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FDA Approves First Monthly Injection For People Living with HIV

The US Food and Drug Administration (FDA) has given the green light to a monthly shot for people living with HIV that could replace the current daily pills

The US Food and Drug Administration (FDA) has given the green light to a monthly shot for people living with HIV that could replace the current daily pills needed to manage their condition. 

The US regulators approved the first long-acting drug combo for adults with HIV-1 on Thursday, January 21. It’s called Cabenuva and consists of two drugs, cabotegravir and rilpivirine, that can be injected in an intramuscular shot each month. 

There is no effective cure for HIV, but modern antiretroviral therapies can allow people with HIV to live healthy and happy lives. These therapies involve taking medicine that helps to maintain a low viral load, the amount of HIV in the blood is called viral load. If successful, antiretroviral therapy can make the viral load so low that it can't be detected by a test, what’s known as viral suppression.

The hope is that this new monthly shot can replace the current antiretroviral regimen in adults who have achieved viral suppression (with a viral load less than 50) on daily oral tablets. 

"Currently, the standard of care for patients with HIV includes patients taking daily pills to adequately manage their condition. This approval will allow some patients the option of receiving once-monthly injections in lieu of a daily oral treatment regimen," John Farley, director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research, said in a statement

"Having this treatment available for some patients provides an alternative for managing this chronic condition," added Farley.

Research has found that people living with HIV prefer the idea of monthly shots over daily pills. Monthly shots are easier to manage and easier to adhere to. Furthermore, many have commented that being free from daily medication can approve their quality of life. In one study looking at whether people with HIV prefer monthly injections or daily pills, people often commented that the pills felt like a "daily reminder" of their illness. Many others also said they prefer the idea of a monthly shot as it's more discreet and it will help them avoid some of the social stigmas that still surrounds the condition. 

The FDA approval comes off the back of two open-label randomized clinical trials involving 1,182 HIV-infected adults who were virologically suppressed. The treatment was found to effective at keeping the viral load low while only producing mild side-effects.

The European Medicine Agency also recently approved a similar long-acting injectable antiretroviral therapy for HIV for use in the European Union.

More developments could be in the pipeline too. Last year, scientists reported an early step toward a once-a-year injectable HIV treatment using the drug cabotegravir.

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