A Phase 3 Study to Evaluate Combination Therapy With Daclatasvir and Sofosbuvir in the Treatment of HIV and Hepatitis C Virus Coinfection.

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Hepatitis C

Treatments: Drug: Daclatasvir; Drug: Sofosbuvir

Study type: Interventional

Funder types: Industry

Identifiers

NCT02032888

AI444-216

Details and patient eligibility

About

A study of the efficacy and safety of the combination of daclatasvir and sofosbuvir in the treatment of hepatitis C virus and HIV coinfection.

Enrollment: 238 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Key Inclusion Criteria:

• Patients must be able to understand and agree to/comply with the prescribed dosing regimens and procedures, report for regularly scheduled study visits, and reliably communicate with study personnel about adverse events and concomitant medications
• Patients chronically infected with hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6, as documented by positive HCV RNA at screening
• Patients who are HCV treatment-naive
• Patients who are HCV treatment-experienced and who have had prior anti-HCV therapies discontinued or completed at least 12 weeks prior to screening
• Patients with HCV RNA ≥10,000 IU/mL at screening
• Patients with HIV-1 infection

Key Exclusion Criteria:

• Presence of AIDs-defining opportunistic infections, as defined by the Centers of Disease Control and Prevention, within 12 weeks prior to study entry
• Patients infected with HIV-2
• Liver or any other organ transplant (including hematopoietic stem cell transplants) other than cornea and hair
• Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to screening
• Documented or suspected hepatocellular carcinoma, as evidenced by previously obtained imaging studies or liver biopsy (or on a screening imaging study/liver biopsy if this was performed
• Evidence of decompensated liver disease, including radiologic criteria, a history or presence of ascites, bleeding varices, or hepatic encephalopathy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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238 participants in 3 patient groups

Daclatasvir + Sofosbuvir (Treatment-naive) 12 weeks

Experimental group

Description:

Treatment-naïve participants received daclatasvir 30, 60, or 90 mg, and sofosbuvir, 400 mg, once daily for 12 weeks

Treatment:

Drug: Sofosbuvir

Drug: Daclatasvir

Daclatasvir + Sofosbuvir (Treatment-naive) 8 weeks

Experimental group

Description:

Treatment-naïve participants received daclatasvir, 30, 60, or 90 mg, and sofosbuvir, 400 mg, once daily for 8 weeks

Treatment:

Drug: Sofosbuvir

Drug: Daclatasvir

Daclatasvir + Sofosbuvir (Treatment-experienced) 12 weeks

Experimental group

Description:

Treatment-experienced participants received daclatasvir, 30, 60, or 90 mg, and sofosbuvir, 400 mg, once daily for 12 weeks

Treatment:

Drug: Sofosbuvir

Drug: Daclatasvir