(dolutegravir)

ViiV Healthcare Submits Regulatory Applications to the US FDA for a New Dispersible Tablet Formulation of Abacavir/Dolutegravir/Lamivudine to Treat HIV in Children

Shots: ViiV Healthcare has reported a regulatory submission to the US FDA for the approval of a new dispersible tablet formulation of the fixed-dose combination of abacavir, dolutegravir & lamivudine. The submission is based on modeled data and in line with regulatory recommendations The company expands its approval for Triumeq (abacavir/ dolutegravir/ lamivudine) to lower …

ViiV Healthcare Submits Regulatory Applications to the US FDA for a New Dispersible Tablet Formulation of Abacavir/Dolutegravir/Lamivudine to Treat HIV in Children Read More »

ViiV Healthcare Presents Three-Year Results of Dovato (dolutegravir/lamivudine) in P-III TANGO Study for the Treatment of HIV at IDWeek 2021

Shots: The P-III TANGO study evaluating the antiviral efficacy and safety of dolutegravir/lamivudine switching to a 2DR vs TAF based regimens in HIV-infected adults who had not experienced prior virologic failure The results showed that the 2-drug regimen demonstrated a non-inferior efficacy based on plasma HIV-1 RNA ≥50 c/mL @144wks. & resulted in no virologic …

ViiV Healthcare Presents Three-Year Results of Dovato (dolutegravir/lamivudine) in P-III TANGO Study for the Treatment of HIV at IDWeek 2021 Read More »

ViiV Healthcare’s Tivicay (dolutegravir, dispersible tablets) Receives the EMA’s Approval for Children with HIV

Shots: The approval is based on P1093 & ODYSSEY (Penta20) studies assessing safety, tolerability & dose-finding of Tivicay (5mg) in pediatric patients aged 4wks.-18yrs. while the second study assessed the 1L & 2L treatment in patients of the same age The approval includes updated dosing recommendations for Tivicay film-coated tablets (10/25/50mg) for children aged ≥6yrs. …

ViiV Healthcare’s Tivicay (dolutegravir, dispersible tablets) Receives the EMA’s Approval for Children with HIV Read More »