SAHPRA chief executive Dr Boitumelo Semete-Makokotlela.
Cape Town - The South African Health Products and Regulatory Authority (SAHPRA) has registered a new “sweet-tasting” combination antiretroviral treatment for infants and young children with HIV.
This treatment comes in granules that can be sprinkled on soft food or dissolved in milk or water. The treatment does not require refrigeration.
The “4-in-1" formulation, approved by SAHPRA, with the trade name Quadrimune has been developed by the non-profit entity, Drugs for Neglected Diseases initiative (DNDi), and Cipla.
Unlike the traditional protease inhibitor-containing paediatric ARV formulations, the new treatment combines the antiretrovirals abacavir, lamivudine, lopinavir and ritonavir in a novel manner of administering it to children and infants.
SAHPRA has also registered dolutegravir dispersible tablets for children with HIV by Macleods (Trade names - Syromak 10 ODT and Kovasyp 10 ODT) and Mylan (trade names - Odinstri and Ristegra dispersible tablets). This comes after the recent registration of dolutegravir dispersible tablets for this cohort by the innovator company GSK (Tivicay) which paved the way for the registration of generic medicines.
“These new treatment regimens for infants and children with HIV heralds a huge breakthrough. The formulations are also recommended by the World Health Organisation (WHO). SAHPRA is committed to enabling access to innovative health products that work well and that adhere to the tenets of safety, quality and efficacy,” said SAHPRA chief executive Dr Boitumelo Semete-Makokotlela.
Sahpra separately also announced it had registered the COVID-19 vaccine, Coronavac, on June 14, 2022 with conditions.
The Coronavac is an inactivated SARS-CoV-2 virus indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus in individuals 18-59 years of age. The Coronavac is administered by intramuscular injection as two doses between 14-28 days apart from the initial dose.
Sahpra said the authorisation was based on acceptable safety, quality and efficacy data submitted by CURANTO PHARMA (PTY) LTD as a rolling submission over the period March 2021 to June 2022.
“The authorisation is, however, subject to a number of conditions which includes that the vaccine is supplied and administered in accordance with the National Department of Health (NDoH) COVID-19 vaccination plan and applicable guidelines. Further conditions relate to the reporting of the results of ongoing studies and conformance with pharmacovigilance activities as outlined in the approved risk management plan, including the submission of periodic safety updates,” Sahpra said.
The most common side effects reported were pain at the injection site, headache, tiredness, muscle pain and nausea.
The current assigned shelf-life of the vaccine is twenty-four months when stored at acceptable for the final product in a vial or prefilled syringe, when stored at +2-8°C and protected from light.
Cape Times
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