Why use HCV Therapy Selector?
HCV Therapy Selector is an uniquely handy and complete source of information for the physician and his patient with hepatitis C to select the best fitting treatment. Guideline recommendations indicate which therapies according to experts are eligible for a particular patient profile.
HCV Therapy Selector provides patient profile specific information about the likelihood of cure of hepatitis C infection for all published treatment regimens of FDA and EMA approved drugs, and treatment-specific information about side effects, costs and reimbursement. The cure rates are based on data from phase 2, phase 3 and prospective real-life clinical studies and statistical processing.
HCV Therapy Selector is developed by the completely independent LiverDoc organisation, in collaboration with Erasmus Medical Center Rotterdam, the Netherlands Association for the Study of the Liver (NASL), and ExpertDoc.
LiverDoc and ExpertDoc make clinical decision support products to bring unbiased academic knowledge to the busy physician and informed choice to the patient.
Funding of the HCV Therapy Selector has come from LiverDoc’s own resources without contributions of the pharmaceutical industry.
How is HCV Therapy Selector constructed?
HCV Therapy Selector connects patient profiles, published treatment combinations and clinical study results.
Patient profiles for chronic HCV infection are based on characteristics crucial for treatment decision making: HCV genotype 1-6, stage of cirrhosis (no/Child A/Child B-C), previous treatment (no/(peg)interferon/sofosbuvir), thereby creating 54 patient profiles. Special comorbidity like HIV co-infection, HBV co-infection, liver transplant, renal failure increases the number of patient profiles further.
Published treatment combinations concern all published treatment combinations based on drugs approved by the FDA and European Medicines Agency.
Study results (cure of infection: HCV RNA not detectable 12-24 weeks after stopping antiviral therapy=SVR) were obtained from published preregistration clinical trials as well as prospective real-life postregistration studies with at least 8 patients with a specific treatment regimen. From each publication, data (total number of patients treated and SVR evaluable, and number of patients with SVR) were extracted per patient profile. Regularly supplementary data had to be obtained from the first author or study sponsor. After an internal and external check the data were entered into a certified SQL database.
The cure rate (% SVR) was calculated by a computer program, which aggregated the data from various studies for each patient profile - treatment regimen combination, and then divided the number of persons with a cure x 100 by the number of evaluable persons. In addition, all data of more than 30000 patients were used in a meta-analysis (M.A.) to estimate the SVR percentages and its 95% predictive interval for each specific combination of patient profile – therapy regimen.
Quality of evidence was graded according to a simple system: ‘high’ (at least 80 patients, data from two or more studies), ‘moderate’ (at least 40 patients or 80 patient data from one study) and ‘low’
(less than 40 patients).
Adverse effects are shown if such effects are clinically relevant by its severity or by a higher frequency than in placebo-controlled trials.
Costs and reimbursement information are derived from robust sources like www.hepatitisc.uw.edu (USA), www.journal-officiel.gouv.fr (FR), www.riziv.fgov.be (BE), www.g-ba.de (DE), www.agenziafarmaco.gov.it, and www.medicijnkosten.nl (NL).