Dolutegravir (DTG), a drug previously feared to cause deformities in unborn children, is now the preferred HIV treatment option, even among women of reproductive age.
The World Health Organisation which is now updating its HIV therapy guidelines to show DTG as the first-line treatment option, recommended the drug based on its efficacy, tolerability and high genetic barrier to resistance.
In making its decision, WHO said it considered mathematical models of the benefits and harm associated with two HIV drugs — DTG and Efavirenz — the values and preferences of people with HIV as well as factors related to the implementation of HIV programmes in different countries and cost.
“Initial research had highlighted a possible link between DTG and defects in infants. This concern was reported in May 2018 from a study in Botswana,” WHO said on Monday.
There had been fears about the risk of defects in the brain, spine or spinal cord being higher for babies of women on DTG. As a result, countries like Kenya halted plans to make DTG-based regimens the preferred first-line therapy.
With studies advising caution in the use of DTG among women of childbearing age, Kenya’s Health Ministry ordered hospitals to stop prescribing the drug to those who tested positive for HIV.
In July 2018, then Director of Medical Services Dr Jackson Kioko asked county health bosses to ensure that pregnant and lactating mothers who had already been prescribed DTG to continue using it until they stopped breastfeeding.
Those of childbearing age — between 15 and 49 years — who were on the drug, were to be given Efavirenz as the first-line treatment.
In his memo, Dr Kioko said DTG which was launched in Kenya last year, was not recommended for pregnant and breastfeeding women “due to limited safety data.”
Unhappy with the order, HIV-positive women went to court.
Patricia Asero, the vice-chairperson of the International Community of Women Living with HIV-Kenya termed the decision as “unfair” and an abuse of their fundamental rights.
“We take ARVs to suppress the virus and improve our health. Compared with Efavirenz, DTG has been shown to have better outcomes. It’s therefore unfair for the government to deny us the drug,” she said.
Meanwhile, initial tests on a new drug and method of blocking infection offers hope that one of the biggest obstacles to combating HIV could be overcome by keeping people on medication.
The approach uses a small implant the size of a matchstick, inserted in the upper arm, to slowly release the medication that appears to block the virus for a year or more. If it is proved safe and successful in larger studies, the method could be a major improvement for people at high risk of contracting HIV who have trouble adhering to the once-a-day pill regimen and other methods used currently.
The new drug, islatravir, and the implant were developed by the drug company Merck and described at a news conference at an international gathering of HIV researchers in Mexico City. It was tested on just 12 people, at two different concentrations. Another four test subjects received a placebo, in an early study designed to assess the safety of the drug and implant. They are years away from being publicly available.
But the effort has prompted interest because the new drug is potent and the method of releasing it could solve a long-standing problem for people who have trouble with other methods of blocking HIV.
In a separate study also released at the conference, Janssen Pharmaceutical Companies announced progress in broadening the response produced by a vaccine for a wide range of HIV strains circulating throughout the world.
That study tested a four-vaccine regimen on 152 healthy adults in Kenya, Rwanda and the US. The vaccine appears to have a long-lasting effect, according to Hanneke Schuitemaker, a Janssen vice president who also spoke at Tuesday's news conference. The company, part of Johnson & Johnson, plans additional study.
By Pauline Kairu and Angela Oketch. Additional reporting from The Washington Post