Community-based Treatment of Chronic Hepatitis C Monoinfection and Coinfection With HIV in the District of Columbia

• Status: Completed
• Trial end date: 2018-07-13
• Target enrollment: 0
• Participant gender: All

Summary

Background:

• Treatment for Hepatitis C has changed a lot in the past 2 years. Most of this change comes from a combination of medicines that is yielding high cure rates. But its long-term effects are uncertain. One problem is that a lot of people need the treatment, but only a few specialists can give it. The success rate for Hepatitis C treatment by primary care doctors, nurse practitioners, or physician assistants is largely unknown. Researchers want to see how provider type affects treatment outcomes. They will conduct a large, community-based study in the District of Columbia.

Objectives:

• To see if people can be treated for Hepatitis C safely and successfully in community-based health centers.

Eligibility:

• Adults who need treatment for chronic Hepatitis C infection.

Design:

• Participants will be screened with blood tests. Their current medicines will be reviewed.

• Participants will give researchers access to their medical records. Researchers will follow participants through these records.

• Participants will see a primary care or infectious disease provider. The provider will tell them about their treatment. They will be told how often they will visit the provider and how often they will have their blood drawn. They will get a calendar of study visits.

• Participants will take Harvoni for 8, 12, or 24 weeks. They will visit their care provider monthly.

• Participants will have monthly follow-up visits for up to 3 months after they finish their medicine.

• Participants will have yearly follow-up visits with their care provider for up to 10 years.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institutes of Health Clinical Center (CC)
• Treatments: Ledipasvir; Ledipasvir, sofosbuvir drug combination; Sofosbuvir

Criteria

• INCLUSION CRITERIA:

1. Male or female at least 18 years of age at time of screening who is determined to be eligible based on evaluation by a treating provider,

2. Documentation of genotype 1 (GT-1) infection, liver fibrosis staging by any AASLD/IDSA guideline approved measurement, and HIV status determination.

3. Chronic HCV genotype-1 infection prior to study enrollment. Chronic HCV-infection is defined as the following: positive for anti-HCV Ab or HCV RNA at least 6 months before screening, and positive for HCV RNA and anti-HCV Ab at the time of screening

4. Compensated liver disease, both with and without cirrhosis, as determined clinically by referring provider

5. If coinfected with HIV, stable HIV disease as determined by a treating provider

6. Subjects must be able to understand and adhere to the study visit schedule and all other protocol requirements, and must voluntarily sign and date an informed consent form, approved by an Institutional Review Board (IRB), prior to the initiation of any screening or study specific procedures.

EXCLUSION CRITERIA:

1. Women who are pregnant or breastfeeding

2. Screening laboratory analyses showing any of the following abnormal laboratory results:

• Estimated Glomerular Filtration Rate (eGFR) < 30 mL/min as estimated by the Modification of Diet in Renal Disease (MDRD) equation (utilized by LabCorp):

eGFR = 175 times SerumCr(-1.154) age(-0.203 1.212 (if patient is black) 0.742 (if female)

3. Diagnosis of hepatocellular carcinoma as defined by pre-screening medical history

4. Any other conditions in the opinion of the investigator that would interfere with the compliance or endpoints of the study.