Antiretrovirals should be taken as HIV prophylaxis, says WHO
Antiretroviral medicines should be taken by HIV-negative people who are at risk of infection, the World Health Organization has advised in new guidance.
The WHO is encouraging countries to introduce pre-exposure prophylaxis (PrEP), which has proven in studies to be effective at reducing HIV infection. Outcomes of the PrEP project will be monitored in order to identify the groups that will benefit most from the approach, it says.
Last week, Gilead’s tenofovir-emtricitabine combination drug Truvada was approved by the US Food and Drug Administration for prophylactic use in at-risk individuals, based on early PrEP trial findings.
A spokesman for Gilead told The Journal that discussions are under way with the European Medicines Agency over submitting Truvada for approval for prophylactic use in Europe. “Specific plans for filing [for a licence extension] are not yet finalised,” he said.
An EMA spokeswoman confirmed that the agency cannot approve the drug for prophylactic use until an application is received.
Citation: The Pharmaceutical Journal URI: 11104529
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