A Multi - Disciplinary Research Collaboration.

GHU research findings on sickle cell drug attract national attention

GLOBAL HEALTH UGANDA RESEARCH FINDINGS ON SICKLE CELL DRUG ATTRACT NATIONAL ATTENTION  – By Esther Ssebyala (Administrator- GHU)

Global Health Uganda (GHU) Ltd is a multidisciplinary research collaboration that brings together researchers and scientists from various local and international institutions. GHU has been involved in a number of research projects for the past 15 years in collaboration with several institutions from the USA, UK, among others and scientists/researchers from Makerere University and Mulago hospital.

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                        The NOHARM Study team outside the Sickle Cell Clinic in Mulago

One of the recently concluded studies on the ‘Novel Use of Hydroxyurea in an African Region with Malaria’, conducted in collaboration with Indiana University and with support from Doris Duke Charitable foundation (DDCF) found that Hydroxyurea is safe and effective for use in children with sickle cell Disease (SCD) in malaria endemic areas.

Research studies done in high income settings in the North America and Europe, indicate that hydroxyurea is very effective in reducing the complications associated with SCD in malaria free regions. Consequently Hydroxyurea is used in those settings and has greatly improved the lives of SCD patients there. However this drug is not being used in malaria endemic regions, where the problem of SCD is greatest, because it is not known how the drug reacts with malaria. The NOHARM study was therefore set up to establish whether Hydroxyurea is equally beneficial in a malaria region as it is in the west. 

The specific objectives of the study were:

  • To determine the incidence of malaria in children with SCA treated with Hydroxyurea vs. placebo. 
  • To establish the frequency of hematologic toxicities and adverse events in children with SCA treated with Hydroxyurea vs. placebo.

This study was conducted at the Mulago hospital sickle cell clinic between August 2014 and November 2017. A total of 208 children aged 1 to 4 years were enrolled and randomized to receive either a placebo or Hydroxyurea for 1 year. The incidence of malaria and frequency of sickle cell related complications were compared between the two groups. The study found that there was no adverse reaction between Hydroxyurea and malaria and that the drug is just as effective in a malaria endemic area, here in Uganda, as it is in the west. The frequency of sickle cell related complications like painful crisis, blood transfusions and hospitalization were less in participants given the drug than those on the placebo.

At a dissemination workshop organized on February 28th, 2018, the researchers led by Dr. Robert Opoka were able to present these findings to the public and the Ministry of Health. As a result the Minister of Health, Dr. Jane Ruth Aceng accepted that the drug needed to be made available to all SCD patients who need it. She directed the National Drug Authority (NDA) to immediately register hydroxyurea as a treatment for sickle cell anemia, so that it can be made available and accessible to SCD patients in the country.

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                Our Principle Investigators with Dr. Aceng at the recent dissemination Workshop

It’s such a joy to see that our work is bringing hope to people living with the sickle cell disease, who for long had no reliable remedy for their ailment.

We thank the research team for the work well done. We appreciate the guidance and leadership of the study Principal Investigators, Dr. Chandy John from Indiana University, Dr. Russel Ware of Cincinnati Children’s Hospital Medical Center and Dr. Robert O.Opoka from Makerere University College of Health Sciences.Special thanks to the management of the Sickle Cell Clinic, under the leadership of Dr. Philip Kasirye. We appreciate all the collaborators that made this work possible, Prof Heather Hume and Prof Christopher Ndugwa, thank you for your expert guidance and contribution.

The drug used in the study was donated by ADDMEDICA, which is a medical product company based in France. Global Health Uganda is proud to have been the implementer of this project.

These same findings were published in the journal ‘BLOOD’ http://www.bloodjournal.org/content/early/2017/10/18/blood-2017-06-788935?sso-checked=true which is the official journal for the American Society of Hematology.

With the success of the NOHARM study, the team has embarked on an extension study dubbed NOHARM-MTD (Maximum tolerated dose). The main objective of the extension study is to identify a dose that best suits the children. One that gives maximum benefits but with limited side effects. Keep your ears on the ground for more interesting findings.

Well done team and keep flying high!

 

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