Grazoprevir + Elbasvir for the treatment of acute hepatitis C genotype 1/4.The Dutch Acute HCV in HIV Study (DAHHS-2)

• Conditions: Acute Hepatitis C in HIV infected patients; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2015-003210-24-BE
• Lead Sponsor: Erasmus MC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-10
• Last Update Posted: 14 March 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. HIV positive
2. Acute HCV genotype 1 or 4 infection (=26 weeks old at the baseline
visit) according to definition mentioned above
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Not on cART and a CD4 <500 at the time of screening
2. Patients on cART for >6 months with a HIV viral load >400 copies
3. Disallowed co-medication that cannot be stopped or replaced:
Therefore ALL co-medication, including over-the-counter drugs should
be checked for potential drug-drug interactions using the investigators
brochure (appendix A). In particular, care should be taken for patients
that are taking >10mg atorvastatin or >5mg rosuvastatin per day and
the dose should be reduced to the lowest dose available (10mg for
atorvastatin and 5 for rosuvastatin). Alternatively a switch to
pravastatin may be preferred. When in doubt about drug-drug
interactions, contact the coordinating investigator.
4. History of liver cirrhosis of any etiology. Inclusion of patients with a
chronic well-controlled HBV (HBV-DNA allowed if fibroscan excludes >F1 fibrosis. Fibroscan reports <5 years
old can be used for screening.
5. 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified