The USFDA has recently approved the antiviral drug Dolutegravir for the treatment of HIV-1 infection in infants at least four weeks old and weighing 3 kgs. Dolutegravir tablet and suspension form are intended for administration with other antiretroviral medications. Dolutegravir’s effectiveness is evident from a clinical trial involving 75 HIV-1 infected participants including infants, children, and adolescents, between the ages of four weeks to 18 years. The trial was designed to analyze the efficacy, safety, and pharmacokinetics of dolutegravir.
The outcome measured was the percentage of viral load at 24 and 48 weeks and levels of CD4 cells in the patient’s body. At 24 weeks, 62% of participants showed an undetectable viral load while at 48 weeks, 69% of participants were found with a very low viral count. Also, the level of CD4 cells was found to be higher in the study subjects.…
