Consultation on updated guideline on clinical development of medicines for treatment of HIV infection

30 September 2013

The European Medicines Agency (EMA) has released a draft revision of its Draft guideline on the clinical development of medicinal products for the treatment of human-immunodeficiency-virus (HIV) infection (revision 3), for a six-month public consultation.

Comments should be sent using the no later than 31 March 2014, to [e-mail].

Over the past few years, the authorisation and subsequent use of new, potent antiretroviral agents (ARTs) 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 much rarer.

The proposed revision takes account of these developments, particularly the significantly lower number of treatment-experienced patients failing on their current regimen, in setting out a regulatory pathway for the development of new medicines for HIV infections.

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:

• the term 'treatment naïve' now refers to patients who have not previously received antiretroviral therapy, and who are infected with HIV without mutations conferring drug resistance in the major viral populations, as determined by standard genotypic assays;
• in populations that might harbour drug-resistant viruses, the new focus is on the evaluation of the in vitro and in vivo activity of a new agent against HIV, including virus with demonstrated resistance that is relevant to the class of the new agent. The term 'treatment experienced' is no longer used, as it does not adequately define a target patient population.

Guidance is provided on the development programmes and type of data that should be provided for new ARTs.