Tenofovir (Viread), the nucleotide analogue from
Gilead, was the centre of controversy today at the XIV World AIDS Conference in Barcelona as activists protested over lack of consultation regarding access in southern Europe, and the company failed to provide news on a price reduction that could bring the drug within reach of resource-limited countries.
Tenofovir appears to be as effective as, and less toxic
than, stavudine, in combination with lamivudine and
efavirenz in a treatment-naïve population, according
to lead investigator, Dr Schlomo Staszewski, reporting
week 48 results from Study 903 during a press
conference today, ahead of his scheduled oral
presentation during Friday’s late breaker sessions.
But the company's news angle on Viread – which was
approved in the US last October and the EU in February
2002 based primarily on data in the treatment-
experienced - was marred by Italian protestors who
took over Gilead’s promotional stand for several
hours, angry at Gilead Italy’s lack of patient
consultation over the drug, which will not be made
available in Italy and Greece until the end of the
year.
Defending the company's position, Executive VP of Operations Mark Perry told aidsmap: “It was a personal issue that got elevated to a level
that I don’t quite understand.”
Commenting on concerns about access to Viread outside of northern
Europe and the US, Perry said: “the issue of access to our drug – and all drugs
– is critical. We will certainly make it available at
steeply discounted prices in the developing world, and
we are gathering data and building relationships with
governments and NGOs to help us achieve this, since no
one company can do that on their own.”
The cost of Viread - around $4100 (2650 pounds) a year
in the US, France, Germany and UK - is not just an
issue in the developing world. The drug's price has
already been dropped to $3000 (1940 pounds) in Spain
and Portugal - where it was launched this week - after
negotiation between the drug company and their
respective goverments, and the same will happen in
Italy and Greece, says Perry.
More trials are planned for tenofovir, both as a pill
and as a microbicide gel. Study 903 will continue to
144 weeks, in order to examine the long-term
adverse-effects of the drug, particularly focusing on
lactate levels and lipodystrophy. The NIH are already
carrying out a Phase 1 trial examining tenofovir's
potential as a topical gel, and Gilead hopes that
Phase II studies will go ahead in Asia and Africa.
The company are also partnering with Family Health
International to study the novel use of once a day
Viread pills as HIV pre-exposure prophylaxis in
sexually active women in Africa; and the forthcoming
DART study in Zimbabwe and Uganda will test Viread
with Combivir with and without lab monitoring “to see
the impact of a regimen in a less-than-ideal clinical
setting,” adds Perry.