Immunologic Effects of HCV Therapy With HARVONI in HCV Genotype 1 Chronically Mono-infected Active and Former IDUs

• Status: Completed
• Trial end date: 2016-11-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Rockefeller University
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Ledipasvir; Ledipasvir, sofosbuvir drug combination; Sofosbuvir

Criteria

Inclusion Criteria:

1. Ability to give written informed consent in English

2. Age≥18 and ≤55

3. HCV antibody positive

4. HCV RNA >1,000 copies/mL plasma

5. HCV treatment naive

6. HCV genotype 1a or 1b or mixed type 1

7. AST, ALT <10x ULN

8. Direct bilirubin <3.0

9. Platelet count >50,000

10. Creatinine clearance >30mL/min as estimated by Cockroft Gault

11. Hemoglobin >10 if female, >11 if male

12. Albumin > 2.8

13. INR<2.0

14. If Group A: urine dip for opiates + and active injection drug use of heroin defined as injecting at least 3 times per week.

15. If Group B then no IDU for at least 4 months and a negative urine for opiates at screening.

16. Venous access for phlebotomy

17. Willingness to agree to effective contraception during the course of the study.

18. 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:

1. HIV infection

2. Chronic infection with Hepatitis B

3. Uncompensated cirrhosis

4. 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)

5. Any medical condition that in the opinion of the investigator would interfere with study participation and medical adherence

6. Pregnancy/breast feeding

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