1. Market Research
  2. > Pharmaceutical
  3. > Therapy Market Trends
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

Summary






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?



Get Industry Insights. Simply.

  • Latest reports & slideshows with insights from top research analysts
  • 150+ Million searchable statistics with tables, figures & datasets
  • More than 25,000 trusted sources
  • Single User License — provides access to the report by one individual.
  • Department License — allows you to share the report with up to 5 users
  • Site License — allows the report to be shared amongst all employees in a defined country
  • Corporate License — allows for complete access, globally.
Ahmad helps you find the right report:
Testimonials

The research specialist advised us on the best content for our needs and provided a great report and follow-up, thanks very much we shall look at ReportLinker in the future.

Kate Merrick

Global Marketing Manager at
Eurotherm by Schneider Electric

We were impressed with the support that ReportLinker’s research specialists’ team provided. The report we purchased was useful and provided exactly what we want.

Category Manager at
Ikea

ReportLinker gave access to reliable and useful data while avoiding dispersing resources and spending too much time on unnecessary research.

Executive Director at
PwC Advisory

The customer service was fast, responsive, and 100% professional in all my dealings (...) If we have more research needs, I'll certainly prioritize working with ReportLinker!

Scott Griffith

Vice President Marketing at
Maurice Sporting Goods

The research specialist provided prompt, helpful instructions for accessing ReportLinker's product. He also followed up to make sure everything went smoothly and to ensure an easy transition to the next stage of my research

Jessica P Huffman

Research Associate at
American Transportation Research Institute

Excellent customer service. Very responsive and fast.

Director, Corporate Strategy at
Ingredion

I reached out to ReportLinker for a detailed market study on the Air Treatment industry. The quality of the report, the research specialist’s willingness to solve my queries exceeded my expectations. I would definitely recommend ReportLinker for in-depth industry information.

Mariana Mendoza

Global Platform Senior Manager at
Whirlpool Corporation

Thanks! I like what you've provided and will certainly come back if I need to do further research works.

Bee Hin Png

CEO at
LDR Pte Ltd

The research specialist advised us on the best content for our needs and provided a great report and follow-up, thanks very much we shall look at ReportLinker in the future.

Kate Merrick

Global Marketing Manager at
Eurotherm by Schneider Electric

FAQ
  • How we can help
    • I am not sure if the report I am interested in will fulfill my needs. Can you help me?
    • Yes, of course. You can call us at +33(0) 4 37 65 17 03 or drop us an email at researchadvisor@reportlinker.com to let us know more about your requirements.
    • We buy reports often - can ReportLinker get me any benefits?
    • Yes. Set up a call with a Senior Research Advisor to learn more - researchadvisor@reportlinker.com or +33(0) 4 37 65 17 03.
    • I have had negative experiences with market research reports before. How can you avoid this from happening again?
    • We advise all clients to read the TOC and Summary and list your questions so that we can get more insight for you before you make any purchase decision. A research advisor will accompany you so that you can compare samples and reports from different sources, and choose the study that is right for you.

  • Report Delivery
    • How and when I will receive my Report?
    • Most reports are delivered right away in a pdf format, while others are accessed via a secure link and access codes. Do note that sometimes reports are sent within a 12 hour period, depending on the time zones. However, you can contact us to escalate this. Should you need a hard copy, you can check if this option is offered for the particular report, and pay the related fees.
  • Payment conditions
    • What payment methods do you accept?
      1. Credit card : VISA, American Express, Mastercard, or
      2. You can download an invoice to pay by wire transfer, check, or via a Purchase Order from your company, or
      3. You can pay via a Check made out in US Dollars, Euros, or British Pounds for the full amount made payable to ReportLinker
    • What are ReportLinker’s Payment Terms?
    • All payments must normally be submitted within 30 days. However, you can let us know if you need extended time.
    • Are Taxes and duties included?
    • All companies based in France must pay a 20% tax per report. The same applies to all individuals based in the EU. All EU companies must supply their VAT number when purchasing to avoid this charge.
    • I’m not satisfied. Can I be refunded?
    • No. Once your order has been processed and the publisher has received a notification to send you the report, we cannot issue any refund or cancel any order. As these are not ‘traditional’ products that can be returned, reports that are dispatched are considered to be ‘consumed’.
  • User license
    • The license that you should acquire depends on the number of persons that need to access the report. This can range from Single User (only one person will have the right to read or access the report), or Department License (up to 5 persons), to Site License (a group of persons based in the same company location), or Corporate License (the entire company personnel based worldwide). However, as publishers have different terms and conditions, we can look into this for you.

ref:plp2014

Reportlinker.com © Copyright 2020. All rights reserved.

ReportLinker simplifies how Analysts and Decision Makers get industry data for their business.

Make sure you don’t miss any news and follow us on