First-line treatment with dolutegravir/lamivudine (DTG/3TC) was found to be effective among patients with newly diagnosed HIV infection, including those with significantly increased baseline viral loads, according to research presented at IDWeek, held virtually from September 29 to October 3, 2021.

Investigators conducted a secondary analysis of a single-arm study which included treatment-naïve adults with newly diagnosed HIV infection who started DTG/3TC treatment within 14 days of their initial diagnosis despite a lack of available baseline laboratory results. The primary analysis showed the efficacy and safety of DTG/3TC as first-line treatment at 24 weeks.

The secondary analysis included results of first-line treatment with DTG/3TC in a test-and-treat setting through week 48. The investigators adjusted antiretroviral therapy (ART) among patients with either resistance to DTG/3TC, hepatitis B virus coinfection, or a greater than 30 mL/min/1.73 m2 on measurement of baseline creatinine clearance. The investigators conducted efficacy analyses on the proportion of patients with HIV-1 RNA viral loads of less than 50 copies/mL at week 48, regardless of ART regimen.


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Among a total of 131 patients included in the study, 10 had their DTG/3TC treatment adjusted. Of this subset of 10 patients, 100% of those with available baseline laboratory results (n=7) had less than 50 copies/mL on measurement of HIV viral load at week 48. At week 48, 82% (n=107) of patients included in the study and 97% (n=107) of those with available baseline laboratory results had an HIV viral load of less than 50 copies/mL.

Among a total of 19 patients with a baseline HIV viral load of greater than 500,000 copies/mL, 17 (89%) had less than or equal to 50 copies/mL on measurement of HIV viral load at week 48 and 2 were lost to follow-up. In addition, 10 patients had baseline HIV viral loads of greater than1 million copies/mL, 9 (90%) of whom achieved an HIV viral load of less than or equal to 50 copies/mL at week 48; the remaining patient was lost to follow-up.

Of 17 patients with baseline HIV viral loads of greater than or equal to 500,000 copies/mL and available laboratory results through week 48, 13 (76%) achieved virologic suppression at week 24. Of note, 1 of these 17 patients was switched from DTG/3TC to a different ART regimen prior to week 48. Of 9 patients with a baseline HIV viral load of greater than or equal to 1 million copies/mL and available laboratory results through week 48, 8 (89%) achieved virologic suppression at week 24.

“These [findings] provide evidence for the efficacy and feasibility of using DTG/3TC as first-line [treatment] in a test-and-treat setting,” the investigators concluded.

Disclosure: Some author(s) declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

Reference

Rolle CPM, Berhe M, Singh T, et al. High rates of virologic suppression with DTG/3TC in newly diagnosed adults with HIV-1 infection and baseline viral load >500,000 c/mL: 48-week subgroup analysis of the STAT study. Presented at: IDWeek; September 29 to October 3, 2021. Poster 75.