First PBS-listed TAF-based combo

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16 Jun 2016

On 1 April, a new once-a-day combination pill was listed on the Pharmaceutical Benefits Scheme. Described as a “breakthrough” next gen drug, Genvoya is the first to contain the reformulated tenofovir (TAF).

Tenofovir 2.0 better targets the immune cells, which allows for reduced dosing. Genvoya contains just 10mg of TAF as opposed to 300mg of the original tenofovir (TDF), meaning less toxicity — meaning a reduced risk of developing kidney and bone damage.

“Studies have shown that TAF is similarly effective as TDF in virological suppression but is less likely to cause renal injury or bone demineralisation,” said NAPWHA Treatment Officer, Tony Maynard. “Efficacy is similar but toxicities are reduced.”

Gilead-developed Genvoya’s other components are 150mg of elvitegravir, 150mg of cobicistat and 200mg of emtricitabine. Taken with food, Genvoya is suitable for people aged 12 years or older, and is appropriate as a first-line treatment option or for people choosing to switch regimens. Common side effects of Genvoya include gastrointestinal symptoms (notably diarrhoea), nausea, fatigue and headache — these symptoms are usually temporary.

Clinical trials found that no side effects were more common in women than in men. However, as Genvoya’s safety has not been studied among pregnant women, Gilead advises: “Genvoya should not be used in pregnant women unless the potential benefits outweigh the potential risks to the foetus.”

Genvoya is not recommended for people with severe kidney damage and should not be used in combination with other antiretroviral drugs, since it may interact with a number of commonly used medications.

In short: the improved compliance a fixed-dose combination like Genvoya can offer, along with the reduced toxicity, will no doubt prove attractive to some.