-Inhibitor-Based Triple Therapy.
Langness JA, Tabano D, Wieland A, et al 
Ann Hepatol. 2017 May - Jun 2017;16(3):366-374
Abstract

Efficacy, safety, and pharmacokinetics of simeprevir, daclatasvir, and ribavirin in patients with recurrent hepatitis C virus genotype 1b infection after orthotopic liver transplantation: The Phase II SATURN study.
Forns X, Berenguer M, Herzer K,  et al
Transpl Infect Dis. 2017 Mar 13.
Abstract

Aplastic Anemia and Severe Myelosuppression with Boceprevir or Simeprevir-Containing Hepatitis C Virus Treatment.
Senín A, Broquetas T, Cañete N, et a|
 ,l Ann Hepatol
. 2017 Feb 15;16(2):312-317.
Abstract

Efficacy, safety and pharmacokinetics of simeprevir and TMC647055/ritonavir with or without ribavirin and JNJ-56914845 in HCV genotype 1 infection.
Bourgeois S, Van Vlierberghe H, Moreno C, et al
BMC Gastroenterol
. 2017 Feb 10;17(1):26.
Abstract

Safety and effectiveness of a 12-week course of sofosbuvir and simeprevir ± ribavirin in HCV-infected patients with or without HIV infection: a multicentre observational study.
Bruno G, Saracino A, Fabrizio C, Scudeller L, et al
Int J Antimicrob Agents. 2017 Fe
b 2
Abstract

FULL-TEXT ARTICLE
Efficacy of a 12-Week Simeprevir Plus Peginterferon/Ribavirin (PR) Regimen in Treatment-Naïve Patients with Hepatitis C Virus (HCV) Genotype 4 (GT4) Infection and Mild-To-Moderate Fibrosis Displaying Early On-Treatment Virologic Response.
Asselah T, Moreno C, Sarrazin C, et al
PLoS One. 2017 Jan 5;12(1):e0168713
Paper

Efficacy and Safety of Simeprevir and Sofosbuvir With and Without Ribavirin in Subjects With Recurrent Genotype 1 Hepatitis C Post-Orthotopic Liver Transplant: The Randomized GALAXY Study.
O'Leary JG, Fontana RJ, Brown K,  et al
Transpl Int
. 2016 Nov 29.
Abstract

Simeprevir in combination with sofosbuvir in treatment-naïve and -experienced patients with hepatitis C virus genotype 4 infection: a Phase III, open-label, single-arm study (PLUTO).
Buti M, Calleja JL, Lens S,  et al
Aliment Pharmacol T
her
. 2016 Nov 29
Abstract

Elucidating the Plasma and Liver Pharmacokinetics of Simeprevir in Special Populations Using Physiologically Based Pharmacokinetic Modelling.
Snoeys J, Beumont M, Monshouwer M, Ouwerkerk-Mahadevan S.
Clin Pharmacokine
t
. 2016 Nov 29
Abstract

Simeprevir, daclatasvir and sofosbuvir for hepatitis C virus-infected patients with decompensated liver disease.
Lawitz E, Poordad F, Gutierrez JA, et al  
J Viral Hepat
.
2016 Nov 23.
Abstract

Simeprevir plus sofosbuvir for eight or 12 weeks in treatment-naïve and treatment-experienced hepatitis C virus genotype 4 patients with or without cirrhosis.
El Raziky M, Gamil M, Ashour MK, et al
J Viral Hepat. 2016 Oct 27.
Abstract

Real life Egyptian experience of efficacy and safety of Simeprevir\ Sofosbuvir therapy in 6211 chronic HCV genotype IV infected patients
Eletreby R, Elakel W, Said M, et al
Liver Int. 2016 Oct 6.
Abstract

Virology analyses of HCV genotype 4 isolates from patients treated with simeprevir and peginterferon/ribavirin in the Phase III RESTORE study.
Fevery B, Verbinnen T, Peeters M,et al
J Viral Hepat
.
2016 Oct 3
Abstract

Effectiveness and tolerability of simeprevir and sofosbuvir in nontransplant and post-liver transplant patients with hepatitis C genotype 1.
Lutchman G, Nguyen NH, Chang CY, et al
Aliment Pharmacol Ther. 2016 Aug 10.
Abstract

FULL-TEXT ARTICLE
An Open-Label Trial of 12-Week Simeprevir plus Peginterferon/Ribavirin (PR) in Treatment-Naïve Patients with Hepatitis C Virus (HCV) Genotype 1 (GT1).
Asselah T, Moreno C, Sarrazin C,  et al
PLoS One. 2016 Jul 18;11(7):e0158526.
Paper

Colitis during new direct-acting antiviral agents (DAAs) therapy with sofosbuvir, simeprevir and ribavirin for genotype 1b hepatitis C.
Izzo I, Zanotti P, Chirico C, et al
Infection
. 2016 Jun 16.
Abstract

Successful Treatment of Hepatitis C with Simeprevir, Sofosbuvir, and Ribavirin in an HIV Coinfected Liver Transplant Patient with Advanced Chronic Kidney Disease.
Maruyama A, Hussaini T, Partovi N,  

Can J Infect Dis Med Microbiol
. 2016;2016:8372835.
Abstract

FULL-TEXT ARTICLE
Sustained Virologic Response at 24 Weeks after the End of Treatment Is a Better Predictor for Treatment Outcome in Real-World HCV-Infected Patients Treated by HCV NS3/4A Protease Inhibitors with Peginterferon plus Ribavirin.
Kanda T, Nakamoto S, Sasaki R,  et al
Int J Med Sci. 2016 Apr 10;13(4):310-5.
Paper

Sofosbuvir and Simeprevir without Ribavirin Effectively Treat Hepatitis C Virus Genotype 1 Infection after Liver Transplantation in a Two-Center Experience.
Jackson WE, Hanouneh M, Apfel T, et al
Clin Transplant. 2016 Mar 28.
Abstract

FULL-TEXT ARTICLE
Lower response to simeprevir and sofosbuvir in HCV genotype 1 in routine practice compared with clinical trials.
Yee BE, Nguyen NH, Jin M, et al
BMJ Open Gastroenterol. 2016 Mar 2;3(1):e000056
Paper

Simeprevir and sofosbuvir with or without ribavirin to treat recurrent genotype 1 hepatitis C virus infection after orthotopic liver transplantation.
Crittenden NE, Buchanan LA, Pinkston CM, et al 
Liver Transpl
. 2016 Feb 25.
Abstract

FULL-TEXT ARTICLE
Simeprevir Plus Sofosbuvir (12 and 8 Weeks) in HCV Genotype 1-Infected Patients Without Cirrhosis: OPTIMIST-1, a Phase 3, Randomized Study.
Kwo P, Gitlin N, Nahass R, Bernstein D, et al
Hepatology
. 2016 Jan 22
Paper


Simeprevir and Sofosbuvir (SMV-SOF) for 12 Weeks for the Treatment of Chronic Hepatitis C Genotype 1 Infection: A Real World (Transplant) Hepatology Practice Experience
Pillai AA, Wedd J, Norvell JP,  et al
Am J Gastroenterol
. 2016 Feb 2

Abstract
.

Simeprevir Plus Sofosbuvir (12 and 8 Weeks) in HCV Genotype 1-Infected Patients Without Cirrhosis: OPTIMIST-1, a Phase 3, Randomized Study.
Kwo P, Gitlin N, Nahass R, Bernstein D, et al

Hepatology
. 2016 Jan 22.
Abstract.

Simeprevir plus peginterferon/ribavirin for HCV genotype 1-infected treatment-naïve patients in China and South Korea.
Wei L, Han T, Yang D, Heo J, et al
J Gastroenterol Hepatol
. 2016 Jan 18.
Abstract

FULL-TEXT ARTICLE
Simeprevir with pegylated interferon alfa 2a plus ribavirin for treatment of hepatitis C virus genotype 1 in patients with HIV: a meta-analysis and historical comparison.
Andersohn F, Claes AK, Kulp W, et al
BMC Infect Dis. 2016 Jan 11;16(1):10.
Paper

FULL-TEXT ARTICLE
Tolerability and effectiveness of sofosbuvir and simeprevir in the post-transplant setting: systematic review and meta-analysis.
Nguyen NH, Yee BE, Chang C, et al
BMJ Open Gastroenterol. 2016 Jan 4;3(1):e0000
66.
Paper

Simeprevir plus sofosbuvir in patients with chronic hepatitis C virus genotype 1 infection and cirrhosis: A Phase 3 study (OPTIMIST-2).
Lawitz E, Matusow G, DeJesus E, et al
Hepatology
. 2015 Dec 24.
Abstract

Early Viral Response Predicts the Efficacy of Antiviral Triple Therapy with Simeprevir, Peg-Interferon and Ribavirin in Patients Infected with Hepatitis C Virus Genotype 1.
Nishida N, Iwanishi M, Minami T,  et al 

Dig Dis
. 2015 Oct 21;33(6):708-714
Abstract

Successful treatment of hepatitis C virus infection with sofosbuvir and simeprevir in the early phase of an allogeneic stem cell transplant.
Piñana JL, Serra MÁ, Hernández-Boluda JC,  et al
Transpl Infect Dis. 2015 Oct 20.
Abstract

Efficacy and safety of simeprevir in combination with peginterferon and ribavirin for patients with hepatitis C genotype 1 infection: A meta-analysis of randomized trials.
Cui X, Kong Y, Jia J.
Rev Esp Enferm Di
g
. 2015 Oct;107(10). d
Abstract

Drug-Drug Interactions with the NS3/4A Protease Inhibitor Simeprevir.
Ouwerkerk-Mahadevan S, Snoeys J,et al
Clin Pharmacokinet
. 2015 Sep 9.
Abstract

Simeprevir and sofosbuvir for treatment of hepatitis C infection.
Chopp S, Vanderwall R, Hult A, Klepser M.
Am J Health Syst Pharm
. 2015 Sep 1;72(17):1445-55.
Abstract

Predictive factors for 24 weeks sustained virologic response (SVR24) and viral relapse in patients treated with simeprevir plus peginterferon and ribavirin.
Nakayama M, Kobayashi H, Fukushima K,  et al
Hepatol In
t
. 2015 Aug 12.
Abstract

Evaluation of the Pharmacokinetics and Renal Excretion of Simeprevir in Subjects with Renal Impairment.
Ouwerkerk-Mahadevan S, Beumont-Mauviel M,  et al
Drugs R D. 2015 Aug 7.
Abstract

Efficacy and safety of simeprevir in combination with peginterferon and ribavirin for patients with hepatitis C genotype 1 infection: A meta-analysis of randomized trials.
Cui X, Kong Y, Jia J
z
Rev Esp Enferm Dig. 2015 Jul 13;107.
Abstract

Development and validation of two screening assays for the HCV NS3 Q80K polymorphism associated with reduced response to combination treatment regimens containing simeprevir.
Chui CK, Dong WW, Joy JB, et al 
J Clin Microbiol. 2015 Jul 1.
Abstract

Antiviral Treatment with Sofosbuvir and Simeprevir in a Kidney-Transplant Recipient with HCV-Decompensated Cirrhosis: Viral Eradication and Removal from the Liver Transplant Waiting List.
Bonacci M, Londoño MC, Esforzado N, et al 
Transpl Int. 2015 Jun 13.
Abstract

Effectiveness of triple therapy with simeprevir for chronic hepatitis C genotype 1b patients with prior telaprevir failure.
Ogawa E, Furusyo N, Dohmen K,  et al
J Viral Hepa
t
. 2015 Jun 15.
Abstract

Evolution of simeprevir-resistant variants in virological non-responders infected with HCV genotype 1b.
Akuta N, Suzuki F, Sezaki H,  et al
J Med Virol
. 2015 Apr;87(4):609-18
Abstract

Multicenter experience using simeprevir and sofosbuvir with or without ribavirin to treat hepatitis C genotype 1 after liver transplant.
Pungpapong S, Aqel B, Leise M,  et al
Hepatology. 2015 Feb 26.
Abstract

A Cross-Sectional Study Comparing the Frequency of Drug Interactions After Adding Simeprevir- or Sofosbuvir-Containing Therapy to Medication Profiles of Hepatitis C Monoinfected Patients.
Patel N, Nasiri M, Koroglu A, et al
Infect Dis Ther
. 2015 Jan 28.
Abstract

Simeprevir and Sofosbuvir for Treatment of Chronic Hepatitis C Infection.
Childs-Kean LM, Hand EO.
Clin Ther. 2015 Jan 16. pii: S0149-2918(14)00870-4
Abstract

Efficacy and safety of simeprevir with PegIFN/ribavirin in naïve or experienced patients infected with chronic HCV genotype 4.
Moreno C, Hezode C, Marcellin P,  et al
J Hepatol. 2015 Jan 14. pii: S0168-8278(15)00002-
Abstract

Simeprevir: A Review of Its Use in Patients with Chronic Hepatitis C Virus Infection.
Sanford M.
Drugs. 2015 Jan 6.
Abstract

The Combination of Simeprevir and Sofosbuvir is More Effective Than That of Peginterferon, Ribavirin, and Sofosbuvir for Patients with Hepatitis C-related Child's Class A Cirrhosis.
Pearlman BL, Ehleben C, Perrys M.
Gastroenterology
. 2014 Dec 31. pii: S0016-5085(14)01579-0.
Abstract

Simeprevir added to peginterferon and ribavirin lessens time with fatigue, depressive symptoms and functional limitations in patients with chronic hepatitis C compared with peginterferon and ribavirin: results from 1161 patients in the QUEST-1, QUEST-2 and PROMISE studies.
S
cott J, Gilles L, Fu M, Brohan E, et al
J Viral Hepa
t
. 2014 Dec 9.
Abstract

Controlling hepatitis C with simeprevir.
Dusheiko G.
Lancet Infect Dis. 2014 Dec 4
Abstract

Hepatic Decompensation Likely Attributable to Simeprevir in Patients with Advanced Cirrhosis.
Stine JG, Intagliata N, Shah NL, et al
Dig Dis Sci. 2014 Nov 6
Abstract
Simeprevir with peginterferon/ribavirin for treatment of chronic hepatitis C virus genotype 1 infection: pooled safety analysis from Phase IIb and III studies.
Manns MP, Fried MW, Zeuzem S,  et al
J Viral Hepat
. 2014 Nov 3.
Abstract

Severe liver injury associated with simeprevir plus pegylated interferon/ribavirin therapy in a patient with treatment-naïve genotype 1b hepatitis C virus: a case report.
I
gawa T, Fushimi S, Matsuo R,  et al
Clin J Gastroenterol
. 2014 Oct;7(5):465-70.
Abstract

Use of simeprevir following pre-emptive pegylated interferon/ribavirin treatment for recurrent hepatitis C in living donor liver transplant recipients: a 12-week pilot study.
Tanaka T, Sugawara Y, Akamatsu N,  et al.
J Hepatobiliary Pancreat Sci
. 2014 Oct 22.
Abstract

Simeprevir plus sofosbuvir, with or without ribavirin, to treat chronic infection with hepatitis C virus genotype 1 in non-responders to pegylated interferon and ribavirin and treatment-naive patients: the COSMOS randomised study.
Lawitz E, Sulkowski M
Lancet. 2014 Jul 26.
Abstract

Patients eligible for treatment with simeprevir in a French center.
Morel V, Duverlie G, Brochot E.
J Clin Virol
. 2014 Jul 3.
Abstract

Simeprevir (TMC435) once daily with peginterferon α-2b and ribavirin in patients with genotype-1 hepatitis-C virus infection: the CONCERTO-4 study
Kumada H, Hayashi N, Izumi N, et al
Hepatol Res. 2014 Jun 24.
Abstract

Simeprevir with pegylated interferon alfa 2a plus ribavirin in treatment-naive patients with chronic hepatitis C virus genotype 1 infection
(QUEST-1): a phase 3, randomised, double-blind, placebo-controlled trial.
Jacobson IM, Dore GJ, Foster GR, et al
Lancet. 2014 Jun 3.
Abstract

Simeprevir with pegylated interferon alfa 2a or 2b plus ribavirin in treatment-naive patients with chronic hepatitis C virus genotype 1 infection
(QUEST-2): a randomised, double-blind, placebo-controlled phase 3 trial.

Manns M, Marcellin P, Poordad F, et al

Lancet
. 2014 Jun 3.

Abstract

Simeprevir for the treatment of chronic hepatitis C genotype 1 infection
Takehara T.
Expert Rev Anti Infect The
r
. 2014 Jun 2:1-9.
Abstract

Simeprevir with Peginterferon and Ribavirin Leads to High Rates of SVR in Patients with HCV Genotype 1 Who Relapsed After Previous Therapy: a Phase 3 Trial.
Forns X, Lawitz E, Zeuzem S,  et al
Gastroenterology
. 2014 Mar 3.
Abstract

Hepatitis C virus: Here comes all-oral treatment.
Dugum M, O'Shea R.
Cleve Clin J Med. 2014 Mar;81(3):159-72.
Abstract

Simeprevir increases rate of sustained virologic response among treatment-experienced patients with HCV genotype-1 infection: a phase IIb trial
Zeuzem S, Berg T, Gane E,  et al
Gastroenterology. 2014 Feb;146(2):430-441.e6
Abstract

Second-wave IFN-based triple therapy for HCV genotype 1 infection: simeprevir, faldaprevir and sofosbuvir.
Asselah T, Marcellin P.
Liver Int. 2014 Feb;34 Suppl 1:60-8.
Abstract

Discovery and Development of Simeprevir (TMC435), a HCV NS3/4A Protease Inhibitor.
Rosenquist A, Samuelsson B, Johansson PO,  et al
J Med Chem. 2014 Jan 21.
Abstract

Hepatitis: Sustained virologic response in treatment-experienced patients with HCV genotype 1 is increased by simeprevir.
[
No authors listed]
Nat Rev Gastroenterol Hepatol
. 2013 Dec 10.
Abstract

Sofosbuvir (GS-7977), a pan-genotype, direct-acting antiviral for hepatitis C virus infection.
Rodríguez-Torres M
Expert Rev Anti Infect Ther
. 2013 Dec;11(12):1269-79.

Abstract

Simeprevir: First Global Approval.
Vaidya A, Perry CM.
Drugs. 2013 Nov 30
Abstract

Simeprevir Increases Rate of Sustained Virologic Response Among Treatment-Experienced Patients with HCV Genotype-1 Infection: a Phase IIb Trial.
Zeuzem S, Berg T, Gane E,  et al
Gastroenterology
. 2013 Oct 31
Abstract

Once-daily simeprevir (TMC435) with peginterferon/ribavirin for treatment-naïve hepatitis C genotype 1-infected patients in Japan: the DRAGON study.
Hayashi N, Seto C, Kato M, et al
J Gastroenterol. 2013 Sep 5.
Abstract

Once-daily simeprevir (TMC435) with pegylated interferon and ribavirin in treatment-Naïve genotype 1 hepatitis C: The randomized PILLAR study.
Fried MW, Buti M, Dore GJ,  et al
Hepatology. 2013 Aug 2.
Abstract

Durability of SVR in chronic hepatitis C patients treated with peginterferon-α2a/ribavirin in combination with a direct-acting anti-viral.
Rutter K, Hofer H, Beinhardt S,  et al
Aliment Pharmacol Ther. 2013 Jul;38(2):118-23
Abstract

Virologic response and characterisation of HCV genotype 2-6 in patients receiving TMC435 monotherapy (study TMC435-C202).
Lenz O, Vijgen L, Berke JM,
J Hepatol. 2013 Mar;58(3):445-51
Abstract

Efficacy of re-treatment with TMC435 as combination therapy in hepatitis C virus-infected patients following TMC435 monotherapy.
Lenz O, de Bruijne J, Vijgen L,  et al
Gastroenterology. 2012 Nov;143(5):1176-8.e1-6
Abstract

TMC435 for the treatment of chronic hepatitis C.
Tanwar S, Trembling PM, Dusheiko GM.
Expert Opin Investig Drugs. 2012 Aug;21(8):1193-209
Abstract

Antiviral activity of TMC435 monotherapy in patients infected with HCV genotypes 2-6: TMC435-C202, a phase IIa, open-label study.
Moreno C, Berg T, Tanwandee T, Thongsawat S,  et al
J Hepatol. 2012 Jun;56(6):1247-53.
Abstract

Molecular modeling study on the resistance mechanism of HCV NS3/4A serine protease mutants R155K, A156V and D168A to TMC435.
Xue W, Pan D, Yang Y,  et al
Antiviral Res. 2012 Jan;93(1):126-37.
Abstract

Rapid viral response of once-daily TMC435 plus pegylated interferon/ribavirin in hepatitis C genotype-1 patients: a randomized trial.
Manns M, Reesink H, Berg T, et al
Antivir Ther. 2011;16(7):1021-33
Abstract

FULL-TEXT ARTICLE
In vitro resistance profile of the hepatitis C virus NS3/4A protease inhibitor TMC435.
Lenz O, Verbinnen T, Lin TI, et al
Antimicrob Agents Chemother. 2010 May;54(5):
Paper



Vaniprevir
 

     Journal Papers, Abstracts, and Commentaries

  Combination of Vaniprevir with Peginterferon and Ribavirin Significantly Increases the Rate of Sustained Viral Response in Treatment-Experienced Patients with Chronic HCV Genotype 1 Infection and Cirrhosis.
Rodriguez-Torres M, Stoehr A, Gane EJ, et al
Clin Gastroenterol Hepatol. 2013 Oct 10.
Abstract

Emergence of resistance-associated variants after failed triple therapy with vaniprevir in treatment-experienced non-cirrhotic patients with hepatitis C-genotype 1 infection: a population and clonal analysis.
Barnard RJ, McHale CM, Newhard W, et al
Virology. 2013 Sep 1;443(2):278-84
Abstract

Characterization of vaniprevir, a hepatitis C virus NS3/4A protease inhibitor, in patients with HCV genotype 1 infection: Safety, antiviral activity, resistance, and pharmacokinetics.
Lawitz E, Sulkowski M, Jacobson I,  et aL
Antiviral Res
. 2013 Sep;99(3):214-20.
Abstract

A phase 2B study of MK-7009 (vaniprevir) in patients with genotype 1 HCV infection who have failed previous pegylated interferon and
ribavirin treatment.
Lawitz E, Rodriguez-Torres M, Stoehr A, et al
J Hepatol. 2013 Jul;59(1):11-7.
Abstract

 


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