Radboudumc research leads to simplified dose of HIV medication for children

31 August 2020

For children living with HIV, an adapted, simpler combination therapy is now available. Combination therapy uses two or three drugs at the same time to inhibit HIV. One of these drugs is dolutegravir. Thanks to research by the Radboudumc it is now clear that the use of one easily available tablet of dolutegravir in children gives just as good treatment results as a combination of different, less readily available tablets of the drug.

Especially in countries where the number of infections is high and good care is less accessible, this makes it easier to treat children. These results, published today in the scientific journal The Lancet HIV, are included in the treatment guidelines of the World Health Organization (WHO).

1.7 million children live with HIV

Worldwide, about 1.7 million children are infected with HIV (the human immunodeficiency virus, which can cause the disease AIDS), of which 1.2 million live south of the Sahara. These children need life-long medication to inhibit the virus, so that illness, death and infection of others can be prevented. It is estimated that by 2018 only 56% of HIV-infected children had access to proper medication. In addition, the effect in children and teenagers is less good than in adults.
  
It was already known that dolutegravir in combination with other medications is a good treatment for all HIV-infected adults, because the drug effectively inhibits the growth of the virus and the virus does not quickly become resistant. Moreover, it is a safe and inexpensive drug, which is widely available: from high to low income countries, an important starting point for the WHO to put health care in different countries on an equal footing.

Lack of access to good treatment 

It is also known that treatment methods for children often lag behind those for adults. In the case of HIV-inhibiting treatments, children over 12 years of age and 40 kilos of weight received the same dosage of dolutegravir as adults (one tablet of 50 mg daily). But younger children, or those with a lower weight, had to take two or more tablets daily, of a lower amount (10mg and 25mg), a dosage that was not approved by all drug agencies.
  
David Burger: "This led to problems: these lower doses are not easily available in low and middle income countries, so national programs could not be started up properly and the risk of errors in dosage and intake increased. Moreover, this medication was not appropriate for small children weighing less than 20 kilos. In short, there was a need to achieve a simpler and more practical dosage of dolutegravir for children".

Easier dosage leads to good results

The study set up by Burger with colleagues Pauline Bollen and Angela Colbers from the Radboudumc and colleagues from the Medical Research Council Clinical Trials Unit, University College London, focused on simplifying the dose of dolutegravir that children have to take every day, which had to be equally effective and not cause any additional side effects. They did this by giving 62 HIV-positive children between the ages of 6 and 18 from Uganda and Zimbabwe different doses of medication, taking into account their weight. They were followed for almost half a year. This showed that one tablet of dolutegravir of 50 mg daily, the same dosage as adults, works well with the children and that their body reacts to the drug in the same way as the more difficult dosage to give. This benefits the treatment of the children.
  
As a result of this study, the World Health Organization WHO has adjusted the guidelines for treatment in HIV-positive children and the FDA has recently approved this dosage.

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