The National Health Surveillance Agency (Anvisa) approved a new drug for the treatment of HIV. It is a combination of two substances – lamivudine and dolutegravir sodium – in a single tablet.
For the agency, the approval represents an advance in the treatment, as it brings together two antiretroviral drugs in a daily dose. “The possibility of single doses simplifies the treatment and adherence of patients”, he informed, through a note.
According to the leaflet approved by Anvisa, the new drug reduces the amount of HIV in the body, keeping it at a level considered low. In addition, the drug promotes an increase in the count of CD4 cells, which play an important role in maintaining a healthy immune system, helping to fight infections.
Recommendation
The new drug will be indicated as an adjunct regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents over 12 years old weighing at least 40 kilos, with no history of previous antiretroviral treatment or in replacement of the current antiretroviral regimen in virologically suppressed people.
Registration was granted to GlaxoSmithKline Brasil Ltda. which, according to Anvisa, presented efficacy and safety studies with data that support the authorized indications. The approved package insert can be consulted on here.
The National Health Surveillance Agency (Anvisa) approved a new drug for the treatment of HIV. It is a combination of two substances – lamivudine and dolutegravir sodium – in a single tablet.
For the agency, the approval represents an advance in the treatment, as it brings together two antiretroviral drugs in a daily dose. “The possibility of single doses simplifies the treatment and adherence of patients”, he informed, through a note.
According to the leaflet approved by Anvisa, the new drug reduces the amount of HIV in the body, keeping it at a level considered low. In addition, the drug promotes an increase in the count of CD4 cells, which play an important role in maintaining a healthy immune system, helping to fight infections.
Recommendation
The new drug will be indicated as an adjunct regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents over 12 years old weighing at least 40 kilos, with no history of previous antiretroviral treatment or in replacement of the current antiretroviral regimen in virologically suppressed people.
Registration was granted to GlaxoSmithKline Brasil Ltda. which, according to Anvisa, presented efficacy and safety studies with data that support the authorized indications. The approved package insert can be consulted on here.
