Meeting News

CAC progression elevated in men with HIV on testosterone therapy

Sabina A. Haberlen

Among men with HIV, those who used testosterone therapy had elevated risk for significant coronary artery calcium progression compared with those who did not, according to an abstract presented at CROI.

There was also a trend toward testosterone therapy use being associated with noncalcified plaque volume progression in this population, according to the researchers.

“The cardiovascular outcomes of long-term testosterone therapy use remain unclear in the HIV population,” Sabina A. Haberlen, PhD, assistant scientist at the Johns Hopkins Bloomberg School of Public Health, said during a presentation. “Since 2015, the FDA has required a warning about the potential increased risk of heart attack and stroke on all testosterone products. Yet none of the trials or observational studies in the evidence base to date includes a defined subgroup of men with HIV. Therefore, our research question was whether coronary atherosclerosis progression differs by testosterone use in men with HIV.”

Haberlen and colleagues analyzed 300 men with HIV aged 40 to 70 years from the CVD ancillary study of the Multicenter AIDS Cohort Study, of whom 15% were ongoing users of testosterone therapy (use at baseline and follow-up scans), 7% were new users (use at follow-up scan but not baseline scan) and 8% were former users who had stopped by the time of the follow-up scan.

At a mean follow-up of 4.5 years, compared with former users, ongoing users (adjusted RR = 1.99; P < .05) and new users (aRR = 2.37) had elevated risk for CAC progression, Haberlen said.

For noncalcified plaque progression, risk in new users was higher than risk in former users (aRR = 2.16; P < .05), but the same was not true for risk in ongoing users (aRR = 1.52; P > .05), she said.

“Surprisingly, the never-use group also had an elevated risk for progression compared with the former-use group, though not statistically significant,” Haberlen said.

In addition, she said, there was a relationship between baseline low serum total testosterone (< 300 ng/dL) and CAC progression (aRR = 1.97; P < .001), but not between low testosterone and noncalcified plaque progression (aRR = 0.97; P = .93).

“To our knowledge, these are the first HIV-specific data addressing testosterone therapy in subclinical cardiovascular disease outcomes” in men with HIV, Haberlen said. “We found that the risk of atherosclerosis progression was two times greater among current compared to former users, though we cannot rule out the possibility that these results are driven by residual differences between the groups rather than an effect of the testosterone therapy itself. However, it is notable that our findings are similar to those on subclinical atherosclerosis progression from the randomized controlled [testosterone] trials that were conducted among older men with testosterone deficiency.”

These and other data “suggest that it would be prudent to for clinicians to monitor closely cardiovascular risk factors and recommend interventions to lower cardiovascular risk among men with HIV on or considering testosterone therapy,” she said. – by Erik Swain

Reference:

Haberlen SA, et al. Abstract 642. Presented at: Conference on Retroviruses and Opportunistic Infections; March 8-11, 2020; Boston.

Disclosure: Haberlen reports no relevant financial disclosures.

Sabina A. Haberlen

Among men with HIV, those who used testosterone therapy had elevated risk for significant coronary artery calcium progression compared with those who did not, according to an abstract presented at CROI.

There was also a trend toward testosterone therapy use being associated with noncalcified plaque volume progression in this population, according to the researchers.

“The cardiovascular outcomes of long-term testosterone therapy use remain unclear in the HIV population,” Sabina A. Haberlen, PhD, assistant scientist at the Johns Hopkins Bloomberg School of Public Health, said during a presentation. “Since 2015, the FDA has required a warning about the potential increased risk of heart attack and stroke on all testosterone products. Yet none of the trials or observational studies in the evidence base to date includes a defined subgroup of men with HIV. Therefore, our research question was whether coronary atherosclerosis progression differs by testosterone use in men with HIV.”

Haberlen and colleagues analyzed 300 men with HIV aged 40 to 70 years from the CVD ancillary study of the Multicenter AIDS Cohort Study, of whom 15% were ongoing users of testosterone therapy (use at baseline and follow-up scans), 7% were new users (use at follow-up scan but not baseline scan) and 8% were former users who had stopped by the time of the follow-up scan.

At a mean follow-up of 4.5 years, compared with former users, ongoing users (adjusted RR = 1.99; P < .05) and new users (aRR = 2.37) had elevated risk for CAC progression, Haberlen said.

For noncalcified plaque progression, risk in new users was higher than risk in former users (aRR = 2.16; P < .05), but the same was not true for risk in ongoing users (aRR = 1.52; P > .05), she said.

“Surprisingly, the never-use group also had an elevated risk for progression compared with the former-use group, though not statistically significant,” Haberlen said.

In addition, she said, there was a relationship between baseline low serum total testosterone (< 300 ng/dL) and CAC progression (aRR = 1.97; P < .001), but not between low testosterone and noncalcified plaque progression (aRR = 0.97; P = .93).

“To our knowledge, these are the first HIV-specific data addressing testosterone therapy in subclinical cardiovascular disease outcomes” in men with HIV, Haberlen said. “We found that the risk of atherosclerosis progression was two times greater among current compared to former users, though we cannot rule out the possibility that these results are driven by residual differences between the groups rather than an effect of the testosterone therapy itself. However, it is notable that our findings are similar to those on subclinical atherosclerosis progression from the randomized controlled [testosterone] trials that were conducted among older men with testosterone deficiency.”

These and other data “suggest that it would be prudent to for clinicians to monitor closely cardiovascular risk factors and recommend interventions to lower cardiovascular risk among men with HIV on or considering testosterone therapy,” she said. – by Erik Swain

Reference:

Haberlen SA, et al. Abstract 642. Presented at: Conference on Retroviruses and Opportunistic Infections; March 8-11, 2020; Boston.

Disclosure: Haberlen reports no relevant financial disclosures.

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