HCV HIV Clinical Trial
Official title:
A Phase IV Pilot Study to Assess Community-Based Treatment Efficacy in Chronic Hepatitis C Monoinfection and Coinfection With HIV in the District of Columbia
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.
Treatment for hepatitis C has been revolutionized in the last 2 years with the advent of
combination antiviral therapy yielding high cure rates; although, the long term effects of
treatment remain uncertain. Use of these medications has been limited to clinical trial
settings typically by highly specialized care teams in tertiary care hospitals. As the
prevalence of hepatitis C is significant, there exists a significant imbalance between
patients who require treatment and specialists who provide treatment. Success rates in
treatment of hepatitis C by primary care doctors or physician extenders, such as nurse
practitioners or physician assistants, is largely unknown.
As such, we propose the first community-based, large scale, longitudinal study of directly
acting antiviral (DAA)-based treatment for chronic hepatitis C, set in the District of
Columbia. Within this study, approximately 600 HCV genotype 1 monoinfected and HCV/HIV
coinfected subjects will be treated with ledipasvir/sofosbuvir (90 mg/400 mg) fixed dosed
combination for 8-24 weeks, based on the medication labeling instructions, and followed for
both immediate (SVR12) and long term (comorbid disease, cirrhosis, hepatocellular carcinoma,
transplantation and mortality) outcomes over a 10 year study period. The study will be
conducted exclusively in the District of Columbia clinics associated with the NIH DC
Partnership for AIDS/HIV Progress (DC PFAP), which serves a population comprised primarily of
minorities, with a high degree of negative predictors of treatment response. In this study,
participants will be assigned to treatment either by (1) an ID or hepatology specialist, (2)
primary care provider, or (3) physician extender. Please see Figure 1 study schema for an
approximate distribution of subjects. Each of these provider groups will undergo uniform
training on treatment of hepatitis C and management of adverse events prior to initiation of
study. All subjects will sign informed consent and agree to treatment and follow up phases of
the study. During the course of the study, subjcts will be clinically evaluated based on
American Association for the Study of Liver Diseases (AASLD)/ the Infectious Diseases Society
of America (IDSA) guidelines for the management of hepatitis C. Clinical data from subjects
will be captured in a city wide cohort database, which will store guideline-driven data
points from each clinic visit within the network.
Through this trial we will explore the efficacy of managing hepatitis C subjects with
directly acting antiviral therapy in an urban, community-based setting, and investigate the
effect of provider type (specialist, primary care, or physician extender) on treatment
outcome. We will detail the safety and tolerability of this treatment. We will assess
variability in treatment outcomes between monoinfected and HIV-coinfected subjects. Finally,
we will evaluate the public health impact of large-scale treatment of HCV infected subjects
in preventing long-term clinical outcomes. As the first interferon (IFN)- and ribavirin
(RBV)-free, urban community-based treatment utilizing new standard of care criteria, this
study will serve as a model for implementation of similar practice patterns globally.
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