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

NCT02339038 | Completed Phase 4 Results FDA Drug

• 3 other identifiers: 15N06415-CC-N064999915064
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

HCV HIV

Keywords

Community Based Research; Hepatitis C Virus and Human Immunodeficiency Virus; Ledipasvir/Sofosbuvir; Fixed Dose Combination; Sustained Viral Response

Outcome Measures

Primary Outcomes (1)

• Number of Subjects Who Achieve Sustained Viral Response (SVR12) 12 Weeks After the Stop of Treatment Drugs

  The primary outcome was the number of patients with sustained viral response measured 12 weeks after the stop of treatment. The viral response was assessed by serum HCV RNA concentrations lower than the limit of quantification (\<15IU/mL).

  At least 12 weeks after completion of medication

Study Arms (1)

Standard of Care

OTHER

Standard of care treatment using Ledipasvir 90 mg and Sofosbuvir 400 mg fixed dose combination by mouth daily for 2, 3, or 6 months

Drug: Ledipasvir 90 mg and Sofosbuvir 400 mg

Interventions

Ledipasvir 90 mg and Sofosbuvir 400 mg DRUG

Ledipasvir 90 mg and Sofosbuvir 400 mg fixed dose combination as per standard of care treatment guidelines

Also known as: Harvoni

Standard of Care

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• Documentation of genotype 1 (GT-1) infection, liver fibrosis staging by any AASLD/IDSA guideline approved measurement, and HIV status determination.
• 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
• Compensated liver disease, both with and without cirrhosis, as determined clinically by referring provider
• If coinfected with HIV, stable HIV disease as determined by a treating provider
• 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.

You may not qualify if:

• Women who are pregnant or breastfeeding
• 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)
• Diagnosis of hepatocellular carcinoma as defined by pre-screening medical history
• Any other conditions in the opinion of the investigator that would interfere with the compliance or endpoints of the study.

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (2)

Unity Health Care, Inc./DC General

Washington D.C., District of Columbia, 20002, United States

Location

Family Medical and Conseling Services

Washington D.C., District of Columbia, 20020, United States

Location

Related Publications (4)

• Mohd Hanafiah K, Groeger J, Flaxman AD, Wiersma ST. Global epidemiology of hepatitis C virus infection: new estimates of age-specific antibody to HCV seroprevalence. Hepatology. 2013 Apr;57(4):1333-42. doi: 10.1002/hep.26141. Epub 2013 Feb 4.

  PMID: 23172780 BACKGROUND

• Denniston MM, Jiles RB, Drobeniuc J, Klevens RM, Ward JW, McQuillan GM, Holmberg SD. Chronic hepatitis C virus infection in the United States, National Health and Nutrition Examination Survey 2003 to 2010. Ann Intern Med. 2014 Mar 4;160(5):293-300. doi: 10.7326/M13-1133.

  PMID: 24737271 BACKGROUND

• Branch AD, Van Natta ML, Vachon ML, Dieterich DT, Meinert CL, Jabs DA; Studies of the Ocular Complications of AIDS Research Group. Mortality in hepatitis C virus-infected patients with a diagnosis of AIDS in the era of combination antiretroviral therapy. Clin Infect Dis. 2012 Jul;55(1):137-44. doi: 10.1093/cid/cis404. Epub 2012 Apr 24.

  PMID: 22534149 BACKGROUND

• Kattakuzhy S, Gross C, Emmanuel B, Teferi G, Jenkins V, Silk R, Akoth E, Thomas A, Ahmed C, Espinosa M, Price A, Rosenthal E, Tang L, Wilson E, Bentzen S, Masur H, Kottilil S; ASCEND Providers. Expansion of Treatment for Hepatitis C Virus Infection by Task Shifting to Community-Based Nonspecialist Providers: A Nonrandomized Clinical Trial. Ann Intern Med. 2017 Sep 5;167(5):311-318. doi: 10.7326/M17-0118. Epub 2017 Aug 8.

  PMID: 28785771 DERIVED

MeSH Terms

Conditions

Hepatitis C; Acquired Immunodeficiency Syndrome

Interventions

ledipasvir; Sofosbuvir; ledipasvir, sofosbuvir drug combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; HIV Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Limitations and Caveats

Although primary outcome is complete, the study remains active for prolonged observation and numerous secondary outcomes, with a projected closure date in 2025.

Results Point of Contact

• Title: Masur, Henry
• Organization: NIH Clinical Center

HMasur@cc.nih.gov

+1 301 496 9320

Study Officials

• Henry Masur, M.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2015
• First Posted: January 15, 2015
• Study Start: January 7, 2015
• Primary Completion: June 15, 2016
• Study Completion: July 13, 2018
• Last Updated: August 14, 2018
• Results First Posted: July 12, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)