enero 25

First Two-Drug HIV Treatment Approved by FDA


On Nov. 21, the FDA approved the first treatment that uses only two drugs to manage HIV, the virus responsible for AIDS. The new treatment consists of a once-a-day tablet, marketed under the name Juluca, which combines a fixed dose of dolutegravir and rilpivirine.

Dolutegravir is an integrase strand transfer inhibitor, first approved by the FDA in August 2013, which blocks integrase, the enzyme that the HIV virus used to insert its DNA into the DNA of the host. Dolutegravir can be used by children older than 12 and adults who are both treatment-naïve and treatment-experienced.

Rilpivirine is a non-nucleoside reverse transcriptase inhibitor that binds to the HIV’s reverse transcriptase enzyme and blocks it, preventing the replication of the virus. Juluca can be used by adults who have been suppressed for six months and who have shown no history of resistance to other medicines. This new drug combination is designed to control HIV while addressing common side effects caused by a three or four-drug combinations.

Juluca is manufactured by ViiV Healthcare, a company majorly-owned by GlaxoSmithKline (GKS) with smaller shares owned by Pfizer and Shionogi. GSK is now developing another two-drug combination that will replace rilpivirine with lamivudine, another antiretroviral drug.

HIV impacts 36.7 million people worldwide, with approximately 1.6 million new infections in 2016 and 1 million dying that same year due to AIDS-related diseases, according to UNAIDS. Common antiretroviral treatments are combinations of three to four drugs either taken together or already mixed within a same pill.

Source: FDA, UNAIDS, Medscape and AIDS Info.



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