Category Archives: Genotype 1b

Effectiveness, Safety and Clinical Outcomes of Elbasvir/Grazoprevir: Results From a Spanish Real World Cohort

Effectiveness, Safety and Clinical Outcomes of Elbasvir/Grazoprevir: Results From a Spanish Real World Cohort

This is a multicentre, descriptive, observational and ambispective (also known as a historical prospective) study carried out in patients who are treated with Zepatier (Elbasvir/Grazoprevir) in hospitals that included their data in Hepa-C Registry (directed by the Spanish Association for the Study of the Liver and the Networked Biomedical Research Centre for Hepatic and Digestive Diseases).

To read more about the study, click here

Real World Evidence of the Effectiveness of Paritaprevir/r – Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C in Colombia (outCome)

The interferon-free combination regimen of Paritaprevir/r – Ombitasvir with or without Dasabuvir (ABBVIE REGIMEN) ± Ribavirin (RBV) for the treatment of chronic hepatitis C (CHC) has been shown to be safe and effective in randomized controlled clinical trials with strict inclusion and exclusion criteria under well controlled conditions.

To read the entire clinical trial description, click here

Scale-up of Treatment of Hepatitis C Infection Among People Who Inject Drugs (DARLO-C)

This study is a phase IV, open-label, single arm, multicentre study whose aim is to assess whether interferon-free and ribavirin-free Direct Acting Antiviral (DAA) Hepatitis C Virus (HCV) therapy with grazoprevir/elbasvir, will be feasible for the treatment of People who inject drugs (PWID) with recent injecting drug use and chronic HCV genotype 1 or 4 infection.

To read the entire study description, click here

Treatment of Hepatitis C Virus Infection With Generic Sofosbuvir/ Ledipasvir in Iranian Patients (HepCC-2)

Treatment of Hepatitis C Virus Infection With Generic Sofosbuvir/ Ledipasvir in Iranian Patients (HepCC-2)

Hepatitis C virus (HCV) infection with around 0.5% and 2.2% prevalence in Iran and world is one of the public health problems resulting in chronic liver disease, cirrhosis and hepatocellular carcinoma. All cases of chronic HCV infections are candidates of treatment to prevent advanced liver diseases. The previous Pegylated-interferon and Ribavirin therapy was not efficient in all cases and results in numerous number of side-effects. Introduction of direct acting antiviral agents (DAAs) such as Sofosbuvir and Ledipasvir make the eradication of HCV possible however these regimens are not affordable and available in developing countries. The generic DAAs are manufactured in many of these countries such as Iran to provide the treatment with reasonable price.

To read the entire clinical trial description, click here

A Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Combination Treatment of AL-335, Odalasvir, and Simeprevir in Japanese Participants With Chronic Hepatitis C Genotype 1 or 2 Virus Infection, With or Without Compensated Cirrhosis Who Are Direct Acting Antiviral Treatment-naïve (never been treated)

A Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Combination Treatment of AL-335, Odalasvir, and Simeprevir in Japanese Participants With Chronic Hepatitis C Genotype 1 or 2 Virus Infection, With or Without Compensated Cirrhosis Who Are Direct Acting Antiviral Treatment-naïve (never been treated)

The main purpose of this study is to evaluate the safety and tolerability of a combination treatment of AL-335, odalasvir (ODV), and simeprevir (SMV) for 8 weeks in Japanese participants with genotype 1 or 2 chronic hepatitis C virus (HCV) infection with or without compensated cirrhosis who are direct-acting antiviral (DAA) naive–never been treated with all orals.

To view the entire study description, click here

Efficacy and Safety of MK-3682 + Ruzasvir (MK-8408) in Treating Hepatitis C Virus Infection Genotypes 1-6 (MK-3682-041)

This is a nonrandomized (participants may decide which drugs they want to take), multi-site, open-label trial to evaluate a novel two-drug combination regimen (MK-3682 450 mg + ruzasvir [RZR; MK-8408] 180 mg once daily [q.d.] for 12 weeks) in male and female treatment-naïve (TN taken once-a-day) or treatment-experienced (TE) participants with chronic hepatitis C virus (HCV) infection genotype (GT) GT1, GT2, GT3, GT4, GT5, or GT6 who have not previously received HCV direct-acting antiviral (DAA) therapy. Cirrhotic (C) and non-cirrhotic (NC) participants with and without human immunodeficiency virus (HIV) co-infection will be enrolled.

Efficacy and Safety of MK-3682 + Ruzasvir (MK-8408) in Treating Hepatitis C Virus Infection Genotypes 1-6 (MK-3682-041)

To read the entire clinical trial description, click here

Study of Oral Treatments for Hepatitis C (PRIORITIZE)

The study will compare the effectiveness of FDA approved medicines for hepatitis C (HCV) to find out if they work equally well under real-world conditions—that is outside of standard clinical trials. Patients can consent to participate in the study and be randomly assigned to receive one of the HCV therapies in their current community or academic (university) clinics. The study will follow patient reported outcomes using surveys that can be completed on devices with Internet access or by telephone. Once participants are randomized (assigned to a HCV treatment by a computer program), all medical care, laboratory testing, and any disease or side effect management will be performed in the usual manner by your HCV treatment provider.

A Pragmatic, Randomized Study of Oral Regimens for Hepatitis C: Transforming Decision-Making for Patients, Providers, and Stakeholders

Study of Oral Treatments for Hepatitis C (PRIORITIZE)

To read the entire clinical trial description, click here…

Efficacy and Safety of MK-3682B (MK-5172 + MK-3682 + MK-8408) Fixed Dose Combination in Chronic HCV Participants Failing Prior Antiviral Treatment (MK-3682-021)

This is a study of MK-5172 (grazoprevir [GZR]) (100 mg), MK-3682 (450 mg) and MK-8408 (ruzasvir) (60 mg) for 16 weeks with ribavirin (RBV) or 24 weeks without RBV in cirrhotic (C) or non-cirrhotic (NC) hepatitis C virus (HCV) genotype (GT) 1 or GT3-infected participants who have previously failed a direct-acting antiviral regimen (DAA). The combination regimen will be administered as two fixed-dose combination (FDC) tablets, referred to as MK-3682B, given once-daily.

Efficacy and Safety of MK-3682B (MK-5172 + MK-3682 + MK-8408) Fixed Dose Combination in Chronic HCV Participants Failing Prior Antiviral Treatment (MK-3682-021)

 To read the entire clinical trial description, click here…

 

 

 

Exploring Renal Transplants Using Hepatitis C Infected Donors for HCV-negative Recipients (EXPANDER-1)

Johns Hopkins Hospital Baltimore, MD:  There is a tremendous shortage of kidneys needed for transplants.  In a first of its kind study, a hepatitis C (HCV) infected kidney is being transplanted into HCV-negative person and being treated with Zepatier with and without ribavirin in the HCV-infected livers that are genotype 1.  In the HCV-infected kidney that is genotype 2 or 3 the people will be treated with Zepatier or sofosbuvir.  Treatment is occurring at the time of the transplant.

Exploring Renal Transplants Using Hepatitis C Infected Donors for HCV-negative Recipients (EXPANDER-1)

To read the entire clinical trial description, click here…