Switching to dolutegravir/lamivudine (DTG/3TC)-based antiretroviral therapy (ART) is a robust switch option for patients with HIV infection, as cardiometabolic health outcomes after 3 years were similar between those who switched regimens vs continued 3- to 4-drug regimens of tenofovir alafenamide (TAF)-based ART. These study findings were published in Open Forum Infectious Diseases.
Researchers performed a phase 3, randomized, open-label, noninferiority study to evaluate cardiometabolic outcomes among virologically-suppressed patients with HIV infection. Eligible patients were randomly assigned 1:1 to either switch to once-daily DTG/3TC (50/300 mg) or continue their TAF-based ART regimen. Cardiometabolic outcomes were compared between the groups at 3 years. Mixed-model repeated-measures and logistic regression analyses were used to assess cardiometabolic parameters through week 144.
A total of 369 patients switched to DTG/3TC and 372 continued their TAF-based regimen, of whom the median ages were 40 and 39 years, respectively.
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At Week 144, no significant difference in weight gain was observed between patients who switched vs continued their current regimen. Baseline weight increased by at least 5% among 39% of patients who switched to DTG/3TC and 31% of those who continued TAF-based ART regimens. In addition, 13% of patients who switched regimens and 12% of those who continued their current regimen experienced at least a 10% increase in weight from baseline (adjusted odds ratio, 1.11; 95% CI, 0.68-1.80), most of whom were women in both groups.
Changes in BMI categories from baseline to Week 144 were also similar between the groups. Of patients who switched regimens, 8% shifted from a baseline BMI of less than 30 kg/m2 (underweight, normal, and overweight) to a postswitch BMI of 30 kg/m2 and higher. A similar shift in BMI was observed among 6% of patients who continued TAF-based ART regimens.
In the adjusted analysis, the percent change in serum leptin from baseline through Week 144 was similar between patients who switched (21.4%; 95% CI, 11.2-32.5) vs continued (21.2%; 95% CI, 12.1-31.0) their current regimen, including after stratification by BMI category. The percent changes from baseline through week 144 in fasting serum glucose, fasting serum insulin, serum HbA1c, and homeostatic model assessment of insulin resistance (HOMA-IR) were also similar between the groups.
The rate of metabolic syndrome at week 144 was similar between the groups, occurring more often among women, those with hypertension, and those with HOMA-IR at baseline.
Further analysis showed a similar reduction in hepatic fibrosis rates between baseline and week 144 among patients who switched vs continued their current ART regimen (-11.9% vs -10.6%). The percentage of patients at increased risk for coronary artery disease, defined as a Framingham risk score of 10% and higher, was also similar between the groups at week 144 (24% vs 22%, respectively).
Study limitations include the predominance of White men and a potentially insufficient follow-up duration. In addition, many analyses were performed post hoc, and several potential confounders, such as diet, lifestyle, and cardiometabolic risk factors prior to ART initiation, were not adequately measured.
According to the researchers, “Our findings, in combination with previously demonstrated 3-year durable efficacy and good safety and tolerability, support the 2DR DTG/3TC as a robust switch option.”
Disclosure: This research was supported by ViiV Healthcare, and multiple study authors declared affiliations with industry. Please see the original reference for a full list of disclosures.
Reference
Batterham RL, Espinosa N, Katlama C, et al. Cardiometabolic parameters 3 years after switch to dolutegravir/lamivudine vs maintenance of tenofovir alafenamide–based regimens. Open Forum Infect Dis. Published online July 12, 2023. doi:10.1093/ofid/ofad35
This article originally appeared on Infectious Disease Advisor
