Anvisa (National Health Surveillance Agency) approved the first treatment for HIV that combines two different substances in a single pill. The new drug is a combination of the substances lamivudine and dolutegravir sodium.
According to Anvisa, the possibility of a single dose simplifies the treatment and adherence of patients. Before, the patient had to take two pills or more depending on the type of treatment.
“The approval represents an advance in the treatment of people who are carriers of the virus that causes AIDS, as it combines in a daily dose two antiretroviral drugs that were not available in a single pill,” the regulatory agency said in a statement.
According to the leaflet approved by Anvisa, the new drug reduces the amount of HIV in the body, keeping it at a low level.
In addition, it promotes an increase in the count of CD4 cells, a type of white blood cell that plays an important role in maintaining a healthy immune system, helping to fight infections.
The drug may be indicated as a complete regimen for the treatment of infection by the human immunodeficiency virus type 1 (HIV-1) in adults and adolescents over 12 years old weighing at least 40 kg, with no history of previous antiretroviral treatment or in substitution for current antiretroviral regimen in virologically suppressed people.
The registration was granted to the GlaxoSmithKline Brasil Ltda laboratory, which for this purpose presented efficacy and safety studies with data that support the authorized indications.
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