Dutch Acute HCV in HIV Study (DAHHS-2): Grazoprevir/Elbasvir for Acute HCV
DAHHS-2
Grazoprevir (MK-5172)+ Elbasvir (MK-8742) for the Treatment of Acute Hepatitis C Genotype 1/4. The Dutch Acute HCV in HIV Study (DAHHS-2)
1 other identifier
interventional
80
2 countries
9
Brief Summary
New and recently EMA/FDA approved direct acting antiviral (DAA) combination therapies cure 95% or more of the patients chronically infected with HCV genotype 1 and 4. Grazoprevir (MK-5172) and elbasvir (MK-8742) combination therapy is such a, albeit not yet EMA/FDA approved combination DAA therapy. It is likely that the synergistic effect of the host's immune response and antiviral therapy when given during the first 6 months of HCV infection makes antiviral therapy during acute HCV infection more effective. In this study the investigators would like to document that treatment of acute HCV with grazoprevir (MK-5172), elbasvir (MK-8742) is effective and can ben shortened from 12 to 8 weeks for HCV genotype 1 and 4 infection without substantial loss in efficacy. Study design and intervention: Prospective open label interventional clinical trial in which 80 acute HCV genotype 1 or 4 patients co-infected with HIV will receive 8 weeks of grazoprevir and elbasvir (a once-daily combination tablet). Study population: 80 Adult HIV positive patients with an acute HCV genotype 1 or 4 infection from 10 HIV treatment centers in the Netherlands and Belgium will be included. Primary endpoint: Sustained viral response (SVR) 12 weeks after the end of therapy in ITT study population (=genotype 1 and 4).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Feb 2016
Typical duration for phase_3
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 5, 2015
CompletedFirst Posted
Study publicly available on registry
November 9, 2015
CompletedStudy Start
First participant enrolled
February 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 11, 2019
CompletedResults Posted
Study results publicly available
July 8, 2019
CompletedJuly 8, 2019
April 1, 2019
2.2 years
November 5, 2015
January 11, 2019
April 16, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
SVR12 (Reinfection Not Considered Failure)
Sustained viral response (SVR) 12 weeks after the end of therapy in all patients who started treatment in which reinfections are not considered failure
12 weeks
Secondary Outcomes (1)
SVR12 (Reinfection Equals Failure)
week 12
Study Arms (1)
Treatment group
EXPERIMENTALGrazoprevir/elbasvir single tablet regimen (100/50mg)
Interventions
Eligibility Criteria
You may qualify if:
- HIV positive
- Acute HCV genotype 1 or 4 infection (≤26 weeks old at the baseline visit)
You may not qualify if:
- Not on cART and a CD4 \<500 at the time of screening
- Patients on cART for \>6 months with a HIV viral load \>400 copies
- Disallowed co-medication that cannot be stopped or replaced
- Protease inhibitor based and NNRTI based cART regimens are not allowed. Therefore, the inability to switch to a HAART regimen consisting of 2 nucleoside/tide reverse transcriptase inhibitors and an allowed third agent which can be raltegravir (Isentress®) 400mg BID, dolutegravir (Tivicay) 50mg QD or rilpivirine 25mg QD.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Institute of Tropical Medicine Antwerp (ITG)
Antwerp, Belgium
Erasmus Medical Center (EMC)
Rotterdam, South Holland, 3000 CA, Netherlands
Onze Lieve Vrouwe Gasthuis (OLVG)
Amsterdam, Netherlands
Slotervaart Hospital
Amsterdam, Netherlands
Rijnstate Hospital
Arnhem, Netherlands
University Medical Center Groningen (UMCG)
Groningen, Netherlands
Maastricht University Medical Center (MUMC)
Maastricht, Netherlands
Radbout University Medical Center
Nijmegen, Netherlands
Utrecht Medical University Center (UMCU)
Utrecht, Netherlands
Related Publications (2)
Popping S, Cuypers L, Claassen MAA, van den Berk GE, De Weggheleire A, Arends JE, Boerekamps A, Molenkamp R, Koopmans MPG, Verbon A, Boucher CAB, Rijnders B, van de Vijver DAMC. Persistent Transmission of HCV among Men Who Have Sex with Men despite Widespread Screening and Treatment with Direct-Acting Antivirals. Viruses. 2022 Sep 2;14(9):1953. doi: 10.3390/v14091953.
PMID: 36146760DERIVEDBoerekamps A, De Weggheleire A, van den Berk GE, Lauw FN, Claassen MAA, Posthouwer D, Bierman WF, Hullegie SJ, Popping S, van de Vijver DACM, Dofferhoff ASM, Kootstra GJ, Leyten EM, den Hollander J, van Kasteren ME, Soetekouw R, Ammerlaan HSM, Schinkel J, Florence E, Arends JE, Rijnders BJA. Treatment of acute hepatitis C genotypes 1 and 4 with 8 weeks of grazoprevir plus elbasvir (DAHHS2): an open-label, multicentre, single-arm, phase 3b trial. Lancet Gastroenterol Hepatol. 2019 Apr;4(4):269-277. doi: 10.1016/S2468-1253(18)30414-X. Epub 2019 Jan 17.
PMID: 30660617DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. B. J. A. Rijnders
- Organization
- Erasmus MC
Study Officials
- PRINCIPAL INVESTIGATOR
B Rijnders, PhD
Erasmus Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
November 5, 2015
First Posted
November 9, 2015
Study Start
February 1, 2016
Primary Completion
April 1, 2018
Study Completion
January 11, 2019
Last Updated
July 8, 2019
Results First Posted
July 8, 2019
Record last verified: 2019-04