Effectiveness of HCV treatment by non-specialists (general practicioners or family-doctors) compared to specialists (hepatologists, gastroenterologists or infectious disease doctors) in the brazilian public health system

Randomized open-label and non-inferiority clinical trial to evaluate treatment retention, safety and cost-effectiveness of simplified and decentralized HCV treament compared to standard-of-care in the brazilian public health system

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

REBEC

Registry ID

RBR-4qmypqq

Enrollment

Unknown

Registered

2021-10-01

Start date

2021-12-01

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C

Interventions

Experimental arm (n=70): treatment by non-specialists (GP/family-doctors) using sofosbuvir/velpatasvir (SOF/VEL) 400/100 mg 01 tablet daily po for 12 weeks Control arm (n=70): treatment by specialist

B18.2

D03.383.742.686.850.877.500

Eligibility

Age

18 Years to 79 Years

Inclusion criteria

Inclusion criteria: Age between18 and 79 years-old; presence of chronic hepatitis C

Exclusion criteria

Exclusion criteria: Pregnancy; HBV co-infection; HIV co-infection; use of medications with potential interaction with SOF/VEL; presence of acute disease, neoplasm, solid organ transplant or use of immunossupressor; presence of clinical signs of decompensated cirrhosis; refusal to participate

Design outcomes

Secondary

Measure	Time frame
Incidence rate of adverse events during treatment with sofosbuvir/velpatasvir 400/100 mg po daily during 12 weeks;Rates of unplanned clinical visits during treatment and monitoring (48 weeks);Rates of retention to chronic hepatitis C treatment measured by number of attendance to scheduled clinical visits and self reported missed doses;Cost per case of sustained virological response (SVR) case	—

Primary

Measure	Time frame
Proportion of participants with sustained virological response 12 weeks after end-of-treatment (SVR12)	—

Countries

Brazil

Contacts

Public ContactHugo Perazzo

hugo.perazzo@ini.fiocruz.br++5521 3865-9587

Outcome results

None listed

Source: REBEC (via WHO ICTRP)