Simplified Antiviral Treatment Strategy for Hepatitis C in Myanmar

NCT03579576 | Completed

• 1 other identifier: EQUIPHCV01-MY
• Study Type: observational
• Target: 803
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Hepatitis C; Hepatitis B; HIV Infections

Keywords

PWID; MSM; HCV; HIV

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  24 weeks ( 12 weeks post treatment)

Secondary Outcomes (3)

• HCV genotype and subtype

  At baseline

• Validity and reliability of Cepheid GeneXpert in monitoring SVR12

  Testing done at baseline and 24 weeks

• HIV Viral load among HCV/HIV co-infected patients

  HIV Viral load at 24 weeks ( 12 weeks post HCV treatment)

Study Arms (1)

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)

Drug: sofosbuvir 400 mg/velpatasvir 100 mg (SOF/VEL) orally once daily for 12 weeks with or without weight-based ribavirin.

Interventions

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.

HCV infected patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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).
• 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.
• Presence of HIV-1 infection, documented by rapid HIV test or HIV-1 ELISA test kit at any time prior to entry.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Right to Care: lead
• Community Partners International: collaborator
• Myanmar Liver Foundation: collaborator
• Boston University: collaborator
• University of California, Los Angeles: collaborator
• Ministry of Health and Sports, Myanmar: collaborator

Study Sites (3)

Waimaw

Kāchen, Kachin State, Burma

Location

Myanmar Liver Foundation Clinic

Mandalay, Burma

Location

Myanmar Liver Foundation Charity Clinic

Yangon, Burma

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Dry Blood spots ( DBS) will collected at baseline, 4, 8, 12 and 24 weeks for viral load and resistance testing will be determination where applicable

MeSH Terms

Conditions

Hepatitis C; Hepatitis B; HIV Infections

Interventions

Sofosbuvir; velpatasvir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Hepadnaviridae Infections; DNA Virus Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Ian Sanne, MBBCH,FRCP

  Right to Care

  STUDY CHAIR

• Khin Pyone Khi, MBBS,FRCP,PhD

  Myanmar Liver Foundation

  PRINCIPAL INVESTIGATOR

• Charles Chasela, PhD

  Right to Care

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2018
• First Posted: July 6, 2018
• Study Start: December 20, 2017
• Primary Completion: March 30, 2019
• Study Completion: June 30, 2019
• Last Updated: July 29, 2019

Record last verified: 2018-06

Locations

BU (3)