GSK v Gilead: Truvada leavepieces and over‑interpretation of non‑inferiority (AUTH/2057/10/07)

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Key facts

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Case number	AUTH/2057/10/07
Parties	GlaxoSmithKline v Gilead Sciences Limited
Medicine	Truvada (emtricitabine and tenofovir)
Comparator mentioned	Kivexa (abacavir and lamivudine)
Promotional material	Two leavepieces: “Study highlights: BICOMBO – efficacy outcomes” (ref 164/UKM/07-08/CM/505) and “Study highlights: BICOMBO – safety outcomes” (ref 164/UKM/07-08/CM/510)
Study referenced	BICOMBO (open-label, non-inferiority design; 48-week interim data from a 3-year study)
Complaint received	12 October 2007
Case completed	7 January 2008
Applicable Code year	2006
Breach clauses	Clause 7.2 (x3), Clause 7.3, Clause 7.10 (x2)
Appeal	No appeal
Sanctions	Undertaking received; additional sanctions: Not stated

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

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GlaxoSmithKline (GSK) complained about Gilead’s promotion of Truvada (emtricitabine/tenofovir) using two “Study highlights: BICOMBO” leavepieces: one on efficacy outcomes and one on safety outcomes.
BICOMBO was an investigator-sponsored, open-label, collaborative study jointly funded by GSK and Gilead, randomising virologically suppressed patients to switch NRTI backbone to Truvada or Kivexa while keeping the third agent unchanged.
The study was designed for non-inferiority: primary endpoint treatment failure through 48 weeks; secondary endpoints included virological failure and lipid/other safety measures.
GSK alleged the efficacy leavepiece (bar chart + bullets) created an impression of Truvada superiority despite the study not being powered for superiority and being interim (48-week) data from a 3-year study.
GSK also challenged the safety leavepiece claim that switching to Truvada provided a “significantly more favourable lipid profile” and argued it lacked balance/clinical context and conflicted with Truvada SPC statements (eg hypertriglyceridaemia listed as a common adverse event).

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Breach for the efficacy outcomes leavepiece: the Panel ruled it implied Truvada superiority vs Kivexa and was misleading.
No breach on certain points: omission of baseline resistance testing was not misleading per se; the retrospective HLA-B*5701/suspected HSR statement was not misleading/ambiguous and did not disparage Kivexa; no breach of high standards.
Breach for the safety outcomes leavepiece: the “more favourable lipid profile” presentation was misleading due to lack of clinical significance/context; and triglyceride messaging was misleading without noting SPC hypertriglyceridaemia; and the piece was misleading for not making clear the data were from secondary endpoints (risking the impression the study was primarily a safety study).
Case completed 7 January 2008; no appeal.

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