Safety and Efficacy of Ledipasvir/Sofosbuvir in Adults With Chronic HCV Infection
NCT ID: NCT02472886
Last Updated: 2018-11-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
153 participants
INTERVENTIONAL
2015-06-17
2016-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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LDV/SOF
Treatment-naive participants with genotype 1 HCV infection without cirrhosis will receive LDV/SOF FDC for 8 weeks.
LDV/SOF
90/400 mg FDC tablet administered orally once daily
LDV/SOF Coinfected with HIV-1
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.
LDV/SOF
90/400 mg FDC tablet administered orally once daily
LDV/SOF+RBV Retreatment
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.
LDV/SOF
90/400 mg FDC tablet administered orally once daily
RBV
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)
Interventions
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LDV/SOF
90/400 mg FDC tablet administered orally once daily
RBV
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)
Other Intervention Names
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Eligibility Criteria
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Exclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Tallinn, , Estonia
Tartu, , Estonia
Krasnoyarsk, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Samara, , Russia
Stavropol, , Russia
Tyumen, , Russia
Yekaterinburg, , Russia
Countries
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References
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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.
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.
Other Identifiers
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2015-000690-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-337-1463
Identifier Type: -
Identifier Source: org_study_id
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