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to Section One | to Arts & Entertainment
posted Friday, March 22, 2019 - Volume 47 Issue 12
Gilead set to introduce new PrEP drug
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Gilead set to introduce new PrEP drug

More expensive but better for patients with kidney problems

by Mike Andrew - SGN Staff Writer

The pharmaceutical giant Gilead has announced successful clinical trials of a new PrEP drug called Descovy. Gilead also developed the standard PrEP medication, Truvada.

In a study of 5,387 Cis men who have sex with men and Trans women at risk of acquiring HIV through sex, the new drug proved just as effective in preventing HIV infection as Truvada.

Mike Elliott, Gilead's vice president of medical affairs in Europe, the Middle East, and Africa said the results were 'quite exciting.'

'The study backs almost exactly what we expected,' he told the British publication Gay Star News.

During the study, code-named DISCOVERY, seven people receiving a once-daily dose of Descovy acquired sexually transmitted HIV, compared to 15 control subjects given Truvada during the trial.

In other words, Descovy met the pre-established criteria for noninferiority to Truvada.

'It didn't get to that superiority [over Truvada] but showed very good efficacy and numerically fewer transmissions than Truvada,' Elliott said.

'And then there are those important measures on renal and bone.'

Patients receiving Descovy reportedly showed fewer negative side effects in kidney malfunction and bone density loss that Truvada patients might.

That improvement was welcomed by Matthew Hodson, executive director of National AIDS Manual (NAM)/aidsmap, a website that publishes HIV-related news stories.

'It's really good news that there is a formulation for PrEP for people that have kidney problems,' he said.

'The number of people who are going to benefit [is] quite low, it's maybe better for older people, over the age of 40 and is more likely to be recommended for people who have preexisting kidney problems.'

Skepticism
Dr. Will Nutland, co-founder of PrEPster, a program that seeks to 'educate and agitate' for PrEP access in England, where PrEP is not paid for by the National Health Service, expressed reservations about the new medication.

'The current formulation of PrEP (TDF/FTC) works incredibly well, with very few sides effects for the vast majority of people. TDF/FTC was the formulation of PrEP used in all other major international PrEP trials and is the formulation used in the England IMPACT Trial and by NHS Scotland,' he said.

'Given current patent issues on Descovy - and its relative high cost compared with current formulations of oral PrEP - its unlikely to be widely used in the near future.

'The generic versions of TDF/FTC PrEP (Gilead's patented version is Truvada) are cheap [and] widely available, have very few side effects, and are expected to be the main drug of choice for oral PrEP into the foreseeable future. Current available versions of PrEP work very well.'

Gilead said it did not know what the market cost of Descovy would be. But Elliot denied its readiness for market coincided with the end of the US patent for Truvada.

'Once we developed [the formulation for Descovy], we moved it rapidly through for treatment,' Elliot said.

'So it was not related on that patent expiry date; it was related on when we made the discovery and how quickly we could move through development.

'So I don't think anyone would say we moved it slowly through development. From having the molecules and starting the study has been fairly quick.'

The Gilead statement noted that the patent for the tenofovir disoproxil fumarate component of Truvada expired in July 2017 and that Gilead retained exclusive rights for the drug's pediatric use until January 2018. The patent for emtricitabine, the other medication in Truvada, does not expire until 2021, according to Gilead.

Gilead's Descovy patent expires in 2022 in the United States and in 2021 in the European Union.

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