Pregnant women on dolutegravir experience better HIV viral suppression rates vs. efavirenz
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The results of five randomized controlled trials showed greater and faster rates of virologic suppression among pregnant women with HIV who took dolutegravir compared to those who took efavirenz, researchers reported at AIDS 2020.
However, this did not translate to a lower risk for vertical transmission, according to a meta-analysis of the studies by Sumbal Fatima Asif, PhD, of Imperial College London, and colleagues.
The studies assessed primary and secondary outcomes among 1,074 pregnant women taking either dolutegravir or efavirenz. Primary endpoints included viral suppression, number of stillbirths, neonatal deaths and vertical transmission. Secondary endpoints included the total number of mother and infants experiencing one or more adverse events, preterm births and small-for-gestational-age infants.
Last year, WHO strengthened its recommendation for dolutegravir as a first-line treatment for HIV in all populations — including pregnant women — after data from the Tsepamo study showed a lower prevalence of neural tube defects among infants born to mothers taking dolutegravir than previously reported.
According to Asif and colleagues, their analysis showed significant differences only in preterm births and viral suppression rates. The risk for preterm birth was 4% higher in women using efavirenz (RD = -0.04, 95% CI, -0.07 to 0), and the odds of viral suppression were almost three times higher in women using dolutegravir (OR = 2.90, 95% CI, 1.54-5.46).
No significant differences were found between treatment groups in regard to mother-to-child-transmission. Five total cases of mother-to-child-transmission were reported, among women taking dolutegravir.
Perspective
Back to TopMonica Gandhi, MD, MPH
What the study showed in the comparison is that dolutegravir has better virologic suppression rates compared with efavirenz. This is not that surprising because this is why we've all been so interested in dolutegravir — it really does seem to have better virologic suppression rates, at least in other settings, compared with efavirenz.
There was a 90% virologic suppression rate among those on dolutegravir vs. 72% among the pooled women on efavirenz. What was a little surprising was that adverse events were actually not higher among children or mothers on efavirenz vs. dolutegravir.
The risk for preterm births was slightly higher in women using efavirenz. It was 4% higher, but no other adverse effects were worse or better among mothers and infants in those two groups.
Interestingly — and this is a little confusing — we thought that if there was going to be any maternal-to-child transmission, it would occur in women who are on efavirenz because the virologic suppression rates were better among women on dolutegravir. However, that was not the case in this meta-analysis and, in fact, there was no significant difference between the treatments regarding the number of maternal-to-child transmission. There were actually five maternal-to-child transmission events in total across these five trials, and they all occurred in women on dolutegravir.
That is an unexplained finding. It isn't statistically significant. I don't think that we must conclude from this study that efavirenz is better than dolutegravir at preventing mother-to-child transmission. People start on drugs at multiple times; people don't take them perfectly, and we don't know about those five women and their viral loads.
I will say that it was intriguing that, in general, although dolutegravir had better virologic suppression rates, there were not worse outcomes for the women on efavirenz.
I would say one final thing, which is that this doesn't prove that dolutegravir is a better drug for mothers. In general, there are so many advantages to dolutegravir over efavirenz — in terms of a higher genetic greater resistance, tolerability, potency and fewer drug interactions — that WHO switched to dolutegravir for all, including women, a year ago.
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Asif SF, et al. Faster virological suppression with dolutegravir versus efavirenz in pregnancy does not lower the risk of HIV mother-to-child transmission: A meta-analysis of 5 clinical trials in 1074 pregnant women. Presented at: International AIDS Conference; July 6-10, 2020 (virtual meeting).
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