World AIDS Day 2013 – Revised guidance to facilitate development of new medicines

The European Medicines Agency plays a key role in the authorisation of medicines to treat human immunodeficiency virus (HIV) infection and acquired immunodeficiency syndrome (AIDS). All antiretroviral medicines in the European Union (EU) have to be authorised centrally at European level, rather than in each Member State separately. This aims to allow the rapid availability of the medicines across the EU.

There are approximately 34 million people living with HIV globally. Over the past few years, the authorisation and availability of new, potent antiretroviral agents has changed the landscape of HIV treatment. With these new medicines, most patients are now able to achieve sustained viral suppression. Viral resistance has also become less frequent.

However, new antiretroviral agents are still needed for patients infected with virus that shows extensive resistance to existing therapies or who cannot tolerate certain agents, or combinations of agents, to which their virus remains susceptible.

In its draft revised guideline on the clinical development of medicines for the treatment HIV infection, the Agency sets out development strategies to facilitate the development of such agents.

The document provides a new definition of populations included in clinical trials, moving away from a focus on treatment history (distinguishing between treatment-naïve and treatment-experienced patients) to an emphasis on documented viral resistance. Guidance is provided on the development programmes and the type of data that should be provided for new antiretroviral agents. The draft guideline was released for a six-month public consultation in September 2013.

Over the past year, the Agency’s Committee for Medicinal Products for Human Use(CHMP) recommended granting marketing authorisation for four new therapies for HIV‑1 infection (Tivicay, Vitekta, Tybost, Stribild).

So far, a total of 34 anti-HIV medicines have been authorised in the EU on the recommendation of the Agency. The Agency has also recommended the authorisation of medicines used to treat infections and cancers in patients with AIDS.

In addition, the Agency has given opinions on three anti-HIV medicines for use exclusively in markets outside the EU. These opinions are given in cooperation with the World Health Organization (WHO) for diseases of major public-health interest.

More on World AIDS Day

World AIDS Day is held on 1 December each year and is an opportunity for people worldwide to unite in the fight against HIV, show their support for people living with HIV and commemorate people who have died. World AIDS Day was the first ever global health day and was first held in 1988.