Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Participants With Chronic HCV

Hepatitis C Virus Infection Clinical Trial

Official title:

A Phase 3, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks in Subjects With Chronic HCV

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02671500
• Other study ID #: GS-US-342-1518
• Status: Completed
• Phase: Phase 3
• Start date: April 19, 2016
• Est. completion date: March 27, 2018

Study information

• Verified date: December 2018
• 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 efficacy, safety, and tolerability of treatment with sofosbuvir (SOF)/velpatasvir (VEL; GS-5816) fixed-dose combination (FDC) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 375
• Est. completion date: March 27, 2018
• Est. primary completion date: January 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Willing and able to provide written informed consent

• HCV RNA = 10^4 IU/mL at screening

• Chronic HCV infection (= 6 months) documented by prior medical history or liver biopsy

• Any HCV genotype (1, 2, 3, 4, 5, 6 or indeterminate)

• HCV treatment-naive or treatment-experienced

• Liver imaging within 6 months of Day 1 is required in cirrhotic patients only to exclude hepatocellular carcinoma (HCC)

Key Exclusion Criteria:

• Current or prior history of clinically-significant illness (other than HCV), gastrointestinal disorder, clinical hepatic decompensation, or post-operative condition that could interfere with the absorption of the study drug

• Pregnant or nursing female or male with pregnant female partner

• Chronic liver disease of a non HCV etiology

• Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

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

Related Conditions & MeSH terms

• Hepatitis C
• Hepatitis C Virus Infection
• Virus Diseases

Intervention

Drug:
• SOF/VEL
SOF/VEL (400/100 mg) FDC tablet administered orally once daily

Locations

Country	Name	City	State
China	Beijing Friendship Hospital Affiliate of Capital Medical University	Beijing
China	Peking University First Hospital	Beijing
China	Peking University People's Hospital	Beijing
China	Xiangyan Hospital, Central South University	Changsha	Hunan
China	Beijing Ditan Hospital	Chaoyang	Beijing
China	West China Hospital, Sichuan University	Chengdu	Sichuan
China	The Second Affiliated Hospital of Chongqing Medical University	Chongqing
China	Guangzhou Eighth People's Hospital	Guangdong
China	Nanfang Hospital of Southern Medical University	Guangzhou	Guangdong
China	The Third Affiliated Hospital, Sun Yat-Sen University	Guangzhou	Guangdong
China	The People's Hospital of Hainan Province	Hainan
China	Shanghai Public Health Clinical Center	Hongkou	Shanghai
China	Shanghai Ruijin Hospital	Huangpu	Shanghai
China	The 2nd Xiangya Hospital of Central South University	Hunan
China	The Second Hospital of Nanjing	Jiangsu
China	The First Hospital of Jilin University	Jilin
China	Jinan Infectious Disease Hospital	Jinan
China	Shengjing Hospital of China Medical University	Liaoning
China	The First Affiliated Hospital of NanChang University	Nanchang
China	The First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi
China	Rui Jin Hospital Shanghai Jiao Tong University School of Medicine	Shanghai
China	Shanghai Renji Hospital	Shanghai
China	The 3rd Hospital of Hebei Medical University	Shijiazhuang
China	Tongji Hospital Affiliated to Tongji Medicine University	Wuhan	Hubei
China	Henan Province People's Hospital	Zhengzhou
Malaysia	University of Malaya	Kuala Lumpur
Malaysia	Hospital Tengku Ampuan Afzan	Pahang
Singapore	National University Hospital	Singapore
Singapore	Singapore General Hospital	Singapore
Thailand	Chulalongkorn Hospital	Bangkok
Thailand	Ramathibodi Hospital Mahidol University	Bangkok
Thailand	Siriraj Hospital	Bankok
Thailand	Maharaj Nakhon Chiangmai Hospital	Chiang Mai
Thailand	Songklanagarind Hospital	Songkla
Vietnam	Bach Mai Hospital	Hanoi
Vietnam	National Hospital for Tropical Disease	Hanoi
Vietnam	Ho Chi Minh City Hospital for Tropical Diseasees	Ho Chi Minh
Vietnam	People's Hospital 115	Ho Chi Minh City

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

China,  Malaysia,  Singapore,  Thailand,  Vietnam, 

References & Publications (2)

Lim SG, Rosmawati M, Phuong L, Hoi PT, McNabb BL, Lu S, et al. Safety and Efficacy of Sofosbuvir/Velpatasvir in a Genotype 1-6 HCV Infected Population from Singapore, Malaysia, Thailand, and Vietnam: Results from a Phase 3, Clinical Trial [Abstract 1094].

Wei L, Xie Q, Huang Y, Wu S, Xu M, Tang H, et al. Safety and Efficacy of Sofosbuvir/Velpatasvir in Genotype 1-6 HCV-Infected Patients in China: Results from a Phase 3 Clinical Trial. [Abstract 637]. Hepatology 2018; 68 (1 Suppl): 379A.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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; ie, 15 IU/mL) at 12 weeks after stopping study treatment.	Posttreatment Week 12
Primary	Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event		Up to 12 weeks
Secondary	Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)	SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.	Posttreatment Week 4
Secondary	Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)	SVR 24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.	Posttreatment Week 24
Secondary	Percentage of Participants With HCV RNA < LLOQ On Treatment		Weeks 1, 2, 4, 6, 8, 10, and 12
Secondary	Change From Baseline in HCV RNA		Baseline and up to Week 12
Secondary	Percentage of Participants With Overall Virologic Failure	Virologic failure was defined as: (1) 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) or (2) Virologic relapse: confirmed HCV RNA = LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.	Up to Posttreatment Week 24