The study will evaluate the proportion of patients with undetectable HCV RNA at 12 weeks post-treatment (SVR12) following a course of DAA therapy delivered using a simplified schedule of safety and virological monitoring.
A total of 200 HIV/HCV co-infected patients who plan to commence DAA therapy at Specialist Hospital Waibargi and Mingaladon, will be enrolled by simple random sampling. In addition to standard of care medical procedures, each participant will complete a questionnaire and have blood taken for standard HCV RNA testing. They will also have a finger-stick capillary blood sample collected for a HCV point of care test, using the the Xpert HCV Assay performed in the GeneXpert point of care machine. Dried blood spot collection (DBS) for HCV core antigen and HCV RNA testing will be collected as a research sample. Concordance between standard of care method and new DBS method will be evaluated. The proportion of patients reaching SVR will be calculated.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
200
Xpert HCV Assay performed on the GeneXpert point of care machine
The Kirby Institute, University of New South Wales Australia
Sydney, New South Wales, Australia
Proportion of patients with undetectable HCV RNA at 12 weeks post-treatment (SVR12)
To evaluate the proportion of patients with undetectable HCV RNA at 12 weeks post-treatment (SVR12) following a course of DAA therapy delivered using a simplified schedule of safety and virological monitoring.
Time frame: 12 weeks post completion of commenced treatment
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