FDA approves extended dosing interval for ViiV HIV drug, cutting antiretroviral dosing by half

USA – The U.S. Food and Drug Administration has approved ViiV Healthcare’s HIV treatment Cabenuva for use every two months, which means patients only need to receive an injectable dose six times per year.

Cabenuva was approved for use once a month last year, reducing antiretroviral treatments from once daily to only 12 times per year.

Cabenuva (cabotegravir and rilpivirine) was developed to replace antiretroviral regimens currently used by some HIV-positive adults with virologically suppressed disease.

This dosing regimen is only available to those who are already virologically suppressed, have no history of treatment failure, and have no suspected resistance to either of the active ingredients.

Cabenuva’s recent FDA approval allows for monthly or every other month dosing. The label expansion comes just a few days after the one-year anniversary of Cabenuva’s initial approval, which marked the historic approval of a long-acting HIV treatment that can be given once a month rather than daily.


The most recent approval was based on data from the Phase IIIb ATLAS-2M study, which found that dosing Cabenuva every other month was non-inferior to monthly dosing.

The study also discovered that the rates of virologic suppression were comparable whether dosing was done monthly or every two months.

This was an important secondary endpoint of the Phase IIIb study. Cabenuva maintained a safe profile in HIV patients, with the most common side effects being injection site reaction, fatigue, dizziness, and musculoskeletal pain.

ViiV Healthcare, founded by GlaxoSmithKline, Pfizer, and Shinogi Limited, is laser-focused on developing new HIV therapeutics, a disease that has been present in society for the past 41 years.

In the 41 years since its discovery, HIV has claimed the lives of an estimated 35 million people. It is currently estimated that approximately 1.1 million Americans are infected with HIV, and approximately 38,000 Americans are diagnosed with the infection each year, a significant decrease from peak infections.

ViiV Healthcare’s head of North America, Lynn Baxter, expressed delight at the latest Cabenuva approval.

Today’s approval is a remarkable achievement given where HIV treatment was just a decade ago. We know some people living with HIV struggle with taking daily oral pills, and Cabenuva may allow them to maintain viral suppression while significantly reducing dosing to as few as six times a year,” Baxter said in a statement.

The US government has made a concerted effort to eradicate the disease. The White House launched an initiative during the previous presidential administration to reduce the number of new HIV infections in the United States by 75 percent by 2025.

The goal is to reduce HIV infections by at least 90% by 2030, resulting in an estimated 250,000 fewer HIV infections. The current administration has stepped up to the plate and pledged to meet the target.

Several approaches are being developed to combat HIV, including gene therapies developed by companies such as American Gene Technologies and other treatments developed by Merck and Gilead Sciences.

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