Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination, With or Without Ribavirin, in Egyptian Adults With Chronic Genotype 4 HCV Infection

Browse trials for

• Infections 6,687
• Communicable Diseases 4,452
• Hepatitis C 2,321
• Hepatitis 3,380

Keywords

• HCV genotype 4 (GT-4)
• HCV
• Sustained Virologic Response
• Direct Acting Antiviral
• Combination Therapy
• GS-7977
• GS-5885
• Ribavirin
• Sofosbuvir
• ledipasvir
• Hepatitis C
• Hepatitis C, Chronic
• Liver Diseases
• Virus Diseases
• Antiviral Agents

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 255 is above the median of 120 across 4,200 interventional studies indexed under Infections.

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.

Eligibility criteria

Study arms

• Experimental
  LDV/SOF 8 wk TN (Cohort 1, Group 1)

  LDV/SOF for 8 weeks (treatment-naive (TN))

  Drug: LDV/SOF

• Experimental
  LDV/SOF+RBV 8 wk TN (Cohort 1, Group 2)

  LDV/SOF+RBV for 8 weeks (treatment-naive)

  Drug: LDV/SOF · Drug: RBV

• Experimental
  LDV/SOF 12 wk TN (Cohort 1, Group 3)

  LDV/SOF for 12 weeks (treatment-naive)

  Drug: LDV/SOF

• Experimental
  LDV/SOF+RBV 12 wk TN (Cohort 1, Group 4)

  LDV/SOF+RBV for 12 weeks (treatment-naive)

  Drug: LDV/SOF · Drug: RBV

• Experimental
  LDV/SOF+RBV 12 wk TE (Cohort 2)

  Treatment-experienced (TE) participants who completed treatment in Gilead sponsored study GS-US-334-0138 or in Cohort 1 of this study and did not achieve SVR12 will receive LDV/SOF+RBV for 12 weeks.

  Drug: LDV/SOF · Drug: RBV

• Experimental
  LDV/SOF 12 wk TE (Cohort 3, Group 1)

  LDV/SOF for 12 weeks (treatment-experienced)

  Drug: LDV/SOF

• Experimental
  LDV/SOF+RBV 12 wk TE (Cohort 3, Group 2)

  LDV/SOF+RBV for 12 weeks (treatment-experienced)

  Drug: LDV/SOF · Drug: RBV

Interventions

• DrugLDV/SOF

  90/400 mg FDC tablet administered orally once daily

  Also known as: Harvoni®, GS-5885/GS-7977

• DrugRBV

  Tablets administered orally in a divided daily dose based on weight (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

Primary outcomes

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

   SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.

   Time frame: Posttreatment Week 12

2. Percentage of Participants Who Discontinued LDV/SOF Drug Due to an Adverse Event (AE)

   Time frame: 12 weeks

Secondary outcomes

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

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

   Time frame: Posttreatment Weeks 4 and 24

2. Percentage of Participants With Overall Virologic Failure

   Virologic failure was defined as * On-treatment virologic failure * confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ, while on treatment (ie, breakthrough), * confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment (ie, rebound), * HCV RNA persistently ≥ LLOQ through 8 weeks of treatment (ie, nonresponse) * Relapse * HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement

   Time frame: Up to Posttreatment Week 24

Baseline characteristics

Publications

• Shiha G, Waked I, Soliman R, Abdelrazek W, Hassany M, Fouad R, et al. Ledipasvir/sofosbuvir for 8 or 12 weeks with or without ribavirin in HCV genotype 4 patients in Egypt. [Abstract OP158]. Asian Pacific Association for the Study of the Liver (APASL); 2017 15-19 February; Shanghai, China
• Shiha G, Esmat G, Hassany M, Soliman R, Elbasiony M, Fouad R, Elsharkawy A, Hammad R, Abdel-Razek W, Zakareya T, Kersey K, Massetto B, Osinusi A, Lu S, Brainard DM, McHutchison JG, Waked I, Doss W. Ledipasvir/sofosbuvir with or without ribavirin for 8 or 12 weeks for the treatment of HCV genotype 4 infection: results from a randomised phase III study in Egypt. Gut. 2019 Apr;68(4):721-728. doi: 10.1136/gutjnl-2017-315906. Epub 2018 Apr 17. PubMed 29666174 ↗

Individual participant data

Plan to share: Yes — Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.

Supporting information: Study protocol, Sap