La Food and Drug Administration (FDA) – ente regolatorio americano – approva l’analogo non nucleosidico etravirina (conosciuto come TMC 125). Il nome commerciale sarà “Intelence”. Azienda produttrice: Tibotec.
Indicazione: per pazienti pre-trattati che hanno evidenza di replicazione virale e ceppi di HIV-1 resistenti ad un NNRTI e ad altri agenti antiretrovirali. In pazienti che abbiano avuto fallimento con regimi terapeutici contenenti altri NNRTI, si raccomanda di non utilizzare il farmaco in associazione con soli N(t)RTI. Su pazienti naive e pediatrici la sicurezza e l’efficacia del farmaco non sono ancora stabiliti.
Il farmaco è in compresse da 100 mg, la somministrazione è di 200 mg per due volte al dì. Quindi: 2+2. Da prendere con cibo.Il farmaco non può essere co-somministrato con tipranavir/rtv, fosamprenavir/rtv, atazanavir/rtv, altri inibitori delle proteasi senza ritonavir, altri NNRTI.Principali effetti collaterali: rash e nausea (> 10%).
Studi approvativi: The FDA’s approval of etravirine is based primarily on data from 599 adults who received etravirine in two randomized, double-blind, placebo-controlled trials. After 24 weeks of treatment, more of the patients who received etravirine along with background therapy experienced reductions in the level of HIV in their blood than did those who received a placebo and background therapy.
The most common adverse events reported were rash and nausea. Patients developing a rash while taking etravirine should contact their doctor. To avoid drug interactions, patients starting etravirine treatment should tell their prescribers and pharmacists about all the medications they take. Information about drug interactions is contained in the etravirine package insert.
In the overall development program for etravirine, rare cases of serious skin reactions such as Stevens-Johnson syndrome and erythema multiforme were reported. Patients taking etravirine may develop infections, including opportunistic infections or other conditions that may develop in patients living with HIV infection. The long-term effects of etravirine are not known, and its safety and effectiveness in children ages 16 years and younger has not been studied.
Etravirine also has not been studied in pregnant women. Women who are taking HIV medications when they become pregnant are advised to consult their physician or other health care professional about use of etravirine during pregnancy and about registering with the Antiviral Pregnancy Registry.
Fonte: FDA