Apretude, as the drug is called, has a long-lasting effect and must be administered every two months, the regulatory entity points out.

It will serve “to prevent infection by the human immunodeficiency virus (HIV) in adults and adolescents at risk who have tested negative just before starting treatment and whose body mass exceeds 35 kilograms”, underlines the source.

The safety and efficacy of Apretude were evaluated in two trials.

One of them included 4,566 cisgender men (people whose gender identity and expression matches their biological sex assigned to them when they were born), and transgender women who have sex with men.

Side effects of Apretude include local skin reactions, fatigue, fever, headaches, muscle and back pain, and inflammation of the skin.

The US Food and Drug Administration endorsed the injection, but noted a series of precautions related to hypersensitivity reactions, hepatotoxicity (liver damage) and depressive disorders.

HIV is a lentivirus, a genus of the retrovirus family, which causes the development of Acquired Immune Deficiency Syndrome (AIDS).

That disease progresses to immune system failure, allowing opportunistic infections and life-threatening cancers to develop.

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