RIO DE JANEIRO, BRAZIL – The Brazilian Health Regulatory Agency (ANVISA) has approved the first HIV treatment combining two different substances in a single pill. The new drug is a combination of lamivudine and sodium dolutegravir.
Previously, patients were required to take two pills or more, depending on the type of treatment.
“The approval represents a breakthrough in the treatment of people with the virus that causes AIDS, since it combines two antiretroviral drugs that were not available in a single pill in a daily dose,” the regulator said in a statement.
According to the package insert approved by ANVISA, the new drug reduces the amount of HIV in the body, maintaining it at low levels.
In addition, it promotes an increase in the CD4 cell count, a type of white blood cell that plays a key role in maintaining a healthy immune system, thereby aiding in the fight against infections.
The drug may be indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents over 12 years of age weighing at least 40 kg, with no history of previous antiretroviral treatment or as a substitute for the current antiretroviral regimen in people with virological suppression.
Registration was granted to the laboratory GlaxoSmithKline Brasil Ltda., which submitted efficacy and safety studies with data supporting the authorized indications.