Ledipasvir/sofosbuvir: the fixed dose combination in the new era of treatment for HCV

Reviews in Health Care ◽

10.7175/rhc.v6i3.1178 ◽

2015 ◽

Vol 6 (3) ◽

pp. 87-98

Author(s):

Alessia Ciancio

Keyword(s):

Clinical Evidence ◽

Phase Iii ◽

New Era ◽

Single Pill ◽

Treatment Naïve ◽

Dose Combination ◽

Hcv Genotype 1 ◽

Chronic Hcv ◽

Phase Iii Studies

Interferon-based treatment is not suitable for many patients with hepatitis C virus (HCV) infection because of contraindications, other reasons for ineligibility and side-effects. The fixed dosed combination ledipasvir/sofosbuvir (LDV / SOF) is the first approved regimen that doesn’t require administration with interferon or ribavirin. LDV / SOF is also the first single-pill approved for the treatment of chronic HCV genotype 1 in both treatment-naïve and treatment-experienced patients. The results of the phase III studies demonstrate the combination has been very well tolerated and SVR rates consistently above 90%. Objective of this review is to present clinical evidence of efficacy and safety of the combination LDV / SOF in different subgroups of patients with HCV.

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1425 SIMEPREVIR (TMC435) WITH PEGINTERFERON/RIBAVIRIN FOR CHRONIC HCV GENOTYPE-1 INFECTION IN TREATMENT-NAÏVE PATIENTS: RESULTS FROM QUEST-1, A PHASE III TRIAL

Journal of Hepatology ◽

10.1016/s0168-8278(13)61424-5 ◽

2013 ◽

Vol 58 ◽

pp. S574 ◽

Author(s):

I. Jacobson ◽

G.J. Dore ◽

G.R. Foster ◽

M.W. Fried ◽

M. Radu ◽

...

Keyword(s):

Phase Iii ◽

Phase Iii Trial ◽

Hcv Genotype ◽

Treatment Naïve ◽

Hcv Genotype 1 ◽

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Su1060 Faldaprevir Plus Pegylated Interferon/Ribavirin Did Not Increase Anaemia Compared With Pegylated Interferon/Ribavirin in HCV Genotype-1, Treatment-Naïve Patients: Pooled Analysis of Phase III Studies

Gastroenterology ◽

10.1016/s0016-5085(14)63551-4 ◽

2014 ◽

Vol 146 (5) ◽

pp. S-977

Author(s):

Tarik Asselah ◽

Donald M. Jensen ◽

Graham Foster ◽

Mark Sulkowski ◽

Denis Ouzan ◽

...

Keyword(s):

Pegylated Interferon ◽

Pooled Analysis ◽

Phase Iii ◽

Hcv Genotype ◽

Treatment Naïve ◽

Hcv Genotype 1 ◽

Phase Iii Studies

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P9: Efficacy and safety of simeprevir in treatment naïve HCV genotype 1-infected patients with METAVIR F2 fibrosis: QUEST-1 and QUEST-2 Phase III studies

Journal of Viral Hepatitis ◽

10.1111/jvh.12333_8 ◽

2014 ◽

Vol 21 ◽

pp. 25-26

Keyword(s):

Phase Iii ◽

Efficacy And Safety ◽

Hcv Genotype ◽

Treatment Naïve ◽

Hcv Genotype 1 ◽

Phase Iii Studies

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Safety of aclidinium bromide/formoterol fumarate fixed-dose combination in COPD: pooled analyses of three Phase III studies

Pneumologie ◽

10.1055/s-0035-1544790 ◽

2015 ◽

Vol 69 (S 01) ◽

Author(s):

S Korn ◽

E Kerwin ◽

JF Donohue ◽

P Shrestha ◽

A Leselbaum ◽

...

Keyword(s):

Fixed Dose Combination ◽

Phase Iii ◽

Three Phase ◽

Aclidinium Bromide ◽

Dose Combination ◽

Phase Iii Studies ◽

Formoterol Fumarate

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Phase III, Multicenter Open-Label Study to Investigate the Efficacy of Elbasvir and Grazoprevir Fixed-Dose Combination for Eight Weeks in Treatment-Naïve, HCV GT1b-Infected Patients, with Non-Severe Fibrosis

SSRN Electronic Journal ◽

10.2139/ssrn.3522580 ◽

2020 ◽

Author(s):

Armand Abergel ◽

Tarik Asselah ◽

Arianne Mallat ◽

Brigitte Chanteranne ◽

Frederic Faure ◽

...

Keyword(s):

Fixed Dose Combination ◽

Phase Iii ◽

Open Label Study ◽

Label Study ◽

Treatment Naïve ◽

Dose Combination ◽

Severe Fibrosis

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1413 SIMEPREVIR (TMC435) WITH PEGINTERFERON/RIBAVIRIN FOR TREATMENT OF CHRONIC HCV GENOTYPE-1 INFECTION IN TREATMENT-NAÏVE PATIENTS: RESULTS FROM QUEST-2, A PHASE III TRIAL

Journal of Hepatology ◽

10.1016/s0168-8278(13)61412-9 ◽

2013 ◽

Vol 58 ◽

pp. S568 ◽

Author(s):

M. Manns ◽

P. Marcellin ◽

F.P. Fred Poordad ◽

E. Stanislau Affonso de Araujo ◽

M. Buti ◽

...

Keyword(s):

Phase Iii ◽

Phase Iii Trial ◽

Hcv Genotype ◽

Treatment Naïve ◽

Hcv Genotype 1 ◽

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869a Simeprevir (TMC435) With Peginterferon/Ribavirin for Treatment of Chronic HCV Genotype-1 Infection in Treatment-Naive Patients: Results From QUEST-2, a Phase III Trial

Gastroenterology ◽

10.1016/s0016-5085(13)60541-7 ◽

2013 ◽

Vol 144 (5) ◽

pp. S-151 ◽

Author(s):

Fred Poordad ◽

Michael P. Manns ◽

Patrick Marcellin ◽

Evaldo Stanislau Affonso de Araujo ◽

Maria Buti ◽

...

Keyword(s):

Phase Iii ◽

Phase Iii Trial ◽

Hcv Genotype ◽

Treatment Naïve ◽

Hcv Genotype 1 ◽

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P1127 SIMEPREVIR (TMC435) WITH PEGINTERFERON/RIBAVIRIN FOR TREATMENT OF CHRONIC HCV GENOTYPE 1 INFECTION IN TREATMENT-NAIVE EUROPEAN PATIENTS IN THE QUEST-1 AND QUEST-2 PHASE III TRIALS

Journal of Hepatology ◽

10.1016/s0168-8278(14)61287-3 ◽

2014 ◽

Vol 60 (1) ◽

pp. S456 ◽

Author(s):

G.R. Foster ◽

I.M. Jacobson ◽

G.J. Dore ◽

M. Fried ◽

M. Manns ◽

...

Keyword(s):

Phase Iii ◽

Hcv Genotype ◽

Phase Iii Trials ◽

Treatment Naïve ◽

Hcv Genotype 1 ◽

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P1125 PHARMACOKINETIC-RESPONSE ANALYSIS OF FALDAPREVIR IN TREATMENT-NAIVE PATIENTS WITH CHRONIC HCV GENOTYPE-1 INFECTION: A POOLED ANALYSIS OF TWO PHASE III TRIALS

Journal of Hepatology ◽

10.1016/s0168-8278(14)61285-x ◽

2014 ◽

Vol 60 (1) ◽

pp. S454-S455 ◽

Author(s):

G.R. Foster ◽

C. Cooper ◽

D. Dieterich ◽

P. Ferenci ◽

J. Crespo ◽

...

Keyword(s):

Pooled Analysis ◽

Phase Iii ◽

Response Analysis ◽

Two Phase ◽

Hcv Genotype ◽

Phase Iii Trials ◽

Treatment Naïve ◽

Hcv Genotype 1 ◽

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P723 FALDAPREVIR PLUS PEGYLATED INTERFERON/RIBAVIRIN DID NOT INCREASE ANAEMIA COMPARED WITH PEGYLATED INTERFERON/RIBAVIRIN IN HCV GENOTYPE-1, TREATMENT-NAIVE PATIENTS: POOLED ANALYSIS OF PHASE III STUDIES

Journal of Hepatology ◽

10.1016/s0168-8278(14)60885-0 ◽

2014 ◽

Vol 60 (1) ◽

pp. S310-S311

Author(s):

T. Asselah ◽

D.M. Jensen ◽

G.R. Foster ◽

M.S. Sulkowski ◽

D. Ouzan ◽

...

Keyword(s):

Pegylated Interferon ◽

Pooled Analysis ◽

Phase Iii ◽

Hcv Genotype ◽

Treatment Naïve ◽

Hcv Genotype 1 ◽

Phase Iii Studies

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