Aids, ViiV Healthcare: effective switch to a 2-drug regimen

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. ” This was reported by ViiV Healthcare, a company with a majority of GlaxoSmithKline, in participation with Pfizer and Shionogi. The company, which specializes in treatments against the HIV virus, has 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 the efficacy of dolutegravir / lamivudine and its positive barrier against the development of resistance, showing that people can keep HIV under control by taking fewer drugs,” 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 stresses – 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. data offer clinicians a further reason to be confident in switching to this two-drug regimen in virologically suppressed people. “The primary endpoint was reached at week 48 – a note reads – demonstrating the non-inferiority of switching to dolutegravir. / lamivudine versus continuation with Car in the Intention to Treat-Exposed population analysis (defined as all randomized study participants), 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 arm vs 1.2% 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 diversified and representative of the global HIV community – said Kimberly Smith, Head of Research & Development ViiV Healthcare – This study is a great example and it is exciting to see that the results continue to be extraordinary. Salsa is the second switch study that demonstrates the non-inferiority of efficacy of dolutegravir / lamivudine and the high barrier to resistance, without any participant experiencing virologic failure in the dolutegravir / lamivudine study arm. These results demonstrate its versatility for participants who had previously undergone a wide range of different regimes, consolidating its position in the am part of the HIV treatment paradigm “.