Hepatitis CNCT03579576
Simplified Antiviral Treatment Strategy for Hepatitis C in Myanmar
An observational study of Hepatitis C and Hepatitis B, run by Right to Care at 3 sites in Burma.
Trial summary
The project will evaluate cost and treatment outcomes of a simplified hepatitis C virus (HCV) testing, treatment and care model integrated with HIV testing and treatment among key affected populations including people who inject drugs (PWID) in Myanmar. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Hepatitis B, HIV Infections
- What is being tested?
- sofosbuvir 400 mg/velpatasvir 100 mg (SOF/VEL) orally once daily for 12 weeks with or without weight-based ribavirin.
- Type of treatment
- Pill or oral medicine
- How many people
- 803 participants
- Where
- 3 sitesBurma
- Study dates
- 20 Dec 2017to 30 Jun 2019
- Phase
- Observational
- 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
Study population: The target population are key population including Female Sex Workers, Men who have sex with men and People Who Use InjecaAll HCV-infected men and women aged 18 years or older. The study population eligible for HCV treatment will be HCV treatment naïve or experienced (pegylated interferon [PegIFN] and ribavirin [RBV] only), HCV-infected men and women aged 18 years or older with HCV genotype 1, 2, 3, 4, 5 or 6, with or without HIV-1 co-infection. Participants with compensated cirrhosis (Child-Pugh Class A) and hepatitis B infection will be eligible for HCV treatment. Patients with decompensated liver cirrhosis (Child-Pugh Class B or C) or prior treatment with HCV DAAs will not be eligible for treatment.
Who may be able to join
- Ability and willingness of participant to provide informed consent.
- Men and women age 18 years.
- Active HCV infection as defined by detectable serum or plasma HCV RNA at any time prior to study entry. Documentation may be obtained from medical records if available. NOTE: If no medical records on HCV infection are available, active HCV infection must be confirmed by a detectable HCV RNA PCR prior to project entry.
- Allowed HCV treatment history:
- HCV treatment naïve defined as not having been previously treated for Hepatitis C infection with any medications approved for the treatment of HCV in any country.
- HCV treatment experienced with interferon with or without ribavirin only (no prior DAA treatment).
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- Chronic Hepatitis B status must be documented by hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb), and hepatitis B core antibody (HBcAb) testing. Participants with positive HBsAg must be already on an active HBV regimen at study entry.
- HIV-1 infection status must be documented as either absent or present, as defined below:
- Absence of HIV-1 infection, as documented by rapid HIV test or HIV-1 enzyme immunoassay (ELISA) test kit, within 60 days prior to entry.
- OR
- Presence of HIV-1 infection, documented by rapid HIV test or HIV-1 ELISA test kit at any time prior to entry.
- OR
- HIV-1 infection confirmed by medical documentation as participant is registered in care at AIDS Center and receiving or preparing to initiate ARV treatment.
- HIV co-infected participants taking ART or planning to initiate ART, should be:
- Tolerating ART for at least 2 weeks without signs of needing to modify or discontinue the ART regimen before initiating HCV treatment.
- AND
- The ART regimen must be a regimen that can be co-administered with SOF/VEL.
- Participants who are assigned to receive ribavirin as part of the treatment protocol must have hemoglobin ≥11.0 g/dL
- For females of reproductive potential who will receive ribavirin, a negative urine pregnancy test (urine -HCG with a sensitivity of <25 mIU/mL) within 48 hours prior to project entry (HCV treatment initiation) must be documented.
- Male and female participants who are able to impregnate or become pregnant (ie, of reproductive potential) and are participating in sexual activity that could lead to pregnancy must agree to practice contraception/birth control as indicated below or agree to not participate in a conception process while on treatment with ribavirin through at least 12 weeks post-treatment.
- Life expectancy >12 months, in the opinion of the site investigator
Who cannot join
- Child-Pugh Score corresponding to Class B or C (decompensated cirrhosis). This requires assessment for encephalopathy and ascites, as well as measurement of serum bilirubin, albumin, and international normalized ratio (prothrombin time).
- Breastfeeding or pregnancy if patient will be receiving ribavirin.
- Known allergy/sensitivity or any hypersensitivity to components of drug(s) or their formulation.
- Acute tuberculosis (TB) infection. They will be followed and offered enrolment when they complete TB treatment.
- Renal impairment defined as estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2 or end-stage renal disease receiving dialysis as treatment with SOF/VEL is contraindicated (https://www.mdcalc.com/mdrd-gfr-equation).
- Unwilling to provide informed consent for participation in the project.
- Prior treatment with any HCV Direct Acting Agents (DAA).
- Unable or unwilling to adhere to the HCV treatment course and monitoring in the opinion of the investigator.
Trial locations and contacts
3 sites in 1 country.
Burma3 sites
Waimaw
Kāchen, Kachin State
Myanmar Liver Foundation Clinic
Mandalay
Myanmar Liver Foundation Charity Clinic
Yangon
About this study
Official title: Demonstration Project on Assessment of Simplified Antiviral Treatment Strategy for Hepatitis C in Myanmar
The project will evaluate cost and treatment outcomes of a simplified hepatitis C virus (HCV) testing, treatment and care model integrated with HIV testing and treatment among key affected populations including people who inject drugs (PWID) in Myanmar.
Read the detailed description
Affected populations will be screened for HCV and HIV and treated with direct a fixed-dose combination of sofosbuvir 400 mg/velpatasvir 100 mg (SOF/VEL) orally once daily for 12 weeks with or without weight-based ribavirin. Before and after completion of the treatment course viral load assessments will be undertaken using low-cost laboratory monitoring for comparison to standard HCV viral load measurement. Up to 800 patients enrolled on treatment will be followed up at 4, 8, 12 and 24 weeks when Sustained Viral Load ( SVL) will be determined. Safety monitoring will be undertaken at applicable visits for those on Ribavirin and all adverse events will be reported based on Good Clinical Practice. In addition to assessing to assessing cost outcomes, the project will assess HCV treatment efficacy in terms of sustained virologic response at 12 weeks after end of HCV treatment (defined as undetected HCV RNA or less than lower limit of detection), compare the cost of low cost HCV viral assay platforms to standard of care, assess rates of ART initiation and virologic suppression of HIV-infected persons within the simplified HCV testing and treatment model and impact of HIV co-infection in participants on the HCV treatment outcome of sustained virologic response (SVR12). The project will be conducted 3 treatment sites in Yangon, Mandalay, and Kachin state in Myanmar.
- Conditions
- Hepatitis C, Hepatitis B, HIV Infections
- Being tested
- sofosbuvir 400 mg/velpatasvir 100 mg (SOF/VEL) orally once daily for 12 weeks with or without weight-based ribavirin.
- Keywords
- PWID, MSM, HCV, HIV
- Medical subject headings
- Hepatitis C, Hepatitis B, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sofosbuvir 400 mg/velpatasvir 100 mg (SOF/VEL) orally once daily for 12 weeks with or without weight-based ribavirin.Drug
Direct Acting anti-HCV drugs given to all HCV infected participants at baseline.Those with Co-infections like HIV and or HBV will be given treatment as per national guidelines.
| Study group | Role | What they receive |
|---|---|---|
| HCV infected patients | All participants found HCV infected with or without HIV will be initiated treatment and followed up until 24 weeks ( 12 weeks after treatment) Receives: Drug: sofosbuvir 400 mg/velpatasvir 100 mg (SOF/VEL) orally once daily for 12 weeks with or without weight-based ribavirin. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated cost of HCV screening per patient screened and per case identified and the cost per successfully treated patient for HCV mono-infected and co-infected participants
The average cost to the provider per patient achieving SVR12 will be estimated, as will the average cost per other outcomes achieved, such as per patient screened and per patient remaining in care by other specified endpoints, stratified by HIV status and by any other important patient or site characteristics that are identified as drivers of cost. The study will also estimate the average cost to "produce" a successful outcome (SVR12), which is the ratio of total costs for the intervention for the entire sample enrolled to the number of patients achieving the primary outcome. This latter estimate captures the costs incurred for patients who do not have successful outcomes and thus relates resource utilization to health outcomes.
Measured: Two years. This will be after data on Viral load response is complete.
Overall Sustained Viral load response (SVR12) across all groups of HCV genotype, fibrosis stage, HIV and HBV co-infection.
This will be the main treatment outcome of all patients initiated on treatment. Baseline viral load is done at entry with treatment initiated for those positive and eligible. Patients initiated on treatment will be assessed for viral load response at 24 weeks ( 12 weeks post treatment). This will also help in development of Care cascade for HCV testing, treatment and SVR12 in key populations co-infected with HIV/HCV, HIV/HCV/HBV, HBV/HCV and HCV mono-infected.
Measured: 24 weeks ( 12 weeks post treatment)
Secondary outcomes (3)
HCV genotype and subtype
HCV Genotype and subtypes will be determined at entry for all patients. Frequency of resistance associated substitutions (RAS) among participants registered for the project will also be determined.
Measured: At baseline
Validity and reliability of Cepheid GeneXpert in monitoring SVR12
150 patients will be evaluated for HCV viral load at entry and exit ( SVR12) comparing cepheid Gene Xpert and Roche real time PCR ( Standard method)
Measured: Testing done at baseline and 24 weeks
HIV Viral load among HCV/HIV co-infected patients
HCV/HIV co-infected patients will either be on treatment at the time of HCV treatment initiation but those not on ART will be initiated and will assess rates of ART initiation and virologic suppression of HIV-infected persons within the simplified HCV testing and treatment model.
Measured: HIV Viral load at 24 weeks ( 12 weeks post HCV treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study start20 Dec 2017
- Primary completion30 Mar 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 803 participants (actual)
Sponsor and investigators
- Lead sponsor
- Right to Care
- Sponsor type
- University, hospital or other
- Collaborators
- Community Partners International, Myanmar Liver Foundation, Boston University, University of California, Los Angeles, Ministry of Health and Sports, Myanmar
- Responsible party
- Sponsor
- Investigators
- Ian Sanne, MBBCH,FRCP, Study chair, Right to CareKhin Pyone Khi, MBBS,FRCP,PhD, Principal investigator, Myanmar Liver FoundationCharles Chasela, PhD, Study director, Right to Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03579576
- Sponsor's protocol ID
- EQUIPHCV01-MY
- Status last verified
- Jun 2018
- First submitted
- 24 Jun 2018
- Last updated
- 29 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demonstration Project on Assessment of Simplified Antiviral Treatment Strategy for Hepatitis C in Myanmar
- ClinicalTrials.gov ID
- NCT03579576
- Acronym / sponsor ID
- EQUIPHCV01-MY
- Conditions
- Hepatitis C, Hepatitis B, HIV Infections
- Keywords
- PWID, MSM, HCV, HIV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 803 participants (actual)
- Lead sponsor
- Right to CareUniversity, hospital or other
- Collaborators
- Community Partners International, Myanmar Liver Foundation, Boston University, University of California, Los Angeles, Ministry of Health and Sports, Myanmar
- Study start
- 20 Dec 2017 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 6 Jul 2018 (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 project will evaluate cost and treatment outcomes of a simplified hepatitis C virus (HCV) testing, treatment and care model integrated with HIV testing and treatment among key affected populations including people who inject drugs (PWID) in Myanmar.
Detailed description
Affected populations will be screened for HCV and HIV and treated with direct a fixed-dose combination of sofosbuvir 400 mg/velpatasvir 100 mg (SOF/VEL) orally once daily for 12 weeks with or without weight-based ribavirin. Before and after completion of the treatment course viral load assessments will be undertaken using low-cost laboratory monitoring for comparison to standard HCV viral load measurement. Up to 800 patients enrolled on treatment will be followed up at 4, 8, 12 and 24 weeks when Sustained Viral Load ( SVL) will be determined. Safety monitoring will be undertaken at applicable visits for those on Ribavirin and all adverse events will be reported based on Good Clinical Practice. In addition to assessing to assessing cost outcomes, the project will assess HCV treatment efficacy in terms of sustained virologic response at 12 weeks after end of HCV treatment (defined as undetected HCV RNA or less than lower limit of detection), compare the cost of low cost HCV viral assay platforms to standard of care, assess rates of ART initiation and virologic suppression of HIV-infected persons within the simplified HCV testing and treatment model and impact of HIV co-infection in participants on the HCV treatment outcome of sustained virologic response (SVR12). The project will be conducted 3 treatment sites in Yangon, Mandalay, and Kachin state in Myanmar.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HCV infected patients | – | Drug: sofosbuvir 400 mg/velpatasvir 100 mg (SOF/VEL) orally once daily for 12 weeks with or without weight-based ribavirin.All participants found HCV infected with or without HIV will be initiated treatment and followed up until 24 weeks ( 12 weeks after treatment) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target population are key population including Female Sex Workers, Men who have sex with men and People Who Use InjecaAll HCV-infected men and women aged 18 years or older. The study population eligible for HCV treatment will be HCV treatment naïve or experienced (pegylated interferon [PegIFN] and ribavirin [RBV] only), HCV-infected men and women aged 18 years or older with HCV genotype 1, 2, 3, 4, 5 or 6, with or without HIV-1 co-infection. Participants with compensated cirrhosis (Child-Pugh Class A) and hepatitis B infection will be eligible for HCV treatment. Patients with decompensated liver cirrhosis (Child-Pugh Class B or C) or prior treatment with HCV DAAs will not be eligible for treatment.
Key inclusion criteria (21 listed)
- Ability and willingness of participant to provide informed consent.
- Men and women age 18 years.
- Active HCV infection as defined by detectable serum or plasma HCV RNA at any time prior to study entry. Documentation may be obtained from medical records if available. NOTE: If no medical records on HCV infection are available, active HCV infection must be confirmed by a detectable HCV RNA PCR prior to project entry.
- Allowed HCV treatment history:
- Chronic Hepatitis B status must be documented by hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb), and hepatitis B core antibody (HBcAb) testing. Participants with positive HBsAg must be already on an active HBV regimen at study entry.
Key exclusion criteria (8 listed)
- Child-Pugh Score corresponding to Class B or C (decompensated cirrhosis). This requires assessment for encephalopathy and ascites, as well as measurement of serum bilirubin, albumin, and international normalized ratio (prothrombin time).
- Breastfeeding or pregnancy if patient will be receiving ribavirin.
- Known allergy/sensitivity or any hypersensitivity to components of drug(s) or their formulation.
- Acute tuberculosis (TB) infection. They will be followed and offered enrolment when they complete TB treatment.
- Renal impairment defined as estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2 or end-stage renal disease receiving dialysis as treatment with SOF/VEL is contraindicated (https://www.mdcalc.com/mdrd-gfr-equation).
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 |
|---|---|---|
| sofosbuvir 400 mg/velpatasvir 100 mg (SOF/VEL) orally once daily for 12 weeks with or without weight-based ribavirin.Direct Acting anti-HCV drugs given to all HCV infected participants at baseline.Those with Co-infections like HIV and or HBV will be given treatment as per national guidelines. | Drug | HCV infected patients |
Primary outcome
Estimated cost of HCV screening per patient screened and per case identified and the cost per successfully treated patient for HCV mono-infected and co-infected participants
Time frame: Two years. This will be after data on Viral load response is complete.
The average cost to the provider per patient achieving SVR12 will be estimated, as will the average cost per other outcomes achieved, such as per patient screened and per patient remaining in care by other specified endpoints, stratified by HIV status and by any other important patient or site characteristics that are identified as drivers of cost. The study will also estimate the average cost to "produce" a successful outcome (SVR12), which is the ratio of total costs for the intervention for the entire sample enrolled to the number of patients achieving the primary outcome. This latter estimate captures the costs incurred for patients who do not have successful outcomes and thus relates resource utilization to health outcomes.
Overall Sustained Viral load response (SVR12) across all groups of HCV genotype, fibrosis stage, HIV and HBV co-infection.
Time frame: 24 weeks ( 12 weeks post treatment)
This will be the main treatment outcome of all patients initiated on treatment. Baseline viral load is done at entry with treatment initiated for those positive and eligible. Patients initiated on treatment will be assessed for viral load response at 24 weeks ( 12 weeks post treatment). This will also help in development of Care cascade for HCV testing, treatment and SVR12 in key populations co-infected with HIV/HCV, HIV/HCV/HBV, HBV/HCV and HCV mono-infected.
3 secondary outcomes
HCV genotype and subtype
Time frame: At baseline
Validity and reliability of Cepheid GeneXpert in monitoring SVR12
Time frame: Testing done at baseline and 24 weeks
HIV Viral load among HCV/HIV co-infected patients
Time frame: HIV Viral load at 24 weeks ( 12 weeks post HCV treatment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2019.
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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.
Ian Sanne, MBBCH,FRCP study chair
Right to Care
Khin Pyone Khi, MBBS,FRCP,PhD principal investigator
Myanmar Liver Foundation
Charles Chasela, PhD study director
Right to Care
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C and Hepatitis B, run by Right to Care at 3 sites in Burma.
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 21 inclusion and 8 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: finished, as of the sponsor's last update on 29 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Burma. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Estimated cost of HCV screening per patient screened and per case identified and the cost per successfully treated patient for HCV mono-infected and co-infected participants (time frame: Two years. This will be after data on Viral load response is complete.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jul 2019.