Hepatitis C Clinical Trial
— HEPCSTRATEGYOfficial title:
Effect of Strategic Purchasing of Antiviral Drugs and the Clinical Pathway for the Treatment of Chronic Hepatitis C in Colombia
Hepatitis C is a public health problem and the high cost of the Direct-Acting Antivirals
(DAA) is one of the main limitations for treatment worldwide.
In Colombia, the Ministry of Health and Social Protection (MoHSP) has made progress in
addressing Hepatitis C problem in order to control the infection and resolve barriers to
access to medicines. One of the strategies implemented was the purchase of DAA, in
association with the PAHO, and the instauration of the Clinical Pathway for the treatment of
chronic hepatitis C.
The implementation of the Clinical Pathway has required the integration of health care
processes and the respective report in the health information systems, allowing a high level
of control in the monitoring of the Hepatitis C and the subsequent generation of indicators.
However, there is limited information on the effects of the strategic purchase and the
instauration of the Clinical Pathway on the costs of care, clinical outcomes and the quality
of health care for patients with Hepatitis C in Colombia.
The aim of this study is to establish the effect of strategic purchasing and the Clinical
Pathway for the treatment of chronic Hepatitis C, in the clinical results, in the general
costs and quality of health care of Hepatitis C patients in Colombia.
Status | Recruiting |
Enrollment | 124 |
Est. completion date | November 30, 2020 |
Est. primary completion date | July 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients diagnosed with Chronic Hepatitis C confirmed by quantitative HCV RNA test - Patient affiliated to the contributory system of one Health Promoting Enterprise from Colombia. - Patients with prescription of pharmacological treatment for Hepatitis C. Exclusion Criteria: - Patients with incomplete information in at least one of the following variables: fibrosis, cirrhosis (if applicable), antiviral drug. |
Country | Name | City | State |
---|---|---|---|
Colombia | Medicarte | Medellín | Antioquia |
Lead Sponsor | Collaborator |
---|---|
Universidad de Antioquia |
Colombia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Access to treatment | Proportion of patients who initiates treatment, in comparison with the total number of patients with indication of treatment (confirmed diagnosis and prescription of treatment). | 2 months | |
Secondary | Opportunity at the start of treatment | The difference in days between the date of the first prescription of the antiviral treatment and the start date. | 2 months | |
Secondary | Effectiveness | Proportion of treated patients that achieved Sustained Virological Response (SVR), that is, undetectable HCV viral load (lower than the Lower Quantification Limit -LL-), 12 weeks after the end of the DAA therapy (SVR12) or 24 weeks after the end of treatment for the schemes that include interferon (SVR24) | 6 months | |
Secondary | Drug-related problem | Proportion of patients who initiated treatment and who presented at least one Drug-Related Problem registered in the clinical history, database and / or pharmacovigilance reports. | 6 months |
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