ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi Limited as shareholders, has announced 96-week data from the LATTE-2 study. LATTE-2 is a phase IIb, open-label study investigating the long-acting, injectable formulations of cabotegravir (ViiV Healthcare) and rilpivirine (Janssen Sciences Ireland UC) as a two-drug treatment for patients with HIV-1 infection who had already achieved viral suppression with a three-drug oral regimen of cabotegravir plus two nucleoside reverse transcriptase inhibitors (NRTIs). The study results were published online in The Lancet and were presented at the annual conference of the International AIDS Society (IAS) in Paris, France.

Fixed-dose oral treatments containing three or more medicines have advanced HIV treatment by reducing pill burden and providing convenience for people living with HIV. As research into new medicines for HIV progresses, adherence to therapy continues to be essential to achieving viral suppression and reducing the emergence of resistance mutations. The LATTE-2 study sought to evaluate injectable cabotegravir and rilpivirine dosed once every four or eight weeks compared with daily oral dosing with cabotegravir + 2 NRTIs.

Following 96 weeks of maintenance treatment in the LATTE-2 study, viral suppression rates (%) for the two-drug regimen dosed every eight weeks (94%) or every four weeks (87%) were comparable to the rate observed in patients continuing with a three-drug oral regimen (84%). Two patients in the eight-week dosing group and one patient in the oral regimen group met protocol-defined virologic failure criteria; neither patient had evidence of resistance at failure. Injection site pain was the most commonly reported injection site reaction (ISR) reported by patients receiving injectable cabotegravir and rilpivirine, most ISRs were mild (84%) or moderate (15%) in severity, with a median symptom duration of three days.

John C Pottage Jr, Chief Scientific and Medical Officer for ViiV Healthcare, said “These study results are important because we now have data showing the durability and tolerability of long-acting viral suppression for a two-drug regimen out to 96 weeks. Administration of long-acting parenteral medication removes the daily dosing burden for patients and the LATTE-2 results showed that long-acting cabotegravir and rilpivirine maintained viral suppression, with no virologic failures in the four-week dosing group. We look forward to results from our phase III programme with long-acting cabotegravir and rilpivirine in 2018.”

LATTE-2 (NCT02120352) is an ongoing international multicentre, parallel group, open-label study that included 309 HIV infected adults who had not received prior anti-retroviral treatment. Enrolled patients were suppressed virologically (HIV-1 RNA <50 c/mL) during a 20-week induction period with daily oral cabotegravir (30mg) + 2 NRTIs and subsequently randomised to one of three study arms in the maintenance period: intramuscular cabotegravir long acting formulation (400mg) + rilpivirine long acting formulation (600 mg) every four weeks; intramuscular cabotegravir long acting formulation (600mg) + rilpivirine long acting formulation (900mg) every eight weeks; or oral cabotegravir (30mg) + 2 NRTIs. The primary endpoint evaluated antiviral activity and safety through 32 weeks of maintenance treatment and the study will continue up to 104 weeks of treatment.

Cabotegravir is an investigational integrase strand transfer inhibitor and analogue of dolutegravir. 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 long-acting nanosuspension formulation for intramuscular injection.

Edurant (rilpivirine) is a prescription HIV medicine that is used with other antiretroviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1) in patients: Who have never taken HIV medicines before, and Who have an amount of HIV in their blood (called “viral load”) that is no more than 100,000 copies/mL. Your healthcare professional will measure your viral load.

Edurant should be taken in combination with other HIV medicines. Your healthcare professional will work with you to find the right combination of HIV medicines.