Kenya has introduced a strawberry-flavoured tablet for children living with the human immunodeficiency virus (HIV).
The paediatric formulation of dolutegravir, a drug recommended as first-line anti-retroviral for HIV treatment by the World Health Organisation (WHO), has been hailed as a game changer in managing the virus in children as it makes treatment easier and cheaper.
The new drug comes as a tablet that can be dissolved in water or juice, making it easier to give to children too young to swallow tablets.
Kenya and Uganda are among six African countries identified to receive the dolutegravir (pDTG), which comes in formulations of 10 milligrams.
Other countries picked for the donations of up to 100,000 packs of the new drug by the Unitaid, a global health agency, and Clinton Health Access Initiative (CHAI) include Benin, Malawi, Nigeria, and Zimbabwe.
The first-line HIV treatment is recommended by the World Health Organisation from the age of four weeks and three kilogrammes, but it had been out of reach for babies because of the lack of appropriate formulations.
The flavouring renders the drug more palatable to children compared with current options that are bitter to the taste or otherwise hard for children to ingest, paediatric HIV experts attest.
An estimated 1.8 million children worldwide live with HIV, but only half receive any treatment, often hard to administer due to the bitter taste or incorrectly dosed by crushing adult pills.
About 100,000 children die from Aids-related causes annually.
According to Unaids, treatment coverage among children living with HIV lags behind adult treatment coverage in most of the sub-Saharan African countries with large HIV epidemics. In addition, studies indicate that large proportions of people enrolled on treatment have family members, including children, whose HIV status is unknown.
“Treatment coverage among children living with HIV in 2019 was just 53 percent, representing a global failure to provide life-sustaining care to 840,000 of the 1.8 million children living with HIV,” notes the UN agency.
Kenya, which received 47,000 packs of Dolutegravir (DTG) 50mg donated to the Ministry of Health by the United Nations and 28,000 packs of Dolutegravir 10mg from Unitaid through the CHAI, is implementing a phased transition of children and adolescents living with HIV to optimal regimens.
The phased transition from the use of Nevirapine to Efavirenz then to (DTG) 50 mg and now to DTG 10mg kicked off in October 2019.
To date, the health ministry said, the programme has transitioned more than 65 per cent of children on the first-line Antiretroviral Therapy (ART) to DTG-based regimens.
“Data shows that the lowest suppression is amongst the younger children. This can be attributed to several factors but key is that some of the ARVS for children, such as Lopinavir solution, have challenges of storage, palatability as well as dosing and administration,” explained Dr Catherine Ngugi, who heads the National Aids and STIs Control Programme (Nascop).
“The availability of DTG 50mg film-coated tablets will foster improved adherence among the Children and Adolescents Living with HIV thereby improving treatment outcomes in children and adolescents,” said Dr Mercy Mwangangi, chief administrative secretary at the ministry.
In low- and middle-income countries, the paediatric formulation of dolutegravir will cost about $36 per child per year, based on the pricing agreement brokered by Unitaid and Clinton Health Access Initiative with generic manufacturers Viatris and Macleods.
However, since the drug is not a standalone treatment for HIV, and must be taken in combination with other drugs as part of a HIV therapy regimen, the overall cost of treatment under the new pricing agreement will be about $120 per child per year, from the current $480, according to Unitaid and Clinton Access Health Initiative.
Keeping the promise
On World Aids Day in December 2020, Unitaid and Clinton Health Access Initiative released a statement about the dolutegravir and announced a pricing agreement to make it available in low- and middle-income countries.
DTG belongs to a class of ARVs called HIV integrase inhibitors and is the WHO’s recommended first-line drug to treat HIV. It is said to be more effective, easier to take, has fewer side effects than alternatives, and has a high genetic barrier to developing drug resistance.
The Pediatric DTG (pDTG) 10mg dispersible tablet is targeted for children between three kilogrammes and 20kg. Thereafter, children above 20kg are treated with DTG 50mg.