The combination drug regimen of dolutegravir and lamivudine (Dovato, ViiV Healthcare) demonstrated non-inferior efficacy compared to the continuation of a current antiretroviral regimen (CAR) of at least 3 drugs, according to 48-week data from the SALSA study presented at the International AIDS Society Conference 2021. The drug also resulted in zero cases of virologic failure and no development of resistance in virologically suppressed adults with HIV-1 who have not previously experienced virologic failure.

“It is exciting to have more data re-affirming Dovato’s efficacy and positive barrier against resistance development, showing that people can keep their HIV under control while taking fewer medicines,” said Josep Llibre, MD, PhD, in a press release. “The results are particularly meaningful given that the SALSA trial demographics represent the people living with HIV that we see in daily practice, including women, people over 50 years old and a range of different ethnic groups. These findings give physicians another reason to feel confident switching virologically suppressed people to this 2-drug regimen.”

The SALSA study population is diverse and provides representation for a broad population of individuals living with HIV on a variety of different regimens of at least 3 drugs, according to the study authors. Participants were gathered from more than 120 study sites globally, from a variety of racial backgrounds and with a significant portion of these patients being female (39%) and 50 years of age or over (39%).

“At ViiV Healthcare, we are committed to ensuring our clinical trials are diverse and representative of the global HIV community; this study is an excellent example of that, and it is exciting to see that the results continue to be outstanding,” said Kimberly Smith, MD, head of Research and Development at ViiV healthcare, in the release. “SALSA is the second switch study to demonstrate Dovato’s non-inferior efficacy and high barrier to resistance, with no participants experiencing virologic failure in the Dovato arm of the study. These findings demonstrate its versatility for participants who had previously been on a broad range of different regimens, cementing its place in the HIV treatment paradigm.”

Adverse event (AE) rates were similar between the dolutegravir/lamivudine and CAR arms at 73% and 70%, respectively. Rates of AEs rarely led to study withdrawal in either arm, with a 2% withdrawal rate in the dolutegravir/lamivudine arm and a 1% withdrawal rate in the CAR arm.

The most common AEs in the dolutegravir/lamivudine arm were weight increase (8%), headache (7%), and COVID-19 (6%), whereas headache (7%), upper respiratory tract infection (6%), and COVID-19 (4%) were most common in the CAR arm.

Fuente: PharmacyTimes
Fecha: 7/28/21