search
Back to results

Safety and Efficacy of Sofosbuvir + Velpatasvir With or Without Ribavirin in Treatment-Naive Adults With Chronic HCV Infection

Primary Purpose

Hepatitis C

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SOF
VEL
RBV
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C focused on measuring Hepatitis, HCV Genotype 1, HCV Genotype 2, HCV Genotype 3, HCV Genotype 4, HCV Genotype 5, HCV Genotype 6, treatment naive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Chronic HCV infection
  • Body mass index (BMI) ≥ 18 kg/m^2
  • HCV RNA ≥ 10000 IU/mL at screening
  • Use of highly effective contraception methods if female of childbearing potential or sexually active male
  • Must not have cirrhosis

Exclusion Criteria:

  • Current or prior history of clinically significant illness other than HCV
  • Screening ECG with clinically significant abnormalities
  • Prior exposure to HCV specific direct acting antiviral agent
  • Prior treatment of HCV with interferon or ribavirin
  • Pregnant or nursing female or male with pregnant female partner
  • Chronic liver disease of non-HCV etiology
  • Hepatitis B
  • Active drug abuse
  • Use of any prohibited concomitant medications

Sites / Locations

  • UCSD
  • University of California San Diego Medical Center
  • VA Long Beach Healthcare System
  • Los Angeles Medical Center
  • Ruane Peter J MD Incorporated
  • Cedars Sinai Medical Center
  • National Research Institute
  • Huntington Medical Research Institutes Liver Center
  • Kaiser Permanente Medical Grp
  • Medical Associates Research Group, Inc.
  • Kaiser Permante
  • University of Colorado
  • University of Florida Center for Clinical Trials Research
  • Borland-Groover Clinic
  • University of Miami
  • Orlando Immunology Center
  • Tampa General Hospital
  • South Florida Center of Gastroenterology, P.A
  • Center For Hepatitis C/Atlanta Medical Center
  • Gastrointestinal Specialists of Georgia, PC
  • Northwestern University
  • Indiana University School of Medicine
  • Indianapolis Gastroenterology & Hepatology, Inc.- ARC
  • Mercy Medical Ctr
  • Johns Hopkins University
  • Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center
  • Henry Ford Health System
  • ID Care
  • Southwest C.A.R.E. Center
  • North Shore/Long Island Jewish PRIME
  • Weill Cornell Medical College-New York Presbyterian Hospital
  • Asheville Gastroenterology Associates, P.A.
  • Duke University Medical Center
  • Cumberland Research Associates, LLC
  • Digestive Health Specialists, PA
  • University of Pennsylvania Health System
  • UPMC Center For Liver Diseases
  • VA Pittsburgh Healthcare System
  • University Gastroenterology
  • Gastro One
  • Nashville Gastrointestinal Specialists Inc.
  • Texas Clinical Research Institute, LLC
  • Methodist Transplant Physicians
  • Alamo Medical Research, LTD d/b/a American Research Corporation
  • Metropolitan Research
  • INOVA Institute of Research & Education
  • The Liver Institute of Virginia
  • Digestive and Liver Disease Specialists, Ltd.
  • Virginia Mason Medical Center
  • Fundacion de Investigacion de Diego

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

SOF+VEL 25 mg 12 Weeks (GT1)

SOF+VEL 100 mg 12 Weeks (GT1)

SOF+VEL 25 mg 12 Weeks (GT2/4/5/6)

SOF+VEL 100 mg 12 Weeks (GT2/4/5/6)

SOF+VEL 25 mg 12 Weeks (GT3)

SOF+VEL 100 mg 12 Weeks (GT3)

SOF+VEL 25 mg 8 Weeks (GT1)

SOF+VEL 25 mg + RBV 8 Weeks (GT1)

SOF+VEL 100 mg 8 Weeks (GT1)

SOF+VEL 100 mg + RBV 8 Weeks (GT1)

SOF+VEL 25 mg 8 Weeks (GT2)

SOF+VEL 25 mg + RBV 8 Weeks (GT2)

SOF+VEL 100 mg 8 Weeks (GT2)

SOF+VEL 100 mg + RBV 8 Weeks (GT2)

Arm Description

Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg for 12 weeks.

Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg for 12 weeks.

Participants with genotype 2, 4, 5, or 6 HCV infection will receive SOF+VEL 25 mg for 12 weeks.

Participants with genotype 2, 4, 5, or 6 HCV infection will receive SOF+VEL 100 mg for 12 weeks.

Participants with genotype 3 HCV infection will receive SOF+VEL 25 mg for 12 weeks.

Participants with genotype 3 HCV infection will receive SOF+VEL 100 mg for 12 weeks.

Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg for 8 weeks.

Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg plus RBV for 8 weeks.

Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg for 8 weeks.

Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg plus RBV for 8 weeks.

Participants with genotype 2 HCV infection will receive SOF+VEL 25 mg for 8 weeks.

Participants with genotype 2 HCV infection will receive SOF+VEL 25 mg plus RBV for 8 weeks.

Participants with genotype 2 HCV infection will receive SOF+VEL 100 mg for 8 weeks.

Participants with genotype 2 HCV infection will receive SOF+VEL 100 mg plus RBV for 8 weeks.

Outcomes

Primary Outcome Measures

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.
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

Secondary Outcome Measures

Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.
Percentage of Participants With Virologic Failure
Virologic failure was defined as: 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.

Full Information

First Posted
May 10, 2013
Last Updated
October 19, 2018
Sponsor
Gilead Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT01858766
Brief Title
Safety and Efficacy of Sofosbuvir + Velpatasvir With or Without Ribavirin in Treatment-Naive Adults With Chronic HCV Infection
Official Title
A Phase 2, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir + GS-5816 for 12 Weeks in Treatment-Naive Subjects With Chronic HCV Infection
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) + velpatasvir (VEL; GS-5816) with or without ribavirin (RBV) in treatment-naive adults with chronic genotype (GT) 1, 2, 3, 4, 5, or 6 hepatitis C virus (HCV) infection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
Keywords
Hepatitis, HCV Genotype 1, HCV Genotype 2, HCV Genotype 3, HCV Genotype 4, HCV Genotype 5, HCV Genotype 6, treatment naive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
379 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SOF+VEL 25 mg 12 Weeks (GT1)
Arm Type
Experimental
Arm Description
Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg for 12 weeks.
Arm Title
SOF+VEL 100 mg 12 Weeks (GT1)
Arm Type
Experimental
Arm Description
Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg for 12 weeks.
Arm Title
SOF+VEL 25 mg 12 Weeks (GT2/4/5/6)
Arm Type
Experimental
Arm Description
Participants with genotype 2, 4, 5, or 6 HCV infection will receive SOF+VEL 25 mg for 12 weeks.
Arm Title
SOF+VEL 100 mg 12 Weeks (GT2/4/5/6)
Arm Type
Experimental
Arm Description
Participants with genotype 2, 4, 5, or 6 HCV infection will receive SOF+VEL 100 mg for 12 weeks.
Arm Title
SOF+VEL 25 mg 12 Weeks (GT3)
Arm Type
Experimental
Arm Description
Participants with genotype 3 HCV infection will receive SOF+VEL 25 mg for 12 weeks.
Arm Title
SOF+VEL 100 mg 12 Weeks (GT3)
Arm Type
Experimental
Arm Description
Participants with genotype 3 HCV infection will receive SOF+VEL 100 mg for 12 weeks.
Arm Title
SOF+VEL 25 mg 8 Weeks (GT1)
Arm Type
Experimental
Arm Description
Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg for 8 weeks.
Arm Title
SOF+VEL 25 mg + RBV 8 Weeks (GT1)
Arm Type
Experimental
Arm Description
Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg plus RBV for 8 weeks.
Arm Title
SOF+VEL 100 mg 8 Weeks (GT1)
Arm Type
Experimental
Arm Description
Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg for 8 weeks.
Arm Title
SOF+VEL 100 mg + RBV 8 Weeks (GT1)
Arm Type
Experimental
Arm Description
Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg plus RBV for 8 weeks.
Arm Title
SOF+VEL 25 mg 8 Weeks (GT2)
Arm Type
Experimental
Arm Description
Participants with genotype 2 HCV infection will receive SOF+VEL 25 mg for 8 weeks.
Arm Title
SOF+VEL 25 mg + RBV 8 Weeks (GT2)
Arm Type
Experimental
Arm Description
Participants with genotype 2 HCV infection will receive SOF+VEL 25 mg plus RBV for 8 weeks.
Arm Title
SOF+VEL 100 mg 8 Weeks (GT2)
Arm Type
Experimental
Arm Description
Participants with genotype 2 HCV infection will receive SOF+VEL 100 mg for 8 weeks.
Arm Title
SOF+VEL 100 mg + RBV 8 Weeks (GT2)
Arm Type
Experimental
Arm Description
Participants with genotype 2 HCV infection will receive SOF+VEL 100 mg plus RBV for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
SOF
Other Intervention Name(s)
GS-7977, PSI-7977, Sovaldi®
Intervention Description
400 mg tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
VEL
Other Intervention Name(s)
GS-5816
Intervention Description
Tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
RBV
Other Intervention Name(s)
Ribasphere®
Intervention Description
200 mg 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 Outcome Measure Information:
Title
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
Description
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Time Frame
Posttreatment Week 12
Title
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Time Frame
Up to 12 weeks
Secondary Outcome Measure Information:
Title
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Description
SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.
Time Frame
Posttreatment Weeks 4 and 24
Title
Percentage of Participants With Virologic Failure
Description
Virologic failure was defined as: 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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chronic HCV infection Body mass index (BMI) ≥ 18 kg/m^2 HCV RNA ≥ 10000 IU/mL at screening Use of highly effective contraception methods if female of childbearing potential or sexually active male Must not have cirrhosis Exclusion Criteria: Current or prior history of clinically significant illness other than HCV Screening ECG with clinically significant abnormalities Prior exposure to HCV specific direct acting antiviral agent Prior treatment of HCV with interferon or ribavirin Pregnant or nursing female or male with pregnant female partner Chronic liver disease of non-HCV etiology Hepatitis B Active drug abuse Use of any prohibited concomitant medications
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John McNally, PhD
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
UCSD
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
University of California San Diego Medical Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
VA Long Beach Healthcare System
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Facility Name
Los Angeles Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Ruane Peter J MD Incorporated
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
National Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Huntington Medical Research Institutes Liver Center
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Kaiser Permanente Medical Grp
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Medical Associates Research Group, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Kaiser Permante
City
San Francisco
State/Province
California
ZIP/Postal Code
94080
Country
United States
Facility Name
University of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
University of Florida Center for Clinical Trials Research
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Borland-Groover Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Orlando Immunology Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
South Florida Center of Gastroenterology, P.A
City
Wellington
State/Province
Florida
ZIP/Postal Code
33414
Country
United States
Facility Name
Center For Hepatitis C/Atlanta Medical Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30344
Country
United States
Facility Name
Gastrointestinal Specialists of Georgia, PC
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Indiana University School of Medicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Indianapolis Gastroenterology & Hepatology, Inc.- ARC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
Mercy Medical Ctr
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
ID Care
City
Hillsborough
State/Province
New Jersey
ZIP/Postal Code
08844
Country
United States
Facility Name
Southwest C.A.R.E. Center
City
Santa Fe
State/Province
New Mexico
ZIP/Postal Code
87505
Country
United States
Facility Name
North Shore/Long Island Jewish PRIME
City
Lake Success
State/Province
New York
ZIP/Postal Code
11041
Country
United States
Facility Name
Weill Cornell Medical College-New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Asheville Gastroenterology Associates, P.A.
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Cumberland Research Associates, LLC
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28303
Country
United States
Facility Name
Digestive Health Specialists, PA
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
University of Pennsylvania Health System
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
UPMC Center For Liver Diseases
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
VA Pittsburgh Healthcare System
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15240
Country
United States
Facility Name
University Gastroenterology
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
Gastro One
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Nashville Gastrointestinal Specialists Inc.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37211
Country
United States
Facility Name
Texas Clinical Research Institute, LLC
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Methodist Transplant Physicians
City
Dallas
State/Province
Texas
ZIP/Postal Code
75203
Country
United States
Facility Name
Alamo Medical Research, LTD d/b/a American Research Corporation
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Metropolitan Research
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
INOVA Institute of Research & Education
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
The Liver Institute of Virginia
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23602
Country
United States
Facility Name
Digestive and Liver Disease Specialists, Ltd.
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Fundacion de Investigacion de Diego
City
Santurce
ZIP/Postal Code
00909
Country
Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
18 months after study completion
IPD Sharing Access Criteria
A secured external environment with username, password, and RSA code.
IPD Sharing URL
http://www.gilead.com/research/disclosure-and-transparency
Citations:
Citation
Everson GT, Tran TT, Towner WJ , Davis MN, Wyles D, Nahass R, McNally J, Brainard DM, Han L, Doehle B, Mogalian E, Symonds WT, McHutchison JG, Morgan T, Chung RT. Safety and Efficacy of Treatment with the Interferon-Free, Ribavirin-Free Combination of Sofosbuvir + GS-5816 for 12 Weeks in Treatment Naive Patients with Genotype 1-6 HCV Infection. Journal of Hepatology, Volume 60, Issue 1, Supplement, Page S46. April 2014 (EASL 2014).
Results Reference
result
Citation
Tran TT, Morgan TR, Thuluvath PJ, Etzkorn K, Hinestrosa F, Tong M, McNally J, Brainard DM, Han L, Doehle B, Mogalian E, McHutchison JG, Chung RT, Everson GT. Safety and Efficacy of Treatment with Sofosbuvir+ GS-5816±Ribavirin for 8 or 12 Weeks in Treatment Naïve Patients with Genotype 1-6 HCV Infection. Hepatology (2014), 60: 4 (suppl) 237A.
Results Reference
result
Citation
Doehle B, Gontcharova V, Chodavarapu1 RK, McNally J, Chung RT, Everson GT, McHutchison JG, Miller MD, Mo H. Resistance Analysis of Treatment-Naive HCV Genotype 1-6 Infected Patients Treated with Sofosbuvir in Combination with GS-5816 for 12 Weeks. Hepatology (2014), 60: 4 (suppl) 1138A.
Results Reference
result
PubMed Identifier
26551051
Citation
Everson GT, Towner WJ, Davis MN, Wyles DL, Nahass RG, Thuluvath PJ, Etzkorn K, Hinestrosa F, Tong M, Rabinovitz M, McNally J, Brainard DM, Han L, Doehle B, McHutchison JG, Morgan T, Chung RT, Tran TT. Sofosbuvir With Velpatasvir in Treatment-Naive Noncirrhotic Patients With Genotype 1 to 6 Hepatitis C Virus Infection: A Randomized Trial. Ann Intern Med. 2015 Dec 1;163(11):818-26. doi: 10.7326/M15-1000. Epub 2015 Nov 10.
Results Reference
result

Learn more about this trial

Safety and Efficacy of Sofosbuvir + Velpatasvir With or Without Ribavirin in Treatment-Naive Adults With Chronic HCV Infection

We'll reach out to this number within 24 hrs