Effect of Strategies for the Treatment of Chronic Hepatitis C in Colombia

Summary

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.

Conditions

• Hepatitis C

Interventions

OTHER

Health care under the strategic purchase-Clinical pathway

1\) purchase of DAA by the MoHSP; 2) diagnosis of the patient (confirmed by quantitative HCV RNA test); 2) prescription of the treatment by a specialist in internal medicine, hepatology or Infectious disease; 3) daily supervised drug administration by a nurse or weekly treatment dispensing by pharmacist; 4) Pharmaceutical Care (includes: consultation with pharmacist at weeks 0, 4, week of the end of treatment (8, 12 or 24) and week of evaluation of effectiveness (week 12 or 24 after the end of treatment); health education and administrative support. In case of identifying any Drug-related Problem, the respective pharmaceutical intervention was made.

OTHER

Usual care process prior strategic purchase-clinical pathway

1\) diagnosis of the patient (confirmed by quantitative HCV RNA test); 2) prescription of the treatment by a specialist in hepatology; 3) weekly treatment dispensing by pharmacist; 4) patient use; 5) Pharmaceutical Care (includes: consultation with pharmacist at weeks 0, 4, 8, week of the end of treatment (12 or 24) and week of evaluation of effectiveness (week 12 or 24 after the end of treatment); health education and administrative support). In case of identifying any Drug-related problem, the respective pharmaceutical intervention was made.

Sponsors & Collaborators

• Universidad de Antioquia

  lead OTHER

Principal Investigators

• Mónica Ledezma, Msc · Universidad de Antioquia

• Pedro Amariles, PhD · Universidad de Antioquia

• Andrea Salazar, PhD · Universidad de Antioquia

Study Design

Allocation

NON_RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-04-01

Primary Completion

2020-07-31

Completion

2020-11-30

Countries

• Colombia

Study Locations