Entecavir

PBAC's latest decision on Entecavir: Recommended with restriction (2006). Considered for For the treatment of chronic hepatitis B infection in nucleos(t)ide naïve patients and lamivudine resistant patients.

Eligible population

Patients aged 16 years or older with chronic hepatitis B who satisfy all of the following criteria: (i) histological evidence of chronic hepatitis on liver biopsy; (ii) abnormal serum ALT levels in conjunction with documented chronic hepatitis B infection (HBe antigen positive and/or HBV DNA positive); (iii) female patients of child-bearing age are not pregnant, not breast-feeding, and are using an effective form of contraception. Persons with Child’s class B or C cirrhosis should have their treatment discussed with a transplant unit prior to initiating therapy.

Therapy area

Gastroenterology

Line of therapy

First-line for nucleos(t)ide-naïve patients; Second-line for lamivudine resistant patients

Evidence base

RCT

Primary endpoint

OS | PFS | DFS | ORR | QoL | Surrogate

Key trials

AI463-027, AI463-022, AI463-026

Comparator

Lamivudine 100 mg (nucleoside-naïve patients); Adefovir dipivoxil 10 mg (lamivudine-resistant patients)

Economic model

Cost-minimisation

Risk sharing

Risk-sharing arrangement in place — The Committee requested the sponsor provide an update on resistance rates and pharmacovigilance reports in 12 months. The Committee advised the PBPA that the authority may wish to consider entering into a risk sharing arrangement with the sponsor to take into account the potential for usage outside of the restriction and for the development of resistance.