Short Duration Therapy of Acute Hepatitis C Genotypes 1 or 4

NCT02886624 | Completed Phase 2 Results DMC

• 1 other identifier: IMEA 50
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of this study is to assess the rate of sustained virological response (SVR) 12 weeks after 8-week oral treatment with grazoprevir 100mg/elbasvir 50mg (MRK-combo) in patients with acute hepatitis C genotype1 or 4.

Conditions

Acute Hepatitis C; HIV

Outcome Measures

Primary Outcomes (1)

• Sustained Virological Response 12 Weeks Post-treatment (SVR12)

  Undetectable plasma HCV RNA (\<12 IU/mL) 12 weeks post-treatment.

  12 weeks

Secondary Outcomes (5)

• Virological Failure

  12 weeks

• Treatment Adherence

  8 weeks

• Number of Participants With Undetectable HIV RNA

  12 weeks

• CD4 Cell Count

  12 weeks

• Incidence of HCV Re-infection

  48 weeks

Study Arms (1)

Grazoprevir/Elbasvir

EXPERIMENTAL

Once-daily, oral grazoprevir/elbasvir combination therapy at fixed-dose (100mg/50mg) for 8 weeks

Drug: Grazoprevir/Elbasvir

Interventions

Grazoprevir/Elbasvir DRUG

Once-daily, oral grazoprevir/elbasvir combination therapy at fixed-dose (100mg/50mg) for 8 weeks

Also known as: Zepatier

Grazoprevir/Elbasvir

Eligibility Criteria

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

You may qualify if:

• Adult ≥18 years.
• A recent acute HCV infection \[defined by (i) detectable HCV RNA within 6 months after a negative HCV RNA or HCV serology test OR (ii) detectable HCV RNA and acute clinical hepatitis within 5 months prior to screening visit (ALT ≥250 IU/L with normal ALT within the preceding 8 months OR ALT ≥500 IU/L with either no measured ALT or with abnormal ALT within the preceding 8 months)\] or reinfection \[defined by documented de novo infection after prior clearance post-treatment (defined by one negative HCV RNA ≥6 months after end of treatment) or spontaneously (defined by two negative HCV RNA a minimum of 6 months apart OR documented infection with a new viral strain, confirmed by phylogenetic or genotypic analysis)\] within 5 months prior screening OR (iii) patients having reported a risk factor for HCV contamination (traumatic sexual intercourse, intranasal, rectal or intravenous drug use) ≥6 months AND presenting a negative HCV RNA or HCV serology test within 12 months.
• Infection with HCV genotype 1 or 4 (confirmed at screening visit or by using a previous biological test performed 1 to 4 weeks before week 0).
• Plasma HCV-RNA ≥ 1000 IU/mL (confirmed at screening visit or by using a previous biological test performed 1 to 4 weeks before week 0).
• Confirmed HIV infection (only for HIV co-infected patients).
• Without HIV treatment or with an authorized stable HIV treatment for at least two weeks (only for HIV co-infected patients).
• Body weight ≥40 kg and ≤125 kg.
• Female patients with child-bearing potential and their heterosexual partners must use adequate contraception from the date of screening until 30 days after administration of the last dose of study drug. Male participants must agree to consistently and correctly use a condom, while their female partner must use adequate contraception from the date of screening until 30 days after administration of the last dose of study drug.
• Informed and signed consent.
• Patients with Health insurance (Sécurité Sociale or Couverture Médicale Universelle).

You may not qualify if:

• Opportunistic infections (stage C), active or occurred within 6 months prior to baseline.
• Primary HIV infection.
• Co-infection with Hepatitis B virus (HBsAg-positive) without appropriate treatment (TDF or TAF) for at least 2 weeks.
• Confirmed cirrhosis (before acute HCV diagnosis).
• Any other causes of acute hepatitis.
• Pregnant or breast-feeding women.
• Liver transplant recipients.
• Evolutive malignancy.
• Patients with a history of non-adherence, who will be at risk of being unable to respect the study follow-up timetable.
• Patients under legal gardianship or incarcerated.
• Hemaglobulin \<10 g/dL (female) or \<11g/dL (male).
• Platelet count \<50,000/mm3.
• Neutrophil count \< 750/mm3.
• Other antiretroviral drugs than those allowed in the study.
• Contra-indications to grazoprevir and/or elbasvir or to any of the excipients listed in the summary of the product characteristics.

Sponsors & Collaborators

• Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba: lead
• Merck Sharp & Dohme LLC: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (6)

CHU de Lyon

Lyon, 69317, France

Location

CHU de Nice

Nice, 06200, France

Location

Hôpital Saint-Antoine

Paris, 75012, France

Location

Hôpital La Pitié-Salpêtrière

Paris, 75013, France

Location

Hôpital Bichat

Paris, 75018, France

Location

Hôpital Tenon

Paris, 75020, France

Location

Related Publications (4)

• Gambotti L, Batisse D, Colin-de-Verdiere N, Delaroque-Astagneau E, Desenclos JC, Dominguez S, Dupont C, Duval X, Gervais A, Ghosn J, Larsen C, Pol S, Serpaggi J, Simon A, Valantin MA, Velter A; Acute hepatitis C collaborating group. Acute hepatitis C infection in HIV positive men who have sex with men in Paris, France, 2001-2004. Euro Surveill. 2005 May;10(5):115-7.

  PMID: 16077209 BACKGROUND

• Fierer DS, Dieterich DT, Fiel MI, Branch AD, Marks KM, Fusco DN, Hsu R, Smith DM, Fierer J. Rapid progression to decompensated cirrhosis, liver transplant, and death in HIV-infected men after primary hepatitis C virus infection. Clin Infect Dis. 2013 Apr;56(7):1038-43. doi: 10.1093/cid/cis1206. Epub 2012 Dec 21.

  PMID: 23264364 BACKGROUND

• European AIDS Treatment Network (NEAT) Acute Hepatitis C Infection Consensus Panel. Acute hepatitis C in HIV-infected individuals: recommendations from the European AIDS Treatment Network (NEAT) consensus conference. AIDS. 2011 Feb 20;25(4):399-409. doi: 10.1097/QAD.0b013e328343443b. No abstract available.

  PMID: 21139491 BACKGROUND

• Rockstroh JK, Nelson M, Katlama C, Lalezari J, Mallolas J, Bloch M, Matthews GV, Saag MS, Zamor PJ, Orkin C, Gress J, Klopfer S, Shaughnessy M, Wahl J, Nguyen BY, Barr E, Platt HL, Robertson MN, Sulkowski M. 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. Lancet HIV. 2015 Aug;2(8):e319-27. doi: 10.1016/S2352-3018(15)00114-9. Epub 2015 Jul 9.

  PMID: 26423374 BACKGROUND

MeSH Terms

Interventions

elbasvir-grazoprevir drug combination

Results Point of Contact

• Title: Prof. Karine Lacombe
• Organization: Hôpital Saint Antoine

karine.lacombe2@aphp.fr

+33 1 49 28 24 38

Study Officials

• Karine Lacombe, MD, PhD

  Hôpital Saint-Antoine, Service des maladies infectieuses et tropicales

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: August 29, 2016
• First Posted: September 1, 2016
• Study Start: May 31, 2017
• Primary Completion: December 31, 2018
• Study Completion: September 16, 2019
• Last Updated: January 29, 2020
• Results First Posted: January 29, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data are available as of January 1, 2020 and will be available for request until December 31, 2025.
• Access Criteria: Please contact the Principal Investigator for further details.

Locations

FR (6)