Phase 3
Completed N=80
Dutch Acute HCV in HIV Study (DAHHS-2): Grazoprevir/Elbasvir for Acute HCV
Source: ClinicalTrials.gov NCT02600325 ↗Enrolled (actual)
80
Serious AEs
2.5%
Results posted
Jul 2019
Primary outcomePrimary: SVR12 (Reinfection Not Considered Failure) — 79 participants
◆ Published Evidence
Established
43citations · ~6 / year
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.
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).
Linked Publications (2)
-
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.
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Persistent Transmission of HCV among Men Who Have Sex with Men despite Widespread Screening and Treatment with Direct-Acting Antivirals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY SVR12 (Reinfection Not Considered Failure) |
79 | — |
| SECONDARY SVR12 (Reinfection Equals Failure) |
75 | — |
Eligibility Criteria
Inclusion Criteria
- HIV positive
- Acute HCV genotype 1 or 4 infection (≤26 weeks old at the baseline visit)
Exclusion Criteria
- Not on cART and a CD4 6 months with a HIV viral load >400 copies
- Disallowed co-medication that cannot be stopped or replaced
- History of liver cirrhosis of any etiology. Inclusion of patients with a chronic well-controlled HBV (HBV-DNA F1 fibrosis
- 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.
Data sourced from ClinicalTrials.gov (NCT02600325) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.