Treatment for type 3 chronic hepatitis C virus infection: comparing 12 and 24 weeks of antiviral drugs - is longer therapy worthwhile?

Phase 1

• Conditions: Adult patients chronically infected with genotype 3 hepatitis C virus with cirrhosis; MedDRA version: 20.0 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2016-000599-87-GB
• Lead Sponsor: Queen Mary University of London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-27
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

•Voluntarily signed informed consent form
•Aged 18 years or older
•Chronic HCV infection, defined by anti-HCV antibody or HCV RNA detection for greater than 6 months
•Infected with genotype 3 HCV (identified by referring hospital)
•Meets NHS England treatment criteria to commence sofosbuvir/velpatasvir
•Pre-treatment HCV RNA >10,000 iu/mL (can be any time before treatment week 0)
•HCV RNA > or equal to 30 iu/mL at treatment week 2 (+/- 3 days)
•Has cirrhosis defined by: evidence of portal hypertension, OR APRI >2 plus AST:ALT ratio >1, OR radiological evidence of cirrhosis, OR fibroscan score >11.5kPa, OR liver biopsy showing cirrhosis
•Patients with decompensated cirrhosis (variceal bleeding, ascites and encephalopathy) can be included
•Patients with malignancy including hepatocellular carcinoma can be included
•Patients with liver transplant can be included
•Patients coinfected with chronic hepatitis B virus or human immunodeficiency virus can be included
•Female subjects of childbearing potential must have documented negative pregnancy test prior to enrolment (negative urinary pregnancy test), and if engaged in heterosexual intercourse must use protocol specified method of contraception (see below) during study drug treatment and for 30 days after last dose
•Male subjects engaged in heterosexual intercourse with a female of childbearing potential should protocol specified method of contraception during study drug treatment and for 30 days after last dose

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

•Any of the above inclusion criteria not met
•Any of the following criteria excludes a subject from enrolling into this study
•Clinically-significant medical or psychiatric illness (other than chronic HCV) in the past, present, or being evaluated, that may interfere with participant treatment, safety, assessment or compliance with the protocol.
•Severe renal impairment with eGFR <30 mL/min/1.73m2 or requiring dialysis
•Alcohol consumption or illicit drug abuse likely to interfere with participant treatment, safety, assessment or compliance with protocol, as deemed by the investigator
•Previous exposure to sofosbuvir (or other NS5B inhibitor) or NS5A inhibitor
•Severe allergy to study drugs, its metabolites or formulation excipient (see SmPC for details)
•Any investigational medicinal product = 6 weeks prior to treatment start
•Pregnant or nursing female, or males wishing to conceive during the period of study treatment + 30 days after
•Patients who adhered to less than 90% of prescribed sofosbuvir/velpatasvir at screening
•In accordance with the SmPC of sofosbuvir/velpatasvir concomitant use of the following medications are contraindicated:

Anticonvulsants - carbamazepine, phenytoin, phenobarbital, oxcarbazepine
Antimycobacterials – rifampicin, rifabutin, rifapentine
Antiretrovirals - efavirenz
St John’s wort
Modafinil
Proton-pump inhibitors should be avoided and if necessary, should be administered 4 hours after at maximum doses equivalent to 20mg omeprazole per day.
Amiodarone should be avoided and if necessary, close monitoring is required

Please consult the SmPC and Section 15.16 and 17 for list of medications to be used with caution or monitoring.

Participants taking these medications must have discontinued prior to starting sofosbuvir/velpatasvir (this is expected to be in line with standard care practice). Definition of child-bearing potential and effective contraception:

Subjects are considered not of child-bearing potential if they are surgically sterile (undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal (women aged = 45 years of age with cessation of previously occurring menses for = 12 months) or they have medically-documented ovarian failure.

Effective contraception include:
•True abstinence: when this is in line with the preferred and usual lifestyle of the subject (Periodic abstinence, e.g. calendar, ovulation, symptothermal, post-ovulation methods, declaration of abstinence for the duration of the trial, and withdrawal are not acceptable methods of contraception)
•Male partner vasectomy or other medical condition causing azoospermia
•Male partner using condom
•Intrauterine device
•Female barrier method (cervical cap or diaphragm with spermicidal agent)
•Tubal sterilisation
•Levonorgestrel implant
•Injectable progesterone
•Oral contraceptive (combined or progesterone only)
•Contraceptive vaginal ring
•Transdermal contracep

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified