EMA Publish Concept Paper on HIV Prevention Medical Products
Besides the ongoing efforts to develop preventive vaccines, other HIV prevention methods are currently also under development: oral and topical Pre-Exposure Prophylaxis (PrEP) for HIV sexual transmission.
After decades of research in these fields, the positive results of two recent studies have called the attention of the scientific community and regulators.
1- tenofovir 1% vaginal gel has been shown to reduce the risk of HIV acquisition by 39% (incidence rate ratio versus placebo = 0.61 (CI: 0.4 to 0.94; p=0.017) in the double blind placebo-controlled CAPRISA study performed in 889 women in South Africa.
2- the oral fixed dose combination Truvada (tenofovir and emtricitabine) has been shown to reduce the HIV incidence as compared to placebo by 44% (CI: 15 to 63; p=0.005) in the iPrEx study performed in 2499 men who have sex with men (MSM).
These approaches are developed as potential “complementary” tools to the standard prevention that still mainly relies on condom use.
This concept paper addresses the need for a reflection paper on the key aspects to be covered by the non clinical and clinical developments of oral and topical PrEP in view of potential future applications for marketing authorisation, including applications for a scientific opinion under article 58 for countries outside the EU.
Although it is acknowledged that different populations at risk could be targeted by oral and topical (genital and rectal) PrEP in different epidemiological contexts (from low level to generalised HIV epidemics) with varying HIV prevalences, both oral and topical PrEP approaches are being addressed in parallel in this document as they will raise similar issues.
Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
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