Sofosbuvir Plus Ribavirin in Treatment-Naive and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 Hepatitis C Virus (HCV) Infection

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• Hepatitis C 2,356

Hepatitis C

2,356 studies on the registry are indexed under Hepatitis C; 101 are open to participants now.

This study's enrollment of 60 is below the median of 79 across 1,660 interventional studies indexed under Hepatitis C.

Lead sponsor

Gilead Sciences is the lead sponsor of 689 studies on the registry; 24 are open to participants now.

Of its 261 completed or terminated interventional studies of FDA-regulated products, 251 (96%) have results posted.

Study arms

• Experimental
  SOF+RBV 12 Weeks

  Treatment-naive and treatment-experienced participants will receive SOF+RBV for 12 weeks.

  Drug: SOF · Drug: RBV

• Experimental
  SOF+RBV 24 Weeks

  Treatment-naive and treatment-experienced participants will receive SOF+RBV for 24 weeks.

  Drug: SOF · Drug: RBV

Interventions

• DrugSOF

  Sofosbuvir (SOF) 400 mg tablet administered orally once daily

  Also known as: GS-7977, PSI-7977, Sovaldi®

• DrugRBV

  Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)

Primary outcomes

1. Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)

   SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.

   Time frame: Posttreatment Week 12

2. Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)

   The percentage of participants discontinuing any study drug due to an adverse event was summarized.

   Time frame: Up to 24 weeks

Secondary outcomes

1. Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

   SVR4 and SVR24 were defined as HCV RNA \< LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.

   Time frame: Posttreatment Weeks 4 and 24

2. Percentage of Participants Experiencing On-treatment Virologic Failure

   On-treatment virologic failure was defined as: 1. Viral breakthrough: HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or 2. Viral rebound: \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or 3. Nonresponse: HCV RNA persistently ≥ LLOQ through 8 weeks of treatment

   Time frame: Up to 24 weeks

3. Percentage of Participants Experiencing Viral Relapse

   Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA \< LLOQ) at end of treatment, but did not achieve an SVR.

   Time frame: Up to Posttreatment Week 24

Baseline characteristics