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FDA Continues to Facilitate Access to New HIV Treatment Options

Once faced with a daunting cocktail of pills, people living with HIV now need only one or two pills, thanks to the FDA.

Today, there are many FDA-approved drugs for people with human immunodeficiency virus or HIV. Though there is no cure at this time, medicines for HIV slow the progression of the virus in the body. Left untreated, HIV damages the immune system until a person with HIV develops acquired immunodeficiency syndrome or AIDS. A person with AIDS is likely to die from infections or diseases because of severe damage to the immune system.

HIV is a type of virus called a retrovirus. Medicines that treat HIV are called antiretroviral therapies or ARTs. Modern ARTs can keep the amount of HIV in the body so low that it cannot be measured by current standard tests, limiting the damage to the immune system. Keeping a person’s virus level undetectable helps them live healthier for longer and prevents sexual transmission of the virus to others.

The early days of HIV treatment involved taking a lot of pills every day on a complicated schedule, often with serious side effects. It was difficult for many people with HIV to consistently follow this regimen.

Today, people living with HIV have several, simpler options for treatment. These medicines work well to control HIV in the body.

Advances in treatment are happening regularly. In April 2019, the FDA approved the first two-drug complete treatment pill for people newly diagnosed with HIV. Unlike the first medicines for HIV, this treatment is just one pill every day. This is not the first once-daily pill approval, but previous approvals were for triple-drug regimens.

In July 2020, the FDA approved a new type of ART for adults whose HIV cannot be fully treated with currently approved HIV medicines.

In addition to using condoms, someone at high risk of HIV can take a daily pill that lowers their chance of getting HIV from sex by 99%. Now many people at high risk have two FDA-approved options for this type of daily pill, called pre-exposure prophylaxis or PrEP.

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