None listed
Conditions
Brief summary
In March 2016, several new, all oral treatments became available in Australia for chronic hepatitis C virus (HCV) infection, bringing the “interferon era” to a close. These new treatments are much easier to take and more effective than the previous standard treatment, which was based on an injected medicine called interferon. Although we know these new treatments are very safe with side effect rates in clinical trials similar to placebo (sugar pills), we don’t know exactly how much monitoring is needed during a course of treatment. A “standard” monitoring plan has recently been developed by Australian experts, but this is based on what we know of the new treatments, and it has never been directly compared with less intensive monitoring. For the old interferon-based treatments, patients had some blood tests and a clinic appointment every 2 to 4 weeks for at least 24 weeks. For the new all-oral treatments, we know that much less intense monitoring is needed, but different monitoring strategies have not been tested in clinical trials. The purpose of SIMPLICITY is to compare “standard monitoring” with “minimal monitoring”, to determine if minimal monitoring results in similar cure rates but with lower cost and better patient satisfaction. The SIMPLICITY trial is being co-ordinated by Associate Professor Joshua Davis, who is based at John Hunter Hospital in Newcastle, and at the Menzies School of Health Research in Darwin. It aims to enrol a total of 100 participants at two sites in Australia (Darwin and Newcastle). There are no medications being given specifically as part of this study. You will receive the same medications whether or not you choose to take part in this study. The only difference between the two study arms is the number of blood tests and clinic visits during your course of treatment.
Interventions
Arm 2: Simplified Monitoring
Patients are treated exactly the same as if they were not in a trial apart from the degree of monitoring (which will be LESS than in the standard arm.
Treatment is with either 12 weeks of Sofosbuvir/Ledipasvir for Genotype 1 hepatitis C virus infection, or Sofosbuvir/Daclatasvir for genotype 3 hepatitis C.
Face to face clinic appointment at base line and prescription dispensing, week 4 phonecall and week 12 phonecall to make sure they are taking their medications an
Arm 2: Simplified Monitoring Patients are treated exactly the same as if they were not in a trial apart from the degree of monitoring (which will be LESS than in the standard arm. Treatment is with either 12 weeks of Sofosbuvir/Ledipasvir for Genotype 1 hepatitis C virus infection, or Sofosbuvir/Daclatasvir for genotype 3 hepatitis C. Face to face clinic appointment at base line and prescription dispensing, week 4 phonecall and week 12 phonecall to make sure they are taking their medications and they are ok. week 24 FBC, EUC, LFTs, HCV qualitative viral load, Week 26 Last clinic appointment conducted in person to get the results of the week 24 blood tests. Phonecalls are perfromed by the nursing staff. Appointments are made by the nursing staff. (Qualatative is the pathology measurement we do we only want to know if the virus is detected or not detected at this satge, we don't want a level measured)
Sponsors
Royal Darwin Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
These are patients who have tested to being positve to the Hepatitis C Virus and further genotype testing performed to decifer if they have either Genotype 1 or 3 as the treatment prescribed is different for each genotype. Treatment naive (cirrhotic or not); treatment experienced (only if non-cirrhotic) – this refers to previous treatment with PEG/Riba but not DAAs Planned to begin treatment with 8 or 12 weeks of Sof/Led or 12 weeks of Sof/Dac but without ribavirin If HIV+ve, must be on a stable, non-interacting antiretroviral regimen for at least 3 months prior to randomisation AND have an undetectable HIV viral load and a CD4 count >=200 cells/microlitre.
Exclusion criteria
Genotype 1 Treatment experienced cirrhotic (because need for 24 weeks treatment and/or ribavirin) Genotype 3 cirrhotic (regardless of Rx experience) – because of the need for 24 weeks treatment Child-Pugh class B or C cirrhotic (i.e. decompensated cirrhosis) Any co-morbidities which, in the opinion of the investigators, needs any special monitoring beyond that in the minimal monitoring arm. High risk of poor adherence (a subjective measure, as assessed by the investigators)
Outcome results
None listed