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Incidence of metabolic complications among treatment-naive adults living with HIV-1 randomized to B/F/TAF, DTG/ABC/3TC or DTG+F/TAF after 144 weeks.
Low and Similar Rates of New Metabolic Problems: 3 Years With 3 ART Regimens
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IDWeek, September 29-October 3, 2021
Mark Mascolini
Metabolic abnormalities like diabetes and hypertension emerged at low rates over 3 years in 2 international trials of common first-line antiretroviral therapy (ART) regimens: bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF), dolutegravir/abacavir/lamivudine (DTG/ABC/3TC), and DTG + F/TAF [1]. Nor did incidence of metabolic upsets differ much between the 3 regimens in these trials.
But the proportion of trial participants with a normal body mass index (BMI) when these previously untreated people started ART fell across study arms, while the proportion of overweight, obese, or morbidly obese people rose through 144 weeks in all treatment arms. Also, the value of this analysis is limited by the young age of participants and the large majority of men.
Metabolic abnormalities like obesity, diabetes, and out-of-line lipids contribute to higher rates of cardiovascular disease in people with HIV than in the general population. Keeping an eye on metabolic parameters in HIV-positive people can help them ameliorate or avoid comorbidities that require additional medications, more frequent care, and perhaps more trips to the hospital.
To get an overview of treatment-emergent metabolic changes with 3 of today's most popular first-line regimens, researchers who worked on Study 1489 (B/F/TAF vs DTG/ABC/3TC) and Study 1490 (B/F/TAF vs DTG + F/TAF) compiled and compared metabolic data in people taking these combinations for 144 weeks, or about 3 years.
The two trials gathered 1274 participants, 634 randomized to B/F/TAF, 315 to DTG/ABC/3TC, and 325 to DTG + F/TAF. Treatment arms did not differ substantially in proportion of men (90% overall), blacks (33% overall), or Hispanics (about 25% overall). Treatment groups were also similar in median age when the trials began (33 years overall, range 18 to 77), which is not representative of the aging HIV population in the United States or countries with similar HIV epidemics. (In 2018 the Centers for Disease Control and Prevention figured that 51% of US residents with diagnosed HIV were 50 or older [2]).
In Study 1489 pretreatment rates of diabetes and hypertension were 4.5% and 12.1%, and in Study 1490 those pretreatment rates were 6.8% and 18.8%. Rates of treatment-emergent diabetes and hypertension with B/F/TAF were 0.7% and 10% in Study 1489 and 2.1% and 5.8% in Study 1490. In these trials incidence of on-treatment diabetes and hypertension were 1.3% and 6.9% with DTG/ABC/3TC and 2.3% and 6.5% with DTG + F/TAF. None of the between-regimen differences were anywhere close to statistical significance.
Pretreatment total-to-HDL cholesterol ratio stood at 3.7 in all 4 treatment arms of Study 1489 and Study 1490. After 144 weeks, that ratio stayed the same in one B/F/TAF group, dwindled a bit (improved) in the other B/F/TAF group, and also dipped modestly with the other two antiretroviral regimens. (The American Heart Association says an ideal total-to-HDL ratio is 3.5 [3]).
Through 144 weeks median gain in body mass index (BMI) measured 1.3 kg/m2 with B/F/TAF in Study 1489 and 1.4 kg/m2 in Study 1490. Median BMI gains were 1.1 kg/m2 with DTG/ABC/3TC in Study 1489 and 1.7 kg/m2 with DTG + F/TAF in Study 1490. Women in Study 1489 had a twice-higher 144-week BMI jump with DTG/ABC/3TC than with B/F/TAF (2.9 vs 1.5 kg/m2). BMI upticks over 144 weeks were modestly higher in blacks getting B/F/TAF or DTG + F/TAF (2.1 and 2.2 kg/m2) in Study 1490 than in nonblacks getting those regimens in that trial (1.3 and 1.2 kg/m2).
Proportions of people with normal initial BMI dropped 7% to 15% through 144 weeks across treatment arms in Study 1489 and Study 1490. Each trial saw corresponding jumps of 9% to 15% in proportions of overweight, obese, or morbidly obese people:
Drop in proportion of normal-weight people over 144 weeks
42% to 35% with B/F/TAF in Study 1489
46% to 38% with DTG/ABC/3TC in Study 1489
46% to 37% with B/F/TAF in Study 1490
50% to 35% with DTG + F/TAF in Study 1490
Increase in proportion overweight, obese, or morbidly obese people over 144 weeks
53% to 63% with B/F/TAF in Study 1489
52% to 61% with DTG/ABC/3TC in Study 1489
52% to 62% with B/F/TAF in Study 1490
48% to 63% with DTG + F/TAF in Study 1490
With the caveats that these trial populations are 90% male and much younger than the US HIV population, this 2-trial analysis offers some reassuring data on metabolic changes through 144 weeks of treatment. But the analysis also confirms concerning gains in BMI in the first years of treatment with these common antiretroviral regimens.
References
1. Daar E, Orkin C, Sax P, et al. Incidence of metabolic complications among treatment-naive adults living with HIV-1 randomized to B/F/TAF, DTG/ABC/3TC or DTG+F/TAF after 144 weeks. IDWeek, September 29-October 3, 2021. Abstract 69.
2. Centers for Disease Control and Prevention. HIV in older Americans. https://www.cdc.gov/hiv/group/age/olderamericans/index.html
3. healthline. Understanding the cholesterol ratio: what it is and why it's important. https://www.healthline.com/health/cholesterol-ratio
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