The study, known as the Flamingo, has been published in the scientific journal The Lancet, one of the most prestigious in the world. Staff from the IrsiCaixa AIDS Research Institute and the Fight AIDS Foundation have participated , along with other national and international researchers.
It demonstrates the high efficiency of a new HIV drug that has been already approved in the U.S., Canada, Australia and Europe. In Spain, it is its licensing and marketing process.
SOMETHING ABOUT ANTIRETROVIRAL TREATMENT (ART):
Antiretroviral drugs are classified into different families depending on what mechanism they use to block the infection cycle. Usually, antiretroviral treatment consists of 3 drugs from 2 different families. In people starting treatment for the first time the combination is usually:
- Two nucleoside reverse-transcriptase (RT) inhibitors: reverse-transcriptase is one of the molecules forming the HIV and facilitates the conversion of RNA (retrovirus genetic material) into DNA, so that HIV can infect target cells in the human body. Depending on whether the drug blocks the formation of DNA strand incorporating a novel molecule called nucleoside, or if it acts on the molecule itself, the drug is known as nucleoside or non-nucleoside, respectively.
- A third drug, that can be:
- A non-nucleoside everse-transcriptase (RT) inhibitor, as efavirenz for instance.
- A protease inhibitor. Protease is the enzyme responsible for the synthesis of viral proteins. For example, a drug called darunavir.
- Un inhibidor de la integrasa*, como raltegravir. Los fármacos de esta familia actúan bloqueando la replicación del VIH evitando la integración del material genético del virus en el de las células del sistema inmunitario humano.
- An integrase inhibitor*, as raltegravir. Drugs from this family act by blocking HIV replication preventing the integration of the genetic material of the virus into the cells of the human immune system.
Dolutegravir is an *integrase inhibitor, so it can be used as the third drug in the combined therapy. Recent studies had shown that its effectiveness was superior to that of the non-nucleoside RT inhibitor called efavirenz, and similar to other integrase inhibitors, but with the advantage of showing no resistances, a very common phenomenon in this family of drugs. When HIV infects the body mutations are developed very quickly, which makes the virus resistant to drugs: this is one of the main obstacles to the effectiveness of treatment.
In the Flamingo study, dolutegravir is compared to darunavir, a protease inihidor, showing once again superiority both in tolerance and efficiency. In addition, it has been confirmed that, so far, emergence of resistances has not been observed in patients starting treatment for the first time with this new drug.
Given the results, dolutegravir emerges as best third drug candidate for combined ART. According to Bonaventura Clotet, who is the first author of the article, "the study will impact on clinical practice, positioning the integrase inhibitors as the first line of treatment."
The Flamingo study involved 484 patients from 64 research centers in Europe, USA , Chile and Puerto Rico. Spain was the second country after the U.S., in number of patients included in the study.
Link to the article.