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Current Trials for Hepatitis


Title: Efficacy and Safety of Ledipasvir/Sofosbuvir, With or Without Ribavirin, in HCV Infected Participants Who Have Failed Prior Treatment With Sofosbuvir-based Therapies
(1746 Rescue)

Study contact: Melanie Dean  615-936-1745

Principal Investigator: Michael Porayko, MD

This study will evaluate the efficacy, safety and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) for 12 weeks with or without ribavirin (RBV) in participants without cirrhosis, and LDV/SOF FDC for 12 weeks with RBV or LDV/SOF FDC for 24 weeks without RBV in participants with cirrhosis.

Sponsor: Gilead Sciences

-Eligibility Requirements:

Men and women 18 years of age and older

Inclusion Criteria:

HCV RNA > 15 IU/mL at screening
HCV genotype 1 or 4
Chronic HCV infection (≥ 6 months)
Prior virologic failure after treatment with SOF in combination with simeprevir (SMV) ± RBV or with RBV ± PEG
Cirrhotic and non-cirrhotic as determined by standard methods
Male and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception

Exclusion Criteria:

Prior exposure to approved or experimental non-structural protein (NS5A) inhibitors
Prior exposure to nucleos(t)ide polymerase inhibitors, other than SOF
Pregnant or nursing female or male with pregnant female partner
Coinfection with HIV or hepatitis B virus
Current or prior history of clinical hepatic decompensation
Hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers)
Chronic use of systemic immunosuppressive agents
History of clinically significant illness or any other medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol


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Enrolling by invitation only

Title: A Registry for Subjects With Cirrhosis Who Achieve a Sustained Virologic Response Following Treatment With a Sofosbuvir-Based Regimen Without Interferon for Chronic Hepatitis C Infection
(1431 Registry)

Study Contact: Melanie Dean 615-936-1745

Principal Investigator: Michael Porayko, MD

This Registry will enroll cirrhotic participants with or without decompensated liver disease who have achieved a sustained virologic response (SVR) after receiving a sofosbuvir (SOF)-based regimen without interferon (IFN) while participating in a Gilead-sponsored hepatitis C virus (HCV) study or commercially at selected sites. Once enrolled, participants will be followed for up to 5 years.

Sponsor: Gilead Sciences

Eligibility Requirements:

Ages: 18 years and older

Inclusion Criteria:

·         Willing and able to provide written informed consent

·         Have either previously participated in a Gilead-sponsored HCV study and received a sofosbuvir-containing regimen without interferon OR at pre-selected sites only, have received an all-oral SOF-based regimen outside a clinical study. These individuals must have documentation of the regimen, start and end of treatment dates (month and year), and of having achieved SVR12.

·         Have achieved SVR either in a Gilead-sponsored study, as defined in the treatment protocol OR for individuals who enroll after receiving an all-oral SOF-based regimen outside a clinical study, SVR will be defined as HCV RNA < LLOQ approximately 12 weeks following last dose of treatment.

·         Have liver cirrhosis, as defined in the treatment protocol, and have not had a liver transplant after receiving a SOF-containing regimen OR individuals who enroll after receiving an all-oral SOF-based regimen outside a clinical study, will have had cirrhosis confirmed prior to initiation of HCV treatment.

Exclusion Criteria:

·         Individuals planning to initiate a new course of HCV therapy, including approved products and any investigational agents, during the course of this Registry

·         History of clinically-significant illness or any other major medical disorder that may interfere with the follow-up, assessments, or compliance with the protocol

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