Chronic Hepatitis B
Conditions
Brief summary
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).
Interventions
DRUGGS-4774
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.
DRUGGS-9620
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.
Sponsors
Gilead Sciences
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Must have participated in a Gilead-sponsored chronic hepatitis B (CHB) study no more than 120 days prior to Baseline (Day 1), except for participants from previous Gilead-sponsored study number GS-US-174-0149, who will have up to one year from their last visit in that protocol. * Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures * Must be willing and able to comply with the visit schedule and study requirements * Must have documented HBV DNA \< 2,000 IU/mL at time of screening visit, which shall occur no later than 1 year post last study visit in GS-US-174-0149 * Must have documented hepatitis B surface antigen (HBsAg) negative status anytime during participation in GS-US-174-0149 regardless of ongoing HBV treatment Key
Exclusion criteria
* Patient participating or planning to participate in another clinical study with an investigational agent * History of clinically-significant illness or any other major medical disorder that may interfere with follow-up, assessments or compliance with the protocol * Believed by the Study Investigator to be inappropriate for study participation for any reason not otherwise listed * Received TDF monotherapy either as part of GS-US-174-0149 Arm C (TDF monotherapy arm) or for TDF retreatment, and have taken any HBV antiviral therapy since completion of GS-US-174-0149 Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with serum hepatitis B surface antigen (HBsAg) decline ≥ 0.5 log10 IU/ml from baseline at Week 48 | Week 48 | This endpoint will be measured for participants who are HBsAg positive at baseline. |
| Proportion of participants who remain HBsAg negative at Week 48 | Week 48 | This endpoint will be measured for participants who are HBsAg negative at baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants who remain HBsAg negative at Week 144 | Week 144 | This endpoint will be measured for participants who are HBsAg negative at baseline. |
| Proportions of participants with hepatitis B envelope antigen (HBeAg) loss and seroconversion at Week 48 | Week 48 | This endpoint will be measured for participants who are HBeAg positive at baseline. |
| Proportions of participants with HBeAg loss and seroconversion at Week 144 | Week 144 | This endpoint will be measured for participants who are HBeAg positive at baseline. |
| Proportion of participants with serum HBsAg decline ≥ 0.5 log10 IU/ml from baseline at Week 144 | Week 144 | This endpoint will be measured for participants who are HBsAg positive at baseline. |
| Proportions of participants who remain HBeAg negative and HBeAb positive at Week 144 | Week 144 | This endpoint will be measured for HBeAg positive who achieved HBeAg seroconversion during the parental study. |
| Proportion of participants with HBV DNA < the lower limit of quantitation (LLOQ) at Weeks 48, 96 and 144 | Weeks 48, 96 and 144 | This endpoint will be measured for participants who are on treatment with oral antiviral (OAV) anti-HBV. |
| Change from Baseline in HBV DNA at Weeks 48, 96, and 144 | Baseline; Week 48; Week 96; Week 144 | — |
| Proportions of participants who remain HBeAg negative and hepatitis B envelope antibody (HBeAb) positive at Week 48 | Week 48 | This endpoint will be measured for HBeAg positive who achieved HBeAg seroconversion during the parental study. |
| Proportion of participants who achieve HBsAg loss at Weeks 48 and 144 | Weeks 48, 144 | This endpoint will be measured for participants who are HBsAg positive at baseline. |
Countries
Australia, Canada, Hong Kong, India, Italy, New Zealand, South Korea, United States
Outcome results
None listed