By Kudakwashe Pembere
A first line regimen for HIV/AIDS treatment in Zimbabwe called TLE 400 saved the country $3, 6 million this year alone. The treatment proving to be a ‘wonder’ drug miraculously reducing side effects along with a significant spend was launched yesterday in Harare.
The drug funded by the Bill and Melinda Gates Foundation was made by one of the world’s leading global pharmaceutical companies called Mylan.
On March 10, 2017, Mylan received tentative approval from the U.S. FDA under PEPFAR for its New Drug Application for the fixed-dose combination Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate Tablets, 400 mg/300 mg/300 mg (TLE400).
Explaining the new drug on the sidelines of the launch, New Avakash International Product manager Kudakwashe Chapfika said TLE 400 is 200 milligrams less than TLE600 efavirenz-wise.
“What’s happening is this is the official launch of TLE 400 which is now a first line regimen in terms of treatment of HIV/AIDS in Zimbabwe. So TLE 400 in the sense that the efavirenz part is actually 400 milligrams as opposed to the last one which was TLE600 which has 600 milligrams of efavirenz,” he said.
TLE400 was recommended by the WHO in 2016 as an alternative for first-line therapy for adults living with HIV.
Comparing the TLE600 to TLE400, the latter is cost effective and has fewer side effects like rash as seen in the former.
“The reduction is important because the 400 has lower side effects and also crucially its also cost effective,” said Chapika who added, “I think from Dr Apollo’s presentation she highlighted that there was a cost saving of around $3, 6 million this year the shift from the 600 to 400mg, so crucially its lowering side effects lesser side effects and also cost effective.”
Chapfika also said TLE400 is now in supply in both private and public health institutions in the country.
“I think as presented by esteemed presenters like Dr Tsitsi Apollo from the Ministry of Health this actually the first line treatment in most of the patients who are actually on ART And we have already started supplying stocks for the public and private sector.
“This was an official launch to say we have the product in stock and the product is already rolled out in the public and private sector,” he added.
Priotising TLE400 for adolescents
Dr Apollo while responding to questions from the floor said TLE 400 will be administered to adolescents at the moment due to this age group’s challenges in adhering to treatment.
“In terms of transitioning from TLE 600 to TLE 400 we are using phased approach and the reason why we are using the phased approach is we have limited stocks of TLE400 at this point and therefore we are quantifying our requirements and matching what we need to do on the ground.
“So we prioritise certain populations. So currently we have prioritised the adolescent age group and because this is an age group where we know they have challenges in terms of adherence to treatment and many of these adolescents actually compared to adults they have poor rates of retention if you look at our program data following these adolescents by 12 months and 24 months they have the worst retention rates and they challenges in terms of retention in terms of viral suppression data. So we are prioritizing initially the adolescents,” she said.
Dr Apollo also said preference will also be given to patients resisting the TLE600.
“We also prioritizing patients who don’t tolerate TLE600,” she added.
Due to limited stocks, she said selected health facilities have the drug but as more are shipped in, it will be distributed to more.
“This is basically because we have limited stocks of TLE400 and we are pushing these supplies to selected health facilities so we cannot push them to all the 1500 health facilities because we have limited stocks at the moment. But we have shipments that are planned coming in the next couple of months and there as we receive more shipments we open up to more facilities and open up in terms of the prioritized groups,” she said.