Simplified Antiviral Treatment Strategy for Hepatitis C in Ukraine
|ClinicalTrials.gov Identifier: NCT04038320|
Recruitment Status : Completed
First Posted : July 30, 2019
Last Update Posted : July 30, 2019
|Condition or disease||Intervention/treatment|
|Hepatitis C Virus||Drug: Sofosbuvir/ledipasvir (SOF/LDV)|
|Study Type :||Observational|
|Actual Enrollment :||868 participants|
|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|
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.
- 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.
- 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.
- HCV genotype [ Time Frame: At baseline ]HCV genotype will be determined at entry for all patients.
- HCV subtype [ Time Frame: Baseline ]All genotypes will be subtyped once
- 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.
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04038320
|Clinic of the Institute of Epidemiology and Infectious Diseases, National Academy of Medical Sciences of Ukraine|
|Kyiv City Clinical Hospital #5|
|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|