Gilead donates Truvada to HIV trial patients

Gilead has donated 2,000 bottles of its Truvada (emtricitabine+tenofovir) to patients who took part in a UK clinical study that established its use in HIV prevention, so they can continue with treatment until funding is in place.

NHS England has so far refused to pay for its use in pre-exposure prophylaxis (PrEP) among people at high risk of infection, saying this responsibility lies with local authorities.

Gilead made the decision after receiving a request from PROUD study investigators to continue to supply Truvada to participants.

The study ends this month, and due to lack of routine commissioning in England, the one-time donation is intended to allow participants to continue to access treatment for a further six months while a final funding decision is expected.

Politicians on the influential Health Committee have said that “fragmentation and confusion” in England's National Health Service is to blame for the mess over funding of the HIV prevention drug, Truvada.

Sheena McCormack, professor of clinical epidemiology at the Medical Research Council Clinical Trials Unit, which conducted the study, praised Gilead for its decision.

She said: “We reported the results in February 2015 and did not expect to have to wait so long for a policy decision from NHS England. We thank Gilead for helping us to support PROUD participants during this time.”

The committee said in a report into public health after 2013, that the saga over use of Gilead's drug in HIV pre-exposure prophylaxis (PrEP) is an example of how new funding arrangements are causing disjointed decision making about disease prevention services.

In 2013, responsibility for public health passed from the NHS to local authorities, and the report assesses the impact of these changes.

The changes to funding led to NHS England saying earlier this year that local authorities should pay for PrEP, even though it had been under consideration by its specialised commissioning services for 18 months.

A legal fight is ongoing, after NHS England appealed a High Court judge's ruling that there was nothing to stop the NHS funding PrEP.

The committee concluded that “the outstanding issue of who is responsible for commissioning PrEP for HIV needs immediate resolution, and we recommend that NHS England and (Department of Health) clarify the position without delay.”

Ben Bradshaw, Health Committee member and Trustee of the Terrence Higgins Trust HIV charity, said: “PrEP, the game-changing HIV prevention tool, has been held up by squabbling, confusion and delays, amidst the fragmentation of who commissions public health services, as today’s health committee report highlights. This is a false economy as it leaves people at risk of HIV who, if they become infected, will need lifelong treatment and support from the NHS.”