On December 21, the FDA approved Isentress (trade name: latilavir) for use in combination with other antiretroviral drugs for the treatment of children aged 2-18 years and young people with HIV-1 infection.
The drug is a HIV integrase chain transfer inhibitor drug that acts by slowing the spread of HIV in the body. According to the FDA's accelerated approval process, this drug was first approved for use in adults in October 2007.
"Many young children and adolescents are suffering from HIV infection. The approval of this drug provides an important additional option for their treatment," said Edward Cox, director of the antibacterial product office at the FDA's Center for Drug Evaluation and Research. .
Isentress is a pill that is taken twice daily and can be taken with food or taken alone. The pellets were also made into chewable tablets. Because these two dosage forms are not interchangeable, chewable tablets are only approved for children aged 2-11 years.
Ninety-six children and adolescents aged 2 to 18 years who were infected with HIV-1 participated in a single-factor, multicenter clinical trial that evaluated the safety and efficacy of Isentress. These patients were previously treated with anti-HIV-1 infection before taking Isentress. After 24 weeks of treatment with Isentress, the HIV virus in the blood of 53% of the patients was low enough to be undetectable.
Sleep disorders (insomnia) and headaches are serious side effects from treatment and are the most reported adverse reactions. Such side effects occur in children and adults in similar frequency. There has been a case report of severe insomnia caused by treatment in a pediatric case, and another case of pediatric manifestation was a drug-induced rash. Once these side effects occur, stop the drug.
Isentress does not cure HIV infection. Patients must adhere to continuous anti-HIV treatment to control HIV infection and reduce the incidence of HIV complications.
The drug is a HIV integrase chain transfer inhibitor drug that acts by slowing the spread of HIV in the body. According to the FDA's accelerated approval process, this drug was first approved for use in adults in October 2007.
"Many young children and adolescents are suffering from HIV infection. The approval of this drug provides an important additional option for their treatment," said Edward Cox, director of the antibacterial product office at the FDA's Center for Drug Evaluation and Research. .
Isentress is a pill that is taken twice daily and can be taken with food or taken alone. The pellets were also made into chewable tablets. Because these two dosage forms are not interchangeable, chewable tablets are only approved for children aged 2-11 years.
Ninety-six children and adolescents aged 2 to 18 years who were infected with HIV-1 participated in a single-factor, multicenter clinical trial that evaluated the safety and efficacy of Isentress. These patients were previously treated with anti-HIV-1 infection before taking Isentress. After 24 weeks of treatment with Isentress, the HIV virus in the blood of 53% of the patients was low enough to be undetectable.
Sleep disorders (insomnia) and headaches are serious side effects from treatment and are the most reported adverse reactions. Such side effects occur in children and adults in similar frequency. There has been a case report of severe insomnia caused by treatment in a pediatric case, and another case of pediatric manifestation was a drug-induced rash. Once these side effects occur, stop the drug.
Isentress does not cure HIV infection. Patients must adhere to continuous anti-HIV treatment to control HIV infection and reduce the incidence of HIV complications.
Gauze Sheet,100%Cotton Gauze Sheet,Medical Gauze Swabs Sheet,Disposable Gauze Swabs
Shaoxing Weijian Medical Supplies Co.,Ltd. , https://www.wetourmedical.com