Perspective

6 treatments per year? Injectable HIV regimen effective when given every 2 months

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

Reference:

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.

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

Reference:

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.

    Perspective
    Paul A. Volberding

    Paul A. Volberding

    Newer models of HIV drug delivery, certainly including long-acting injectables, are exciting and deserve our attention. These will probably not be best for every patient, but they expand the options available as we try to optimize our treatment approaches. Every 2 months is probably better than every month as an injection and may be a popular option compared with daily pills for some of our patients. This is all a healthy evolution in our means of managing successful HIV care.

    • Paul A. Volberding, MD
    • Infectious Disease News Chief Medical Editor
      Professor of medicine
      Director, AIDS Research Institute
      University of California, San Francisco

    Disclosures: Volberding reports chairing a data and safety monitoring board for Merck.