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HEALTH HIV Report with Specialist Filippo von Schloesser Read on about the latest concerns and findings Words by Filippo von Schloesser was born about ten years ago, when clinicians made a parallel with the malaria prevention with chloroquine and the emergence of thousands of newly infected people was noticed, especially among sex workers in the Far East. Later on, Truvada was tested in several clinical trials, especially in Africa where women are particularly exposed to the virus by infected men who are not even aware of their serological status. The studies have shown a high percentage of people taking Truvada were protected and did not develop the HIV infection along the time, even though they were exposed to the virus. New studies to confirm HIV PREVENTION PrEP, the new milestone On May 10, the US Food and Drug Administration Advisory Committee voted in support of the third HIV prevention tool. After the condom (primary prevention) and after the HIV testing (secondary prevention), the first pharmacological tool has been approved and will finally be an FDA decision later on this year. What is PrEP? As we described in several previous ML issues, PrEP means pre-exposure- prophylaxis, or the use of a specific antiretroviral (Truvada), widely in use to treat HIV positive people, can now be taken by HIV negative people in order to prevent being infected with the virus. The candidates to access PrEP are those who are HIV negative, at risk of contracting the virus due to the fact that they are partners of HIV positive persons or they might be exposed to the virus due to their sexual behavior. Where the idea comes from The idea of a pharmacological prevention 84 MIAMI LIVING More studies are planned, and within the next few years up to 33,000 people may take part in 22 different studies worldwide to demonstrate the feasibility of this tool to prevent HIV. In the US, nine studies in 4,255 men who have sex with men are planned; these include specific studies amongst African-Americans and adolescents. In the latter case, a study amongst 18 to 22-year- olds is ongoing, with a possible extension to 15 to 17-year-olds. Conflictual issues Many conflicting points are raised by the FDA PrEP approval. The first point is the measure of risk in a medication that requires sense and sensibility. All medications have side effects and Truvada might produce kidney impairment and/or a decrease of bone mineral density. Another issue suggests that PrEP will lead to the worsening of the HIV epidemic, since PrEP users might reduce their use of high efficacy preventive tools, such as the condom. The behavioral lack of inhibition is a potential concern, and the real challenge for the people who wish to access PrEP is the total adherence to the treatment: not one single pill can be avoided or forgotten not to lose the pharmacological protection against the virus. An additional point is the concern of who can afford it. Truvada is expensive, no insurance will pay for a prophylaxis that allows risky behavior, so everyone will be charged full price. This is why most activists groups have asked the producer to strongly decrease the price. Finally, there is a moral point: how ethical it is to access an antiretroviral that can forgive a sexual behavior when million of people in low income countries, already threatened by the disease have no access at all to any antiretroviral treatment? Many people who will access PrEP might decide they feel protected enough not to get tested as frequently as they are now… a scary scenario! Furthermore, we have to consider that PrEP protects against HIV, but not all other sexually transmitted diseases. What will happen if and when the incidents of HIV decrease, thanks to PrEP, and syphilis or gonorrhea become the next incurable infections, as antibiotics are no longer effective? Conclusions In a recent large survey proposed to serodiscordant couples, 50% of the UK citizens interviewed on this subject admitted they would like to have access to PrEP. Is PrEP the millennium panacea? Not at all, PrEP will probably protect some people from HIV, especially in Africa and in most low income countries. South Florida will probably take advantage, as many migrants come with little information on HIV prevention, but a strong commitment from NGOs and local authorities is needed in order to ensure correct counseling and follow-up of the people who still do not have the correct perception of the risk. HIV is still here, it has not been declared by WHO a chronic disease, but worldwide it is considered a life-threatening disease. ML