Germany’s cost-effectiveness watchdog has concluded that Viiv’s triple HIV combination Triumeq does provide a significant added benefit over existing therapies, but only in previously untreated adults.
Triumeq combines ViiV’s antiretroviral stalwarts lamivudine and abacavir with its new integrase inhibitor Tivicay (dolutegravir), which was backed by IQWIG last year.
Triumeq was not found to be better than existing therapies for adult HIV patients who had previously been treated with antiretroviral therapies, according to Germany’s Institute for Quality and Efficiency in Health Care (IQWiG), which cited a lack of data in this group.
The agency also concluded there was not enough evidence of an added benefit over comparator drugs in either treatment-naïve or treatment-experienced adolescent patients.
The endorsement of Triumeq in Germany, while partial, is a boost for the new fixed-dose drug that was approved in the US in August 2014 and in Europe the following month. Treatment-naïve patients make up the largest target population for Triumeq, it was noted. Meanwhile, Viiv’s drug was also backed by the Scottish Medicines Consortium last month.
Viiv – set up in 2009 as a partnership between GSK and Pfizer and joined by Shionogi in 2012 – is hoping Triumeq will make inroads into Gilead Sciences’ dominant position in the HIV market, and particularly its big-selling triple therapy Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate).
Atripla pulled in sales of a little over $2.5bn in the first nine months of 2014, actually a little down on the same period of the prior year, suggesting competition in the HIV sector has started to bite.
In trials, Triumeq has demonstrated superior antiretroviral efficacy in treatment-naïve adults compared with Atripla, according to a recent GlobalData report, and will also benefit from being the first once-daily, single-tablet anti-HIV regimen that does not contain tenofovir, a compound which can induce bone toxicity and should not be used in patients with impaired kidney function.
Gilead has a four-drug follow-up called Stribild, which adds integrase inhibitor elvitegravir to the Atripla cocktail and includes a new prodrug of tenofovir designed to reduce its toxicity. This is already racking up impressive early sales of more than $810m in the first nine months of 2014.