The two-drug anti-HIV regimen dolutegravir / lamivudine (2Dr) demonstrated “no less efficacy” than continuing an antiretroviral regimen of at least three drugs (CAR), “with zero cases of virological failure and no development of resistance, in a diverse population of virologically suppressed HIV-1 adults who have not previously experienced virological failure. ” He reports it ViiV Healthcare, a majority company GlaxoSmithKline, in participation with Pfizer and Shionogi. The society, specializing in HIV treatments, announced the 48-week data of the Salsa study at the International Aids Society Conference 2021 (Ias 2021, July 18-21 in virtual mode).
“It is exciting to have more data confirming theefficacy of dolutegravir / lamivudine and its positive barrier against the development of resistance, showing that people can keep HIV under control by taking fewer medications“says Josep Llibre, Infectious Diseases Department, Germans Trias i Pujol University Hospital, Barcelona, principal investigator of the trial that involved patients followed in over 120 centers in North America, Europe, Asia Pacific, South America and Africa.” The results are particularly significant – he points out – considering that the demographics of the Salsa study represent the people living with HIV that we see in daily practice, including women, people over 50 and a mix of different ethnic groups. These data offer clinicians an additional reason to be confident in switching to this two-drug regimen in virologically suppressed individuals. “
The primary endpoint was reached at week 48 – a note reads – demonstrating the non-inferiority of switching to dolutegravir / lamivudine compared to continuation with Car in the analysis of the ‘Intention to Treat-Exposed’ population (defined as all participants randomized to study), based on the proportion of participants with HIV-1 Rna plasma greater than or equal to 50 copies per milliliter (c / mL) at week 48 (Snapshot virologic failure: 0.4% in the dolutegravir / lamivudine vs 1 arm, 2% in the Car arm). Dolutegravir / lamivudine also demonstrated a non-inferior virologic suppression rate at week 48, with 94.3% of participants achieving HIV-1 Rna below 50 c / mL, compared with 92.7% of Car participants. No participant in either arm met the protocol-defined virological withdrawal criteria and, therefore, no development of resistance-conferring mutations was reported.
The overall rates of adverse events (Ea) were similar between the dolutegravir / lamivudine and Car arms (73% vs 70%). The incidence rates of Ea leading to study withdrawal were minimal in both treatment arms (2% dolutegravir / lamivudine vs 1% Car), and no serious drug-related Ea occurred in either group. All AEs in the dolutegravir / lamivudine arm were grade 1-2 (mild). The most common AEs in the dolutegravir / lamivudine arm were weight gain (8%), headache (7%) and Covid-19 (6%), while headache (7%), upper respiratory tract infection (6%), and Covid-19 (4%) were the most common in the Car arm.
At week 48, changes in fasting lipid parameters were minimal and comparable between study arms. From baseline to week 48, changes in renal bone and proximal tubule biomarkers generally favored dolutegravir / lamivudine, suggesting improvement or maintenance of bone and renal function when switching to dolutegravir-based 2Dr. Minimal changes in inflammatory biomarkers were observed in both directions in the two arms, with no evidence of differences between the treatment arms in immune activation or inflammation.
“At ViiV Healthcare we are committed to ensuring that our clinical trials are diverse and representative of the global HIV community – says Kimberly Smith, Head of Research & Development ViiV Healthcare – This study is a prime example and it is exciting to see the results continue to be extraordinary. Salsa is the second switch study demonstrating the non-inferiority of dolutegravir / lamivudine efficacy and the high resistance barrier, with no participant experiencing virological failure in the dolutegravir / lamivudine study arm. results demonstrate its versatility for participants who had previously undergone a wide range of different regimens, cementing its position within the HIV treatment paradigm. “