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Monitoring of Hepatitis C Treatment Using Telemedicine - a Clinical Trial in Public Health System in Brazil

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04039698
Recruitment Status : Recruiting
First Posted : July 31, 2019
Last Update Posted : September 10, 2019
Sponsor:
Collaborators:
Ministry of Health, Brazil
State Secretary of Health of Rio Grande do Sul
TelessaúdeRS / UFRGS
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

Brief Summary:

The study is a non-randomized, single group clinical trial on monitoring hepatitis C therapy using telemedicine. Patients with chronic hepatitis C without cirrhosis will be treated with the pangenotypic regimen of direct acting antivirals sofosbuvir and velpatasvir for 12 weeks after a single visit to the clinic, in which treatment will be prescribed. Patients will be then monitored by telemedicine tools, like instant message application, telephone and video calls and by his or her primary physician when needed. Twelve weeks after treatment conclusion, hepatitis C virus RNA levels will be measured on a blood sample, indicating the cure rate and efficacy of this protocol on HCV treatment.

The primary objective of the study is to address the feasibility and applicability of the usage of telemedicine tools to increase access and monitor HCV treatment with direct-acting antivirals in public health in Brazil.


Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Other: Telemedicine Drug: Velpatasvir/Sofosbuvir Not Applicable

Detailed Description:

Scientific rationale

It`s estimated that 0.7% of the Brazilian population is infected with hepatitis C virus (HCV). In March 2018, the Ministry of Health defined all patients with HCV to be able to receive direct-acting antivirals (DAAs) from the public health system without any charges. Though this "universal-access policy", frequently there are still many obstacles for patients to actually get at the treatment: patients living in cities distant from big centres and underserved by specialized physicians in the country, lack of medical doctors experienced in HCV treatment in the public system, delay between prescription and starting of medications because of administrative issues, and socioeconomic vulnerability among people.

Telemedicine tools are powerful ways of reaching people living distant from big centres, and there are some successful international experiences with hepatitis C treatment in this field, like Project ECHO® (Extension for Community Healthcare Outcomes). In Brazil, there is a national program, geographically located in Porto Alegre, that uses telemedicine to improve healthcare quality in primary care by offering continuous education and teleconsultations (by text or toll-free hotline) to community physicians and other healthcare professionals working in public primary care institutions all over the country.

Primary objective

To address the applicability of telemedicine tools to increase access and monitor HCV treatment with direct-acting antivirals in public health in Brazil.

Research methods

HCV-infected patients in the waiting list for specialized consultation with gastroenterologist or infectious disease physician will be recruited to a meeting that will consist of a HCV lecture followed by individual, focused consultation with medical history, analysis of previous lab results (including fibrosis evaluation by the AST-to-platelets ratio index - APRI) and collection of blood samples. All patients will receive a prescription of pan-genotypic DAA sofosbuvir and velpatasvir regimen for 12 weeks according to the Brazilian Ministry of Health's Treatment Protocol, along with orientations about use and potential side effects and ways to contact the telemedicine centre - mobile phone instant messages and WhatsApp® messages, phone calls and video calls. Issues regarding the administrative process will be held by the study team and medications will be delivered to each patient's city or region at the time they're available.

Before starting treatment, patients will be oriented about treatment administration, its potential side effects and ways of contacting the research team by text messages, phone calls and, when appropriate, teleconsultation by video teleconference with the patient and one of the healthcare professionals of the study. During the treatment course, adverse effects will be monitored and, when present, graded by the Division of AIDS (DAIDS) Table from the National Institutes of Health.

The family physicians working in each patient area will be oriented about this study and HCV treatment. Moreover, they will be invited to join the regular Project ECHO® meetings held by the Brazilian centre located at Porto Alegre. Healthcare professionals also have the toll-free hotline to get in touch with the telemedicine program and investigators. HCV-RNA will be collected 12 weeks after the end of therapy at a local institution next to patient home or city.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Monitoring of Hepatitis C Therapy Using Telemedicine in a Simplified Protocol With Pangenotypic Regimen in Non-cirrhotic Patients - a Single Group Clinical Trial in the National Public Health System in Brazil
Actual Study Start Date : August 23, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

Arm Intervention/treatment
Experimental: Telemedicine
Sofosbuvir 400mg and velpatasvir 100mg qd for 12 weeks Telemedicine support
Other: Telemedicine
Telemedicine monitoring and teleconsultation by video calls

Drug: Velpatasvir/Sofosbuvir
Velpatasvir 100mg / Sofosbuvir 400mg once a day for twelve weeks
Other Name: Epclusa




Primary Outcome Measures :
  1. Sustained virologic response [ Time Frame: 12 weeks post end of antiviral therapy (SVR12) ]
    Proportion of treated patients with undetectable hepatitis C virus RNA levels measured by a real time polymerase chain reaction (PCR) with a lower limit of detection ≤ 12 IU/mL


Secondary Outcome Measures :
  1. Adherence to antiviral treatment [ Time Frame: 12 weeks after antiviral treatment initiation ]
    Proportion of patients with treatment completion

  2. Patient satisfaction with the treatment [ Time Frame: 12 weeks post end of antiviral therapy (SVR12) ]
    Patient satisfaction with the telemedicine support measured by a a questionnaire applied to all participants

  3. Adverse effects [ Time Frame: 12 weeks post end of antiviral therapy (SVR12) ]
    Incidence of adverse effects related to treatment reported by patients

  4. Severe adverse effects [ Time Frame: 12 weeks post end of antiviral therapy (SVR12) ]
    Incidence of severe or life threatening (grade 3 or 4) adverse effects related to treatment reported by patients


Other Outcome Measures:
  1. Rate of primary physicians participation after invitation to project ECHO® [ Time Frame: 12 weeks post end of antiviral therapy (SVR12) ]
    To address the participation rate on Project ECHO® meetings of primary care physicians who referred patients enrolled in the study



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have voluntarily signed the informed consent form;
  • Chronic hepatitis C confirmed by positive HCV-RNA;
  • Have been referred to specialized consultation in gastroenterology or infectious disease in the Brazilian Public Health System in Porto Alegre;
  • Have previous fibrosis staging (eg. liver biopsy, Fibroscan®) or laboratory tests for APRI score calculation.

Exclusion Criteria:

  • Suspicion or diagnosis of cirrhosis based on:
  • Hepatic elastography ≥12.5 kPa on Fibroscan®;
  • APRI score ≥2.0;
  • Clinical, ultrasound or endoscopic evidence of cirrhosis or portal hypertension;
  • Previous HCV treatment with direct acting antivirals;
  • HIV coinfection with antiretroviral treatment incompatible with HCV antivirals;
  • Previous solid organ transplant;
  • Significant comorbidity that may interfere with the HCV treatment
  • Creatinine clearance < 30 mL/min;
  • Platelets < 150.000/mL;
  • Pregnant or breastfeeding female;
  • Woman of childbearing age without use or that does not accept to use effective contraception during treatment and during the 30 days after treatment end;
  • Inability or unwillingness to provide informed consent or abide by the requirements of the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04039698


Contacts
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Contact: Jerônimo C Oliveira, MD +5551994008693 jeronimo.oliveira@telessauders.ufrgs.br

Locations
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Brazil
Hospital de Clínicas de Porto Alegre Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-007
Contact: Jerônimo De Conto Oliveira, MD    51 994008693    jeronimo.oliveira@telessauders.ufrgs.br   
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Ministry of Health, Brazil
State Secretary of Health of Rio Grande do Sul
TelessaúdeRS / UFRGS
Investigators
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Study Chair: Mario R Alvares-da-Silva, PhD Hospital de Clínicas de Porto Alegre
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Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT04039698    
Other Study ID Numbers: 2018-0290
Plataforma Brasil (CAAE) ( Other Identifier: 91278418200005327 )
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We plan to open data that might be useful for policy makers, specially in Brazil, and for researchers interested in replicate the study.
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: starting after the publication
Access Criteria: Researchers or public health policy makers interested in perform analyses to replicate the study or protocol of telemonitoring.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Hospital de Clinicas de Porto Alegre:
Hepatitis C
Telemedicine
Direct acting antivirals
Public Health
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Sofosbuvir
Velpatasvir
Antiviral Agents
Anti-Infective Agents