Rapid Hepatitis C Elimination Trial- A Pilot Study of Daclatasvir/Asunaprevir/BMS-791325 With or Without Ribavirin To Treat Hepatitis C Virus (RHACE 1)

Timothy Morgan, MD

Status: Completed

Conditions: Hepatitis C

Treatments: Drug: DCV/ASV/BMS-791325 + RBV; Drug: DCV/ASV/BMS-791325

Study type: Interventional

Funder types: Other; Industry; Other U.S. Federal agency; NIH

Identifiers

NCT02098616

IRB #1285

AI443-128 (Other Grant/Funding Number)

Details and patient eligibility

About

The purpose of this study is to determine whether treatment with Daclatasvir/Asunaprevir/BMS-791325, with or without ribavirin, for 8, 6, or 4 weeks is feasible for the treatment of genotype 1a chronic hepatitis C in patients without cirrhosis.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects chronically infected with HCV genotype 1a
• HCV RNA ≥ 10,000 IU/mL at screening
• Treatment-naïve subjects with no previous exposure to an interferon formulation (ie, IFNα, pegIFNα), ribavirin (RBV), or HCV direct acting antiviral (DAA; protease, polymerase inhibitor, etc.)

Exclusion criteria

• Evidence of cirrhosis
• Liver or any other organ transplant
• Current or known history of cancer within 5 years prior to enrollment
• Documented or suspected hepatocellular carcinoma (HCC)
• Not eligible for sofosbuvir + pegylated interferon + ribavirin therapy

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 6 patient groups

Arm 1

Experimental group

Description:

Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 8 weeks

Treatment:

Drug: DCV/ASV/BMS-791325

Arm 2

Experimental group

Description:

Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 6, 8 or 12 weeks

Treatment:

Drug: DCV/ASV/BMS-791325

Arm 3

Experimental group

Description:

Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 4 weeks

Treatment:

Drug: DCV/ASV/BMS-791325

Arm A

Experimental group

Description:

Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day plus weight based ribavirin orally twice a day for 8 weeks

Treatment:

Drug: DCV/ASV/BMS-791325 + RBV

Arm B

Experimental group

Description:

Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day plus weight based ribavirin orally twice a day for 6, 8 or 12 weeks

Treatment:

Drug: DCV/ASV/BMS-791325 + RBV

Arm C

Experimental group

Description:

Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day plus weight based ribavirin orally twice a day for 4 weeks

Treatment:

Drug: DCV/ASV/BMS-791325 + RBV