Phase 4
N=34
Immunologic Effects of HCV Therapy With HARVONI in HCV Genotype 1 Chronically Mono-infected Active and Former IDUs
Hepatitis C
Bottom Line
View on ClinicalTrials.gov: NCT02347345 ↗Enrolled (actual)
34
Serious AEs
2.9%
Results posted
Aug 2019
Primary outcome: Primary: sCD14 (ng/mL) — 1986; 1918; 1542; 2060 ng/mL — p=0.07
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Harvoni (Fixed dose combination ledipasvir/sofosbuvir) (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rockefeller University
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY sCD14 (ng/mL) |
1986; 1918; 1542; 2060; 1805; 2036 | 0.07 |
| SECONDARY Virologic Response to Therapy as Measured by HCV RNA |
7781148; 2320026; 0; 0; 0; 0 | — |
| SECONDARY Gene Expression Profiles |
9; 11; 12; 9; 11; 9 | — |
Summary
The investigator's hypothesis is that active injectors will show a partial reduction in markers of immune activation with HCV therapy whereas non-injectors will show a more significant reduction in these markers, and will exhibit levels of immune activation that approach that seen in similarly studied healthy volunteers.This is based on observations that this group of investigators have made. They have shown that individuals who inject drugs have high level of immune activation in blood and tissue. Immune activation or chronic inflammation has been associated with accelerated aging, cardiovascular, renal and liver disease as well as CNS dysfunction. It remains unclear whether increased levels of immune activation are due to non-sterile injection of drugs, chronic infection with Hepatitis C, chronic opiate use, or perhaps combinations of all 3. To understand the potential contribution of infection with Hepatitis C the investigators will compare levels of immune activation pre- and post treatment with an all oral, one pill once daily, interferon sparing treatment of HCV in 2 groups of chronically HCV infected patients- one actively injecting with drugs and the other free of injection for at least 4 months. Immune activation comparisons will also include non-injecting healthy volunteers.
Eligibility Criteria
Inclusion Criteria
- Ability to give written informed consent in English
- Age≥18 and ≤55
- HCV antibody positive
- HCV RNA >1,000 copies/mL plasma
- HCV treatment naive
- HCV genotype 1a or 1b or mixed type 1
- AST, ALT 50,000
- Creatinine clearance >30mL/min as estimated by Cockroft Gault
- Hemoglobin >10 if female, >11 if male
- Albumin > 2.8
- INR<2.0
- If Group A: urine dip for opiates + and active injection drug use of heroin defined as injecting at least 3 times per week.
- If Group B then no IDU for at least 4 months and a negative urine for opiates at screening.
- Venous access for phlebotomy
- Willingness to agree to effective contraception during the course of the study.
- If Group C: - negative urine for opiates at screening
- no recreational drug use for at least 2 years (excluding marijuana)
- HIV, HCV and HBV uninfected
Exclusion Criteria
- HIV infection
- Chronic infection with Hepatitis B
- Uncompensated cirrhosis
- Required use of:
Anticonvulsants: carbamazepine, oxycarbazepine, phenobarbital, and phenytoin
Antimycobacterials: rifabutin, rifampin, rifapentine
Herbal Supplements: St. John's wort
HIV Protease Inhibitors: tipranavir-ritonavir
Antiarrhythmic Drugs: amiodarone (Cordarone, Nexterone, Pacerone)
- Any medical condition that in the opinion of the investigator would interfere with study participation and medical adherence
- Pregnancy/breast feeding
-
Data sourced from ClinicalTrials.gov (NCT02347345). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.