HIV prevention with Truvada could be authorized across the European Union. The Medicines Agency has given its agreement to an extension of the authorization.
The clinical trials are conclusive in the eyes of the European Medicines Agency (EMA). The European authority has agreed to an extension of the marketing authorization for Truvada (Gilead). The antiretroviral can be prescribed to prevent infection in people at risk, according to the recommendation issued on July 22. The European Commission has yet to give its approval.
Two convincing trials
The Committee for Medicinal Products for Human Use (CHMP) recommends the use of Truvada as PrEP (pre-exposure prophylaxis). “Truvada is the first drug to be recommended to reduce the risk of HIV infection in the European Union,” said a statement from the EMA. Adults at high risk of HIV infection are affected by this approval.
The Committee relied on the results of two trials in the United Kingdom to define the target. iPrEX was performed with cisgender men and transgender women who have sex with men. In this population, one daily tablet of Truvada reduced the risk of transmission of the virus by 42%. The Partners PrEP trial, which included heterosexual couples who did not have the same HIV status (serodiscordant), observed a 75% reduction in this risk.
People who do not know their HIV status, or who are HIV positive, will not have access to this new method of prevention. It could indeed promote the resistance of the virus.
Authorized in 6 countries
But the drug should be used in addition to safer sex practices, such as using a condom to protect against other sexually transmitted infections. The EMA’s agreement in principle also specifies the prescription conditions. The Agency decided to follow the scheme tested in the United Kingdom: one tablet per day. “The CHMP notes that not all studies conducted on Truvada as PrEP in the EU were submitted as part of the application,” the statement said. The data from the IPERGAY trial, which assesses PrEP “on demand”, that is to say during sexual activity, were therefore not transmitted to the CHMP.
The need for a new prevention offer is really necessary, in the eyes of the EMA: “In view of the growing number of new infections in the world, the current field of prevention, including screening, support and recourse to condom must be intensified, ”she said. Several countries have already taken this decision: Australia, Canada, Kenya, Peru, South Africa and the United States. In France, a temporary recommendation for use (RTU) was issued in January 2016. As of May 20, 765 people have already benefited from it.
Before the rest of Europe can benefit from continuous PrEP, we will have to wait for the return of the European Commission, the last decision-maker. EU member states will then have to define the price of Truvada and the reimbursement conditions.
.
