To Treat Hepatitis C, Consider Enrolling in a Clinical Study

BY MICHAEL R. PAGE, PHARMD, RPH
PUBLISHED WEDNESDAY, JUNE 10, 2015
Clinical studies are a great opportunity for patients to access new treatment for chronic conditions, such as hepatitis C. Several clinical trials are currently enrolling patients with chronic hepatitis C virus (HCV) infection. In exchange for testing new medications, patients enrolled in clinical trials receive free treatment and are often compensated for their time and travel expenses. One very useful resource for finding clinical trials to enroll in is the website ClinicalTrials.gov. By visiting ClinicalTrials.gov and searching for studies (designated by numbers starting with “NCT” below), you can find out more about each of these clinical trials for patients with HCV.
 
Table 1: Clinical studies currently seeking patients with chronic hepatitis C infection

Treatment On ClinicalTrials.gov: Details
Daclatasvir + sofosbuvir + ribavirin NCT02304159 This clinical trial is seeking patients with genotype 3 HCV who also have cirrhosis. Patients enrolled in this trial will know what treatment they are receiving. Patients will receive all 3 medications for either 16 or 24 weeks.
Sofosbuvir + ribavirin in adolescents and children with HCV genotype 2 or 3 NCT02175758 This clinical trial is testing medications that are already available on the market (Sovaldi and ribavirin) in adolescent and pediatric patients who have chronic HCV infection of genotypes 2 or 3. Patients enrolled in this trial will know what treatment they are receiving.
Asunaprevir + daclatasvir with or without BMS-791325 in patients with both HIV and HCV infection NCT02124044 BMS-791325 is an investigational drug that may help boost the effectiveness of the combination of asunaprevir and daclatasvir. In this trial, half of patients will receive asunaprevir + daclatasvir + placebo, and the other half of patients will receive asunaprevir + daclatasvir + BMS-791325. Every patient in this trial receives active medication.
Ledipasvir + sofosbuvir versus combinations including GS-9857 and GS-5816 NCT02202980 This clinical trial is testing compounds known as pan-genotypic inhibitors that are expected to work against a wider variety of HCV genotypes. Patients enrolled in this trial will know what treatment they are receiving. Treatment will last from 4 to 24 weeks, depending on which treatment is administered.
Ledipasvir + sofosbuvir in patients who have received kidney transplants and also have chronic HCV infection NCT02251717 This clinical trial is testing medications that are already available on the market (Harvoni) in patients who have chronic HCV infection. Patients enrolled in this trial will know what treatment they are receiving. Treatment will last either 12 or 24 weeks, depending on assignment.
Ledipasvir + sofosbuvir in adolescents and children with chronic HCV infection NCT02249182 This clinical trial is testing  medications that are already available on the market (Harvoni) in children and adolescents who have chronic HCV infection. Although this trial does have a placebo group, patients enrolled in this trial will know what treatment they are receiving.
Ledipasvir + sofosbuvir in patients with genotype 1 HCV infection (both treatment-experienced, and treatment-naïve patients) NCT02219685 This clinical trial is testing medications that are already available on the market (Harvoni) in adults with genotype 1 chronic HCV infection.

Investigators will be studying the effect of treatment on cognition. This is a double-blind study, meaning it is possible you will receive a placebo. Approximately 1 in 3 patients will receive placebo.
HCV = hepatitis C virus.

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