Safety and Efficacy of SOF/VEL/VOX FDC for 12 Weeks and SOF/VEL for 12 Weeks in DAA-Experienced Adults With Chronic HCV Infection Who Have Not Received an NS5A Inhibitor

Browse trials for

• Hepatitis C 2,356
• Bronchiolitis Obliterans Syndrome 389

Keywords

• Chronic

Hepatitis C

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

This study's enrollment of 333 is above 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.

Eligibility criteria

Study arms

• Experimental
  SOF/VEL/VOX

  SOF/VEL/VOX for 12 weeks

  Drug: SOF/VEL/VOX

• Experimental
  SOF/VEL

  SOF/VEL for 12 weeks

  Drug: SOF/VEL

Interventions

• DrugSOF/VEL/VOX

  400/100/100 mg FDC tablet administered orally once daily with food

  Also known as: Vosevi®, GS-7977/GS-5816/GS-9857

• DrugSOF/VEL

  Drug pages: Sofosbuvir · Velpatasvir

  400/100 mg FDC tablet administered orally once daily without regard to food

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

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) at 12 weeks after stopping study treatment.

   Time frame: Posttreatment Week 12

2. Percentage of Participants Who Permanently Discontinue Study Drug Due to an Adverse Event

   Time frame: Up to 12 weeks

Secondary outcomes

1. Percentage of Participants With SVR 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 after stopping study treatment, respectively.

   Time frame: Posttreatment Weeks 4 and 24

2. Percentage of Participants With HCV RNA < LLOQ On Treatment

   Time frame: Weeks 1, 2, 4, 8 and 12

3. Change From Baseline in HCV RNA

   Time frame: Weeks 1, 2, 4, 8, and 12

4. Percentage of Participants With Virologic Failure

   * On-treatment virologic failure: * Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while on treatment), or * Rebound (confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or * Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment) * Virologic relapse: * Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at last on-treatment visit.

   Time frame: Up to Posttreatment Week 24

Baseline characteristics

Publications

• Bourliere M, Gordon SC, Flamm SL, Cooper CL, Ramji A, Tong M, Ravendhran N, Vierling JM, Tran TT, Pianko S, Bansal MB, de Ledinghen V, Hyland RH, Stamm LM, Dvory-Sobol H, Svarovskaia E, Zhang J, Huang KC, Subramanian GM, Brainard DM, McHutchison JG, Verna EC, Buggisch P, Landis CS, Younes ZH, Curry MP, Strasser SI, Schiff ER, Reddy KR, Manns MP, Kowdley KV, Zeuzem S; POLARIS-1 and POLARIS-4 Investigators. Sofosbuvir, Velpatasvir, and Voxilaprevir for Previously Treated HCV Infection. N Engl J Med. 2017 Jun 1;376(22):2134-2146. doi: 10.1056/NEJMoa1613512. PubMed 28564569 ↗

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 https://www.gilead.com/about/ethics-and-code-of-conduct/policies.

Supporting information: Study protocol, Statistical analysis plan

Time frame: 18 months after study completion

Access criteria: A secured external environment with username, password, and RSA code.

Data sharing details ↗ · www.gilead.com