Community-based Treatment of Chronic Hepatitis C Monoinfection and Coinfection With HIV in the District of Columbia
Condition: HCV HIV
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Coinfection; Hepatitis
Intervention: Ledipasvir 90 mg and Sofosbuvir 400 mg
Intervention description: Ledipasvir 90 mg and Sofosbuvir 400 mg fixed dose combination as per standard of care treatment guidelines
Intervention MeSH terms: Sofosbuvir; Ledipasvir
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 600.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Community Based Research; Hepatitis C Virus and Human Immunodeficiency Virus; Ledipasvir/Sofosbuvir; Fixed Dose Combination; Sustained Viral Response

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.
    

Eligibility 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.