An injectable two-drug regimen of cabotegravir and rilpivirine administered every 2 months is noninferior to the same injection received monthly, according to results from the phase 3 ATLAS-2M trial.
Researchers designed ATLAS-2M to compare the antiviral activity and safety of long-acting cabotegravir (ViiV Healthcare) and rilpivirine (Janssen Pharmaceuticals) given every 4 or 8 weeks over a 48-week treatment period in adults living with HIV-1 infection whose viral load is suppressed and who are not resistant to either drug, according to a news release.
The phase 3 ATLAS study previously demonstrated that receiving injections of the investigational regimen every 4 weeks is noninferior to a daily three-drug oral regimen for the treatment of HIV and is overwhelmingly preferred by patients.
“This is further progress in our efforts to reduce the number of medicines a person living with HIV must take while also reducing the frequency of treatments,” Kimberly Smith, MD, head of research and development at ViiV Healthcare, said in the release. “The ATLAS-2M study results mean that people living with HIV could maintain viral suppression with six total treatments per year, instead of a daily oral treatment 365 times per year.”
Researchers assessed noninferiority by comparing the proportions of patients with plasma HIV RNA of 50 copies/mL or more using the FDA Snapshot algorithm at 48 weeks. Overall safety, drug resistance and virologic response for the injectable regimen given every 2 months were consistent with results from the ATLAS study, according to the release.
“Approval of this regimen would mark a significant change in the HIV treatment paradigm,” Smith said.
Detailed results from the ATLAS-2M trial will be presented at an upcoming scientific meeting, according to ViiV Healthcare. – by Joe Gramigna
ViiV Healthcare. ViiV Healthcare reports positive phase III study results of investigational, long-acting, injectable HIV-treatment regimen administered every two months. https://www.gsk.com/en-gb/media/press-releases/viiv-healthcare-reports-positive-phase-iii-study-results-of-investigational-long-acting-injectable-hiv-treatment-regimen-administered-every-two-months/. Accessed August 22, 2019.
Disclosures: Smith is an employee of ViiV Healthcare.