The two-drug regimen of dolutegravir-lamivudine (DTG/3TC; Dovato, ViiV Healthcare) achieves comparable efficacy to three-drug therapy regimens in treating people living with advanced HIV, according to 48-week findings from the DOLCE study presented recently at HIV Glasgow, in Scotland.
Conducted at 11 sites across Argentina and Brazil (oral presentation O24), DOLCE randomly selected 230 antiretroviral treatment (ART)–naive people with advanced HIV in a 2:1 ratio to receive either DTG/3TC (n=152) or a three-drug regimen that also included tenofovir and 3TC or emtricitabine (DTG+TDF/FTC) (n=77). Baseline characteristics were similar in the two treatment groups, with a severely immunosuppressed population: 43% of participants had baseline CD4 counts of less than 100 cells/mL, 61% had baseline viral load (VL) greater than 100,000 copies/mL, and 23% had a very high baseline VL at greater than 500,000 copies/mL.
At week 48, DTG/3TC showed comparable efficacy to DTG+TDF/FTC (as measured by the proportion of subjects with VL less than 50 copies/mL), with 82% of individuals in the DTG/3TC group and 80% in the three-drug regimen group achieving a VL less than 50.
Secondary efficacy measures of VL decline, time to viral suppression and CD4 recovery were similar in both arms. Efficacy by baseline VL categories was similar for both arms, including those with baseline VL greater than 500,000 copies/mL with 74% in the DTG/3TC arm, and 67% in the DTG+TDF/FTC arm achieving virological success. The change in median CD4 count from baseline to week 48 showed an increase of 200 cells/mL in the DTG/3TC arm and an increase of 177 cells/mL in the triple-therapy arm.
“It’s encouraging to see additional new data that continue to support the efficacy and safety of two-drug regimens compared with traditional three-drug regimens,” said Pedro Cahn, MD, PhD, the scientific director of the Argentinean public health organization FundaciÓn HuÉsped and DOLCE lead study investigator, in a press release. “The results from DOLCE provide healthcare providers with further confidence in prescribing DTG/3TC and are important findings for people living with HIV taking medicines to suppress their virus.”
“Many three-drug HIV regimens contain tenofovir and are good for many patients, but in clinical practice, I often notice patients complaining of gastrointestinal side effects, including upset stomach, diarrhea and vomiting, and particularly weight gain,” said Anthony Gerber, PharmD, AAHIVP, the collaborative drug therapy management clinical pharmacist in virology and sexual health at Bellevue Hospital, in New York City, who was not involved in the study. “It is helpful to have this two-drug option without TDF for those patients, and these 48-week data further underscore the efficacy of this option. With treatment-naive patients, we will often start them on the DTF/3TC regimen regardless of viral load.”
Safety was comparable in both arms and consistent with known safety profiles, with similar rates of serious adverse events and immune reconstitution inflammatory syndrome. The rate of discontinuation in both arms also was similar (DTG/3TC, 12.8%; DTG+TDF/FTC, 6.8%).
Dr. Gerber reported no relevant financial disclosures.
This article is from the February 2025 print issue.