South African women less likely to receive dolutegravir during early rollout
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Key takeaways:
- Women were less likely to receive the new first-line antiretroviral dolutegravir during early rollout.
- Dolutegravir was associated with similar or better outcomes than efavirenz.
During the early rollout of dolutegravir in South Africa, women were less likely to receive the new treatment than men, despite dolutegravir being associated with improved outcomes, researchers found.
“Dolutegravir has been recommended by the WHO for first-line ART since 2018 and has now been extensively rolled out in low- and middle-income countries,” Jienchi Dorward, BSc, MBChB, MRCGP, MSc, an academic researcher at the Centre for the AIDS Programme of Research in South Africa, told Healio, adding that early in the rollout, however, there were concerns about the potential risk of neural tube defects in infants born to women who were taking the drug at the time of conception.
“Later studies showed that this risk was lower than initially feared, but it meant that early WHO guidelines advised for caution in using dolutegravir in women of childbearing potential,” Dorward said. “We wanted to see whether the fears about neural tube defects affected the rollout of dolutegravir among women in South Africa.”
To assess this and to determine whether the outcomes of retention in care and viral suppression improved with dolutegravir compared with the older efavirenz-based regimen, Dorward and colleagues conducted a cohort study, during which they assessed deidentified data from adults receiving first-line ART at 59 South African clinics between Dec. 1, 2019, and Feb. 28, 2022, using two distinct cohorts.
According to the study, the initiator cohort used Poisson regression models to assess the outcome of initiation with dolutegravir-based ART by gender, and associations between dolutegravir use and the outcomes of 12-month retention in care and viral suppression at less than 50 copies/mL, whereas the transition cohort, which was composed of adults who received nondolutegravir-based first-line ART in December 2019, used Cox proportional hazards models to assess the outcome of transition to first-line dolutegravir by gender.
The researchers also used time-dependent propensity score matching to compare the outcomes of subsequent 12-month retention in care and viral suppression between people who transitioned to dolutegravir and those who had not.
Between Dec. 1, 2019, and Feb. 28, 2022, 45,392 people were initiated on ART in the initiator cohort — 23,945 (52.8%) of whom were nonpregnant women, 4,780 (10.5%) were pregnant women and 16,667 (36.7%) were men. Of these patients, 31,264 (68.9%) were initiated on dolutegravir, 14,102 (31.1%) on efavirenz and 26 (0.1%) on nevirapine.
According to the study, a univariable Poisson regression model showed that pregnant women (RR = 0.57; 95% CI, 0.49-0.66) and nonpregnant women (RR = 0.78, 95% CI, 0.74-0.82) were less likely to be initiated on dolutegravir than were men.
Additionally, people who were initiated on dolutegravir were more likely to be retained in care at 12 months (adjusted RR = 1.09; 95% CI, 1.04-1.14) and virally suppressed (aRR = 1.04; 95% CI, 1.01-1.06) compared with those initiated on nondolutegravir-based regimens.
On Dec. 1, 2019, 180,956 people in the transition cohort were receiving nondolutegravir-based first-line ART, of whom 124,168 (68.6%) were women. By Feb. 28, 2022, 121,174 (67%) people had transitioned to first-line dolutegravir at a median of 283 days. Using a univariable Cox regression model, the researchers found that the hazard of being transitioned to dolutegravir was lower in women than in men (HR = 0.56; 95% CI, 0.56-0.57). They also found that the likelihood of retention in care was higher among the dolutegravir group compared with matched controls (aRR = 1.03; 95% CI, 1.02-1.03).
In the dolutegravir group, 33,423 (90.5%) of patients were suppressed at less than 50 copies/mL compared with 31,648 (89.7%) of the matched controls (aRR = 1.01; 95% CI, 1-1.02).
Dorward said these findings are important because they show the extent to which women were excluded from early dolutegravir rollout although by late 2021, the differences between men and women receiving dolutegravir had “disappeared” — while also providing reassurance that dolutegravir is associated with similar or better outcomes than efavirenz, reflecting findings from other clinical trials.
He added that they also support ongoing efforts to continue transitioning patients to dolutegravir worldwide.
“Efforts should particularly focus on ensuring that women receive updated safety information and are provided the opportunity to use dolutegravir without restrictions,” Dorward said. “More broadly, strategies to introduce newer antiretrovirals at scale should ensure that the necessary safety evidence is been generated as quickly as possible prior to rollout.”
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