GS-5885, GS-9451, Tegobuvir and Ribovirin in Treatment-Experienced Subjects With Chronic Genotype 1a Or 1b Hepatitis C Virus (HCV) Infection

Browse trials for

• Hepatitis A 2,710
• Hepatitis C 2,321
• Hepatitis C, Chronic 1,073
• Hepatitis 3,381

Keywords

• Hepatitis C
• HCV
• Rapid Virologic Response
• Sustained Virologic Response
• Direct Acting Antiviral
• Combination Therapy
• Tegobuvir
• Treatment Experienced
• HCV RNA
• Polymerase inhibitor
• Protease inhibitor
• Interferon intolerant
• Interferon ineligible
• GS-9190
• GS-9451
• GS-5885
• Chronic Genotype 1a or 1b

Hepatitis A

2,710 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 170 is above the median of 100 across 1,887 interventional studies indexed under Hepatitis A.

Lead sponsor

Gilead Sciences is the lead sponsor of 680 studies on the registry; 24 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 249 (96%) have results posted.

Study arms

• Active comparator
  Arm 1

  GS-5885 90 mg QD + GS-9451 200 mg QD + tegobuvir 30 mg BID + RBV BID

  Drug: GS-5885 · Drug: GS-9451 · Drug: tegobuvir · Drug: Ribavirin

• Active comparator
  Arm 2

  GS-5885 90 mg QD + GS-9451 200 mg QD + tegobuvir 30 mg BID + RBV placebo BID

  Drug: GS-5885 · Drug: GS-9451 · Drug: tegobuvir · Drug: placebo to match RBV

• Active comparator
  Arm 3

  GS-5885 90 mg QD + GS-9451 200 mg QD + tegobuvir placebo BID + RBV BID

  Drug: GS-5885 · Drug: GS-9451 · Drug: placebo to match tegobuvir · Drug: Ribavirin

Interventions

• DrugGS-5885

  Drug: GS-5885 tablet GS-5885 tablet, 90 mg, QD

• DrugGS-9451

  Drug: GS-9451 tablet GS-9451 tablet, 200 mg QD

• Drugtegobuvir

  tegobuvir 30 mg BID

• Drugplacebo to match tegobuvir

  tegobuvir placebo BID

• Drugplacebo to match RBV

  Ribovirin placebo BID

• DrugRibavirin

  Ribavirin (Copegus®) BID (1000 mg for subjects weighing \< 75 kg and 1200 mg for subjects weighing ≥ 75 kg) divided BID

Primary outcomes

1. Safety and Tolerability

   To evaluate safety and tolerability of combination therapy with GS-5885, GS-9451, tegobuvir and ribavirin or GS-5885, GS-9451 and tegobuvir or GS-5885, GS-9451 and ribavirin. Safety will be assessed during the study through the reporting of adverse events, clinical laboratory tests, physical examinations, vital signs and 12-lead ECGs at various time points during the study.

   Time frame: 24 weeks

2. Antiviral Activity

   To evaluate the antiviral efficacy as measured by sustained virologic response (SVR, defined as HCV RNA \< lower limit of quantitation \[LLoQ\] 24 weeks post-treatment) of combination therapy with GS-5885, GS-9451, tegobuvir and RBV compared with GS-5885, GS-9451 and tegobuvir or GS-5885, GS-9451 and RBV in treatment-experienced subjects with chronic genotype 1a or 1b HCV infection

   Time frame: 24 weeks

Secondary outcomes

1. Viral Dynamics

   To characterize the viral dynamics of GS-5885, GS-9451 and tegobuvir. The median change from baseline in HCV RNA and time-weighted average change from baseline through Day 10 will be assessed based on plasma HCV RNA sampling times to characterize the viral dynamics of GS-5885, GS-9451 and tegobuvir.

   Time frame: 10 days

2. Composite (or Profile) of Pharmacokinetics Composite (or Profile) of Pharmacokinetics

   To characterize the steady state pharmacokinetics of GS-5885, GS-9451, tegobuvir and ribavirin (if appropriate). Cmax, Tmax, Clast, Tlast, Ctau, λz, AUCtau and T ½

   Time frame: predose, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose

3. Antiviral Efficacy

   To evaluate the antiviral efficacy (as defined by SVR) of adding pegylated interferon alfa-2a (PEG) and RBV (Arm 2 only) for 24-48 weeks to the original treatment regimen in subjects who experience viral breakthrough or relapse and enter the Rescue Therapy Substudy

   Time frame: 24-48 weeks