Sofosbuvir/Velpatasvir/Voxilaprevir Salvage Therapy in Hepatitis C Patients Who Relapsed After DAA Treatment

NCT07565948 | Active Not Recruiting

• 1 other identifier: xiangya HCV project
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This multicenter study evaluates the effectiveness and safety of a 12-week regimen of sofosbuvir/velpatasvir/voxilaprevir in patients with chronic hepatitis C who relapsed after prior direct-acting antiviral therapy. The study assesses the rate of sustained virologic response after treatment, along with changes in liver function and overall safety. It also explores whether clinical factors such as liver cirrhosis, viral genotype, and the use of ribavirin influence treatment outcomes, aiming to better define this regimen as a salvage therapy option.

Conditions

Hepatitis C Virus (HCV)

Keywords

Hepatitis C Virus (HCV)

Outcome Measures

Primary Outcomes (1)

• Sustained Virologic Response at 12 Weeks After Treatment (SVR12)

  Proportion of participants with undetectable HCV RNA 12 weeks after completion of treatment.

  12 weeks after end of treatment

Secondary Outcomes (3)

• On-Treatment Virologic Response

  During treatment (Week 4 and Week 12)

• Normalization of Liver Enzymes

  Baseline to Week 12 of treatment

• Incidence of Adverse Events

  From treatment initiation to 12 weeks after end of treatment

Study Arms (1)

Hepatitis C salvage therapy group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients between the age of 18-75, who have confirmed chronic hepatitis C virus (HCV) infection and experienced virologic relapse after prior direct-acting antiviral (DAA) therapy, with detectable HCV RNA at enrollment, and who received a 12-week regimen of sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) as salvage treatment.

You may qualify if:

• Age ≥18 years at the time of enrollment
• Confirmed chronic hepatitis C virus (HCV) infection
• Documented virologic relapse after prior direct-acting antiviral (DAA) therapy
• Detectable HCV RNA at screening
• Received or planned to receive a 12-week regimen of sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) as salvage therapy
• Willing and able to provide written informed consent

You may not qualify if:

• Pregnant or breastfeeding women
• Participation in another interventional clinical study during the study period

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead

Study Sites (1)

Xiangya Hospital of Central South University

Changsha, Hunan, 410000, China

Location

Related Publications (2)

• Papaluca T, Roberts SK, Strasser SI, Stuart KA, Farrell G, MacQuillan G, Dore GJ, Wade AJ, George J, Hazeldine S, O'Beirne J, Wigg A, Fisher L, McGarity B, Sawhney R, Sinclair M, Thomas J, Valiozis I, Weltman M, Wilson M, Woodward A, Ahlenstiel G, Haque M, Levy M, Prewett E, Sievert W, Sood S, Tse E, Valaydon Z, Bowden S, Douglas M, New K, O'Keefe J, Hellard M, Doyle J, Stoove M, Thompson AJ. Efficacy and Safety of Sofosbuvir/Velpatasvir/Voxilaprevir for Hepatitis C Virus (HCV) NS5A-Inhibitor Experienced Patients With Difficult to Cure Characteristics. Clin Infect Dis. 2021 Nov 2;73(9):e3288-e3295. doi: 10.1093/cid/ciaa1318.

  PMID: 32887983 BACKGROUND

• Llaneras J, Riveiro-Barciela M, Lens S, Diago M, Cachero A, Garcia-Samaniego J, Conde I, Arencibia A, Arenas J, Gea F, Torras X, Luis Calleja J, Antonio Carrion J, Fernandez I, Maria Morillas R, Rosales JM, Carmona I, Fernandez-Rodriguez C, Hernandez-Guerra M, Llerena S, Bernal V, Turnes J, Gonzalez-Santiago JM, Montoliu S, Figueruela B, Badia E, Delgado M, Fernandez-Bermejo M, Inarrairaegui M, Pascasio JM, Esteban R, Marino Z, Buti M. Effectiveness and safety of sofosbuvir/velpatasvir/voxilaprevir in patients with chronic hepatitis C previously treated with DAAs. J Hepatol. 2019 Oct;71(4):666-672. doi: 10.1016/j.jhep.2019.06.002. Epub 2019 Jun 14.

  PMID: 31203153 BACKGROUND

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Huang Yan, Professor

  Xiangya Hospital of Central South University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: May 4, 2026
• Study Start: January 1, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

CN (1)