A Phase 3 Study to Evaluate Combination Therapy With Daclatasvir and Sofosbuvir in the Treatment of HIV and Hepatitis C Virus Coinfection.
A Phase 3 Study to Evaluate Combination Therapy With Daclatasvir and Sofosbuvir in the Treatment of HIV and Hepatitis C Virus Coinfection.
A study of the efficacy and safety of the combination of daclatasvir and sofosbuvir in the
 treatment of hepatitis C virus and HIV coinfection.
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