Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Entecavir · 2 trials · 2 indications
This endpoint is defined as loss of HBsAg at 24 weeks post-treatment (follow-up Week 24)/end of untreated observation (Week 80). The percentage of responders (response rate) and 95% CI (using the Clopper-Pearson method) for the response rate are presented for each group.
| Arm | Type | Description |
|---|---|---|
| Peg-IFN-Alfa-2A + Lamivudine or Entecavir | EXPERIMENTAL | Participants will receive lamivudine or entecavir alone for 8 weeks followed by peg-IFN-alfa-2A in combination with lamivudine or entecavir for 48 weeks. |
| Untreated Control Participants | NO_INTERVENTION | Untreated control participants will be observed up to 80 weeks. |
| Peg-INF-Alfa-2A Monotherapy | EXPERIMENTAL | Participants will receive Peginterferon Alfa 2A subcutaneously once weekly with dosing based on body surface area (BSA) categories for 48 weeks. |
| Placebo, Every Other Day (QOD) | PLACEBO_COMPARATOR | Placebo orally (PO) QOD for 12 weeks + noninvestigational entecavir or tenofovir as prescribed by participant's physician |
| Placebo, Once a Week (QWk) | PLACEBO_COMPARATOR | Placebo PO QWk for 12 weeks + noninvestigational entecavir or tenofovir as prescribed by participant's physician |
| RO6864018, 1200 milligrams (mg) QOD | EXPERIMENTAL | RO6864018 1200 mg PO QOD for 12 weeks + noninvestigational entecavir or tenofovir as prescribed by participant's physician |
| RO6864018, 1200 mg QWk | EXPERIMENTAL | RO6864018 1200 mg PO QWk for 12 weeks + noninvestigational entecavir or tenofovir as prescribed by participant's physician |
| RO6864018, 800 mg QOD | EXPERIMENTAL | RO6864018 800 mg PO QOD for 12 weeks + noninvestigational entecavir or tenofovir as prescribed by participant's physician |
| RO6864018, 800 mg QWk | EXPERIMENTAL | RO6864018 800 mg PO QWk for 12 weeks + noninvestigational entecavir or tenofovir as prescribed by participant's physician |
| Name | Type | Description |
|---|---|---|
| Entecavir | DRUG | Participants will receive entecavir, either as a film-coated tablet or oral solution, once daily at a dose of 0.015 milligrams per kilogram (mg/kg) (maximum daily dose of 0.5 mg). |
| Lamivudine | DRUG | Participants will receive lamivudine, either as a film-coated tablet or oral solution, once daily at a dose of 3 mg/kg (maximum daily dose of 100 mg). |
| Pegylated Interferon Alfa-2A | DRUG | Participants will receive pegylated interferon-alfa-2A at a body surface area (BSA) based dose of 180 micrograms per 1.73 square meter (mcg/1.73m\^2) BSA. |
| Placebo | DRUG | Participants will be administered PO placebo capsules matched to RO6864018, either QOD or QWk for 12 weeks of treatment. |
| RO6864018 | DRUG | Participants will be administered RO6864018 as 200-mg PO capsules at a dose of 800 mg or 1200 mg, either QOD or QWk for 12 weeks of treatment. |
| Tenofovir | DRUG | Tenofovir will be administered as per local labeling. |
Inclusion Criteria: * Positive for HBsAg and HBeAg for more than 6 months prior to baseline * Detectable HBV-DNA (\>20,000 IU/mL) as measured by polymerization chain reaction (PCR) or hybridization on at least 2 occasions at least one month apart with the latest determination obtained less than or ...
Entecavir is used for the treatment of chronic hepatitis B, including pediatric immuno-tolerant chronic hepatitis B. It is a small molecule antiviral being studied in combination with other agents for hepatitis B virus infection. The drug is currently in clinical development for these indications.
Entecavir is a nucleoside analog reverse transcriptase inhibitor that targets the hepatitis B virus polymerase. It works by inhibiting viral DNA replication, thereby reducing the viral load in patients with chronic hepatitis B infection.
Entecavir is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with chronic hepatitis B.
Entecavir is in Phase 2 clinical development for chronic hepatitis B. It has completed a Phase 2 trial (NCT02391805) and a Phase 3 trial (NCT02263079) in pediatric patients with immuno-tolerant chronic hepatitis B.
Entecavir has been studied in two completed trials: NCT02263079, a Phase 3 study in children with HBeAg-positive chronic hepatitis B, and NCT02391805, a Phase 2 study in virologically suppressed adults with chronic HBV infection.
Entecavir is the generic name for the drug also known as Baraclude. It is a nucleoside analog used to treat chronic hepatitis B, and it is being investigated in combination with other therapies for improved outcomes.