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FDA approves a generic form of PrEP

Sexual health advocates hope this will make widen access to PrEP, the medication that helps prevent people contracting HIV

FDA approves a generic form of PrEP
NIAID | Commons
Truvada (PrEP) is used to prevent HIV infection

The FDA (Food and Drug Administration) in the US has approved the first generic form of PrEP.

PrEP is medication that can be taken by someone to prevent them becoming infected with HIV. It’s a daily pill of Truvada, produced by Gilead Sciences. Truvada is a combination of Emtricitabine and Tenofovir Disoproxil Fumarate

The use of PrEP has been credited with driving down HIV infection rates in countries where it has become available, such as the US. Recent countries to approve the prescription of Truvada include Scotland and Portugal.

In England, the NHS is currently conducting a large-scale trial in order to determine PrEP’s cost-efficiency as a HIV prevention drug.

On Thursday the FDA approved a generic form of the drug – a cheaper version of the same ingredients.

The generic Truvada is produced by TEVA Pharmaceuticals of North Wales, Pennsylvania. It will be used as PrEP and also for the treatment of HIV.

It’s believed that the introduction of a generic version in the US could help expand access to PrEP.

Currently, Truvada costs around $18,000 a year in the US, but insurers and patient-assistance programs often cover the costs.

Mitchell Warren, executive director of HIV prevention organization AVAC, told Medscape he hoped a generic version of the drug could be up to 70% cheaper.

However, at the moment, it’s not known when the generic version may become available. Gilead told Poz that it holds the patents to the specific components of Truvada.

A spokesperson for TEVA Pharmaceuticals told GSN, ‘While we’re very pleased to have received approval, no further information is available at this time.’

‘A much-needed breakthrough’

The approval has been welcomed by Human Rights Campaign. However, it hopes pharmaceutical companies will follow Gilead’s lead in offering patient assistance programs to help make the drug affordable.

‘While the timeline is uncertain for when a generic drug will be available to consumers, today’s decision by the FDA is a much-needed breakthrough in our ongoing efforts to expand HIV prevention options, especially for those most vulnerable to HIV and AIDS,’ said Mary Beth Maxwell, HRC Senior Vice President for Programs, Research and Training, in a statement.

‘Despite growing use of PrEP nationally, the drug remains out-of-reach for many in the communities hardest hit by the epidemic, including young gay and bisexual men and transgender women of color.

‘We implore Gilead to continue their critical payment assistance programs and urge other companies to provide similar financial relief.’

Situation in Europe

Matthew Hodson, Executive Director of NAM in the UK said, ‘Although the FDA has now approved a generic version of Truvada, it may be some years before the generic version is available to patients in the US.

‘In the UK and Europe, approval is required from the European Medicines Agency (EMA). Although two generic versions of Truvada are in the process of receiving EMA approval, it’s not yet clear when they will be available.

‘A number of European HIV organisations have already written to Gilead, manufacturers of Truvada, asking that they make it possible for Truvada or a generic equivalent to be offered at generic prices to all European healthcare systems for use as PrEP.

‘It is clear that many governments will only provide PrEP if it is available at a greatly reduced price.’


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