Tenofovir Disoproxil Fumarate With EmtricitabineAdrenaline Viatris
Recommended Infectious diseaseRestricted
Treatment of HIV infection in patients with CD4 cell counts of less than 500 per cubic millimetre or viral load of greater than 10,000 copies per mL.
2
Submissions
2005–05
On the record
—
ICER range
Cost-min
Cost basis
Access path
- TGA registered · Adrenaline Viatris
TGA label narrower than the PBS population
- 2005Recommended · restricted
vs concomitant tenofovir disoproxil fumarate and emtricitabine
- Nov 2005Recommended
Evidence: RCT, Single-arm → RCT
- PBS listing · Restricted
RecommendedDeferredNot recommended
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated by design.
The choice of the cost-minimisation approach was considered valid. PBAC · 2005
Decision context
PopulationHIV-infected adults over the age of 18 years with CD4 cell counts less than 500 per cubic millimetre or viral load greater than 10,000 copies per mL.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2005 | Recommended | concomitant tenofovir disoproxil fumarate and emtricitabine | — | RCT |
| 2005 | Recommended · restricted | concomitant tenofovir disoproxil fumarate and emtricitabine | — | RCT, Single-arm |
Similar precedents
Tenofovir Disoproxil Fumarate With Emtricitabine And Rilpivirine Hydrochloride86%Emtricitabine + Tenofovir Alafenamide84%Tenofovir Disoproxil Fumarate / Emtricitabine83%Tenofovir With Emtricitabine83%Tenofovir Alafenamide / Emtricitabine83%Tenofovir Disoproxil Fumarate With Emtricitabine / Tenofovir Disoproxil Maleate With Emtricitabine / Tenofovir Disoproxil Phosphate With Emtricitabine80%Tenofovir Alafenamide, Emtricitabine, And Rilpivirine80%Emtricitabine/Tenofovir Disoproxil Fumarate79%
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients with CD4 <500/mm³ or viral load >10,000 copies/mL; TGA label has no such biomarker criteria.