ViiV Healthcare Initiates Rolling Submission of New Drug Application with US FDA for Long-Acting Cabotegravir for Prevention of HIV

ViiV Healthcare Initiates Rolling Submission of New Drug Application with US FDA for Long-Acting Cabotegravir for Prevention of HIV


Global specialist HIV company ViiV Healthcare has begun a rolling submission of a new drug application (NDA) with the US FDA for carbotegravir, an investigational, long-acting, injectable drug to prevent HIV. Submissions of regulatory files will begin at the end of this year, focusing initially on countries where clinical trials were conducted.

The company will thus be able to submit sections of the application to the FDA as they are completed. Data submitted will be based on results from two phase IIb/II studies, HPTN 083 and HPTN 084, which evaluated the safety and efficacy of long-acting carbotegravir for HIV prevention in men who have sex with men and transgender women in the former, and in women who are high risk of acquiring HIV in the latter.

Breakthrough Therapy Designation (BTD) was granted to ViiV Healthcare in November 2020, as preliminary clinical evidence from HPTN 083 showed its superiority to daily emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) tablets.

HIV represents a global public health crisis, with 38 million people suffering from the disease and ongoing investigations into new approaches to treatment and prevention. “With today’s announcement we’re one step closer to being able to provide the first, long-acting, therapy to prevent HIV,” said Kimberly Smith, M.D., MPH, Head of Research & Development at ViiV Healthcare. “This is the kind of innovative option for prevention that the field has been asking for, and is supported with efficacy and safety data of cabotegravir compared to daily, oral FTC/TDF. With only six dosing days per year, long-acting cabotegravir would provide an option that eliminates the need for adherence to a daily pill. If approved, cabotegravir would play a role in expanding the PrEP landscape in the US, particularly for those who are most vulnerable to acquiring HIV.”

About HPTN 083 and HPTN 084
The phase IIb/III double-blind study, enrolling 4,566 men and transgender women who have sex with men, evaluated long-acting carbotegravir administered every 8 weeks compared to daily oral FTC/TDF tablets. It was conducted at research centers in Argentina, Brazil, Peru, United States, South Africa, Thailand, and Vietnam.

Results showed an HIV incidence rate of 0.38% in those receiving carbotegravir, lower than the 1.22% in the FTC/TDF group, and long-acting carbotegravir proved to be 69% more effective despite the high level of adherence to oral therapy. Safety was similar in both groups, with 2% discontinuation in the carbotegravir arm and none in the FTC/TDF arm.

HPTN 084 is a similar study enrolling 3,223 women at higher risk of acquiring HIV, in Botswana, Kenya, Malawi, South Africa, Eswatini, Uganda and Zimbabwe. As in the other study, the HIV incidence rate in the carbotegravir arm was lower at 0.21% than that of the FTC/TDF arm at 1.86%, and the long-acting carbotegravir was 89% more effective. Safety was similar in both groups, with no discontinuation.

About HIV Prevention Trials Network (HPTN)
Co-funded by the National Institutes of Health (NIH), the National Institute of Mental Health (NIMH), and the National Institute of Drug Abuse (NIDA), the HPTN is a global collaborative clinical trials network bringing together various parties to develop methods to counter HIV acquisition and transmission. More information can be found at

About ViiV Healthcare
Co-owned by GlaxoSmithKline, Pfizer, and Shionogu, ViiV Healthcare is a global specialist HIV company dedicated to developing innovative treatments for HIV prevention and care, and to supporting communities affected by the epidemic. For more information, visit

About GSK
GSK is a global healthcare company committed to helping people do more, feel better, and live longer. For further information, visit

(Source: GSK, 2021) 


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