FDA Approved Drugs for HIV-1 Infection

What is HIV?

Human immunodeficiency virus 1 (HIV) is a virus that attacks the immune system by destroying CD4+ T cells (a type of white blood cell that fights infection). If HIV is not treated, it can develop into acquired immune deficiency syndrome (AIDS). HIV is transmitted through certain body fluids (blood, semen, pre-seminal fluid, rectal fluid, vaginal fluid and breast milk).

What do HIV drugs do?

The body is unable to clear the HIV virus and there is no effective treatment. However, with proper medical care, it can be controlled with HIV medicines.

HIV medication prevents HIV from multiplying in the body and reduces the amount of virus in the body. The immune system can recover because there is less virus in the body. Although HIV remains in the body, the immune system is strong enough to fight off other infections. By reducing the amount of HIV in the body, HIV drugs can also reduce the risk of transmitting HIV to sexual partners. Treatment with HIV drugs is called antiretroviral therapy (ART). Although ART does not cure HIV, it can help people live longer and healthier lives.

FDA-approved drugs to treat HIV-1 infection

First complete injectable regimen for treating HIV-1 infected adults

The FDA approved CABENUVA (cabotegravir extended-release injectable suspension; rilpivirine extended-release injectable suspension), co-packaged for intramuscular injection. This is the first FDA-approved complete injection regimen for HIV-1 infected adults to be administered once a month.

CABENUVA is a 2-drug co-packaged product of cabotegravir, a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI), and rilpivirine, an HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI), designated as a complete regimen for the treatment of HIV-1 infection in adults to replace a currently failing antiretroviral regimen in patients who are virologically suppressed (HIV-1 RNA below 50 copies/mL) and have no history of treatment with a stable antiretroviral regimen and no known or suspected resistance to cabotegravir or rilpivirine.

The FDA also approved VOCABRIA (cabotegravir) 30 mg tablets, which should be taken in combination with oral rilpivirine (EDURANT) for one month prior to starting treatment with Cabenuva to ensure that the drug is well tolerated before switching to extended-release injectable doses.

VOCABRIA is a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI) used in combination with EDURANT (rilpivirine) for the short-term treatment of virologically suppressed adult HIV-1 infection (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and no known or suspected resistance to cabotegravir or rilpivirine.

New HIV drug for adults with limited treatment options
The US Food and Drug Administration approved Sunlenca (lenacapavir), a new antiretroviral drug for adult patients infected with human immunodeficiency virus type 1 (HIV-1) whose HIV infection cannot be successfully treated with other available therapies due to drug resistance, intolerance or safety concerns. Its availability may help these HIV patients, who have run out of treatment options, to live longer and healthier lives.

Sunlenca is the first of a new class of FDA-approved drugs called capsid inhibitors for the treatment of HIV-1. Sunlenca works by blocking the protein shell (capsid) of the HIV-1 virus, thereby interfering with several important steps in the virus' life cycle.

Sunlenca is given as a starting dose of oral tablets and subcutaneous injections, followed by maintenance injections every six months; Sunlenca is used in combination with other antiretroviral drugs.

It is important to note that patients should not receive Sunlenca if they are taking certain medications that cause Sunlenca levels to decrease, which may lead to loss of virological response and development of viral resistance.

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