Plate Nº 76 · recorded October 10, 2026

Health & Medicine ResearchReported finding

Hydroxyurea safe for African children with sickle cell, 10-year trial finds

A 10-year trial in four African countries found that hydroxyurea, a daily pill for sickle cell anemia, did not increase infections in 606 children — and cut malaria cases by 51%.

By James Calloway3 min read614 words

In brief

  1. 606 children with sickle cell anemia tracked across Angola, DR Congo, Kenya, and Uganda over more than 5,000 patient-years
  2. Malaria cases fell 51% and non-malarial infections fell 38% as hydroxyurea doses rose
  3. Recruitment ran from 2014 to 2016, enrolling children aged 1 to 10
  4. About 80% of global sickle cell cases occur in sub-Saharan Africa, with roughly 550,000 births each year
  5. Study published in The Lancet Haematology; led by Tom Williams of Imperial College London with senior author Russell Ware of Cincinnati Children's Hospital
Children living with sickle cell can be treated safely using hydroxyurea, 10-year trial finds
Plate Nº 76Children living with sickle cell can be treated safely using hydroxyurea, 10-year trial finds — AI-generated

A 10-year study of 606 children and young adults with sickle cell anemia at four sites in Africa found that daily oral hydroxyurea did not raise the risk of infections. Higher doses actually cut malaria cases by 51% and other infections by 38%.

The results, published today in The Lancet Haematology, come from the Realizing Effectiveness Across Continents with Hydroxyurea (REACH) trial, which followed patients in Angola, the Democratic Republic of the Congo, Kenya and Uganda. Researchers tracked more than 5,000 patient-years of treatment, the largest such dataset yet in low-income settings.

Why have doctors been cautious about hydroxyurea?

Hydroxyurea has been a standard sickle cell treatment in high-income countries for years. It works by nudging the body to produce fetal hemoglobin, the form babies make in the womb, which keeps red blood cells from curving into the rigid "sickle" shape that drives the disease.

But the drug also lowers the count of neutrophils, white blood cells that fight bacteria and parasites. In places where malaria is common and clinics are far away, that drop worried physicians, who feared the treatment could leave children more vulnerable to serious illness.

What did the REACH trial measure?

  • Sites: four countries — Angola, DR Congo, Kenya, Uganda
  • Participants: 606 children and young adults with sickle cell anemia
  • Age at enrollment: 1 to 10 years
  • Recruitment window: 2014 to 2016
  • Follow-up schedule: every two to three months
  • Dosing: started at a fixed level for six months, then raised to the maximum each patient could tolerate

Most infections during the trial were recorded through clinical history rather than lab-confirmed testing, which the authors flag as a limitation.

What changed when children took the drug?

The incidence of malaria fell by 51% and non-malarial infections by 38% as hydroxyurea doses rose. The trend ran in the opposite direction of what many clinicians had feared for low-resource settings.

"These findings provide long-awaited data regarding the long-term safety of hydroxyurea used at the maximum tolerated dose in low-income settings," said Russell Ware, a professor at Cincinnati Children's Hospital Medical Center and the study's senior author. "Over 10 years of treatment, the incidence and severity of infections did not increase and, in many cases, decreased."

Tom Williams, the lead author and a professor at Imperial College London's Institute of Global Health Innovation, was equally direct. "Many doctors are cautious about using hydroxyurea because they are worried that it will increase the risks of severe or fatal infections," he said. "In this huge study covering more than 5,000 patient-years of follow-up, we found no increase in illness or death from infections, even when hydroxyurea is used at the maximum tolerated dose."

How big is the global need?

Sickle cell anemia is the most common severe inherited blood disease in humans. About 80% of the world's cases occur in sub-Saharan Africa, and roughly 550,000 babies are born with the condition each year. Pain crises, infections and chronic ill health are hallmarks of the disease.

The authors now recommend that children in low-resource settings receive hydroxyurea at the maximum tolerated dose as part of standard care.

What can the study not tell us?

Infections were mostly identified through clinical reporting rather than real-time lab testing, so some milder cases may have gone unrecorded. The four-country sample, while large, covers only a slice of sub-Saharan Africa, and follow-up beyond a decade remains unknown.

Still, the team argues the data should ease one of the main barriers to wider rollout. "These findings support the wider use of hydroxyurea as standard care," Williams added.

via Medical Xpress (Source)

Filed under

  • hydroxyurea
  • sickle-cell-anemia
  • clinical-trial
  • pediatric-medicine
  • malaria
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Staff writer covering marketplaces and e-commerce at SciBeat.

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