MONTREAL — Patients with advanced HIV/AIDS infections had higher proportion of viral suppression with dolutegravir (Tivicay) treatment versus efavirenz (Sustiva) treatment, a researcher reported.
At 48 weeks, 73.9% of the 92 patients assigned to a dolutegravir-based (DTG) regimen achieved viral suppression in line with the 200 copies/ml assay versus 47.8% of the 92 patients assigned to a efavirenz-containing (EFV) regimen (P<0.001), in accordance with Carlos Brites, MD, PhD, of the Federal University of Bahia in Salvador, Brazil.
Utilizing the more stringent 50 copies/ml assay, the undetectable threshold was attained by 65.2% in the DTG group versus 45.7% in the EFV arm (P<0.001), he said in a presentation at the International AIDS Conference (IAC). Brites also reported that 12 patients in the EFV arm died versus with nine in the DTG group, even though difference had not been statistically different.
As the World Health Organization (WHO) recommends DTG as a preferred HIV treatment in every populations, Brites said there’s limited proof how dolutegravir works in a population with advanced AIDS and low CD4-positive cells. “The majority of studies on integrase inhibitors efficacy were conducted on healthy patients,” Brites and colleagues wrote. “There’s scarce home elevators dolutegravir used in late-presenter HIV patients.”
Late-presenter HIV patients are those identified as having a CD4 cell count <350/mm3 or an AIDS-defining condition no matter CD4 cell count, based on the European Late Presenter Consensus Working Group. WHO defines advanced HIV disease as CD4 cell count <200 cells/mm3 or WHO stage three or four 4 in adults and adolescents.
Brites’ group enrolled symptomatic, treatment-nave, late-presenter HIV patients from AIDS referral centers of five Brazilian cities who had CD4-positive cells counts <50 cells/ml, and have been identified as having an AIDS-defining illness. Patients either received DTG with lamivudine (Epivir) and tenofovir (Viread), or EFV with lamivudine and tenofovir.
Mean patient age in the DTG arm was 39.4 and 37.3 in the EFV arm; about 68% were men. The mean baseline CD4-positive cell count was 23 cells/ml. Probably the most frequent AIDS-defining illnesses were esophageal candidiasis, neurotoxoplasmosis, and bacterial pneumonia.
There have been 12 patients in the DTG arm who have been lost to check out up as were 15 in the EFV arm, however the difference had not been statistically significant, Brites reported. He also noted that certain person in the DTG arm required antiretroviral modification versus 16 in the EFV arm.
By the end of 48 weeks, 44.6% of patients in the DTG arm had increased their CD4-positive counts to >200 cells/ml threshold versus 29.4% of patients in the EFV arm (P<0.001).
“The usage of dolutegravir for treatment of advanced AIDS patients was significantly connected with higher rates of viral suppression at 24 weeks and at 48 weeks,” Brites said. “There have been less treatment interruptions and changes because of adverse events, and an increased proportion of patients reached a CD4-positive count above 200 cells/ml.”
IAC session moderator Chloe Orkin, MD, MBChB, of Queen Mary University of London, told MedPage Today that “we still have those who are presenting late within their disease — making use of their first presentation as an AIDS-defining illness.
It’s estimated that late presenters take into account nearly 40% of most HIV cases in Brazil, 40%-60% of cases in Europe, 72%-83% in Asia, and 35%-89% in Africa, in accordance with a 2021 Pathogens article.
“We are in need of data on what these drugs work when folks are very immunosuppressed. It really is fantastic that, even yet in these patients, there exists a very good reaction to treatment with antiretroviral combination therapy,” Orkin said.
Ed Susman is really a freelance medical writer located in Fort Pierce, Florida, USA.
Brites disclosed relationships with Bristol Myers Squibb (BMS), GlaxoSmithKline, Janssen-Cilag, Merck, and Janssen.
Orkin disclosed multiple relationships with industry including Merck, BMS, and Gilead.