"How's your grandson?" a nurse asks her at the clinic.
The elderly woman from Kosewe, Homa Bay County, does not have a simple answer. She shakes her head in tears. "We’re back in hospital. I’m overwhelmed and I don’t know what to do,” she says in a whisper. “I thought I have been following all the doctors’ instructions. He’s getting worse every day.”
Her grandson is HIV positive. The fear of losing him is weighing down on her. “Please do everything possible to ensure he is back to his normal self,” requests the caregiver of the four-year-old.
A viral load suppression (VLS) test that had been done earlier shows bad news. It turns out the child has a viral load of 265,000 copies, which is too high seven months into the drug. Anything above 1,000 copies is considered dangerous.
According to Centres for Disease Control and Prevention, if taken as prescribed, antiretroviral (ARV) drugs reduce the amount of HIV in the body (viral load) to a very low level, which keeps the immune system working and prevents illnesses. This is called viral suppression. HIV medicine can even make the viral load so low that a viral load test can’t detect it.
The woman had been given ARV drugs that she had to dissolve in water before giving her grandson and another one to be swallowed whole. “I have always observed time when giving the drug, but whenever he takes it, he vomits,” she says, adding that she never adds a second dose after the child vomits.
The nurse tells her this could be to blame for the high viral load: “He could be vomiting the medicine and in this case it is always advisable to readminister another dose of the same drug,” adds the nurse.
The woman is given different drugs, pellets, which she only has to mix with liquids or semi-solid food without crushing. This will be given in combination with another drug to make a complete regimen.
The woman’s story is all too familiar. Many parents and caregivers raising children with HIV face the same challenges.
When you think about children's medicine, a sweet syrup or a flavoured tablet comes to mind. However, for children with HIV this is not always the case.
Although it is mandatory for them to take their ARVs daily to stay healthy and alive, the choice of drugs is limited to bitter, unpalatable syrups and a cocktail of huge tablets. Developing paediatric formulations is a longer process compared to the adult drugs and may not be very profitable to pharmaceutical companies, hence the lack of better medicine.
Some of the drugs are hard to swallow, yet some formulations such as Lopinavir-Ritonavir tablets must be swallowed whole. For many children taking their medicine in tablet form, the drugs may need to be cut in halves or quarters for proper dosing. Other children are forced to ingest unpalatable, alcohol-based syrups that require refrigeration at home.
Poorer viral suppression among children is at least partly attributable to a lack of child-specific and child-friendly treatment options, which leads to inefficiency, side effects, non-adherence to treatment and dropping out of care.
Children are, therefore, not given drugs in the right proportion, and others vomit after taking drugs while others have caregivers who are not well educated about the dosage.
With the challenges surrounding treatment, children are lagging behind.
A look at the preliminary Kenya Population-based HIV Impact Assessment (Kenphia) 2018 report shows that in all the ages, children have the lowest VLS at 48 per cent against a national average among adults of 72 per cent. This means in every 10 children — ages zero to 14 years — in the country only four have a suppressed viral load, raising concerns that hundreds could be dying needlessly.
When Mama Emily Atieno* gave birth to her fourth born at home, she was not aware of his status. Unfortunately, baby Chris* was infected.
It started with a minor cough, which got serious until the boy was bedridden only for the parents to notice his body was turning yellow and he had diarrhoea. The boy was four years old then. “I had to go back to the hospital to explain to the doctors that I was in care and was suspecting that my son was infected during delivery. A test was done and, indeed, he was positive,” she says.
By then, the mother was working in Nairobi. She monitored the son for three months and left him under the care of his father and his uncle.
The father, a veterinary officer, would leave the house early in the morning for work before Chris could take his drugs. His epileptic uncle would suffer an attack and forget to give him the drugs. As a result, Chris also missed his clinic appointments.
The boy would some times go for a week without his drugs and this took a toll on his health. The parents only noticed when he went into a comma twice. It took a neighbour, who was a community health volunteer, raising an alarm.
He was found to have a viral load of 110,000 copies. “My son was to take his drugs at seven o’clock every morning and at night, but would only take the evening drugs,” she says.
The hospital, liaised with the area community health volunteer to supervise the boy by placing him on direct observed treatment where he had to take his drugs at the facility every morning and evening. “During the monitoring process, we received psychosocial support and guidance,” the mother says.
Chris’ viral load dropped from 110,000 to 159 copies while that for the parents was at 21 copies each respectively.
For 14-year-old Jeff*, blame game between his parents worsened his condition. His father blamed his mother for the disease and vice versa.
When the mother tested positive for HIV, his father was in denial and refused to go for testing for about two years. That was in 2016. “My son was sickly, but HIV infection was the last thing on my mind,” says his father.
Unfortunately, Jeff and his mother had different times for taking the drugs and, therefore, there was nobody to remind him to do so. Jeff would miss his medication and his viral load rose to 26,300 copies. When his father finally agreed to be tested and receive treatment, he requested to be given the same timing with Jeff so that they could be taking their drugs and attending their clinics together.
This was in March 2017 and by November the same year Jeff’s viral load had decreased to 2,700 copies. As of August last year, his viral load was at 00 — undetectable.
Highlighting the factors that have made it hard to suppress children’s viral load, Dr Justine Odionyi, Elizabeth Glaser Paediatric Aids Foundation Kenya (EGPAF) technical director, named three reasons: HIV factors, drug factors and patient factors.
Dr Odionyi says out of the 139,000 HIV positive children in Kenya, 93 per cent are on treatment.
The viral suppression rate varies across regions, with Homa Bay doing best among counties at 85 per cent, above the national average of 82 per cent, according to the National Aids and STI Control Programme. Counties in arid and semi-arid areas have a much lower VLS due to a myriad of challenges in those regions.
Dr Odionyi says health systems and facility structures set up in Homa Bay by EGPAF and the county government such as child-only and friendly clinics, caregiver treatment literacy sessions, art therapy for children, psychosocial support groups and training of healthcare providers on paediatric HIV services have led to the good results.
For drug factors, children's medicine is in multiple formulations — syrups, pellets and tablets — that keep changing with a child’s age and weight. Newborns (3kg) are started on a syrup and a dispersible tablet. The drugs are also weight dependent, so the dosage changes as the child grows. “The current drug for children, given to any child below 20kg Lopinavir based regimen of which the syrup formulation given the very young children is bitter, needs refrigeration, causes vomiting and nausea and some level of diarrhoea,” she says.
The syrups can be switched to pellets of the same type of drug when a child is older than three months. “For patients in remote counties such as Turkana, EGPAF had to transport earthen pots to act as a refrigerators/coolers though these were still not able to achieve the temperatures required. The children, however, were still able to suppress,” says Dr Odionyi, who is also a paediatrician.
Younger children have even fewer treatment options. Currently, Zidovudine, Lamivudine and Raltegravir are the recommended ones for those below one month old. “The child, especially those below one year, often needs to go to the hospital to be weighed and their dose adjusted as per their weight,” she says. “Our greatest issue is the unpalatability, storage and multiple formulations as opposed to older children above 35kg who have just one tablet to take once a day,” she says.
Because of lack of fixed dose combinations, children take their drugs twice daily (morning and evening), bringing about adherence issues.
She clarifies that patient factor is the most crucial determinant for adherence to antiretroviral therapy. A caregiver can be given the best drugs, but if a child is not given every day at the right time, it interferes with adherence and effectiveness in the body.
“Children are dependent on caregivers for the administration of the drugs. How committed a caregiver is, how well educated and availability will determine how a child responds to medication,” she says.
Failure by caregivers and parents to give their children drugs on time is very common. “Depending on their job, a parent can forget to give the drug in the morning and give it the evening or fail to observe time,” explains Dr Odionyi. “We are looking forward to the day we will have sweet drugs taken once daily, which will assure us of the viral suppression among children.”
EGPAF has psychosocial support groups for children and caregivers. This happens on the clinic days for the children. “When the children and their caregivers visit the clinic, they are given separate health talks. For younger children, we do art therapy that gives counsellors insights on what they need to address in the children. They use art to express their feelings about what they are currently going through,” she says.
For families under care, they select one clinic day that all members can attend. This way, all issues being faced by the family are addressed to ensure adherence to treatment.
Dr Gina Outtara, clinical trials manager at Drugs for Neglected Diseases Initiatives says: “It is vital that infants and young children with HIV receive treatment as early as possible and are consistently monitored as they have significantly worse treatment outcomes than adults.”
Many children are infected while the mother is pregnant, at delivery or after delivery when the child is breastfeeding, she adds.
Breastfeeding, especially in poor countries, is one of the best ways to improve infant survival, but is also an avenue for women to pass the Aids-causing virus on to their infants.
However, despite Kenya adopting the Option B+ programme by Unicef and the joint United Nations Programme on HIV and Aids, where mothers and their newborns receive ARVs to keep the baby HIV-negative while still enjoying all the benefits of breast milk, new infections in children are still high.
According to Dr Outtara, despite the country doing very well in reducing mother-to-child transmission, there is still a gap in treatment for children as there is a limited range of age-appropriate ARVs.
If approved by the US Food and Drug Administration (FDA) and recommended by the World Health Organization, caregivers will no longer have to worry about dosage, bitterness or children rejecting HIV drugs thanks to Drugs for Neglected Diseases Initiative (DNDi) for manufacturing a four-in-one strawberry flavoured paediatric HIV drug.
The approval by FDA is expected by April 15. Thereafter, the WHO recommends it and countries will be free to adopt it. The drug will be used by children between three kilogrammes and 25kg body weight.
A pilot study was done in six countries: Kenya, Uganda, Tanzania, Cameroon, Burkina Faso and Senegal. DNDi received a $17.3 million grant for their paediatric HIV programme from another non-profit, Unitaid, a substantial amount of which was channelled into the programme.
Dr Catherine Ngugi, the head of National Aids and STIs Control Programme (Nascop) stressed that they were hopeful the medicine will be in Kenya by July.
The medicine will be a relief from the bitter-tasting Lopinavir-Ritonavir, known by its generic name Kaletra, which children spit out or refuse to take altogether. Kaletra also requires refrigeration, a requirement that many mothers cannot meet.
Dr Ngugi said the drug will boost Kenya’s ambitious 90-90-90 target, which seeks to have 90 per cent of all children with HIV diagnosed, 90 per cent of those diagnosed HIV+ receiving treatment and 90 per cent of those children receiving treatment achieving viral load suppression by 2020.
Kenya has received praise for its fight against HIV, but there are challenges that the country has not overcome. One of those is access to paediatric friendly medicine.
Paediatric HIV is considered a neglected disease no wonder DNDi got involved — because not many companies manufacture drugs for it. The country has been participating in the pilot study — still run by DNDi — to try better-tasting medicine in children since 2015.
Between 2015 and 2019, Kenya participated in the LIVING study, where 1,003 children were enrolled across 12 sites in the country. In June 2015, FDA approved an oral 2-in-1 formulation developed by Cipla. These formulations didn’t require refrigeration and could also be sprinkled on food. However, the 2-in-1 still had to be taken with the two other drugs still bitter if left in the mouth for too long and the pellets were also a bit big so very young children found it difficult to take.
In June 2019, DNDi’s LOLIPOP Study resulted in the 4-in-1 known as quadrimune. Dr Dalton Wamalwa of University of Nairobi’s Paediatric Department told the HealthyNation the best gift you can give to a parent, a mother who has HIV, is an HIV free baby. However, he said for those who are already infected, the best gift to the family is to see the baby growing up to adulthood despite HIV.