Un comunicato stampa di ViiV Healthcare annuncia oggi il completamento con successo della fase IIb dello studio LATTE 2 (NCT02120352): sono stati raggiunti gli end point primari a 32 settimane. Le due formulazioni iniettabili ad azione prolungata di cabotegravir (l'inibitore dell'integrasi sperimentale simile al dolutegravir, prodotto da ViiV Healthcare) e rilpivirina (l'NNRTI prodotto da Janssen) hanno permesso una soppressione delle viremie paragonabile a quella di un regime orale formato da cabotegravir + 2 NRTI.
Questo sia per il dosaggio ogni 2 mesi, sia per l'iniezione mensile.
I risultati completi saranno presentati ai prossimi congressi, intanto questo è quel che ci viene anticipato dal comunicato stampa:
- Viral suppression rates (plasma HIV-1 RNA <50 c/ml by FDA snapshot analysis) for patients at 32 weeks receiving two drug maintenance therapy with investigational long acting cabotegravir (CAB LA) and long acting rilpivirine (RPV LA) dosed every 8 weeks (Q8W, 95%) or every 4 weeks (Q4W, 94%) were comparable to the rate observed in patients continuing with a three drug oral regimen of investigational CAB + NRTIs (91%).
Patients switching to CAB LA and RPV LA administered Q4W reported more adverse events (AEs) leading to withdrawal (5%; n=6) compared with those receiving an injection Q8W (2%; n=2) or who continued on oral CAB + NRTIs (2%, n=1). The most common adverse event (AE) reported by patients was injection site pain (93% of injection recipients). Two patients in the Q8W arm (none in the Q4W arm) withdrew for injection intolerance. Two patients met protocol defined virologic failure criteria, Q8W (n=1), oral (n=1); neither patient had evidence of resistance at failure.
"ViiV Healthcare is committed to identifying new therapeutic options for physicians and people living with HIV. These initial phase IIb data investigating long-acting cabotegravir and rilpivirine are promising and build on the results we have seen to date. We look forward to seeing further results as we move into phase III," said John C Pottage, Jr, MD, Chief Scientific and Medical Officer, ViiV Healthcare.
Following the results of the proof of concept two-drug oral dose-ranging study LATTE1, LATTE 2 was initiated as a phase IIb, multicentre, open label 96 week study investigating CAB LA with RPV LA as a two-drug antiretroviral (ART) regimen for suppressive maintenance therapy in ART-naïve, HIV infected adults. LATTE 2 included adults (n=309) who, after reaching virologic suppression on oral therapy with once-daily investigational oral cabotegravir 30mg + 2 NRTIs (n=286, 93%), were subsequently randomised to one of three study arms to receive either CAB LA + RPV LA injections every 4 weeks (n=115, Q4W), 8 weeks (n=115 Q8W) or continued on oral CAB + NRTIs (n=56).
Immagini tratte da Long-acting antiviral agents for HIV treatment, D. Margolis e M. Boffito, Current Opinion in HIV & AIDS: July 2015 - Volume 10 - Issue 4 - p 246–252.
Vi ricordo che i risultati della fase IIb dello studio LATTE (cabotegravir + rilpivirina orali) sono stati pubblicati il mese scorso su The Lancet Infectious Diseases: Cabotegravir plus rilpivirine, once a day, after induction with cabotegravir plus nucleoside reverse transcriptase inhibitors in antiretroviral-naive adults with HIV-1 infection (LATTE): a randomised, phase 2b, dose-ranging trial.
L'articolo è stato accompagnato da un commento, in cui si sottolinea la portata rivoluzionaria del primo regime tutto ad azione prolungata su cui arrivano oggi i primi dati: The LATTE study: a provocative brew.
In un articolo uscito invece su HIV Medicine a settembre 2015 trovate i risultati di uno studio sulla sicurezza della rilpivirina long acting in volontari HIV negativi Safety, Tolerability and Pharmacokinetics of Rilpivirine Following Administration of a Long-Acting Formulation in Healthy Volunteers
