(Source: EMA 2014-11-28）
Today, about 35 million people live with human immunodeficiency virus (HIV) infection globally.
There is currently no cure for HIV infection; however, over the past few years the authorisation and availability of potent antiretroviral medicines has fundamentally changed treatment and management of HIV infection. These life-long treatments can effectively control the virus, enabling patients who have access to these medicines to lead full and active lives.
The European Medicines Agency (EMA) plays a key role in the authorisation of medicines to treat 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 separately in each EU Member State. This allows the rapid availability of these medicines to HIV patients across the EU. To date, 36 anti-HIV medicines have been centrally authorised in the EU.
“The therapeutic options available for patients with HIV infection can effectively control the virus and the development of resistance has become less frequent. However, patients now need simplified and well tolerated treatments to facilitate the management of their disease throughout their lives,” notes Marco Cavaleri, Head of EMA’s Anti-infectives and Vaccines Office.
In 2013 and 2014, medicines that allow HIV patients to take a single pill once per day were approved in the EU. These treatments should improve adherence to therapy as well as patient quality of life.
Current developments should simplify future treatment regimens even further. Long-acting formulations that would allow monthly or less frequent dosing are under development, as observed through the EMA scientific-advice platform. So far in 2014, EMA has received eight requests for scientific advice in relation to HIV medicines, including treatments with simplified regimens, compared with two in 2013 and five in 2012.
New treatments are still needed to improve tolerability and to treat infections with HIV strains that are resistant to existing therapies. To facilitate the development of such agents, EMA is currently revising its guideline on the clinical development of medicines for the treatment HIV infection. A draft revised guideline that sets out new development strategies was under public consultation until March 2014. EMA is currently reviewing the comments received, and plans to publish a final guideline by mid-2015.
Prevention strategies are an important element in the fight against HIV. There are no approved medicines in the EU to prevent HIV infection in people who are at high risk of being infected by the virus. EMA encourages companies to submit marketing authorisation applications for this indication. Following the publication of a reflection paper in 2012, the Agency is now working on further guidance to encourage and facilitate the development of HIV pre-exposure prophylaxis (PrEP) medicines.
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. It has been held annually since 1988.
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