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Physician Views: Gilead's Phase III tenofovir alafenamide (TAF) data in HIV – an initial assessment

Physician Views: Gilead's Phase III tenofovir alafenamide (TAF) data in HIV – an initial assessment

  • October 2014
  • ID: 3509543
  • Format: PDF
  • Firstword Pharma


Following publication of the first Phase III data for Gilead Sciences' HIV therapy tenofovir alafenamide (TAF) on September 24, FirstWord is currently polling infectious disease specialists in the EU5 and US to ascertain their initial views on the results.

Analyst reaction has been positive, with Bernstein's Geoff Porges noting that the data indicates "conversion (from Viread) is significantly more likely, and effectively eliminates the risk that TAF's unique chemistry might confer some new or unexpected adverse event signal that compromises that conversion" ( ViewPoints: Back to its roots – Gilead data supports long-term sustainability in HIV market).

With Viread set to lose patent exclusivity in 2017 (US) and 2018 (EU), TAF is designed to replace Gilead's older drug (it is a nucleotide reverse transcriptase inhibitor - NtRTI - and investigational novel prodrug of tenofovir, the active agent in Viread), specifically in the fixed-dose combination Stribild.

Stribild – launched in 2012 – is expected to generate sales of $1.1 billion in 2014, growing to $4.4 billion by 2020, according to consensus forecasts (Viread is expected to record global sales of around $960 million in 2014, declining to around $420 million by 2020).

Phase III data replicated similar results from Phase II studies, which demonstrated comparable efficacy between Gilead's TAF-containing four-drug regimen and Stribild. However, it is the safety profile of TAF that is designed to drive its usage and conversion of patients from Stribild to Gilead's updated combination.

Phase III data demonstrated a statistically significant difference in the rate of decline in kidney function for the TAF regimen versus Stribild, and a significantly smaller median percentage decrease from baseline in lumbar spine bone mineral density.

Mirroring a trend witnessed in Phase II studies, the TAF regimen did demonstrate an increase in LDL cholesterol levels (a typical occurrence when patients initiate antiretroviral therapy note Gilead, which is mitigated by Viread but - for unknown reasons - not TAF). Analysts suggest that this increase can be effectively treated and should not act as a major barrier to adoption (thus it was a positive that Phase III data mirrored that from Phase II studies).

With these factors in mind, we are asking infectious disease specialists based in the US and EU5 the following questions...

How would you assess the benefit provided by rate of decline in kidney function for the TAF-containing regimen versus Stribild?
Based on the reduction in decline in kidney function demonstrated by the TAF regimen, do you think payers will be in a strong position to argue that the well-characterised and relatively infrequent association of tenofovir with renal impairment can be managed with careful monitoring to avoid serious toxicities and that generic tenofovir should be used in preference to TAF, with TAF reserved for patients with pre-existing renal dysfunction, or for those who develop tenofovir-related renal impairment?
How would you assess the benefit provided by a significantly smaller median percentage decrease from baseline in lumbar spine bone mineral density for the TAF regimen compared to Stribild?
How would you assess the potential disadvantage of negative effects on lipids on the TAF regimen compared to Stribild?
Assuming equal pricing for the TAF regimen and Stribild (factoring in availability of generic Viread from 2017 in the US / 2018 in the EU) – and based on the initial Phase III data for TAF – what percentage of existing Stribild patients, at peak, would you expect to switch to the new regimen?

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