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Safety and Efficacy of Ledipasvir/Sofosbuvir in Adults With Chronic HCV Infection

Primary Purpose

Hepatitis C Virus Infection

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

LDV/SOF

RBV

About this trial

This is an interventional treatment trial for Hepatitis C Virus Infection focused on measuring HCV genotype 1, HCV, Sustained Virologic Response, Direct Acting Antiviral, Combination Therapy, GS-7977, GS-5885, Ribavirin, Sofosbuvir, ledipasvir, Hepatitis C, Hepatitis C, Chronic, Liver Diseases, Virus Diseases, Antiviral Agents, HCV/HIV co-infection

Eligibility Criteria

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

Key Inclusion Criteria:

Participants who failed treatment in Study GS-US-334-0119 who meet relevant inclusion/exclusion criteria are eligible for retreatment in this study
Chronic genotype 1 HCV infection
HCV treatment-naive
HCV RNA > 10,000 IU/mL at screening
Absence of cirrhosis
Screening laboratory values within defined thresholds
Use of two effective contraception methods if female of childbearing potential or sexually active male

Key Exclusion Criteria:

Pregnant or nursing female or male with pregnant female partner
Infection with hepatitis B virus (HBV)
Current or prior history of clinical hepatic decompensation
Chronic use of systemic immunosuppressive agents
History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment, or compliance with the protocol
For HIV-1/HCV co-infected individuals:
- Opportunistic infection within 6 months prior to screening
- Active, serious infection (other than HIV-1 or HCV) requiring parental antibiotics, antivirals or antifungals within 30 days prior to baseline
- Treatment with an antiretroviral (ARV) regimen other than one of those listed in the study protocol

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

LDV/SOF

LDV/SOF Coinfected with HIV-1

LDV/SOF+RBV Retreatment

Arm Description

Treatment-naive participants with genotype 1 HCV infection without cirrhosis will receive LDV/SOF FDC for 8 weeks.

Treatment-naive participants with genotype 1 HCV infection without cirrhosis and who are coinfected with HIV-1 will receive LDV/SOF FDC for 8 weeks.

Participants with genotype 1 or 3 HCV infection who failed to achieve SVR12 in Gilead Study GS-US-334-0119 will receive LDV/SOF FDC + RBV for 12 weeks.

Outcomes

Primary Outcome Measures

Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)

SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.

Percentage of Participants Who Discontinued Study Drug Due to Any Adverse Event (AE)

Secondary Outcome Measures

Percentage of Participants With Sustained Virologic Response (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.

Percentage of Participants With HCV RNA < LLOQ on Treatment

HCV RNA Change From Day 1

Percentage of Participants With Virologic Failure

Virologic failure was defined as On-treatment virologic failure confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ, while on treatment (ie, breakthrough), confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment (ie, rebound), HCV RNA persistently ≥ LLOQ through 8 weeks of treatment (ie, nonresponse) Relapse HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement

Percentage of HIV/HCV- Coinfected Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment and at Posttreatment Week 4

For HIV/HCV- Coinfected Participants, Change From Baseline in CD4 T-cell Count at the End of Treatment and Posttreatment Week 4

Full Information

NCT ID

NCT02472886

First Posted

June 12, 2015

Last Updated

October 19, 2018

Sponsor

Gilead Sciences

1. Study Identification

Unique Protocol Identification Number

NCT02472886

Brief Title

Safety and Efficacy of Ledipasvir/Sofosbuvir in Adults With Chronic HCV Infection

Official Title

A Phase 3b, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of Ledipasvir/Sofosbuvir in Adults With Chronic HCV Infection

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

June 17, 2015 (Actual)

Primary Completion Date

March 30, 2016 (Actual)

Study Completion Date

June 30, 2016 (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

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) with or without ribavirin (RBV) in adults with chronic 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 Virus Infection

Keywords

HCV genotype 1, HCV, Sustained Virologic Response, Direct Acting Antiviral, Combination Therapy, GS-7977, GS-5885, Ribavirin, Sofosbuvir, ledipasvir, Hepatitis C, Hepatitis C, Chronic, Liver Diseases, Virus Diseases, Antiviral Agents, HCV/HIV co-infection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

153 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LDV/SOF

Arm Type

Experimental

Arm Description

Treatment-naive participants with genotype 1 HCV infection without cirrhosis will receive LDV/SOF FDC for 8 weeks.

Arm Title

LDV/SOF Coinfected with HIV-1

Arm Type

Experimental

Arm Description

Treatment-naive participants with genotype 1 HCV infection without cirrhosis and who are coinfected with HIV-1 will receive LDV/SOF FDC for 8 weeks.

Arm Title

LDV/SOF+RBV Retreatment

Arm Type

Experimental

Arm Description

Participants with genotype 1 or 3 HCV infection who failed to achieve SVR12 in Gilead Study GS-US-334-0119 will receive LDV/SOF FDC + RBV for 12 weeks.

Intervention Type

Drug

Intervention Name(s)

LDV/SOF

Other Intervention Name(s)

Harvoni®, GS-5885/GS-7977

Intervention Description

90/400 mg FDC tablet administered orally once daily

Intervention Type

Drug

Intervention Name(s)

RBV

Intervention Description

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 12 Weeks After Discontinuation of Therapy (SVR12)

Description

SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.

Time Frame

Posttreatment Week 12

Title

Percentage of Participants Who Discontinued Study Drug Due to Any Adverse Event (AE)

Time Frame

Up to 12 weeks

Secondary Outcome Measure Information:

Title

Percentage of Participants With Sustained Virologic Response (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

Description

SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.

Time Frame

Posttreatment Weeks 4 and 24

Title

Percentage of Participants With HCV RNA < LLOQ on Treatment

Time Frame

Up to 12 weeks

Title

HCV RNA Change From Day 1

Time Frame

Up to 12 weeks

Title

Percentage of Participants With Virologic Failure

Description

Time Frame

Up to Posttreatment Week 24

Title

Percentage of HIV/HCV- Coinfected Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment and at Posttreatment Week 4

Time Frame

Up to Posttreatment Week 4

Title

For HIV/HCV- Coinfected Participants, Change From Baseline in CD4 T-cell Count at the End of Treatment and Posttreatment Week 4

Time Frame

Up to Posttreatment Week 4

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: Participants who failed treatment in Study GS-US-334-0119 who meet relevant inclusion/exclusion criteria are eligible for retreatment in this study Chronic genotype 1 HCV infection HCV treatment-naive HCV RNA > 10,000 IU/mL at screening Absence of cirrhosis Screening laboratory values within defined thresholds Use of two effective contraception methods if female of childbearing potential or sexually active male Key Exclusion Criteria: Pregnant or nursing female or male with pregnant female partner Infection with hepatitis B virus (HBV) Current or prior history of clinical hepatic decompensation Chronic use of systemic immunosuppressive agents History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment, or compliance with the protocol For HIV-1/HCV co-infected individuals: Opportunistic infection within 6 months prior to screening Active, serious infection (other than HIV-1 or HCV) requiring parental antibiotics, antivirals or antifungals within 30 days prior to baseline Treatment with an antiretroviral (ARV) regimen other than one of those listed in the study protocol 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

Tallinn

ZIP/Postal Code

10167

Country

Estonia

City

Tartu

ZIP/Postal Code

51014

Country

Estonia

City

Ekaterinburg

ZIP/Postal Code

620102

Country

Russian Federation

City

Krasnoyarsk

ZIP/Postal Code

660049

Country

Russian Federation

City

Moscow

ZIP/Postal Code

105275

Country

Russian Federation

City

Moscow

ZIP/Postal Code

107014

Country

Russian Federation

City

Moscow

ZIP/Postal Code

111123

Country

Russian Federation

City

Moscow

ZIP/Postal Code

115446

Country

Russian Federation

City

Moscow

ZIP/Postal Code

117593

Country

Russian Federation

City

Moscow

ZIP/Postal Code

119435

Country

Russian Federation

City

Moscow

ZIP/Postal Code

119991

Country

Russian Federation

City

Moscow

ZIP/Postal Code

125367

Country

Russian Federation

City

Moscow

ZIP/Postal Code

127015

Country

Russian Federation

City

Moscow

ZIP/Postal Code

129090

Country

Russian Federation

City

Moscow

ZIP/Postal Code

129110

Country

Russian Federation

City

Samara

ZIP/Postal Code

443063

Country

Russian Federation

City

St. Petersburg

ZIP/Postal Code

190103

Country

Russian Federation

City

St.petersburg

ZIP/Postal Code

194044

Country

Russian Federation

City

Stavropol

ZIP/Postal Code

355017

Country

Russian Federation

City

Tyumen

ZIP/Postal Code

625026

Country

Russian Federation

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

Zhdanov K., Morozov V., Orlova-Morozova E.A., Salupere R., Kozhevnikova G., et al. Preliminary Results of an Evaluation of Ledipasvir/Sofosbuvir in Treatment-Naive Patients with Chronic HCV or HCV/HIV Co-Infection and Retreatment of Sofosbuvir-treated Patients. 8th International Conference of the White Nights of Hepatology. Saint Petersburg, Russia. June 2-3, 2016. Oral presentation.

Results Reference

result

PubMed Identifier

29177645

Citation

Isakov V, Gankina N, Morozov V, Kersey K, Lu S, Osinusi A, Svarovskaia E, Brainard DM, Salupere R, Orlova-Morozova E, Zhdanov K. Ledipasvir-Sofosbuvir for 8 Weeks in Non-Cirrhotic Patients with Previously Untreated Genotype 1 HCV Infection +/- HIV-1 Co-Infection. Clin Drug Investig. 2018 Mar;38(3):239-247. doi: 10.1007/s40261-017-0606-0. Erratum In: Clin Drug Investig. 2021 Mar;41(3):291.

Results Reference

derived

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Safety and Efficacy of Ledipasvir/Sofosbuvir in Adults With Chronic HCV Infection

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