Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 27 of 115 for:    "Viral Infectious Disease" | "Ledipasvir"

Simplified Antiviral Treatment Strategy for Hepatitis C in Ukraine

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04038320
Recruitment Status : Completed
First Posted : July 30, 2019
Last Update Posted : July 30, 2019
Sponsor:
Collaborators:
All Ukrainian Network of PLHA
Public Health Center of MOH Ukraine
Alliance for Public Health
Boston University
University of California, Los Angeles
Information provided by (Responsible Party):
Right to Care

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 in Ukraine.

Condition or disease Intervention/treatment
Hepatitis C Virus Drug: Sofosbuvir/ledipasvir (SOF/LDV)

Detailed Description:
Affected populations will be screened for HCV and HIV and those HCV positive treated with direct with direct acting anti-HCV agents (DAAs), a fixed-dose combination of sofosbuvir/ledipasvir (SOF/LDV) 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 800 patients enrolled on treatment will be followed up at 4, 8, 12 and 24 weeks when Sustained Viral Response (SVR) 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 (GCP). In addition to assessing cost outcomes, the project will assess HCV treatment efficacy in terms of SVR at 12 weeks after end of treatment ( defined as undetected HCV RNA or less than lower limit of detection), compare the cost of low cost viral assay platforms to standard of care, assess rates of ART initiation and virologic suppression of HIV-infected persons within the simplified HCV treatment model and impact of HIV co-infection in participants on the HCV treatment outcome of SVR12. The project will be conducted at 2 treatment sites in Kiev.

Layout table for study information
Study Type : Observational
Actual Enrollment : 868 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Demonstration Project on Assessment of Simplified Antiviral Treatment Strategy for Hepatitis C in Ukraine
Actual Study Start Date : March 26, 2018
Actual Primary Completion Date : March 30, 2019
Actual Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

Group/Cohort Intervention/treatment
HCV infected patients
All HCV infected confirmed by HCV RNA,
Drug: Sofosbuvir/ledipasvir (SOF/LDV)

SOF/LDV (400mg/90mg) orally once daily with or without food in the morning and will receive treatment for a duration of 12 weeks.

In addition, Ribavirin weight-based (1000 mg for patients <75 kg and 1200 mg for those ≥75 kg) administered orally in two divided doses with food for Genotype 3 patients.





Primary Outcome Measures :
  1. 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 SVR-12 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 investigators will also estimate the average cost to "produce" a successful outcome (SVR-12), 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.

  2. Sustained Viral Response [ 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 a Care cascade model for HCV testing, treatment and SVR12 in key populations co-infected with HIV/HCV, HIV/HCV/HBV, HBV/HCV and HCV mono-infected.


Secondary Outcome Measures :
  1. HCV genotype [ Time Frame: At baseline ]
    HCV genotype will be determined at entry for all patients.

  2. HCV subtype [ Time Frame: Baseline ]
    All genotypes will be subtyped once

  3. Validity of Cepheid Gene-Xpert in monitoring SVR12 [ Time Frame: Testing done and baseline and 24 weeks ]
    150 patients will be evaluated for HCV viral load at entry and exit comparing Cepheid Gen-Xpert and Real time PCR using Ampliscence platform.

  4. HIV viral load among HCV/HIV co-infected patients [ Time Frame: HIV Viral load at 24 weeks ( 12 weeks post HCV treatment) ]
    HCV/HIV co-infected patients will 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 the HIV infected within the simplified HCV testing and treatment model

  5. Reliability of Cepheid Gene-Xpert in monitoring SVR12 [ Time Frame: Testing done and baseline and 24 weeks ]
    Cepheid Gen-Xpert and Real time PCR using Ampliscence platform.


Biospecimen Retention:   Samples Without DNA
Dry blood spots(DBS) collected at baseline, 4, 8, 12 and 24 weeks for viral load and resistance testing will be determined where indicated.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study population are HCV treatment naïve or experienced (pegylated interferon [PegIFN] and ribavirin [RBV] only), HCV-infected with genotype 1, 2, 3, 4, 5 or 6, men and women aged 18 years or older, with or without HIV-1 co-infection, representatives of key populations (PWID, CSW, MSM) and their partners. Participants with compensated cirrhosis or Hepatitis B will be eligible for HCV treatment. Patients with decompensated liver cirrhosis or prior treatment with HCV DAAs will not be eligible for treatment. HCV-infected patients who are not eligible for HCV treatment will be eligible for an observation arm.
Criteria

Inclusion Criteria:

  1. Ability and willingness of participant to provide informed consent.
  2. Attribution to one of the key population groups: People Who Inject Drugs (PWID), medication assisted treatment (MAT) participants, Commercial Sex Workers (CSW) or Men Having Sex with Men (MSM). Documentation of attribution to one of the key population groups will be done through applying Case Reporting Form "Risks Assessment" and "Substance Use and Alcohol Consumption". Additionally, medical record of substance use can be collected
  3. Men and women age 18 years.
  4. 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. If no medical records on HCV infection are available, HCV infection must be confirmed by a detectable HCV RNA PCR prior to project entry.
  5. Allowed HCV treatment history:

    1. 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.
    2. HCV treatment experienced with interferon with or without ribavirin only (no prior DAA treatment, although they will be followed).
  6. 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 hepatitis B surface antigen (HBsAg+) must be on an active HBV regimen at study entry.
  7. HIV-1 infection status must be documented as either absent or present, as defined below:

    1. 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

    2. Presence of HIV-1 infection, documented by rapid HIV test or HIV-1 ELISA test kit at any time prior to entry and confirmed by a second antibody test by a method other than the initial rapid HIV and/or ELISA, or by HIV-1 antigen or plasma HIV-1 RNA viral load.

      OR

    3. HIV-1 infection confirmed by medical documentation as participant is registered in care at AIDS Center and receiving or preparing to initiate ARV treatment.
  8. Participants who are assigned to receive ribavirin as part of the treatment protocol must have haemoglobin ≥110 g/L
  9. For females of reproductive potential, a negative urine pregnancy test (urine -HCG with a sensitivity of <25 mIU/mL) within 48 hours prior to project entry must be documented.
  10. 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.

Note: Acceptable contraception/birth control for this project includes one of the following methods:

  • condoms (male or female) with a spermicide
  • diaphragm or cervical cap with spermicide
  • hormonally impregnated intrauterine device (IUD)
  • non-hormonally impregnated IUD in conjunction with spermicide
  • Hormone-based therapy

Exclusion Criteria

  1. 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). For Child's cirrhosis severity calculator on the following link can be used: http://www.hepatitisc.uw.edu/page/clinical-calculators/ctp . Patients with decompensated cirrhosis and advanced liver disease will not be included to the treatment program, but they will remain under observation and will receive medical care within routine medical practice of the healthcare facility in such clinical cases.
  2. Breastfeeding or pregnancy. Pregnant or breastfeeding woman will be documented and provided access to HCV treatment after resolution of pregnancy and breastfeeding.
  3. Known allergy/sensitivity or any hypersensitivity to components of drug(s) or their formulation.
  4. Active tuberculosis (TB) infection. Given the high TB prevalence in Ukraine, every candidate should be screened for TB signs/symptoms with further medical evaluation for active TB as indicated. In the case of proven active TB infection, the participant is ineligible for HCV treatment (due to the adverse drug interaction of SOF/LDV and rifampicin) but will be followed and offered enrolment when they complete treatment with rifampicin.
  5. 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/LDV is contraindicated (https://www.mdcalc.com/mdrd-gfr-equation). The participant may be rescreened if the renal function improves. Patients with worse renal impairment will not be treated but will be followed and will recive medical aid within routine medical practice of the healthcare facility where project is implemented
  6. Prior treatment with any HCV Direct Acting Agents (DAA).

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): NCT04038320


Locations
Layout table for location information
Ukraine
Clinic of the Institute of Epidemiology and Infectious Diseases, National Academy of Medical Sciences of Ukraine
Kiev, Ukraine
Kyiv City Clinical Hospital #5
Kyiv, Ukraine
Sponsors and Collaborators
Right to Care
All Ukrainian Network of PLHA
Public Health Center of MOH Ukraine
Alliance for Public Health
Boston University
University of California, Los Angeles
Investigators
Layout table for investigator information
Study Chair: Ian Sanne, MBBCH, FRCP Right to Care
Principal Investigator: Svetlana Antonyak, MD Hepatitis and HIV-infection of Institute of Epidemiology and Infectious Diseases of L.V. Gromashevskiy of NAMS of Ukraine
Principal Investigator: Tetiana Benard, MA Right to Care, Ukraine
Study Director: Charles Chasela, PhD Right to Care

Additional Information:
Publications of Results:

Layout table for additonal information
Responsible Party: Right to Care
ClinicalTrials.gov Identifier: NCT04038320     History of Changes
Other Study ID Numbers: EQUIPHCV02-UKR
First Posted: July 30, 2019    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: One to two years after completion of the study
Access Criteria: Based on a concept submitted, reviewed and accepted

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Right to Care:
Hepatitis C Virus
HIV
Key Population
Additional relevant MeSH terms:
Layout table for MeSH terms
Virus Diseases
RNA Virus Infections
Ledipasvir
Hepatitis A
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Flaviviridae Infections
Antiviral Agents
Sofosbuvir
Anti-Infective Agents