PBAC's latest decision on Tenofovir alafenamide / emtricitabine / rilpivirine: Recommended with restriction (2016). Considered for Treatment of human immunodeficiency virus (HIV) infection in treatment-naïve and treatment-experienced patients.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2016
Submissions
1
2016 → 2016
Eligible population
HIV-positive patients; treatment-naïve patients and treatment-experienced patients with baseline viral load <100,000 copies/mL and CD4 cell count >200 cells/mm³.
Therapy area
Infectious disease
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
ORR
Pivotal trial size
668 patients
Key trials
Study 1089, Study 1159, Study 104, Study 111, Study 112