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Clinical Trials

MainTitle

Generic VEL/SOF With or Without RBV for HIV/HCV Coinfected Patients

This study has been completed
Sponsor
National Taiwan University Hospital


Information provided by (Responsible Party)
National Taiwan University Hospital
ClinicalTrials.gov Identifier
NCT03250910

First received: August 8, 2017
Last updated: August 14, 2017
Last Verified: August 2017
History of Changes
Purpose

Purpose

Data are limited regarding the effectiveness and safety of generic velpatasvir plus sofosbuvir (VEL/SOF) with or without ribavirin (RBV) for the treatment of hepatitis C virus (HCV) in patients with human immunodeficiency virus (HIV) coinfection. We aim to compare the effectiveness and safety of VEL/SOF with and without RBV for 12 weeks in HIV/HCV-coinfected and HCV-monoinfected patients The antiviral responses and the adverse events (AEs) are compare between the two groups. The characteristics potentially related to sustained virologic response 12 weeks off therapy (SVR12) are analyzed.

Condition Intervention Phase
Hepatitis C Virus Infection, Response to Therapy of
Human Immunodeficiency Virus

Drug : Sofosbuvir and Velpatasvir
Drug : Ribavirin
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Generic Velpatasvir Plus Sofosbuvir With or Without Ribavirin for the Treatment of Hepatitis C Virus in Patients Coinfected With Human Immunodeficiency Virus

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures

  • Sustained virologic response [ Time Frame: 24 weeks ]
    HCV RNA < LLOQ 12 weeks off therapy

Enrollment: 178
Study Start Date: August 1, 2016
Study Completion Date: July 31, 2017
Primary Completion Date: July 15, 2017 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: HIV/HCV compensated liver disease
Patients without cirrhosis or with compensated cirrhosis (Child-Pugh A) received a generic version of Sofosbuvir and Velpatasvir fixed-dose combination (Sofosvel®, VEL/SOF 100/400 mg film coated tablet, Beacon Pharmaceuticals Ltd. Mymensingh, Bangladesh) 1 tablet per day for 12 weeks.
Drug: Sofosbuvir and Velpatasvir

All patients received a generic version of VEL/SOF fixed-dose combination (Sofosvel®, VEL/SOF 100/400 mg film coated tablet, Beacon Pharmaceuticals Ltd. Mymensingh, Bangladesh) 1 tablet per day for 12 weeks.

Other Name: Sofosvel
Experimental: HIV/HCV decompensated liver disease
Patients with decompensated cirrhosis (Child-Pugh B or C) received Sofosvel® 1 tablet per day in combination with weight-based ribavirin (RBV)(Robatrol®, 200 mg capsule, Genovate Biotechnology Co. Ltd., Hsinchu, Taiwan; 1,200 mg per day if the body weight ≥ 75 kg; 1,000 mg per day if the body weight < 75 mg) for 12 weeks.
Drug: Sofosbuvir and Velpatasvir

All patients received a generic version of VEL/SOF fixed-dose combination (Sofosvel®, VEL/SOF 100/400 mg film coated tablet, Beacon Pharmaceuticals Ltd. Mymensingh, Bangladesh) 1 tablet per day for 12 weeks.

Other Name: Sofosvel
Drug: Ribavirin

Patients with decompensated cirrhosis (Child-Pugh B or C), received weight-based ribavirin (RBV)(Robatrol®, 200 mg capsule, Genovate Biotechnology Co. Ltd., Hsinchu, Taiwan; 1,200 mg per day if the body weight ≥ 75 kg; 1,000 mg per day if the body weight < 75 mg) for 12 weeks.

Other Name: Robatrol
Active Comparator: HCV compensated liver disease
Patients without cirrhosis or with compensated cirrhosis (Child-Pugh A) received a generic version of Sofosbuvir and Velpatasvir fixed-dose combination (Sofosvel®, VEL/SOF 100/400 mg film coated tablet, Beacon Pharmaceuticals Ltd. Mymensingh, Bangladesh) 1 tablet per day for 12 weeks.
Drug: Sofosbuvir and Velpatasvir

All patients received a generic version of VEL/SOF fixed-dose combination (Sofosvel®, VEL/SOF 100/400 mg film coated tablet, Beacon Pharmaceuticals Ltd. Mymensingh, Bangladesh) 1 tablet per day for 12 weeks.

Other Name: Sofosvel
Active Comparator: HCV decompensated liver disease
Patients with decompensated cirrhosis (Child-Pugh B or C) received Sofosvel® 1 tablet per day in combination with weight-based ribavirin (RBV)(Robatrol®, 200 mg capsule, Genovate Biotechnology Co. Ltd., Hsinchu, Taiwan; 1,200 mg per day if the body weight ≥ 75 kg; 1,000 mg per day if the body weight < 75 mg) for 12 weeks.
Drug: Sofosbuvir and Velpatasvir

All patients received a generic version of VEL/SOF fixed-dose combination (Sofosvel®, VEL/SOF 100/400 mg film coated tablet, Beacon Pharmaceuticals Ltd. Mymensingh, Bangladesh) 1 tablet per day for 12 weeks.

Other Name: Sofosvel
Drug: Ribavirin

Patients with decompensated cirrhosis (Child-Pugh B or C), received weight-based ribavirin (RBV)(Robatrol®, 200 mg capsule, Genovate Biotechnology Co. Ltd., Hsinchu, Taiwan; 1,200 mg per day if the body weight ≥ 75 kg; 1,000 mg per day if the body weight < 75 mg) for 12 weeks.

Other Name: Robatrol

Detailed Description:

Due to the lack of effective vaccination and the shared routes of transmission, hepatitis C virus (HCV) infection remains a challenging co-morbidity in patients with human immunodeficiency virus (HIV) infection. It is estimated that approximately 2.3 million people are coinfected with HIV and HCV (HIV/HCV) in the world. Compared to patients with HCV monoinfection, HIV/HCV-coinfected patients tend to have higher serum HCV viral loads, faster hepatic fibrosis progression, and higher risks of hepatic decompensation. Following the commencement of scale-up antiretroviral therapy (ART) that decreases the HIV-related opportunistic infections and malignancies, the liver-related complications have now become the leading cause of morbidity and mortality in HIV/HCV-coinfected patients. On the other hand, the survival rate is improved if these patients achieve sustained virologic response (SVR) by anti-HCV agents.
On the basis of excellent efficacy and safety, treatment by interferon (IFN)-free direct acting antiviral agents (DAAs) has made a paradigm shift for HCV care. Velpatasvir (VEL) is an HCV non-structural protein 5A (NS5A) inhibitor and sofosbuvir (SOF) is an HCV NS5B nucleotide polymerase inhibitor. Both agents are active against HCV with pan-genotypic potency. A fixed-dose combination of VEL at a daily dosage of 100 mg and SOF at a daily dosage of 400 mg (VEL/SOF) with or without weight-based ribavirin (RBV) has been approved by U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) to treat HCV genotype 1-6 patients with compensated and decompensated liver diseases, respectively. Recently, a phase 3 study of VEL/SOF to treat HCV infection in HIV-coinfected patients reveals that this regimen is safe and provides a high and comparable SVR rate to HCV-monoinfected patients.
Although treatment of HCV by IFN-free DAAs is considered highly efficacious and well tolerated, numerous HCV-infected individuals have limited access to the brand-name agents due to the lack of universal governmental reimbursement or private insurance support. Therefore, allowing the generic version of patented DAAs for HCV through voluntary or compulsory licensing may provide patients with greater access to new HCV treatment, particularly in resource-constrained countries. Regarding the real-world experiences of generic IFN-free DAAs, a recent report from China evaluated the effectiveness of a generic version of ledipasvir (LDV) plus SOF (LDV/SOF) with or without RBV for 8-12 weeks in 192 HCV genotype 1b (HCV-1b) patients. The overall SVR rates were excellent (96.8%-96.9%) and most patients tolerated the treatment well. Based on the encouraging results, we aim to evaluate the effectiveness and safety of a generic version of pan-genotypic VEL/SOF-based therapy for HCV in HIV-coinfected patients, and compare the performance of such a regimen in HCV-monoinfected patients.

Eligibility

Eligibility

Ages Eligible for Study: 20 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Inclusion Criteria:

  • Age > or = 20 years
  • Chronic HCV infection, defined as detectable HCV antibody (anti-HCV; Abbott HCV EIA ~#o1~0, Abbott Laboratories, Abbott Park, Illinois, USA) and quantifiable serum HCV RNA (Cobas TaqMan HCV Test v2.0, Roche Diagnostics GmbH, Mannheim, Germany, lower limit of quantification [LLOQ]: 25 IU/mL) for ≥ 6 months

  • Exclusion Criteria:
    • Chronic kidney disease (CKD) stage ≥ 4,
    • Organ transplantation
    • Prior DAA exposure
    • Refusal to provide written informed consent.

    contacts and locations

    Contacts and Locations

    Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

    Please refer to this study by its ClinicalTrials.gov identifier: NCT03250910

    Locations

    Taiwan
    National Taiwan University Hospital, Yun-Lin Branch
    Douliu, Taiwan
    National Taiwan University Hospital
    Taipei, Taiwan

    Sponsors and Collaborators

    National Taiwan University Hospital

    Investigators

    Principal Investigator: Chen-Hua Liu, MD National Taiwan University Hospital
    More Information

    More Information


    Responsible Party: National Taiwan University Hospital  
    ClinicalTrials.gov Identifier: NCT03250910   History of Changes  
    Other Study ID Numbers: 201602026RINC  
    Study First Received: August 8, 2017  
    Last Updated: August 14, 2017  

    Studies a U.S. FDA-regulated Drug Product: No  
    Studies a U.S. FDA-regulated Device Product: No  

    Keywords provided by National Taiwan University Hospital:

    hepatitis C virus
    human immunodeficiency virus
    Direct acting antiviral agent

    Additional relevant MeSH terms:
    Hepatitis
    Hepatitis A
    Virus Diseases
    Hepatitis C
    Immunologic Deficiency Syndromes
    Acquired Immunodeficiency Syndrome
    HIV Infections
    Ribavirin
    Sofosbuvir

    ClinicalTrials.gov processed this data on October 17, 2017
    This information is provided by ClinicalTrials.gov.