Treatment Outcomes in Chronic Hepatitis B Patients on Sequential Therapy With Tenofovir Alafenamide (TAF)
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Intervention: Tenofovir Alafenamide
Intervention description: Tenofovir alafenamide (TAF) is a new formulation of tenofovir with higher intracellular active drug concentration allowing for dosing of only 25 mg once daily and thus can potentially lower the already low risk of renal toxicity and bone loss with tenofovir disoproxil fumarate (TDF).
Intervention MeSH terms: Tenofovir
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 270.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Tenofovir alafenamide (TAF)

Summary:

      Primary Objective:

      To describe rate of persistence and/or improvement of viral suppression with TAF as with
      previous anti-HBV (hepatitis B virus) treatment
    

Eligibility criteria:

        Inclusion criteria:

          1. Male or female, age ≥18 years

          2. Chronic hepatitis B diagnosis confirmed by positive HBsAg or HBV DNA or HBeAg or
             documented history of chronic hepatitis B in physician note

          3. Currently maintained on antiviral therapy for at least 48 weeks with any Hepatitis B
             virus(HBV) DNA value at Screening/Baseline and planned to be switched to TAF by their
             physician

          4. Routinely monitored for serum HBV DNA Polymerase chain reaction(PCR), liver chemistry
             including Aspartate aminotransferase (AST )/alanine transaminase(ALT)/total bilirubin,
             renal chemistry including Blood urea nitrogen(BUN)/Creatinine/Carbon dioxide (CO2) by
             their physicians every 3-6 months and a bone density scan at least every 2 years as
             per routine clinical care (one at baseline and one 2 years after switch).

          5. Estimated creatinine clearance > 15 ml/min (using the Cockcroft-Gault method) at
             Screening/Baseline Visit. (Note: multiply estimated rate by 0.85 for women).

          6. Willing and able to provide informed consent

          7. Able to comply with dosing instructions for study drug administration and able to
             complete the study schedule of assessments

        Exclusion criteria:

          1. Pregnant women, women who are breastfeeding or who believe they may wish to become
             pregnant during the course of the study

          2. Previous recipient of a liver transplant

          3. Co-infection with human immunodeficiency virus (HIV) or hepatitis C (HCV) or hepatitis
             D (HDV)

          4. Severe or uncontrolled comorbidities

          5. Current or known hepatic decompensation (≤2 years) (e.g ascites, encephalopathy, or
             variceal hemorrhage) with a Child-Pugh score of B or C

          6. Malignancy including liver cancer within 5 years except cancers curable by surgical
             resection (e.g. basal cell skin cancer and squamous cell cancer)

          7. On any of the disallowed concomitant medications listed in the prior and concomitant
             medications list (pg. 11). Subjects on prohibited medications who are otherwise
             eligible will need a wash out period of at least 30 days prior to the
             Screening/Baseline visit.

          8. Males and females of reproductive potential who are unwilling to use "effective"
             protocol-specified method(s) of contraception during the study.

          9. Current substance or alcohol abuse judged by the investigator to potentially interfere
             with subject compliance.

         10. Any other clinical conditions that, in the opinion of the Investigator, would make the
             subject unsuitable or unable to comply with any of the study procedures