Dutch Acute HCV in HIV Study (DAHHS)

Phase 2

Completed

• Conditions: Human Immunodeficiency Virus; Hepatitis C
• Interventions: Drug: Boceprevir

• Registration Number: NCT01912495
• Lead Sponsor: Erasmus Medical Center

Brief Summary

Prospective open label proof of concept feasibility interventional clinical trial in which 60 acute HCV genotype 1 patients co-infected with HIV will receive 12 weeks of boceprevir in addition to Standard Of Care Peginterferon + Ribavirin if they show a Rapid Viral Responds at week 4.

The primary hypothesis of this study is that the subset of patients with a Rapid Viral Responds after 4 weeks of triple therapy with boceprevir, peginterferon alpha-2b (P) and ribavirin (RVR4) can be successfully treated with a shorter 12-week triple therapy regimen.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-29
• Study First Submitted QC: 2013-07-29
• Study First Posted: 2013-07-31
• Study Start: 2013-08
• Primary Completion: 2015-08
• Results First Submitted: 2015-12-07
• Study Completion: 2016-01
• Status Verified: 2016-03
• Results First Submitted QC: 2016-03-02
• Last Update Submitted: 2016-03-02
• Results First Posted: 2016-04-01
• Last Update Posted: 2016-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

1. Documented recent HCV genotype 1 infection (≤26 weeks old at the time of the baseline visit) according to definition mentioned below.
2. Plan to start a Standard Of Care therapy for acute HCV consisting of 24 weeks of Peginterferon + Ribavirin. HCV RNA plasma viral load at screening >1000 IU/ml.
3. A previously performed HCV RNA plasma measurement can be used for screening if <4 weeks old.
4. On HAART at the time of screening.
5. Minimum age 18 years.

Exclusion Criteria

1. Disallowed co-medication that cannot be stopped or replaced: Several potentially life-threatening drug-drug interactions (DDI) are possible when boceprevir is combined with other drugs. Therefore ALL co-medication, including over-the-counter drugs should be checked for potential DDI with DDI table in the Dutch summary of product characteristics (SPC, appendix A). If the co-medication is not mentioned in the SPC DDI table, www.HCV-druginteractions.org should be used.
2. Contraindications for the use of full dose of peginterferon alpha-2b or ribavirin: neutrophils <0,75×109/l or thrombocytes < 100.000×109/l or a Hb <6.2mmol/L, creatinine clearance <50ml/min).
3. History of liver cirrhosis or >F1 fibrosis on fibroscan. Inclusion of patients with a chronic well-controlled HBV (HBV-DNA below the limit of detection) with tenofovir, lamivudine or emtricitabine therapy is allowed if fibroscan excludes >F1 fibrosis. Fibroscan reports <2 years old can be used for screening. Fibroscan is not required for other patients at screening.
4. HAART was started <4 weeks before baseline visit.
5. Inability to switch to a HAART regimen consisting of 2 nucleoside/tide reverse transcriptase inhibitors + Raltegravir (Isentress®) 400mg BID or rilpivirine 25mg QD or atazanavir (Reyataz®) 300mg QD + ritonavir (Norvir®) 100mg QD.
6. Patient that virologically failed HAART in the past

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Boceprevir, peginterferon ribavirin	Boceprevir	All patients were intended to be treated in the 12 week peginterferon, ribavirin and boceprevir arm.

Primary Outcome Measures

Name	Time	Method
Sustained Viral Response(SVR) 12 Weeks of Follow up After the End of All Therapy for the Rapid Viral Response at Week 4(RVR4) Population.	12 weeks	The outcome is a number of the patients with an undetectable Hepatitis C Virus (HCV) RNA at week 4 that have an undetectable HCV RNA 12 weeks after end of treatment.

Secondary Outcome Measures

Name	Time	Method
Alterations of Biomarkers by Therapy Induced Viral Eradication: Viral Sequencing, Mutation Analysis, Gene Expression Analysis, and RNA Analysis.	72 weeks
SVR 12 Weeks After the End of All Therapy in the Entire Study Population (With or Without RVR4).	12 weeks	The outcome is a number of all patients who started treatment having an undetectable HCV RNA 12 weeks after the end of therapy
SVR 12 Weeks After End of Therapy in Patients That Started Therapy ≤12weeks After the Presumed HCV Infection Date Versus Those After 12 Weeks.	12 weeks	The number of patients having a undetectable HCV RNA 12 weeks after the end of treatment in the group patients that was treated within 12 week of calculated transmission date.
Safety: Treatment Related (Serious) Adverse Events ((S)AE) and Treatment Discontinuation for (S)AE.	72 weeks	only serious adverse events are recorded in this secondary endpoint
SVR 12 Weeks After End of Therapy in Patients With Already a RVR at Week 1.	12 weeks	The number of patients who were undetectable for HCV at week one that had an undetectable HCV RNA load 12 weeks after the end of treatment

Trial Locations

Locations (9)

Erasmus MC; 🇳🇱 Rotterdam, Zuid Holland, Netherlands

OLVG; 🇳🇱 Amsterdam, Netherlands

Ziekenhuis Rijnstate; 🇳🇱 Arnhem, Netherlands

UMCG; 🇳🇱 Groningen, Netherlands

MUMC; 🇳🇱 Maastricht, Netherlands

UMCU; 🇳🇱 Utrecht, Netherlands

Slotervaart; 🇳🇱 Amsterdam, Netherlands

Radboud UMCN; 🇳🇱 Nijmegen, Netherlands

AMC; 🇳🇱 Amsterdam, Netherlands