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 based on the 200 copies/ml assay versus 47.8% of the 92 patients assigned to a efavirenz-containing (EFV) regimen (P<0.001), according to Carlos Brites, MD, PhD, of the Federal University of Bahia in Salvador, Brazil.
Using the more stringent 50 copies/ml assay, the undetectable threshold was achieved 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, although the difference was not statistically different.
While the World Health Organization (WHO) recommends DTG as a preferred HIV treatment in all populations, Brites said there is limited evidence of how dolutegravir works in a population with advanced AIDS and low CD4-positive cells. “Most of studies on integrase inhibitors efficacy were conducted on healthy patients,” Brites and colleagues wrote. “There is scarce information on dolutegravir use in late-presenter HIV patients.”
Late-presenter HIV patients are those diagnosed with a CD4 cell count <350/mm3 or an AIDS-defining condition regardless of CD4 cell count, according to the European Late Presenter Consensus Working Group. WHO defines advanced HIV disease as CD4 cell count <200 cells/mm3 or WHO stage 3 or 4 in adults and adolescents.
Brites’ group enrolled symptomatic, treatment-naïve, late-presenter HIV patients from AIDS referral centers of five Brazilian cities who had CD4-positive cells counts <50 cells/ml, and had been diagnosed with 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. The most frequent AIDS-defining illnesses were esophageal candidiasis, neurotoxoplasmosis, and bacterial pneumonia.
There were 12 patients in the DTG arm who were lost to follow up as were 15 in the EFV arm, but the difference was not statistically significant, Brites reported. He also noted that one person in the DTG arm required antiretroviral modification versus 16 in the EFV arm.
At 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 use of dolutegravir for treatment of advanced AIDS patients was significantly associated with higher rates of viral suppression at 24 weeks and at 48 weeks,” Brites said. “There were less treatment interruptions and changes due to adverse events, and a higher 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 people who are presenting late in their disease — with their first presentation being an AIDS-defining illness.
It’s estimated that late presenters account for nearly 40% of all HIV cases in Brazil, 40%-60% of cases in Europe, 72%-83% in Asia, and 35%-89% in Africa, according to a 2021 Pathogens article.
“We need data on how these drugs work when people are very immunosuppressed. It is fantastic that, even in these patients, there is a very good response to treatment with antiretroviral combination therapy,” Orkin said.
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.