Clinical trial NCT02472886: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: 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
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2015-06-16
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
timeFrame: Posttreatment Week 12
measure: Percentage of Participants Who Discontinued Study Drug Due to Any Adverse Event (AE)
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Percentage of Participants With Sustained Virologic Response (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
timeFrame: Posttreatment Weeks 4 and 24
measure: Percentage of Participants With HCV RNA < LLOQ on Treatment
timeFrame: Up to 12 weeks
measure: HCV RNA Change From Day 1
timeFrame: Up to 12 weeks
measure: Percentage of Participants With Virologic Failure
timeFrame: Up to Posttreatment Week 24
measure: Percentage of HIV/HCV- Coinfected Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment and at Posttreatment Week 4
timeFrame: Up to Posttreatment Week 4
measure: For HIV/HCV- Coinfected Participants, Change From Baseline in CD4 T-cell Count at the End of Treatment and Posttreatment Week 4
timeFrame: Up to Posttreatment Week 4
Other outcomes:
Locations:
city: Tallinn
country: Estonia
city: Tartu
country: Estonia
city: Ekaterinburg
country: Russian Federation
city: Krasnoyarsk
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Samara
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St.petersburg
country: Russian Federation
city: Stavropol
country: Russian Federation
city: Tyumen
country: Russian Federation
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References:
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.
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.