ViiV Healthcare announced that the Phase IIb study LATTE 2 (NCT02120352) met its
primary endpoint at 32 weeks. These results show that the
investigational, long acting, injectable formulations of cabotegravir
(ViiV Healthcare) and rilpivirine (Janssen) were comparable in
maintaining viral suppression rates to a three drug oral regimen of
investigational cabotegravir and two nucleoside reverse transcriptase
inhibitors (NRTIs). The 32 week results of LATTE 2 will be presented at a
forthcoming scientific conference. ViiV Healthcare and Janssen Sciences
Ireland UC (Janssen) are collaborating to conduct LATTE 2.
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.
Cabotegravir is an investigational
integrase strand transfer inhibitor (INSTI) and analogue of dolutegravir
(Tivicay®). Cabotegravir is being developed by ViiV Healthcare for the
treatment and prevention of HIV and is currently being evaluated as a
once-daily oral tablet formulation and as a LA nanosuspension
formulation for intramuscular (IM) injection.
Rilpivirine is a once daily
non-nucleoside reverse transcriptase inhibitor (NNRTI) used for the
treatment of human immunodeficiency virus (HIV‑1) infection in
combination with other antiretroviral agents in antiretroviral
treatment-naïve adult patients with a viral load ≤ 100,000 HIV RNA
copies/mL. Rilpivirine was developed by Janssen. Rilpivirine is approved in US
and EU as EDURANT® as a single agent tablet dosed at 25mg taken once a
day. The overall safety profile of rilpivirine is based on Phase III
clinical studies. Rilpivirine is also available in the United States
(US) and the European Union as part of a once daily fixed dose
antiretroviral combination with Gilead Sciences Inc’s tenofovir and
emtricitabine. This combination, known as COMPLERA® (US) or EVIPLERA®.
