Phase III Trial of BI 201335 (Faldaprevir) in Treatment Naive (TN) and Relapser Hepatitis C Virus (HCV)-Human Immunodeficiency Virus (HIV) Coinfected Patients (STARTverso 4)

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Hepatitis C, Chronic

Treatments: Drug: PegIFN/RBV; Drug: BI201335 24W; Drug: BI201335; Drug: Bi 201335

Study type: Interventional

Funder types: Industry

Identifiers

NCT01399619

2010-021734-59 (EudraCT Number)

1220.19

Details and patient eligibility

About

the aim of this trial is to evaluate the efficacy and the safety of BI 201335 given for 12 or 24 weeks in combination with PegIFN/RBV given for 24-48 weeks, according to re-randomisation of Early Treatment Success (ETS) patients at 24 weeks to stop PegIFN/RBV or continue PegIFN/RBV until week 48. If no ETS, then PegIFN/RB for 48 weeks, in HCV treatment-naive or relapsers patients coinfected with HIV

Enrollment: 310 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Chronic hepatitis C (HCV) genotype 1 infection
2. Chronic Human Immunodeficiency Virus (HIV) -1 infection
3. HCV treatment naive or HCV treatment experienced but only relapsers
4. Age 18 to 70 years
5. Antiretroviral treatment naive or on stable Highly Active Antiretroviral Therapy (HAART)
6. Karnofsky score >70
7. HCV viral load >1.000 IU/mL

Exclusion criteria

1. HCV infection of mixed genotype (1/2, 1/3, 1/4)
2. Evidence of acute or chronic liver due to chronic HCV infection
3. Hepatitis B virus (HBV) infection with presence of HBs-Ag
4. Active malignancy or history or malignancy within the last 5 years
5. Received concomitant systemic antiviral (other than antiretroviral), hematopoietic growth factor or immunomodulatory treatment in 28 days prior enrolment.
6. Decompensated liver disease,as evidenced by ascites, hepatic encephalopathy, esophageal variceal bleeding, and/or laboratory values that add up to >/= 7 points according tho the Child-Turcotte-Pugh classification
7. Hemoglobin </=11g/dL for women and </= 12 g/dL for men
8. Patients with stable cardiac disease and Hemoglobin <12g/dL
9. Known hypersensitivity to any ingredient of the study drugs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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310 participants in 3 patient groups

BI201335 12W

Experimental group

Description:

patient to receive two capsules of BI 201335 once a day for 12 weeks and pegIFN/RBV for 24 or 48 weeks

Treatment:

Drug: PegIFN/RBV

Drug: PegIFN/RBV

Drug: PegIFN/RBV

Drug: BI201335

BI 201335 24W

Experimental group

Description:

patient to receive two capsules of BI 201335 once a day for 24 weeks and PegIFN/RBV for 24 or 48 weeks

Treatment:

Drug: PegIFN/RBV

Drug: PegIFN/RBV

Drug: PegIFN/RBV

Drug: BI201335 24W

BI 201335 24 W

Experimental group

Description:

patient to receive one capsule of BI 201335 once a day for 24 weeks and pegIFN/RBV for 24 or 48 weeks

Treatment:

Drug: PegIFN/RBV

Drug: PegIFN/RBV

Drug: PegIFN/RBV

Drug: Bi 201335