Hepatitis B Clinical Trial
Official title:
Real-life Data of Switching From Tenofovir Disoproxi Fumarate (TDF) to Tenofovir Alafenamide (TAF) in Virologically Suppressed Chronic Hepatitis B Patients With Antiviral Resistance
- To evaluate the efficacy of switching to tenofovir alafenamide (TAF) 25 mg QD versus
continued tenofovir disoproxil fumarate (TDF) 300 mg QD in CHB patients with antiviral
resistance, as determined by the proportion of virologically suppressed patients at week
48
- To evaluate the safety and tolerability of switching to TAF 25 mg QD versus continuing
TDF 300 mg QD in antiviral-resistant subjects with chronic HBV at week 48
The investigators will conduct a multicenter observational study to evaluate the safety and
efficacy of TAF 25 mg QD in chronic hepatitis B patients with antiviral resistance who switch
from TDF to TAF. The safety and antiviral activity will be assessed as a part of routine
medical care. Subjects will be obtained from an existing cohort of patients treated with a
TDF-based regimen due to antiviral resistance, which has been supported by Gilead
(IN-US-174-1255).
It is anticipated that approximately 300 CHB patients with antiviral resistance taking TDF
300 mg QD will be enrolled in this study. All consecutive patients will be allocated to
receive either TAF 25 mg QD or TDF 300 mg QD (possibly 50% vs. 50%, the proportion of
patients enrolled in the study is an estimate based on the clinical experience.), according
to the decision of the individual patients and their physicians, with informed consent.
Patients are switched independently based on physicians discretion/decision prior to study
enrollment, and the study protocol would NOT have any influence over the process.
All consecutive patients will be prospectively monitored every 6 months during the first year
and thereafter every 6 months up to 3 years. At each visit, a routine examination and
determination of biochemical and virological parameters (HBV DNA level, HBeAg, anti-HBe,
HBsAg [quantitatively, if available], and anti-HBs) will be performed. Lab tests and markers
will be routinely monitored every 6 months.
Recruitment method: In this study, we plan to use an existing cohort of patients treated with
a TDF-based regimen due to antiviral resistance (IN-US-174-1255). Data on all consecutive
patients currently receiving TDF due to antiviral resistance at enrollment will be followed
up prospectively every 3-6 months for 2 years. The patients will be recruited consecutively.
Patients will be recruited only after the treatment decision has been made. No aspect of this
study will interfere with or influence routine medical practice.
Number of study sites: At least seven representative institutes in South Korea. Target
population: Korean adult subjects with CHB receiving TDF due to antiviral resistance.
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