AUTH/3137/12/18: ViiV Healthcare v Gilead Sciences – Biktarvy stand claims and rose imagery at HIV Glasgow | PMCPA Case

📊

Key facts

⌄

Case number	AUTH/3137/12/18
Parties	ViiV Healthcare Ltd v Gilead Sciences Europe Ltd
Product	Biktarvy (bictegravir/emtricitabine/tenofovir)
Setting	HIV Drug Therapy Conference, Glasgow (28–31 October 2018)
Materials	Stand panels BIK\IHQ\18-09\\1177b and BIK\IHQ\18-09\\1177c; revised looping video BIK\IHQ\18-09\\1177a(1) (three simultaneous loops); another looping video BIK\IHQ\18-09\\1177d
Main issues	Broad tolerability superiority claim vs “DTG-containing regimens”; prominence/qualification; rose/thorns imagery implying reduced hazard and disparagement; contextual exaggeration via campaign line
Decision	Breaches upheld on appeal
Applicable Code year	2016
Complaint received	20 December 2018
Case completed	18 November 2019
Sanctions	Undertaking received; additional sanctions not stated

Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

🤖

Got a question about this case?

Ask one of our 13 specialist ABPI advisors — instant answers, 24/7.

Ask AskAnzal AI

🎬 Expert Video Walkthrough

🎬

Video walkthrough — coming for members

Subscribe now and get expert video analysis for every case as we publish them.

Subscribe — from £299/yr

📋

⌄

ViiV complained about Gilead’s promotional materials for Biktarvy used at the HIV Drug Therapy Conference in Glasgow (28–31 Oct 2018).
The complaint focused on a stand panel and videos (original and revised) shown on the stand; inter-company dialogue resolved concerns about the original video, but the revised video proceeded to a case.
Materials on the stand included two static panels (BIK\IHQ\18-09\\1177b and BIK\IHQ\18-09\\1177c), a revised looping video shown as three simultaneous loops (BIK\IHQ\18-09\\1177a(1)), and another looping video (BIK\IHQ\18-09\\1177d).
A prominent headline claim stated: “Better tolerated than DTG-containing regimens”, linked by a dagger to smaller text: “Significantly fewer all grade treatment-related AEs compared to DTG plus ABC/3TC or FTC/TAF (secondary endpoint)”.
Stand imagery included a rose with thorns and several thorns shown removed/dropped; the revised video showed a rose head appearing before/after key claims.
Another claim in the revised video stated: “The beauty of what is possible … Biktarvy … is now a reality”.

⚖️

⌄

Breach: The claim “Better tolerated than DTG-containing regimens” was ruled misleading/exaggerated, not capable of substantiation, and not adequately qualified by the smaller text beneath it.
Breach: The revised video, by association with the rose/thorns imagery and the “better tolerated” claim, implied Biktarvy was less hazardous than DTG-containing regimens; this implication was not substantiated and was disparaging.
Breach: In context (alongside the misleading “better tolerated” claim and rose imagery), “The beauty of what is possible … Biktarvy … is now a reality” was ruled misleading/exaggerated.
No breach: Clause 7.9 (the Panel did not consider the rose head in the video implied Biktarvy was “safe”).
No breach: Clause 2 (the Panel did not consider the circumstances warranted particular censure under Clause 2).
Gilead appealed; the Appeal Board upheld the relevant breaches and the appeal was unsuccessful.

🔒

Members get the complete breakdown — Clauses, Sanction, Signatory Lens, Audit checklist, and 3 Key Questions.

Best value

£249/year

Annual — save £99

£29/mo

Monthly

Join Now — Instant Access