Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir (SOF/VEL) Fixed-Dose Combination (FDC) and Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX ) FDC for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) Infection

Hepatitis C Virus Infection Clinical Trial

Official title:

A Phase 3b Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination and Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic HCV Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04211909
• Other study ID #: GS-US-342-5532
• Status: Completed
• Phase: Phase 3
• Start date: January 3, 2020
• Est. completion date: November 12, 2020

Study information

• Verified date: September 2021
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of therapy with Sofosbuvir/Velpatasvir (SOF/VEL) Fixed-Dose Combination (FDC) and Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX ) FDC in participants with chronic HCV infection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: November 12, 2020
• Est. primary completion date: November 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Key Inclusion Criteria:

• Chronic HCV infected males and non-pregnant/non-lactating females

• Treatment-naive or treatment-experienced individuals

• Non-cirrhosis or compensated cirrhosis at screening

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Related Conditions & MeSH terms

• Communicable Diseases
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Virus Infection
• Infections

Intervention

Drug:
• SOF/VEL
400/100 mg FDC tablet orally once daily.
• SOF/VEL/VOX
400/100/100 mg FDC tablet orally once daily.

Locations

Country	Name	City	State
Korea, Republic of	Dong-A University Hospital	Busan
Korea, Republic of	Inje University Busan Paik Hospital	Busan
Korea, Republic of	Pusan National University Hospital	Busan
Korea, Republic of	Keimyung University Dongsan Hospital	Daegu
Korea, Republic of	Kyungpook National University Hospital	Daegu
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	Chosun University Hospital	Gwangju
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	The Catholic University of Korea, Incheon St. Mary's Hospital	Incheon
Korea, Republic of	Chonbuk National University Hospital	Jeonju
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-D
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Chung-Ang University Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul
Korea, Republic of	SMG-SNU Boramae Medical Center	Seoul
Korea, Republic of	The Catholic University of Korea, Seoul Saint Mary's Hospital	Seoul
Korea, Republic of	VHS (Veterans Health Service) Medical Center	Seoul
Korea, Republic of	Ulsan University Hospital	Ulsan
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Sustained Virologic Response (SVR) < Lower Limit of Quantification (LLOQ) 12 Weeks After Discontinuation of Study Treatment	SVR12 was defined as HCV RNA < LLOQ (i.e., 15 IU/mL) at 12 weeks after stopping study treatment.	Posttreatment Week 12
Primary	Percentage of Participants Who Permanently Discontinued the Study Drug Due to an Adverse Event		First dose date up to 12 weeks plus 30 days
Secondary	Percentage of Participants With SVR < LLOQ 4 Weeks After Discontinuation of Study Treatment	SVR4 was defined as HCV RNA < LLOQ (i.e.15 IU/mL) 4 weeks after stopping study treatment.	Posttreatment Week 4
Secondary	Percentage of Participants With Virologic Failure	Virologic failure was defined as: On-treatment virologic failure: Breakthrough (HCV RNA = LLOQ after having previously had HCV RNA < LLOQ, while on treatment, confirmed with 2 consecutive values), 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	Baseline up to Posttreatment Week 12
Secondary	Percentage of Participants With HCV RNA < LLOQ on Treatment	LLOQ was 15 IU/mL.	Week 2, Week 4, Week 8, Week 12
Secondary	Change From Baseline in HCV RNA		Baseline, Week 2, Week 4, Week 8, Week 12
Secondary	Number of Participants With Alanine Aminotransferase (ALT) Normalization	Number of participants with ALT normalization, defined as ALT > upper limit of normal (ULN) (ULN = 43 U/L) at baseline and ALT = ULN, at each visit was presented.	Baseline, Week 2, Week 4, Week 8, Week 12