Top-line phase 3 results released for cabotegravir/rilpivirine long-acting injections

24 August 2018. Related: Antiretrovirals.

Simon Collins, HIV i-Base

On 15 August 2018, top-line results from the phase 3 ATLAS study reported that monthly injections with the dual long-acting formulation cabotegravir/rilpivirine were non-inferior as a switch option compared to remaining on triple-drug ART. [1]

The Antiretroviral Therapy as Long Acting Suppression (ATLAS) study randomised 570 HIV positive adults who had been virally suppressed for more than six months on their first or second HIV combination. [2]

The top-line results are based on the primary endpoint of viral suppression at week-48. However, as the recent FDA requirement for tigher boundaries for the confidence intervals is likely to apply to both ATLAS and the similar phase 3 FLAIR study, these early results are likely to be very encouraging. 

Additional details were not included in the press statement other than the full study results will be presented at an upcoming medical conference.

comment

The early press release results is a governance requirement for all companies with publicly traded stock.

However, meeting the primary endpoint of non-inferiority is an important marker that injectable ART is one step closer.

Even though oral ART is extremely effective with limited side effects, there has always been considerable interest in alternatives to taking pills. The development of injectable ART is therefore an option that many people have been waiting for.

A multi-country named-patient programme is already open and this includes expanded access in the UK. [3]

This is for people who are in need of new drugs to construct an effective ART combination and who may require the use of injectable drugs.

References

1. ViiV press release. ViiV Healthcare reports positive 48-week results for first pivotal, phase III study for novel, long-acting, injectable HIV-treatment regimen. (15 August 2018)
   https://www.viivhealthcare.com/media/press-releases/2018/viiv-healthcare-reports-positive-48-week-results-for-first-pivotal-phase-iii-study-for-novel-long-acting-injectable-hiv-treatment-regimen.aspx
2. clinicaltrials.gov.  Study evaluating the efficacy, safety, and tolerability of switching to long-acting cabotegravir plus long-acting rilpivirine from current antiretroviral regimen in virologically suppressed HIV-1-infected adults.
   https://clinicaltrials.gov/ct2/show/NCT02951052
3. clinicaltrials.gov.  GSK1265744 (cabotegravir, CAB) for named patient/compassionate use in HIV.
   https://clinicaltrials.gov/ct2/show/NCT03462810