STOP HCV-1 – Stratified Treatment Optimisation for HCV-1

Not Applicable

Completed

• Conditions: Infections and Infestations; Specialty: Infectious diseases and microbiology, Primary sub-specialty: Infectious diseases and microbiology (migration; Hepatitis C infection; UKCRC code/ Disease:

• Registration Number: ISRCTN37915093
• Lead Sponsor: Imperial College London

Brief Summary

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34405118/ (added 19/08/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34723451/ (added 19/05/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-14
• Study Completion: 2019-11-01
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 202

Inclusion Criteria

1. Aged =18 years
2. Infected with HCV genotype 1a or 1b with HCV RNA >LLOQ (lower limit of quantification) on more than one occasion at least six months previously with no intervening results showing undetectable viraemia
3. Plasma HCV RNA >LLOQ at screening
4. No evidence of significant liver fibrosis resulting from any aetiology (defined as Fibroscan* score =7.1kPa, equivalent to F0-F134, within 180 days prior to planned randomisation or biopsy consistent with mild fibrosis (Ishak score <=2/6) within 180 days prior to planned randomisation)
5. BMI >=18kg/m2
6. Laboratory tests: platelets >=60x109/l, haemoglobin >12g/dl (male) or >11g/dl (female), creatinine clearance (estimated glomerular filtration rate (eGFR) (Cockcroft-Gault)) >=60ml/min, international normalised ratio (INR) <1.5xULN
7. Screening HCV viral load <10,000,000IU/ml
8. Written informed consent obtained from the patient

If HIV infected, then an additional eligibility criteria is:
9. On antiretroviral therapy with HIV viral load <50 copies/ml for >24 weeks at the screening visit

Exclusion Criteria

1. Previous direct acting antivirals (DAA) exposure (previous treatment with pegylated-interferon and/or ribavirin allowed)
2. Malignancy within 5 years prior to screening
3. Any condition in the judgement of the investigator which might limit the patient’s life expectancy
4. Currently receiving medication know to interact with study medication (ombitasvir, paritaprevir, dasabuvir, ritonavir, sofosbuvir, ledipasvir, ribavirin; see relevant prescribing information
8. Disorder which may cause ongoing liver disease including, but not limited to, active hepatitis B, ongoing alcohol misuse
5. Any disorder which in the opinion of the investigator may have a significant negative impact on the ability of the patient to adhere to the trial regimen
6. Use of other investigational products within 60 days of screening
7. Known hypersensitivity to any active ingredient and/or excipients of the study medicines, namely Microcrystalline cellulose, Lactose monohydrate, Croscarmellose sodium, Magnesium stearate, Gelatine, Shellac, Propylene glycol, Polyethylene glycol, Ammonium hydroxide, Pregelatinised maize starch, Sodium starch glycolate (type A), Maize starch, Hypromellose, Talc, Ethylcellulose aqueous dispersion, Triacetin, Copovidone, Colloidal anhydrous silica, Polyvinyl alcohol, Macrogol 3350, Sunset yellow FCF aluminium lake (E110), Colouring agent (E132), Titanium dioxide (E171), Yellow iron oxide (E172), Red iron oxide (E172), Black iron oxide (E172).
8. History of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease, in the previous six months
9. Haemoglobinopathies (e.g., thalassemia, sickle-cell anaemia)

Female participants only:
1. Lactating, or pregnant, or planning to become pregnant during the study or within 4 months of the end of the study, or not willing to use effective contraception during the study and for four months after last dose of study medication
2. Currently taking ethinyl-oestradiol-containing medicinal products such as those contained in most combined oral contraceptives or contraceptive vaginal rings

Male participants only:
Planning pregnancy with female partner during the study or within 7 months of the end of the study, or not willing to use effective contraception during the study and for seven months after last dose of study medication

Study & Design

• Study Type: Interventional
• Study Design: Not specified