This Week in HIV Research: When Treating Trans Patients, Check Your Priors

Using common cardiovascular risk assessment tools and sex assigned at birth, transgender women living with HIV appeared to have higher adjusted prevalence ratios (aPRs) for 10-year CVD risk than either cisgender women or cisgender men, though predicted risk scores were lowest when trans women were classified by their gender identity rather than their birth-assigned sex, researchers reported in PLOS One.

Data on 221 trans women, 2,983 cis women and 13,467 cis men came from a collaboration of eight U.S. HIV clinical sites. When trans women were classified by their birth sex, 10-year CVD risk aPRs were 1.25 when compared to cis men and 2.52 to 2.58 (depending on the assessment tool used) when compared to cis women. When trans women were classified by their gender identity, however, aPRs fell; the range was 0.61 to 0.75 compared to cis men and 1.26 to 1.52 compared to cis women.

The aPRs also fell, although by not as great a degree, when trans women were classified by whether they had a history of exogenous sex hormone usage.

Neither the ACC/AHA Pooled Cohort Risk Assessment equations (PCE) nor the Framingham Risk Score—the two tools used in this study—have been validated in transgender women living with HIV, nor do they consider gender-affirming hormone treatment or stress from trans-specific violence and stigma. PCE has also been shown to be more accurate in white men than in Black men or women of any race. (In the current study, racial makeup differed by gender.)

These caveats, as well as the observed differences by gender used, show the practical limitations of these tools when caring for transgender women, study authors noted. “Future investigations of CVD risk among [transgender women] living with HIV should collect data on intermediate CVD outcomes (e.g. coronary artery calcium, carotid artery intima-media thickness) or CVD endpoints (e.g. myocardial infarction, stroke) so that actual (versus predicted) CVD morbidity in [transgender women] can be quantified,” they concluded.

Switching to B/F/TAF (the single-tablet regimen of bictegravir/emtricitabine/tenofovir alafenamide, a.k.a. Biktarvy) from a dolutegravir (Tivicay)-based regimen is safe and effective through 48 weeks even in people resistant to NRTIs, researchers reported in Clinical Infectious Diseases. In the U.S., B/F/TAF is currently approved for treatment-naive people or people who are virally suppressed but have no relevant drug resistance mutations.

The clinical trial randomized 565 people living with HIV who had been virally suppressed on their dolutegravir-based regimen—138 of whom had suspected or confirmed prior NRTI resistance—to switch to B/F/TAF or remain on dolutegravir. At week 48, 0.4% of participants in the switch arm and 1.1% in the remain arm were viremic, defined as having a viral load ≥ 50 copies/mL. No significant difference in efficacy was observed based on prior NRTI resistance.

Weight gain was higher among participants who switched (median: +1.3 kg) than those who stayed on dolutegravir (median: +1.1 kg), probably because TDF’s weight-protective effect was eliminated in the bictegravir group, study authors suggested. They offered that the B/F/TAF regimen may thus be helpful for older people or those with CVD risk factors. Of note due to the nature of this drug-comparison study: Five of the 12 named study authors are employees of Gilead Sciences, the manufacturer of Biktarvy.

All-cause mortality among HIV/HBV coinfected people in the Netherlands dropped significantly after tenofovir-based antiretroviral regimens became common in 2003, an analysis of data from the ATHENA cohort published in Open Forum Infectious Diseases showed.

The adjusted hazard ratio was 0.50 when comparing participants diagnosed after 2003 to participants diagnosed before 2003. Liver- and AIDS-related mortality also dropped.

In Europe, HBV coinfection is becoming less common, with prevalence in the Netherlands declining from 9.8% in 1998 to 5.8% in 2018, likely due to a vaccination campaign and greater awareness among HIV providers, as well as the prophylactic effects of tenofovir against HBV, study authors noted. “Tenofovir-containing regimens, in absence of major contraindications, should be strongly encouraged in this population,” they recommended.

Liver-related mortality was strongly associated with prior exposure to didanosine/stavudine. Although these older drugs are no longer used, providers should be aware of the heightened risk among patients who took them early in the epidemic.

A significant number of participants did not have any HBV-active agents, or only lamivudine, in their regimen. Lower provider vigilance when patients’ regimens include tenofovir may be to blame, study authors wrote. “Importantly, our data demonstrate a need for continued awareness by physicians to maintain optimal HBV suppression,” they concluded.

After controlling for age, women living with HIV (WLHIV) who had a higher syndemic burden—i.e., more adverse conditions—had higher diastolic blood pressure and viral load compared to those with a low burden, a small study published in AIDS found.

Based on data from the Women’s Interagency HIV Study, researchers assessed the syndemic burden of 131 women (average age 60.5 years, 49% Black), specifically focusing on low education (high school degree or less), obesity, cigarette use, and depressive symptoms. A high burden was defined as at least two of these conditions, which the study authors noted are each associated with blood pressure, inflammation, and overall health among people living with HIV.

The researchers found that 88% of study participants had at least one syndemic factor, with 44% meeting the definition of high syndemic burden. Compared to women with low syndemic burden (and after controlling for age), women with high systemic burden had a statistically significant higher average viral load (4.63 log10 vs. 3.88 log10) and diastolic blood pressure (79.3 vs. 73.5). No similar associations were seen for CD4 count or systolic blood pressure.

In addition, no association was observed between the psychosocial conditions investigated and Interleukin-6, an inflammation marker, even though individual conditions have been linked to inflammation. A relatively high overall IL-6 level may account for this finding, study authors noted.

Risk factors don’t arise in isolation and need to be studied together to develop multi-level interventions for improving health, they suggested, concluding: “Targeted interventions to address syndemic burden may help improve health outcomes in WLHIV as well as reduce the risk of hypertension and HIV transmission.”