Health Condition 1: null- Adults infected with viral hepatitis C or being treated for hepatitis C
Conditions
Interventions
None listed
Sponsors
Institute of Human Virology University of Maryland
Eligibility
Inclusion criteria
Inclusion criteria: Be above 18 years old 2. HCV-infected (naïve/treatment experienced) with HCV RNA >2000 IU/ml and being evaluated to undergo standard of care treatment,Willing to sign informed consent
Exclusion criteria
Exclusion criteria: Unable to comply with research study visits 2. Have any condition that the investigator considers a contraindication to study participation 3. Pregnancy of breast feeding. 4. CrCL 30 ml/min by CG equation 5. Patients on concurrent amiodarone therapy 6. Currently on medications as per the prohibited concomitant medication list 7. Decompensated cirrhosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the antiviral efficacy of standard of care treatment for HCV in a in resource limited setting. To determine HCV RNA sensitivity, specificity, and predictive values of the NAAT T8 HCV assay to standard, clinically approved real time PCR assays in a clinical setting Timepoint: 12 weeks post treatment completion | — |
Secondary
| Measure | Time frame |
|---|---|
| Determine the HCV treatment cascade: diagnosis, linkage to care, HCV RNA confirmation, prescription of HCV medication, and achieving cure (SVR). Assess the robustness of the T8-Isothermal reagents and equipment. Determine maintenance and customer support needs. Determine minimal training needs and user appraisal through a user questionnaire. Assess the safety of this regimen in a community-based setting. Timepoint: 12 Weeks Post Treatment | — |
Countries
India
Contacts
Public ContactDr Ajaykumar B malle
KlinEra Community Clinic
Outcome results
None listed