Contract Research & Services
Clinical Trials

ViiV Healthcare begins third phase III HIV trial of cabotegravir/rilpivirine regimen

Published 28 November 2017

ViiV Healthcare, a joint venture of GSK, Pfizer and Shionogi, has commenced a phase III study with a two-drug regimen of its long-acting, injectable cabotegravir and Janssen Sciences Ireland’s long-acting injectable rilpivirine in virally suppressed adults with HIV-1 infection.

The ATLAS-2M study is designed to demonstrate the non-inferior antiviral activity, at 48 weeks of treatment, of long-acting cabotegravir and long-acting rilpivirine administered every eight weeks compared with long-acting cabotegravir and long-acting rilpivirine administered every four weeks.

ATLAS-2M will also assess patient satisfaction and provide comparative data on antiviral activity, pharmacokinetics, safety and tolerability out to 96 weeks. Initial results from this study are anticipated in 2019.

John C Pottage, Jr, MD, Chief Scientific and Medical Officer, ViiV Healthcare said: “We have a patient-centred approach to innovation that seeks to transform how HIV is treated. Our focus on 2-drug regimens is key to this strategy. HIV treatment regimens that do not require daily dosing could be an important part of making HIV feel like a smaller part of patients’ lives and with the ATLAS-2M study, we are evaluating the possibility of maintaining viral suppression with six treatments per year of long-acting cabotegravir and long-acting rilpivirine.”

This study follows the phase III ATLAS (virally suppressed patients) and FLAIR (treatment-naïve patients) studies of monthly dosing with long-acting cabotegravir and long-acting rilpivirine for the treatment of HIV-1 infection. Results from those trials are anticipated in 2018.

About ATLAS-2M (NCT03299049)

The Antiretroviral Therapy as Long Acting Suppression every 2 Months (ATLAS-2M) study is designed to demonstrate the non-inferior antiviral activity and safety of long-acting cabotegravir and long-acting rilpivirine administered every 8 weeks (Q8W) compared with long-acting cabotegravir and long-acting rilpivirine administered every 4 weeks (Q4W) over a 48-week treatment period in adult HIV-1-infected participants.

Participants will be enrolled from Australia, Argentina, Canada, France, Germany, Italy, Mexico, Russia, South Africa, South Korea, Spain, Sweden and the United States. Approximately half of the participants in ATLAS-2M will rollover from the ongoing ATLAS trial, which commenced in October 2016.

Additional participants will be recruited to support a targeted total sample size of approximately 1,020 participants. Participants will be divided into two groups: Group 1 will include participants receiving current anti-retroviral standard of care (SOC) therapy whereas Group 2 will include participants currently receiving long-acting cabotegravir and long-acting rilpivirine Q4W in the ATLAS study. Participants in both groups will be randomised to receive long-acting cabotegravir and long-acting rilpivirine Q4W or Q8W.

Following an oral lead in for SOC participants, the study will be carried out in three phases including a screening phase, maintenance phase and extension phase. Participants choosing not to enter the extension phase can complete their study participation at the Week 100 visit and enter the 52-week Long-Term Follow-Up Phase.

About cabotegravir

Cabotegravir is an investigational integrase strand transfer inhibitor (INSTI) and is not approved by regulatory authorities anywhere in the world. Cabotegravir is being developed by ViiV Healthcare for the treatment and prevention of HIV and is currently being evaluated as a long-acting formulation for intramuscular injection (with a once-daily oral tablet being used to establish safety and tolerability in individuals prior to long-acting injection).

About rilpivirine

EDURANT (rilpivirine), in combination with other antiretroviral agents, is a non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naïve patients with HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy.



Source: Company Press Release