This study will evaluate the long term effects of hepatitis B virus (HBV) treatment on the HBV serologic changes and HBV DNA levels through Week 144. This registry will enroll only individuals who were treated in a Gilead-sponsored trial for chronic hepatitis B (CHB).
Study Type
OBSERVATIONAL
Enrollment
241
Exposure of interest for participants who received GS-4774 (administered as a subcutaneous injection) in a previous Gilead study for chronic hepatitis B virus infection.
Exposure of interest for participants who received GS-9620 (tablets administered orally) in a previous Gilead study for chronic hepatitis B virus infection.
Exposure of interest for participants who received TDF (tablets administered orally) in a previous Gilead study for chronic hepatitis B virus infection.
Proportion of participants with serum hepatitis B surface antigen (HBsAg) decline ≥ 0.5 log10 IU/ml from baseline at Week 48
This endpoint will be measured for participants who are HBsAg positive at baseline.
Time frame: Week 48
Proportion of participants who remain HBsAg negative at Week 48
This endpoint will be measured for participants who are HBsAg negative at baseline.
Time frame: Week 48
Proportion of participants with serum HBsAg decline ≥ 0.5 log10 IU/ml from baseline at Week 144
This endpoint will be measured for participants who are HBsAg positive at baseline.
Time frame: Week 144
Proportion of participants who achieve HBsAg loss at Weeks 48 and 144
This endpoint will be measured for participants who are HBsAg positive at baseline.
Time frame: Weeks 48, 144
Proportion of participants who remain HBsAg negative at Week 144
This endpoint will be measured for participants who are HBsAg negative at baseline.
Time frame: Week 144
Proportions of participants with hepatitis B envelope antigen (HBeAg) loss and seroconversion at Week 48
This endpoint will be measured for participants who are HBeAg positive at baseline.
Time frame: Week 48
Proportions of participants with HBeAg loss and seroconversion at Week 144
This endpoint will be measured for participants who are HBeAg positive at baseline.
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Kaiser Permanente
Sacramento, California, United States
Kaiser Permanente
San Diego, California, United States
Kaiser Permanente
San Francisco, California, United States
Silicon Valley Research Institute
San Jose, California, United States
University of Miami
Miami, Florida, United States
The Queen's Medical Center
Honolulu, Hawaii, United States
Northwestern University
Chicago, Illinois, United States
Digestive Disease Associates, PA
Baltimore, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
...and 27 more locations
Time frame: Week 144
Proportions of participants who remain HBeAg negative and hepatitis B envelope antibody (HBeAb) positive at Week 48
This endpoint will be measured for HBeAg positive who achieved HBeAg seroconversion during the parental study.
Time frame: Week 48
Proportions of participants who remain HBeAg negative and HBeAb positive at Week 144
This endpoint will be measured for HBeAg positive who achieved HBeAg seroconversion during the parental study.
Time frame: Week 144
Proportion of participants with HBV DNA < the lower limit of quantitation (LLOQ) at Weeks 48, 96 and 144
This endpoint will be measured for participants who are on treatment with oral antiviral (OAV) anti-HBV.
Time frame: Weeks 48, 96 and 144
Change from Baseline in HBV DNA at Weeks 48, 96, and 144
Time frame: Baseline; Week 48; Week 96; Week 144