AUTH/3137/12/18: Gilead’s Biktarvy conference stand—“Better tolerated than DTG-containing regimens” claim and rose/thorns imagery ruled misleading

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Key facts

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Case	AUTH/3137/12/18
Complainant	ViiV Healthcare Ltd
Respondent	Gilead Sciences Europe Ltd
Product	Biktarvy (bictegravir/emtricitabine/tenofovir)
Setting	HIV Drug Therapy Conference, Glasgow (28–31 October 2018)
Materials	Stand panel BIK\IHQ\18-09\\1177b; revised video BIK\IHQ\18-09\\1177a(1); context included stand panel BIK\IHQ\18-09\\1177c; separate video BIK\IHQ\18-09\\1177d mentioned but not ruled on
Main issue	Broad comparative tolerability claim and implied messages from imagery/strapline
Applicable Code year	2016
Complaint received	20 December 2018
Case completed	18 November 2019
Outcome	Breach: 7.2, 7.3, 7.4, 7.10, 8.1, 9.1; No breach: 2, 7.2, 7.9
Sanctions	Undertaking received; Additional sanctions: Not stated

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

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ViiV Healthcare complained about Gilead’s promotional materials for Biktarvy (bictegravir/emtricitabine/tenofovir) used at the HIV Drug Therapy Conference in Glasgow (28–31 October 2018).
The complaint focused on a stand panel (BIK\IHQ\18-09\\1177b) and a revised looping video shown on the stand (BIK\IHQ\18-09\\1177a(1)).
The original video issue was resolved via inter-company dialogue and did not proceed; the revised video proceeded.
Key disputed elements were:
- The headline claim: “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)”.
- Rose imagery on the stand (including a rose with dropped thorns on panel BIK\IHQ\18-09\\1177c) and a rose head appearing in the revised video loops.
- The strapline: “The beauty of what is possible … Biktarvy … is now a reality” appearing in the revised video (and also in a separate looping video BIK\IHQ\18-09\\1177d, which was not ruled on as it was not specifically referred to by ViiV).
Gilead argued the claim was qualified and based on Phase 3 data (Gallant et al, Sax et al, Molina et al) and should be read with the adjacent qualifying statement; it also argued the imagery represented multiple product attributes, not hazard/safety comparisons.

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Breach rulings were made (and upheld on appeal) for the “Better tolerated than DTG-containing regimens” claim as used on the stand panel and in the revised video.
Breach rulings were made (and upheld on appeal) for the revised video due to the implication (by association with the rose/thorns imagery and the tolerability claim) that Biktarvy was less hazardous than DTG-containing regimens, and that DTG-containing regimens were disparaged.
Breach rulings were made (and upheld on appeal) for the strapline “The beauty of what is possible … Biktarvy … is now a reality” in the revised video, because in context (alongside the misleading tolerability claim and imagery) it was misleading and exaggerated Biktarvy’s properties.
No breach was ruled for:
- Clause 7.2 in relation to an alleged hanging comparison from the rose head image within the three video loops.
- Clause 7.9 (the Panel did not consider the rose head depicted in the video implied Biktarvy was “safe”).
- Clause 2 (the Panel did not consider the circumstances warranted particular censure).

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