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Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination +/- Ribavirin in Adolescents and Children With Chronic HCV-Infection

Primary Purpose

Hepatitis C Virus Infection

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

LDV/SOF

RBV

About this trial

This is an interventional treatment trial for Hepatitis C Virus Infection

Eligibility Criteria

3 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

Consent of parent or legal guardian required
Chronic HCV infection
Screening laboratory values within defined thresholds

Key Exclusion Criteria:

History of clinically significant illness or any other medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol.
Co-infection with HIV, acute hepatitis A virus, or hepatitis B virus
Clinical hepatic decompensation (i.e., ascites, encephalopathy or variceal hemorrhage)
Pregnant or nursing females
Known hypersensitivity to study medication
Use of any prohibited concomitant medications as within 28 days of the Day 1 visit

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

12 to < 18 Years Old

6 to < 12 Years Old

3 to < 6 Years Old

Arm Description

Participants between 12 to < 18 years of age weighing ≥ 45 kg will receive LDV/SOF FDC (90/400 mg tablet or 4 x 22.5 mg/100 mg tablets or 8 x 11.25/50 mg granules based on swallowability assessment during screening). Treatment duration will be dependent on HCV genotype, prior treatment experience, cirrhosis status, and country of enrollment. United Kingdom: HCV genotypes (GT) 1, 4, 5, or 6 treatment-naive (TN) with or without cirrhosis = LDV/SOF 12 weeks HCV GT 1, 4, 5, or 6 treatment-experienced (TE) without cirrhosis = LDV/SOF 12 weeks HCV GT 1, 4, 5, or 6 TE with cirrhosis = LDV/SOF 24 weeks HCV GT 3 TE with or without cirrhosis = LDV/SOF+RBV 24 weeks United States/Australia/New Zealand: HCV GT 1, 4, 5, or 6 TN with or without cirrhosis = LDV/SOF 12 weeks HCV GT 1, 4, 5, or 6 TE without cirrhosis = LDV/SOF 12 weeks HCV GT 1 TE with cirrhosis = LDV/SOF 24 weeks HCV GT 4, 5, or 6 TE with cirrhosis = LDV/SOF 12 weeks

Participants between 6 to < 12 years of age weighing ≥ 17 kg and < 45 kg will receive LDV/SOF FDC (45/200 mg as 2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules based on swallowability assessment during screening). Treatment duration will be dependent on HCV genotype, prior treatment experience, cirrhosis status, and country of enrollment. United Kingdom: HCV GT 1, 4, 5, or 6 TN with or without cirrhosis = LDV/SOF 12 weeks HCV GT 1, 4, 5, or 6 TE without cirrhosis = LDV/SOF 12 weeks HCV GT 1, 4, 5, or 6 TE with cirrhosis = LDV/SOF 24 weeks HCV GT 3 TE with or without cirrhosis = LDV/SOF+RBV 24 weeks United States/Australia/New Zealand: HCV GT 1, 4, 5, or 6 TN with or without cirrhosis = LDV/SOF 12 weeks HCV GT 1, 4, 5, or 6 TE without cirrhosis = LDV/SOF 12 weeks HCV GT 1 TE with cirrhosis = LDV/SOF 24 weeks HCV GT 4, 5, or 6 TE with cirrhosis = LDV/SOF 12 weeks

Participants between 3 to < 6 years of age weighing ≥ 17 kg will receive LDV/SOF FDC (45/200 mg granules as 4 x 11.25/50 mg packets) and participants weighing < 17 kg will receive LDV/SOF FDC (33.75/150 mg oral granules as 3 x 11.25/50 mg packets). Treatment duration will be dependent on HCV genotype, prior treatment experience, cirrhosis status, and country of enrollment. United Kingdom: HCV GT 1, 4, 5, or 6 TN with or without cirrhosis = LDV/SOF 12 weeks HCV GT 1, 4, 5, or 6 TE without cirrhosis = LDV/SOF 12 weeks HCV GT 1, 4, 5, or 6 TE with cirrhosis = LDV/SOF 24 weeks HCV GT 3 TE with or without cirrhosis = LDV/SOF+RBV 24 weeks United States/Australia/New Zealand: HCV GT 1, 4, 5, or 6 TN with or without cirrhosis = LDV/SOF 12 weeks HCV GT 1, 4, 5, or 6 TE without cirrhosis = LDV/SOF 12 weeks HCV GT 1 TE with cirrhosis = LDV/SOF 24 weeks HCV GT 4, 5, or 6 TE with cirrhosis = LDV/SOF 12 weeks

Outcomes

Primary Outcome Measures

For Participants in the PK Lead-in Phase, Pharmacokinetic (PK) Parameter: AUCtau of GS-331007 (Metabolite of SOF), LDV, and SOF

AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).

Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase or the Treatment Phase

Secondary Outcome Measures

For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA

Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase

For the Treatment Phase, Percentage of Participants With Sustained Virologic Response (SVR) at 4 Weeks After Discontinuation of Therapy (SVR4)

SVR4 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 4 weeks after stopping study treatment.

For the Treatment Phase, Percentage of Participants With SVR at 12 Weeks After Discontinuation of Therapy (SVR12)

SVR12 was defined as HCV RNA < LLOQ at 12 weeks after stopping study treatment.

For the Treatment Phase, Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)

SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.

For the Treatment Phase, Percentage of Participants Experiencing Viral Breakthrough

Viral breakthrough was defined as having confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment.

For the Treatment Phase, Percentage of Participants Experiencing Viral Relapse

Viral relapse was defined as having confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.

For the Treatment Phase, Change From Baseline in HCV RNA

For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment

For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization

ALT normalization was defined as ALT > the upper limit of normal (ULN) at baseline and ALT ≤ ULN at each visit.

For the Treatment Phase, Change From Baseline in Height

For the Treatment Phase, Change From Baseline in Weight

For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair

Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented.

For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development

For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair

For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development

Acceptability of LDV/SOF Tablets as Measured by the Percentage of Participants Able/Unable to Swallow Placebo Tablet at Day 1

Participants who were able/unable to swallow placebo tablets were assessed. Participants 12 to < 18 years old were first asked to perform the swallowability assessment using the 90/400 mg placebo tablet. If they were unable to swallow this, they were then asked to perform the swallowability assessment with 22.5/100 mg placebo tablets. Participants 6 to < 12 years old were to be assessed with the 22.5/100 mg placebo tablets. However, 8 participants were mistakenly assessed using the 90/400 mg placebo tablet.

Acceptability of LDV/SOF Granules as Measured by Palatability at Day 1

Participants who were dosed with granules were asked if they tasted the study drug. If they tasted it, then they were asked to provide a number from 0 to 100 to rate the taste of the study drug, with higher scores indicating better taste. Data was then summarized as percentage of participants choosing the following palatability categories: 1) Did not taste the study drug, 2) Tasted drug with score > 60 to 100, 3) Tasted drug with score 40 to 60, and 4) Tasted drug with score of 0 to < 40.

Full Information

NCT ID

NCT02249182

First Posted

September 23, 2014

Last Updated

February 18, 2020

Sponsor

Gilead Sciences

1. Study Identification

Unique Protocol Identification Number

NCT02249182

Brief Title

Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination +/- Ribavirin in Adolescents and Children With Chronic HCV-Infection

Official Title

A Phase 2, Open-Label, Multicenter, Multi-cohort Study to Investigate the Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination +/- Ribavirin in Adolescents and Children With Chronic HCV-Infection

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Completed

Study Start Date

November 5, 2014 (Actual)

Primary Completion Date

June 15, 2018 (Actual)

Study Completion Date

August 24, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Gilead Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The primary objective of the PK Lead-in Phase of the study is to evaluate the steady state pharmacokinetics (PK) and confirm the dose of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) in hepatitis C virus (HCV)-infected pediatric participants. The PK Lead-in Phase will also evaluate the safety, tolerability, and antiviral activity of 10 days of dosing of LDV/SOF FDC in HCV-infected pediatric participants. The Treatment Phase will be initiated by age cohort after confirmation of age-appropriate LDV/SOF FDC dosage levels. Participants from the PK Lead-in Phase will immediately rollover into the Treatment Phase with no interruption of study drug administration. The primary objective of the Treatment Phase is to evaluate the antiviral efficacy, safety, and tolerability of LDV/SOF FDC +/- ribavirin (RBV) for 12 or 24 weeks in pediatric participants with HCV. During screening, participants will receive placebo to match LDV/SOF FDC to assess ability to swallow tablets.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis C Virus Infection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

226 (Actual)

8. Arms, Groups, and Interventions

Arm Title

12 to < 18 Years Old

Arm Type

Experimental

Arm Description

Arm Title

6 to < 12 Years Old

Arm Type

Experimental

Arm Description

Arm Title

3 to < 6 Years Old

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

LDV/SOF

Other Intervention Name(s)

Harvoni®, GS-5885/GS-7977

Intervention Description

LDV/SOF FDC administered orally once daily

Intervention Type

Drug

Intervention Name(s)

RBV

Other Intervention Name(s)

REBETOL®

Intervention Description

Ribavirin (RBV) oral solution or capsules will be administered orally in a divided daily dose based on weight

Primary Outcome Measure Information:

Title

For Participants in the PK Lead-in Phase, Pharmacokinetic (PK) Parameter: AUCtau of GS-331007 (Metabolite of SOF), LDV, and SOF

Description

AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).

Time Frame

Cohorts 1 and 2 (6 to < 18 years of age): predose, 0.5, 1, 2, 3, 4, 5, 8, and 12 hours postdose on Day 10; Cohort 3 (3 to < 6 years of age): predose, 0.5, 2, 4, 8, and 12 hours postdose on Day 10

Title

Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase or the Treatment Phase

Time Frame

Up to 24 weeks

Secondary Outcome Measure Information:

Title

For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA

Time Frame

Baseline; Weeks 1, 2, 4, 8, and 12

Title

Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase

Time Frame

Up to Day 10

Title

For the Treatment Phase, Percentage of Participants With Sustained Virologic Response (SVR) at 4 Weeks After Discontinuation of Therapy (SVR4)

Description

SVR4 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 4 weeks after stopping study treatment.

Time Frame

Posttreatment Week 4

Title

For the Treatment Phase, Percentage of Participants With SVR at 12 Weeks After Discontinuation of Therapy (SVR12)

Description

SVR12 was defined as HCV RNA < LLOQ at 12 weeks after stopping study treatment.

Time Frame

Posttreatment Week 12

Title

For the Treatment Phase, Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)

Description

SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.

Time Frame

Posttreatment Week 24

Title

For the Treatment Phase, Percentage of Participants Experiencing Viral Breakthrough

Description

Viral breakthrough was defined as having confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment.

Time Frame

Up to 24 weeks

Title

For the Treatment Phase, Percentage of Participants Experiencing Viral Relapse

Description

Viral relapse was defined as having 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

Title

For the Treatment Phase, Change From Baseline in HCV RNA

Time Frame

Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only)

Title

For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment

Time Frame

Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only)

Title

For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization

Description

ALT normalization was defined as ALT > the upper limit of normal (ULN) at baseline and ALT ≤ ULN at each visit.

Time Frame

Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Week 4

Title

For the Treatment Phase, Change From Baseline in Height

Time Frame

Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Weeks 4, 12, and 24

Title

For the Treatment Phase, Change From Baseline in Weight

Time Frame

Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Weeks 4, 12, and 24

Title

For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair

Description

Time Frame

Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24

Title

For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development

Description

Time Frame

Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24

Title

For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair

Description

Time Frame

Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24

Title

For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development

Description

Time Frame

Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24

Title

Acceptability of LDV/SOF Tablets as Measured by the Percentage of Participants Able/Unable to Swallow Placebo Tablet at Day 1

Description

Time Frame

Day 1

Title

Acceptability of LDV/SOF Granules as Measured by Palatability at Day 1

Description

Time Frame

Day 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: Consent of parent or legal guardian required Chronic HCV infection Screening laboratory values within defined thresholds Key Exclusion Criteria: History of clinically significant illness or any other medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol. Co-infection with HIV, acute hepatitis A virus, or hepatitis B virus Clinical hepatic decompensation (i.e., ascites, encephalopathy or variceal hemorrhage) Pregnant or nursing females Known hypersensitivity to study medication Use of any prohibited concomitant medications as within 28 days of the Day 1 visit Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gilead Study Director

Organizational Affiliation

Gilead Sciences

Official's Role

Study Director

Facility Information:

City

Birmingham

State/Province

Alabama

Country

United States

City

Los Angeles

State/Province

California

Country

United States

City

San Francisco

State/Province

California

Country

United States

City

Aurora

State/Province

Colorado

Country

United States

City

Washington

State/Province

District of Columbia

Country

United States

City

Atlanta

State/Province

Georgia

Country

United States

City

Indianapolis

State/Province

Indiana

Country

United States

City

Louisville

State/Province

Kentucky

Country

United States

City

Baltimore

State/Province

Maryland

Country

United States

City

Boston

State/Province

Massachusetts

Country

United States

City

Saint Louis

State/Province

Missouri

Country

United States

City

Omaha

State/Province

Nebraska

Country

United States

City

New York

State/Province

New York

Country

United States

City

Chapel Hill

State/Province

North Carolina

Country

United States

City

Cincinnati

State/Province

Ohio

Country

United States

City

Columbus

State/Province

Ohio

Country

United States

City

Philadelphia

State/Province

Pennsylvania

Country

United States

City

Nashville

State/Province

Tennessee

Country

United States

City

Dallas

State/Province

Texas

Country

United States

City

Fort Worth

State/Province

Texas

Country

United States

City

San Antonio

State/Province

Texas

Country

United States

City

Seattle

State/Province

Washington

Country

United States

City

Morgantown

State/Province

West Virginia

Country

United States

City

Newcastle

State/Province

New South Wales

Country

Australia

City

Westmead

State/Province

New South Wales

Country

Australia

City

Parkville

State/Province

Victoria

Country

Australia

City

Auckland

Country

New Zealand

City

Birmingham

State/Province

England

Country

United Kingdom

City

Leeds

State/Province

England

Country

United Kingdom

City

London

State/Province

England

Country

United Kingdom

City

Glasgow

State/Province

Scotland

Country

United Kingdom

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 www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.

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

https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy

Citations:

Citation

Kirby B, German P, Kanwar B, Ni L, Lakatos I, Ling J, Mathias A. Pharmacokinetics of Once-Daily Sofosbuvir and Ledipasvir/Sofosbuvir in HCV-Infected Adolescents. Hepatology 2015;62 (S1): 1040A-1041A

Results Reference

result

Citation

Garrison KL, Mathias A, Kersey K, Kanwar B, Ni L, Jain A, et al. Pharmacokinetics of Once-Daily Sofosbuvir and Ledipasvir/Sofosbuvir in HCV-Infected Pediatrics Aged 6 to < 12 Years Old. Hepatology 2016;64 (S1): 436A

Results Reference

result

Citation

Schwarz K, Murray KF, Rosenthal P, Bansal S, Lin CH, Ni L, et al. High Rates of SVR12 in Adolescents Treated with the Combination of Ledipasvir/Sofosbuvir. J Hepatol 2016; 64 (2): S184-S185

Results Reference

result

Citation

K.F. Murray, W. Balistreri, S. Bansal, S. Whitworth, H. Evans, R.P. Gonzalez-Peralta, et al. Ledipasvir/sofosbuvir ± ribavirin for 12 or 24 weeks is safe and effective in children 6-11 years old with chronic hepatitis C infection. J Hepatol 2017;66: S33-S62

Results Reference

result

PubMed Identifier

27997679

Citation

Balistreri WF, Murray KF, Rosenthal P, Bansal S, Lin CH, Kersey K, Massetto B, Zhu Y, Kanwar B, German P, Svarovskaia E, Brainard DM, Wen J, Gonzalez-Peralta RP, Jonas MM, Schwarz K. The safety and effectiveness of ledipasvir-sofosbuvir in adolescents 12-17 years old with hepatitis C virus genotype 1 infection. Hepatology. 2017 Aug;66(2):371-378. doi: 10.1002/hep.28995. Epub 2017 Jun 19.

Results Reference

result

PubMed Identifier

28957984

Citation

Younossi ZM, Stepanova M, Balistreri W, Schwarz K, Murray KF, Rosenthal P, Bansal S, Hunt S. Health-related Quality of Life in Adolescent Patients With Hepatitis C Genotype 1 Treated With Sofosbuvir and Ledipasvir. J Pediatr Gastroenterol Nutr. 2018 Jan;66(1):112-116. doi: 10.1097/MPG.0000000000001754.

Results Reference

result

Citation

Begley R, Meng A, Massetto B, Shao J, Ling J, and Mathias A. Pharmacokinetics of Once Daily Sofosbuvir or Ledipasvir/Sofosbuvir in HCV-Infected Pediatrics Aged 3 to <6 Years Old. Hepatology 2018;68 (S1): 582A.

Results Reference

result

Citation

Schwarz KB, Rosenthal P, Murray KF, Honegger JR, Hardikar W, Hague R, et al. Ledipasvir/Sofosbuvir for 12 Weeks Is Safe and Effective in Children 3 to <6 Years Old with Chronic Hepatitis C Virus Infection. Hepatology 2018;68 (S1): 116A-117A.

Results Reference

result

PubMed Identifier

30070726

Citation

Murray KF, Balistreri WF, Bansal S, Whitworth S, Evans HM, Gonzalez-Peralta RP, Wen J, Massetto B, Kersey K, Shao J, Garrison KL, Parhy B, Brainard DM, Arnon R, Gillis LA, Jonas MM, Lin CH, Narkewicz MR, Schwarz K, Rosenthal P. Safety and Efficacy of Ledipasvir-Sofosbuvir With or Without Ribavirin for Chronic Hepatitis C in Children Ages 6-11. Hepatology. 2018 Dec;68(6):2158-2166. doi: 10.1002/hep.30123. Epub 2018 Nov 17.

Results Reference

result

PubMed Identifier

31220349

Citation

Schwarz KB, Rosenthal P, Murray KF, Honegger JR, Hardikar W, Hague R, Mittal N, Massetto B, Brainard DM, Hsueh CH, Shao J, Parhy B, Narkewicz MR, Rao GS, Whitworth S, Bansal S, Balistreri WF. Ledipasvir-Sofosbuvir for 12 Weeks in Children 3 to <6 Years Old With Chronic Hepatitis C. Hepatology. 2020 Feb;71(2):422-430. doi: 10.1002/hep.30830. Epub 2019 Aug 19.

Results Reference

derived

Learn more about this trial

Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination +/- Ribavirin in Adolescents and Children With Chronic HCV-Infection

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