In line with new evidence, the World Health Organization (WHO) on Monday announced it was “strongly” recommending a new medication for the treatment of HIV/AIDS.
The new antiretroviral drug dolutegravir (DTG) – which, with other medication, treats HIV/AIDS – is being recommended as the preferred first- and second-line treatment for all cases, including pregnant women and those who have the potential to give birth.
Earlier studies on the drug – DTG – had suggested that it was linked to neural tube defects in pregnant women.
Neural tube defects are birth defects of the brain and spinal cord leading to condition like spinal bifida.
The preliminary safety concerns about DTG were based on a May 2018 study in Botswana. In the study, of the 426 women who became pregnant while taking DTG, four gave birth to children with spinal bifida.
Based on the initial safety concerns, many countries advised pregnant women and those having the potential to give birth to use the alternative drug, efavirenz (EFV).
However, new expanded evidence-based data from two large trials that compared the efficacy and safety of DTG and EFV in Africa, show that the risks of neural tube defects are significantly lower than earlier studies had claimed.
DTG is more effective, easier to take and has fewer side-effects than alternatively prescribed drugs, said WHO.
It also has a greater genetic barrier to developing drug resistance, which is essential, considering the increasing trend of resistance to EFV and other regimens.
This is quite important because in a survey of 18 countries, 12 reported pre-treatment drug resistance, far above the recommended threshold of 10%.
Thus, all the aforementioned reasons necessitated the review of the 2019 guidelines.
WHO has also reiterated the need for informed consent in treating patients with HIV/AIDS, as it is in the administration of medications in any other conditions.
WHO remarked: “As for any medications, informed choice is important. Every treatment decision needs to be based on an informed discussion with the health provider weighing the benefits and potential risks. WHO also stresses the importance of providing information and options to help women make an informed choice. To this end WHO has convened an advisory group of women living with HIV from diverse backgrounds to advise on policy issues related to their health, including sexual and reproductive health. WHO highlights the need to continually monitor the risk of neural tube defects associated with DTG.”
You may wish to read the WHO recommendation on DTG on WHO website.