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 Ministry of Health has updated its HIV therapy guidelines to show DTG as the first-line treatment option.
The update follows one issued by the World Health Organization (WHO) which in July recommended the drug based on its efficacy, tolerability and high genetic barrier to resistance.
In making its decision, acting director-general of health Dr Wekesa Masasabi said the once feared HIV drug should be given as the first choice for adults and adolescents living with HIV, including adolescent girls and women of childbearing potential.
“Following the updated WHO guidance issued in December and further guidance in July, the ministry, in consultation with various stakeholders including representatives of women living HIV is issuing this updated statement on use of DTG in women and adolescent girls in Kenya,” said Dr Masasabi’s statement to county health chiefs.
Dr Masasabi’s circular added, however, that DTG should be used with caution during the period of conception until the end of the first trimester.
Kenya introduced DTG in 2017 to boost the fight against HIV/Aids, making the country the first country in Africa to roll out the generic version of DTG and the second after Botswana to launch the drug for routine use.
Dolutegravir, manufactured by the Indian pharmaceutical Aurobindo Pharma, will be available free of charge in public hospitals and select private facilities.
But barely a year after introducing the drug, fears about the risk of defects in the brain, spine or spinal cord being higher for babies of women on DTG arose following a study in Botswana.
As a result, the health ministry halted plans to make DTG-based regimens the preferred first-line therapy especially among women of reproductive age.
“Adolescent girls and women of child-bearing potential should be provided with all the information regarding DTG. This information should include the benefits and potential risk of neural tube defects with DTG use during the period of conception until the end of first trimester,” said Dr Masasabi.
With studies advise 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, Director of Medical Services, Dr Jackson Kioko, asked county health bosses to ensure pregnant and lactating mothers put on DTG continued 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 in 2018 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, vice-chairperson of the International Community of Women Living with HIV-Kenya, termed the decision as “unfair” and an abuse of 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.