Chronic Hepatitis CNCT04039698
Monitoring of Hepatitis C Treatment Using Telemedicine - a Clinical Trial in Public Health System in Brazil
A study testing Telemedicine and Velpatasvir/Sofosbuvir in people with Chronic Hepatitis C, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- Telemedicine and Velpatasvir/Sofosbuvir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteBrazil
- Study dates
- 23 Aug 2019to Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-007
About this study
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
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.
Read the 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.
- Conditions
- Chronic Hepatitis C
- Being tested
- Telemedicine, Velpatasvir/Sofosbuvir
- Keywords
- Hepatitis C, Telemedicine, Direct acting antivirals, Public Health
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelemedicineOther
Telemedicine monitoring and teleconsultation by video calls
Velpatasvir/SofosbuvirDrug
Also called Epclusa
Velpatasvir 100mg / Sofosbuvir 400mg once a day for twelve weeks
| Study group | Role | What they receive |
|---|---|---|
| Telemedicine | Experimental | Sofosbuvir 400mg and velpatasvir 100mg qd for 12 weeks Telemedicine support Receives: Other: Telemedicine; Drug: Velpatasvir/Sofosbuvir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained virologic response
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
Measured: 12 weeks post end of antiviral therapy (SVR12)
Secondary outcomes (4)
Adherence to antiviral treatment
Proportion of patients with treatment completion
Measured: 12 weeks after antiviral treatment initiation
Patient satisfaction with the treatment
Patient satisfaction with the telemedicine support measured by a a questionnaire applied to all participants
Measured: 12 weeks post end of antiviral therapy (SVR12)
Adverse effects
Incidence of adverse effects related to treatment reported by patients
Measured: 12 weeks post end of antiviral therapy (SVR12)
Severe adverse effects
Incidence of severe or life threatening (grade 3 or 4) adverse effects related to treatment reported by patients
Measured: 12 weeks post end of antiviral therapy (SVR12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start23 Aug 2019
- Primary completion16 Dec 2020
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Brazil, State Secretary of Health of Rio Grande do Sul, TelessaúdeRS / UFRGS
- Responsible party
- Sponsor
- Investigators
- Mario R Alvares-da-Silva, PhD, Study chair, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04039698
- Sponsor's protocol ID
- 2018-0290
- Other IDs
- Plataforma Brasil (CAAE)
- Status last verified
- Aug 2021
- First submitted
- 30 Jul 2019
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to open data that might be useful for policy makers, specially in Brazil, and for researchers interested in replicate the study.
Publications
Oliveira JC, Schacher FC, Costa MB, Kolling MG, Costa RB, Scherer HC, Fernandes PM, Katz N, Goncalves MR, Rados DV, Alvares-da-Silva MR. TeleHCV: A single-visit protocol and minimal passive remote monitoring are sufficient to achieve high SVR with a sofosbuvir-velpatasvir regimen. Clinics (Sao Paulo). 2025 Apr 23;80:100643. doi: 10.1016/j.clinsp.2025.100643. eCollection 2025.
PubMed 40273497
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04039698
- Acronym / sponsor ID
- 2018-0290
- Conditions
- Chronic Hepatitis C
- Keywords
- Hepatitis C, Telemedicine, Direct acting antivirals, Public Health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Ministry of Health, Brazil, State Secretary of Health of Rio Grande do Sul, TelessaúdeRS / UFRGS
- Study start
- 23 Aug 2019 (actual)
- Primary completion
- 16 Dec 2020 (actual)
- Study completion
- Nov 2021 (estimated)
- First posted
- 31 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telemedicine | Experimental | Other: Telemedicine, Drug: Velpatasvir/SofosbuvirSofosbuvir 400mg and velpatasvir 100mg qd for 12 weeks Telemedicine support |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelemedicineTelemedicine monitoring and teleconsultation by video calls | Other | Telemedicine |
| Velpatasvir/SofosbuvirAlso: EpclusaVelpatasvir 100mg / Sofosbuvir 400mg once a day for twelve weeks | Drug | Telemedicine |
Primary outcome
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
4 secondary outcomes
Adherence to antiviral treatment
Time frame: 12 weeks after antiviral treatment initiation
Patient satisfaction with the treatment
Time frame: 12 weeks post end of antiviral therapy (SVR12)
Adverse effects
Time frame: 12 weeks post end of antiviral therapy (SVR12)
Severe adverse effects
Time frame: 12 weeks post end of antiviral therapy (SVR12)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
- Derived from this study: PubMed 40273497Oliveira JC, Schacher FC, Costa MB, Kolling MG, Costa RB, Scherer HC, Fernandes PM, Katz N, Goncalves MR, Rados DV, Alvares-da-Silva MR. TeleHCV: A single-visit protocol and minimal passive remote monitoring are sufficient to achieve high SVR with a sofosbuvir-velpatasvir regimen. Clinics (Sao Paulo). 2025 Apr 23;80:100643. doi: 10.1016/j.clinsp.2025.100643. eCollection 2025.
- Individual participant dataSharing planned: Yes. We plan to open data that might be useful for policy makers, specially in Brazil, and for researchers interested in replicate the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mario R Alvares-da-Silva, PhD study chair
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine and Velpatasvir/Sofosbuvir in people with Chronic Hepatitis C, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained virologic response (time frame: 12 weeks post end of antiviral therapy (SVR12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04039698, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2021.