Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Nucleos(t)ide Analogues (NA)
Nucleoside Analogues · 1 trial · 1 indication
Participants who stopped pegylated interferon (PEG-IFN) treatment during the add-on phase due to serum HBsAg loss and HBsAg seroconversion were considered as responders.
| Arm | Type | Description |
|---|---|---|
| Pegylated Interferon (Peginterferon) Alfa-2a | EXPERIMENTAL | Participants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than \<0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy. |
| Name | Type | Description |
|---|---|---|
| Pegylated Interferon (Peginterferon) Alfa-2a | DRUG | Peginterferon alfa-2a 180 mcg, subcutaneously (SC) once weekly for 48 weeks. |
| Nucleos(t)ide Analogues (NA) | DRUG | Nucleos(t)ide analogues includes adefovir, entecavir, lamivudine or tenofovir. |
Inclusion Criteria: * Adult participants, 18 - 65 years of age * Chronic hepatitis B * Negative for HBeAg * On monotherapy with any nucleos(t)ide analogue (NA) but telbivudine at enrolment, and HBV DNA persistently below 20 IU/ml for at least 12 months * HBsAg \>100 IU/ml at the beginning of the Le...
Nucleoside Analogues are used in the treatment of chronic hepatitis B, a viral infection of the liver. In this setting they are studied as part of combination regimens, including a Phase 2 trial in which nucleos(t)ide analogue treatment was combined with peginterferon alfa-2a in HBeAg-negative chronic hepatitis B patients with genotype D.
Roche Holding AG, which trades under the ticker RHHBY, is the developer associated with this nucleoside analogue program. Roche sponsored the Phase 2 study evaluating peginterferon alfa-2a added to nucleos(t)ide analogue treatment in chronic hepatitis B.
Nucleoside Analogues are in Phase 2 development for chronic hepatitis B. The program has completed one Phase 2 trial, and no trials are currently active. The drug is investigational and is not approved for use.
Nucleoside Analogues have been evaluated in one completed Phase 2 trial, NCT01706575, titled a study of Pegasys (peginterferon alfa-2a) added to nucleos(t)ide analogue treatment in participants with HBeAg-negative chronic hepatitis B genotype D showing stable HBV DNA suppression. The trial enrolled 76 participants in Italy.
Yes, Nucleoside Analogues are also known as Nucleos(t)ide Analogues, abbreviated NA. The two names refer to the same drug class used in chronic hepatitis B treatment.