AUTH/3165/2/19: Gilead Sciences v ViiV Healthcare (Tivicay/Juluca) – No breach

What happened

• Gilead complained about ViiV materials promoting Tivicay (dolutegravir) and Juluca (dolutegravir/rilpivirine).
• At the HIV Drug Therapy conference (Glasgow, 28–31 Oct 2018), ViiV promoted GEMINI-1 and GEMINI-2 results (dolutegravir + lamivudine) and Gilead alleged this was off-label at the time and inconsistent with the Tivicay SPC.
• Gilead also challenged two claims used in a 2-drug regimen context:
  • Website claim: “Only dolutegravir has shown SUPERIOR EFFICACY vs 5 different ART comparators when evaluated as part of a 3-drug regimens” (item VIIV/DTGRPV/0033/18(3)).
  • Conference stand claim: “Unbeaten in head to head clinical trials” on an interactive panel.
• ViiV argued Tivicay’s indication (“in combination with other anti-retroviral medicinal products”) did not specify a minimum number of ARVs, and that using data not yet in the SPC was acceptable if not inconsistent with the SPC.

Outcome

• No breach of Clause 3.2 (off-label / inconsistency with marketing authorisation/SPC) in relation to promoting Tivicay + lamivudine at the Oct 2018 conference (considered in general, not tied to specific pieces).
• No breach of Clauses 7.2, 7.3, 7.4 for the website claim about “SUPERIOR EFFICACY… in a 3-drug regimen” appearing on a 2DR-focused page.
• No breach of Clauses 7.2, 7.3, 7.4 for the conference claim “Unbeaten in head to head clinical trials”.
• No breach of Clause 9.1 (high standards).
• No breach of Clause 2 (Panel noted Clause 2 is reserved for particular censure; no breach findings meant Clause 2 did not apply).

Clauses

• Clause 2
• Clause 3.2
• Clause 7.2
• Clause 7.3
• Clause 7.4
• Clause 9.1

Sanctions

• None (No breach case; no additional sanctions stated).

ABPI signatory lens

• Why this matters: This case shows how the Panel assesses “off-label” and “misleading” allegations in context—especially where an SPC indication is broad and where claims distinguish between 2-drug and 3-drug evidence. It also highlights that strong headline claims at congress stands must be able to stand alone for passers-by.
• Where teams slip up:
  • Assuming you can rely on “broad indication” language without stress-testing how the SPC reads as a whole (including warnings/precautions and the absence/presence of study data at the time).
  • Using bold, high-impact headline claims (eg “unbeaten”) on congress assets where many viewers won’t click through to detail.
  • Placing 3-drug superiority language on a 2DR page without crystal-clear framing (even if technically accurate).
• Control that would have prevented it:
  • A congress/website claim checklist requiring: (1) what regimen the evidence relates to (2DR vs 3DR), (2) whether the claim can stand alone on first view, and (3) documented rationale that the message is not inconsistent with the SPC at the time of use.

What I’d check in an audit

• Congress booth content governance: approval packs, final artwork, and evidence files for all headline claims used on stand panels (including interactive first screens).
• Whether “first screen must stand alone” was explicitly considered and documented for interactive assets.
• Website page context testing: screenshots showing how claims appear (font size/colour emphasis, proximity to 2DR messaging, and whether regimen qualifiers are prominent enough).
• Evidence mapping: which studies support which claims (3DR superiority vs 2DR non-inferiority) and whether the claim wording matches the study design/endpoints.
• SPC version control at time of use (eg Tivicay SPC pre- and post-Nov 2018 update) and internal rationale for communicating data before SPC update.
• Intercompany challenge handling: records of the on-site discussion and decision not to remove claims during the conference.

What the sanctions tell you

• No sanctions were applied because the Panel ruled no breach across all alleged clauses.
• Even in a no-breach outcome, the Panel’s comments signal expectations: interactive stand headlines should be assessed as standalone claims, and context/layout can affect interpretation.

3 questions to ask your team this week

• For every congress/website headline claim, can it stand alone without relying on click-through detail or verbal explanation?
• When we mix 2DR and 3DR evidence on the same asset, have we made it immediately obvious which regimen each claim relates to?
• Do we have a documented process for using new study data before SPC updates, showing why it is not inconsistent with the current SPC?

Key facts

Download the full case report (PDF)

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