Clinical Trials

Date: 2016-02-23

Type of information: Presentation of results at a congress

phase: 2

Announcement: presentation of results at the American Society of Clinical Oncology (ASCO) annual meeting, in Chicagoat the Conference on Retroviruses and Opportunistic Infections (CROI) in Boston.

Company: ViiV Healthcare (UK - USA) GSK (UK), Janssen Pharmaceuticals, a J&J company (USA - NJ)

Product: cabotegravir and rilpivirine

Action mechanism:

• integrase strand transfer inhibitor/non-nucleoside reverse transcriptase inhibitor. Cabotegravir is an investigational integrase strand transfer inhibitor (INSTI) and analogue of dolutegravir (Tivicay®). The drug 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 (IM) injection.
• Rilpivirine (Edurant®) 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. The drug  was developed by Janssen.

Disease: Infection, Human Immunodeficiency Virus

Therapeutic area: Infectious diseases

Country: Canada, France, Germany, Spain, USA

Trial details:

• LATTE-2  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. (NCT02120352)

Latest news:

• • On 23 February 2016, ViiV Healthcare presented positive results from the LATTE-2 study at the Conference on Retroviruses and Opportunistic Infections (CROI) in Boston. 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 HIV viral suppression with a three drug oral regimen of cabotegravir plus two nucleoside reverse transcriptase inhibitors (NRTIs). The primary endpoint evaluated antiviral activity and safety through 32 weeks of maintenance treatment.
• Following 32 weeks of maintenance treatment, viral suppression rates (%) for the two drug regimen dosed every eight weeks (95%) or every four weeks (94%) were comparable to the rate observed in patients continuing with a three drug oral regimen (91%). One patient 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. The most common drug-related adverse event reported by patients receiving injectable study medication was injection site pain (92%), most of which were mild (82%) or moderate (17%) in severity. ViiV Healthcare now aims to begin Phase III studies this year. During the maintenance period, the most commonly reported adverse events not related to injection site reactions for the injectable treatment groups were nasopharyngitis (20%), headache (14%) and diarrhoea (12%). For patients randomised to oral treatment, the most common adverse events during the maintenance period were nasopharyngitis (25%), headache (7%), and diarrhoea (5%). Serious adverse events occurred in 6% of patients receiving injectable treatment (none drug-related) and 5% of patients receiving oral cabotegravir (none drug-related). One patient in the eight week injectable treatment group died due to an event unrelated to study drug (seizure). Nine patients withdrew from the study due to adverse events. Lab abnormalities that emerged during the maintenance phase (? Grade 3 severity) occurred in 16% of injectable treatment patients and 14% of oral treatment patients through week 32.

 

Is general: Yes