By Yamikani Yapuwa:
Twelve-year-old James was born with HIV in 2009 but was diagnosed with virus three years later.
Her mother, a Mrs Banda, says James has been receiving antiretroviral (ARV) drugs for eight years now.
“The Nevirapine regime was the drugs that my child was taking at the beginning. He had a lot of difficulties swallowing the medication twice every day,” Banda says.
James accesses antiretroviral therapy (ART) services at Dream Centre in Blantyre.
The facility’s medical coordinator Dr Sagno Jean Baptiste concurs that the drug regimen is a burden for children.
“The drug is taken twice daily and the tablets are many. A child weighing less than 25 kilogrammes [kg] takes over six tablets of Nevirapine-based regimen per day. This issue complicates adherence and compliance,” Baptiste says.
The World Health Organisation (WHO) no longer recommends Nevirapine-based regimens due to the increased risk of drug resistance and inferior clinical outcomes.
In 2018, WHO extended the recommendation of optimal paediatric Dolutegravir (DTG) as the preferred first-line treatment to all children over the age of four weeks and 3kg.
According to UNAids 2020 data on Malawi, an estimated 74,000 children between 0 and 14 years are living with HIV and 45,689 are receiving ART.
Furthermore, DTG has been part of the ARV treatment regimens since January 2019 in Malawi but was only available in 50 milligrams (mg) and could only be given to clients weighing from 20kg and above.
This means that children and those weighing below 20kg did not have access to the optimal ARV drug.
However, this has changed as the Ministry of Health has this year rolled out the use of paediatric DTG which is available in 10mg and is being given to children starting from 3kg to 19.9kg.
Ministry of Health Spokesperson Adrian Chikumbe says they started distributing paediatric DTG in phases from June this year and that now they have reached 100 percent coverage.
“The first phase of DTG 10mg distribution was in June 2021 and targeted facilities with high volume paediatric clients. The second phase was in August 2021. The third phase was in October 2021 and in this phase, DTG 10mg was distributed to all ART facilities in Malawi,” Chikumbe explains.
From his experience, Baptiste notes that DTG is an integrase inhibitor and that the drug has a very high barrier to resistance and has shown to be very effective on HIV.
“It is very friendly in term of doses and taste; it has the capacity to suppress the viral load in just three months if well taken.
“It is good for children since they face some issues of adherence with pill burden and many have issues of taste mainly for the younger children,” Baptiste explains.
Unitaid, an international organisation that invests in new ways to prevent, diagnose and treat HIV and Aids, tuberculosis and malaria quickly, cheaply and effectively says that the strawberry-flavoured formulation of the WHO’s recommended first-line treatment for HIV has been designed to overcome many of the barriers that stop young children from taking their medication properly.
“A lack of appropriate paediatric medicines has meant that tablets are often unpalatable to children, due to a bitter taste or use of adult formulations being crushed or broken for children,” reads a report on Unitaid website.
Furthermore, Southern Africa Aids Dissemination Service (SafAids), an organisation championing the use of DTG in Zimbabwe, adds that unlike previous regimens, paediatric DTG only needs to be taken once daily with its dispersible formulation.
“Scientific evidence shows that it has significantly lower side effects than other medication, increasing adherence.
“Above all, its non-requirement of a cold chain supply really responds to the needs of low income countries where cold chain supply requirements remain a challenge,” SafAids says.
A Mrs Dimba, whose daughter accesses paediatric DTG at Dream Centre, says the child’s health and adherence has significantly improved.
“She no longer spends weeks admitted to hospital. My child is now gaining weight; she is also performing well at school,” Dimba explains.
In addition to the anticipated improved acceptability, efficacy and durability, Elizabeth Glaser Paediatric Aids Foundation Communications and Advocacy Officer, Prince Henderson, says paediatric DTG is also expected to be significantly cheaper than former ARV formulations.
Baptiste, however, hints that much as paediatric DTG is working wonders, the problem remains adherence just like with other drugs.
“DTG is not a magic bullet, it is effective when taken well,” he cautions.
To that effect, Henderson encourages parents and guardians to honour their clinic appointments so that the clinical team at their facility can assess their children and provide the necessary guidance.
“Caregivers are also encouraged to discuss with their consulting clinicians if their children are due for viral load sample collection so that viral suppression is well monitored in children.
“They should always seek medical clarification from their health facilities should they have any questions,” Henderson adds.
In ensuring that health personnel have capacity in administering paediatric DTG, Chikumbe says the ministry has conducted site-level orientations with the help of implementing partners.
“We also produced and disseminated communication materials and job aids for clinic use. These job aids have all the information on DTG including how to administer the medicines,” he says.
Meanwhile, information from Clinton Health Access Initiative shows that new paediatric neonatal liquid formulations of DTG for small babies are being developed and are showing promising results when compared to dispersible tablets.