Sofosbuvir/Velpatasvir Fixed-Dose Combination in Adults With Chronic HCV Infection and Child-Pugh Class B Cirrhosis

Browse trials for

• Infections 6,688
• Communicable Diseases 4,453
• Hepatitis C 2,321
• Hepatitis 3,381
• Fibrosis 3,256

Keywords

• Sofosbuvir
• Velpatasvir
• SOF/VEL
• GS-5816
• Hepatitis C
• HCV
• Cirrhosis
• CPT-B

Infections

6,688 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 268 is above the median of 120 across 4,201 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.

Study arms

• Experimental
  SOF/VEL 12 weeks

  Participants will receive SOF/VEL FDC for 12 weeks.

  Drug: SOF/VEL

• Experimental
  SOF/VEL+RBV 12 weeks

  Participants will receive SOF/VEL FDC plus RBV for 12 weeks.

  Drug: SOF/VEL · Drug: RBV

• Experimental
  SOF/VEL 24 weeks

  Participants will receive SOF/VEL FDC for 24 weeks.

  Drug: SOF/VEL

Interventions

• DrugSOF/VEL

  400/100 mg tablets administered orally once daily

  Also known as: GS-7977/GS-5816, Epclusa®

• DrugRBV

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

Primary outcomes

1. Percentage of Participants With Sustained Virologic Response (SVR) 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 Permanently Discontinued Any Study Drug Due to an Adverse Event

   Time frame: Up to 24 weeks plus 30 days

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 at 4 and 24 weeks following the last dose of study drug, respectively.

   Time frame: Posttreatment Weeks 4 and 24

2. Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24

   Time frame: Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24

3. Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24

   Time frame: Baseline; Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24

4. Percentage of Participants With Virologic Failure

   Virologic failure was defined as * On-treatment virologic failure * HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ, while on treatment, * \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, * 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

5. Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 24 in MELD Score

   Model for End-Stage Liver Disease (MELD) scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40; higher scores/increased scores indicate greater severity of disease.

   Time frame: Baseline to Posttreatment Week 24

6. Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 24 in Child-Pugh-Turcotte (CPT) Score

   CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15; higher scores/increased scores indicate greater severity of disease.

   Time frame: Baseline to Posttreatment Week 24

Baseline characteristics

Publications

• Charlton MR, O'Leary JG, Bzowej NH, Muir AJ, Korenblat KM, Fenkel JM, et al. Sofosbuvir/Velapatasvir Fixed Dose Combination for the Treatment of HCV in Patients with Decompensated Liver Disease: The Phase 3 ASTRAL-4 Study. Hepatology 2015; 62 (6): 1387A-1388A.
• Curry MP, O'Leary JG, Bzowej N, Muir AJ, Korenblat KM, Fenkel JM, Reddy KR, Lawitz E, Flamm SL, Schiano T, Teperman L, Fontana R, Schiff E, Fried M, Doehle B, An D, McNally J, Osinusi A, Brainard DM, McHutchison JG, Brown RS Jr, Charlton M; ASTRAL-4 Investigators. Sofosbuvir and Velpatasvir for HCV in Patients with Decompensated Cirrhosis. N Engl J Med. 2015 Dec 31;373(27):2618-28. doi: 10.1056/NEJMoa1512614. Epub 2015 Nov 16. PubMed 26569658 ↗
• Asselah T, Charlton M, Feld J, Foster GR, McNally J, Brainard DM, et al. The ASTRAL Studies: Evaluation of SOF/GS-5816 Single-Tablet Regimen for the Treatment of Genotype 1-6 HCV Infection [Poster P1332]. J Hepatol 2015; 62:S855-S6.
• Younossi ZM, Stepanova M, Charlton M, Curry MP, O'Leary JG, Brown RS, Hunt S. Patient-reported outcomes with sofosbuvir and velpatasvir with or without ribavirin for hepatitis C virus-related decompensated cirrhosis: an exploratory analysis from the randomised, open-label ASTRAL-4 phase 3 trial. Lancet Gastroenterol Hepatol. 2016 Oct;1(2):122-132. doi: 10.1016/S2468-1253(16)30009-7. Epub 2016 Aug 3. PubMed 28404069 ↗
• Younossi ZM, Stepanova M, Feld J, Zeuzem S, Sulkowski M, Foster GR, Mangia A, Charlton M, O'Leary JG, Curry MP, Nader F, Henry L, Hunt S. Sofosbuvir and Velpatasvir Combination Improves Patient-reported Outcomes for Patients With HCV Infection, Without or With Compensated or Decompensated Cirrhosis. Clin Gastroenterol Hepatol. 2017 Mar;15(3):421-430.e6. doi: 10.1016/j.cgh.2016.10.037. Epub 2016 Nov 12. PubMed 27847279 ↗

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