By: Laurie Saloman, MS
From: https://www.contagionlive.com/news/dolutegravir-recommended-for-treatment-naive-expectant-women
With the current availability of different antiretroviral therapies (ART) to control HIV, along with new discoveries about their risks and benefits, the recommendations for their prescription will be reviewed.
When the World Health Organization (WHO) requested input for updating its 2019 guidelines on antiretroviral use , a team of researchers from around the world stepped in to establish the options for regimens containing dolutegravir or efavirenz for people starting ART,
The team, led by Andrew Phillips, PhD, an epidemiologist at the Institute of Global Health, part of University College London, conducted a scientific model study analyzing the pros and cons of dolutegravir- or efavirenz-containing regimens in a population of women taking the drugs at the time of conception. By examining variables such as drug cost, unwanted weight gain, risk of neural tube defects , mother-to-child transmission rates, CD4 counts, and viral resistance, the researchers concluded that dolutegravir-containing regimens generally provide the greatest benefit. Their findings were published in The Lancet HIV .
Dolutegravir proved to be more potent, with a much lower likelihood of viral resistance, and is also better tolerated, meaning people are less likely to stop taking it compared to Efavirenz.
“The main side effects of efavirenz are neurological, such as dizziness,” Phillips told Contagion® . The research team knew that previous studies had raised questions about dolutegravir’s safety profile, specifically neural tube defects. The drug was also found to cause weight gain, an average of 6 kilograms in 48 weeks, or more than 13 pounds, which in itself can cause pregnancy complications.
After evaluating different scenarios, the researchers concluded that, even with the risks of dolutegravir, the drug is appropriate for women starting ART for the first time. “Taking into account the outcomes for infants, such as neural tube defects, stillbirths, and neonatal deaths related to higher maternal weight gain, this was offset by the lower number of children born with HIV with the tenofovir, lamivudine, and dolutegravir regimen in women intending to become pregnant,” they wrote in their report.
The researchers found that regimens containing dolutegravir were less expensive than those containing efavirenz in 87% of situations, mainly due to less use of second-line drugs and fewer HIV-related complications that would require other, more expensive care.
The use of dolutegravir was more conducive to improved health in 83% of cases, primarily due to lower resistance to dolutegravir. They calculated that the reduction in the mortality rate for women on dolutegravir-containing regimens, to 0.36 per 100 person-years, would equate to 1,800 fewer deaths annually in women in Zimbabwe alone. All scenarios were based on countries with a population of approximately 10 million. Their findings and recommendations apply only to women starting ART, they emphasized, not to those considering switching from one regimen to another.
Although the modeling forecasts took into account a variety of scenarios reflecting life in sub-Saharan Africa, the updated WHO guidelines for initiating ART in pregnant women or those trying to conceive are applicable in more developed countries. “The attributes of the drugs are likely to be similar regardless of the context,” Phillips told Contagion® . “The WHO guidelines are not just intended for low-income settings.”
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