The US Centers for Disease Control and Prevention (FDA) has approved the first injectable drug to prevent HIV in at-risk groups, including people who have sex with people with the virus. Apretude even reduced by 90% the chance of cisgender women being contaminated, when compared to other medications.
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Apretude works with two initial injections, given one month apart. Afterwards, the treatment continues with applications every two months. The drug’s safety and effectiveness were evaluated in two clinical trials that compared the drug to Truvada, an oral drug used once a day to prevent the virus that causes Human Immunodeficiency Syndrome (AIDS).
The first study looked at HIV-uninfected men and transgender women who have sex with men and were considered to be at high risk of infection. This group had 4,566 participants. Results showed that individuals who took Apretude had 69% less risk of becoming infected with HIV compared to participants who took Truvada.
The second trial verified the result of injections in cisgender women who were not infected, but who were at risk of contracting the virus. Altogether, there were 3,224 women, who had 90% less risk of being infected.
The director of the FDA’s Center for Drug Evaluation and Research, Debra Birnkrant, called the approval an “important tool in the effort to end the HIV epidemic by providing an option to prevent the virus that doesn’t involve taking a daily pill” .
“This injection, given every two months, will be crucial to addressing the HIV epidemic in the United States, and should help high-risk individuals and certain groups where adherence to daily medication has been a major challenge or not a realistic option.” , stated Birnkrant.
The drug, accepted by the FDA on Monday (20/12), was authorized for adults and adolescents weighing at least 35 kg. In addition, Apretude should only be prescribed to individuals who are confirmed to be HIV-negative to reduce the risk of resistance to the treatment. People who become infected with the virus while receiving injections should seek to initiate appropriate treatment for immunosuppressed patients.
Drug adverse effects for all participants included only application site reactions, headache, fever, fatigue, and back pain. However, the product labeling also includes warnings and precautions regarding hypersensitivity reactions, liver damage and depressive disorders.
The US Centers for Disease Control and Prevention (FDA) has approved the first injectable drug to prevent HIV in at-risk groups, including people who have sex with people with the virus. Apretude even reduced by 90% the chance of cisgender women being contaminated, when compared to other medications.
read more:
Apretude works with two initial injections, given one month apart. Afterwards, the treatment continues with applications every two months. The drug’s safety and effectiveness were evaluated in two clinical trials that compared the drug to Truvada, an oral drug used once a day to prevent the virus that causes Human Immunodeficiency Syndrome (AIDS).
The first study looked at HIV-uninfected men and transgender women who have sex with men and were considered to be at high risk of infection. This group had 4,566 participants. Results showed that individuals who took Apretude had 69% less risk of becoming infected with HIV compared to participants who took Truvada.
The second trial verified the result of injections in cisgender women who were not infected, but who were at risk of contracting the virus. Altogether, there were 3,224 women, who had 90% less risk of being infected.
The director of the FDA’s Center for Drug Evaluation and Research, Debra Birnkrant, called the approval an “important tool in the effort to end the HIV epidemic by providing an option to prevent the virus that doesn’t involve taking a daily pill” .
“This injection, given every two months, will be crucial to addressing the HIV epidemic in the United States, and should help high-risk individuals and certain groups where adherence to daily medication has been a major challenge or not a realistic option.” , stated Birnkrant.
The drug, accepted by the FDA on Monday (20/12), was authorized for adults and adolescents weighing at least 35 kg. In addition, Apretude should only be prescribed to individuals who are confirmed to be HIV-negative to reduce the risk of resistance to the treatment. People who become infected with the virus while receiving injections should seek to initiate appropriate treatment for immunosuppressed patients.
Drug adverse effects for all participants included only application site reactions, headache, fever, fatigue, and back pain. However, the product labeling also includes warnings and precautions regarding hypersensitivity reactions, liver damage and depressive disorders.
