Triple DAAs Regimen in Treating Non-cirrhotic HCV GT1b Subjects

NCT02470858 | Completed Phase 2

• 1 other identifier: H&H_Triple Therapy_1
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The study is designed to test the hypothesis that the addition of a protease inhibitor to dual NS5a-NS5B nucleoside prodrug analog will enhance antiviral efficacy and hence shorten the treatment duration to 3 weeks.

Conditions

Chronic Hepatitis C Infection

Outcome Measures

Primary Outcomes (2)

• Proportion of participants with sustained virologic response 12 weeks after discontinuation of therapy (SVR12)

  SVR12 is defined as HCV RNA \< lower limit of quantification (LLOQ) 12 weeks after last dose of study drug.

  Post treatment Week 12

• Proportion of participants with adverse events leading to permanent discontinuation of study drug(s)

  Baseline up to Week 24

Secondary Outcomes (3)

• Proportion of participants with unquantifiable HCV viral load at specified time points during and after treatment.

  Baseline up to Week 24

• HCV RNA levels and change during and after treatment.

  Baseline up to Week 24

• Proportion of participants with on-treatment virologic breakthrough and relapse

  Baseline up to Week 24

Study Arms (3)

LDV/SOF+ASV

EXPERIMENTAL

Participants with genotype 1b HCV infection will receive LDV/SOF FDC + ASV 3 weeks.

Drug: LDV/SOF+ASV

SOF+DCV+SMV

EXPERIMENTAL

Participants with genotype 1b HCV infection will receive SOF + DCV + SMV for 3 weeks.

Drug: SOF+DCV+SMV

SOF+DCV+ASV

EXPERIMENTAL

Participants with genotype 1b HCV infection will receive SOF + DCV + ASV for 3 weeks

Drug: SOF+DCV+ASV

Interventions

LDV/SOF+ASV DRUG

Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed-dose combination (FDC) tablet; administered orally once daily; Asunaprevir (ASV) 200mg, administered orally twice daily.

Also known as: GS-7977, PSI-7977, GS-5885, Harvoni®, BMS-650032, Sunvepra®

LDV/SOF+ASV

SOF+DCV+SMV DRUG

Sofosbuvir (SOF) 400 mg tablet administered orally once daily; Daclatasvir (DCV) 60 mg tablet administered orally once daily; Simeprevir (SMV) 150 mg tablet orally once daily.

Also known as: GS-7977, PSI-7977, Sovaldi®, BMS-790052, Daklinza®, TMC435, OLYSIO®

SOF+DCV+SMV

SOF+DCV+ASV DRUG

Sofosbuvir (SOF) 400 mg tablet administered orally once daily; Daclatasvir (DCV) 60 mg tablet administered orally once daily; Asunaprevir (ASV) 200mg, administered orally twice daily.

Also known as: GS-7977, PSI-7977, Sovaldi®, BMS-790052, Daklinza®, BMS-650032, Sunvepra®

SOF+DCV+ASV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age equal to or greater than 18 years, with chronic genotype 1b HCV infection;
• HCV RNA level \> 10,000 and \< 10,000,000 IU/ml at Screening;
• Rapid response to triple DAAs therapy with less than 500 IU/ml plasma HCV RNA level at Day 2;
• No evidence of cirrhosis. Cirrhosis defined as any 1 of the following, within 6 months of study entry:
• Liver biopsy showing cirrhosis;
• Fibroscan showing cirrhosis or results\>12.5 kPa ;
• FibroTest® score \>0.75 and an aspartate aminotransferase (AST): platelet ratio index (APRI) \>2 during screening.

You may not qualify if:

• Pregnant or nursing female or male with pregnant female partner;
• HIV or chronic hepatitis B virus (HBV) infection;
• Hematologic or biochemical parameters at Screening outside the protocol-specified requirements;
• Active or recent history (≤ 1 year) of drug or alcohol abuse;
• Hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers);
• History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study, such that it is not in the best interest of the subject to participate.

Sponsors & Collaborators

• Humanity and Health Research Centre: lead
• Beijing 302 Hospital: collaborator
• Emory University: collaborator

Study Sites (1)

Humanity and Health GI and Liver Centre

Hong Kong, Hong Kong, 00852, China

Location

Related Publications (1)

• Lau G, Benhamou Y, Chen G, Li J, Shao Q, Ji D, Li F, Li B, Liu J, Hou J, Sun J, Wang C, Chen J, Wu V, Wong A, Wong CL, Tsang ST, Wang Y, Bassit L, Tao S, Jiang Y, Hsiao HM, Ke R, Perelson AS, Schinazi RF. Efficacy and safety of 3-week response-guided triple direct-acting antiviral therapy for chronic hepatitis C infection: a phase 2, open-label, proof-of-concept study. Lancet Gastroenterol Hepatol. 2016 Oct;1(2):97-104. doi: 10.1016/S2468-1253(16)30015-2. Epub 2016 Jul 25.

  PMID: 27917405 DERIVED

MeSH Terms

Interventions

Sofosbuvir; ledipasvir; ledipasvir, sofosbuvir drug combination; asunaprevir; daclatasvir; Simeprevir

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• George Lau, MD

  Humanity and Health GI and Liver Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2015
• First Posted: June 12, 2015
• Study Start: January 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 1, 2016

Record last verified: 2016-02

Locations

CN (1)