ViiV Healthcare: Triumeq BMJ ad and comparison vs Atripla in treatment-naïve patients (AUTH/2751/3/15)

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Key facts

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Case number	AUTH/2751/3/15
Complainant	Anonymous general practitioner
Company	ViiV Healthcare UK Limited
Medicine	Triumeq (dolutegravir/abacavir/lamivudine)
Material	BMJ hospital edition advertisement (double-page spread); code UK/TRIM/0022/14A
Date of publication	14 March 2015
Main claims challenged	“inner strength”; and superiority vs Atripla in treatment-naïve patients at 48, 96 and 144 weeks
Key reference	Walmsley et al (2013) SINGLE study (also Walmsley et al 2014; Pappa et al 2014 referenced)
Applicable Code	2014
Clauses considered	Clause 3.2 and Clause 7.2
Panel decision	Initially: narrow breach of Clause 7.2 (standalone/footnote issue); otherwise no breach
Appeal outcome	Appeal successful; no breach of Clause 7.2 on the narrow point; overall no breach
Complaint received	13 March 2015
Case completed	17 June 2015

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

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An anonymous general practitioner complained about a ViiV Healthcare UK Triumeq advertisement published in the hospital edition of the BMJ (14 March 2015; UK/TRIM/0022/14A).
The ad headline stated: “inner strength. The only single-pill regimen built with dolutegravir”.
The main comparative claim stated: “The components of Triumeq* form the first HIV regimen to have demonstrated statistically superior efficacy vs Atripla in treatment-naïve patients at 48, 96 and 144 weeks”.
The asterisk footnote stated: “In studies supporting Triumeq, [dolutegravir 50mg + abacavir 600mg/lamivudine 300mg] were used. Bioequivalence has been demonstrated. Atripla is not licensed for initial use in treatment-naïve patients”.
The complainant alleged (1) “inner strength” implied a panacea, (2) it was unfair to compare against Atripla outside its UK licensed indication, and (3) queried whether studies used the fixed-dose combination or the individual components.
The Authority asked ViiV to consider Clauses 3.2 and 7.2 of the 2014 Code.
The Panel initially found a very narrow breach of Clause 7.2 (standalone claim/footnote issue) but ViiV appealed and the Appeal Board overturned that point.

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Final outcome (after appeal): No breach of the Code.
Clause 7.2: Panel initially ruled a breach on a narrow “claim must stand alone” point, but the Appeal Board ruled no breach given the specialised audience and context.
Clause 3.2: No breach (Panel considered Clause 3 did not apply to promotion of a competitor medicine in this context).
“Inner strength” allegation: No breach of Clause 7.2 (the ad was clearly about HIV treatment and did not imply a panacea).
FDC vs components allegation: No breach of Clause 7.2 (the ad made clear it referred to “components of Triumeq” and that bioequivalence had been demonstrated).

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