Delamanid clinical access programme expected
South Africa has become the first country in the world to replace microscopy – or the use of microscopes to detect TB in samples – with the GeneXpert rapid test for the diagnosis of TB, according to Department of Health’s DR-TB, TB and HIV division Dr Norbert Ndjeka.
According to Director of the Department of Health’s DR-TB, TB and HIV division Dr Norbert Ndjeka, the department is currently in talks with Japanese drug maker Otsuka Pharmaceutical to negotiate access to Otsuka’s DR-TB drug delamanid for what will initially be a small number of patients as part of a clinical access programme.
The proposal follows a similar 2012 access programme that paved the way for a national roll out of the DR-TB drug bedaquiline, which was the first new TB drug to hit markets in nearly four decades. South Africa now leads the world in rolling out bedaquiline with almost 2,000 patients initiated on the drug since 2012, Ndjeka told Health-e News.
Bedaquiline and delamanid are part of a wave of new drugs aimed at tackling multidrug-resistant (MDR) and extensively drug-resistant (XDR) TB. MDR and XDR-TB continue to be growing problems in South Africa even as rates of normal – or “drug-sensitive” – TB fall, according to Ndjeka.
MDR-TB is resistant to the two most commonly used TB treatments. XDR-TB is resistant to these first-line drugs as well as at least half of the most commonly used second-line drugs.
South Africa treats about 12,000 MDR-TB patients each year and only 40 percent are ever cured, according to figures presented by the National Department of Health before parliament this year.
Delamanid could help the country improve these cure rates. In an almost 500-person clinical trial, delamanid led to an about 50 percent increase in the amount of MDR-TB patients who no longer showed traces of MDR-TB in test samples after two months when clinicians added the drug to existing treatment regimens.
Although not yet registered for use in South Africa, delamanid has been approved in the European Union, Japan and South Korea. The World Health Organisation has already developed interim guidance for doctors wishing to use the drug.
Delamanid to follow in bedaquiline’s footsteps
[quote float= right]We’ve already set up the committee that will control access to these drugs so basically clinicians wanting to use this drug will present their patients’ (cases) to the committee”
“We are trying to get access through Otsuka so that we can give (delamanid) to a number of patients in the country,” said Ndjeka adding that the Medicines Control Council (MCC) was assisting the department to broker a deal with the drug maker that he hoped would be in place by May.
“We are hoping to establish a delamanid clinical access programme similar to the one we did for bedaquiline,” Ndjeka told Health-e News. “We’ve already set up the committee that will control access to these drugs so basically clinicians wanting to use this drug will present their patients’ (cases) to the committee.”
“Members… then they advise as to whether the patient qualifies for delamanid or not and then design a regimen that is appropriate for that particular patient,” he added.
In 2012, Department of Health and partners like Right to Care and international humanitarian organisation Médecins Sans Frontières started 211 patients on the first new TB drug to be released in 40 years, bedaquiline.
As part of the programme, 12 sites were able to offer the drug to patients following approval from a national clinical advisory committee and drug regulator MCC. Patients were then carefully monitored to allow the MCC to collect additional information on the drug prior to its ultimate registration for use in South Africa in 2014.
Most of the country’s 2,000 patients who have received bedaquiline have also received the new DR-TB drug linezolid. The Department of Health also recently awarded its first tender for linezolid to pharmaceutical company Pfizer. Under the new tender, a month’s treatment with linezolid will cost about R3,000 per patient or about a third of what the Department of Health has paid for the drug over the last three years.
“(The price) it’s a lot better but as we get more patients on to this treatment, we should even be able to get a better price,” Ndjeka said.
Just two years ago, linezolid was being sold at R700 per pill in the private sector. The new government tender brings that cost down to about R100 per tablet. – Health-e News.
An edited version of this story was also published on Health24.com and Engineering News.
- Read more: TB patients smuggle pills as treatment priced out of reach
- Never miss a story. Subscribe to our free, weekly email newsletter
Author
Republish this article
This work is licensed under a Creative Commons Attribution-NoDerivatives 4.0 International License.
Unless otherwise noted, you can republish our articles for free under a Creative Commons license. Here’s what you need to know:
-
You have to credit Health-e News. In the byline, we prefer “Author Name, Publication.” At the top of the text of your story, include a line that reads: “This story was originally published by Health-e News.” You must link the word “Health-e News” to the original URL of the story.
-
You must include all of the links from our story, including our newsletter sign up link.
-
If you use canonical metadata, please use the Health-e News URL. For more information about canonical metadata, click here.
-
You can’t edit our material, except to reflect relative changes in time, location and editorial style. (For example, “yesterday” can be changed to “last week”)
-
You have no rights to sell, license, syndicate, or otherwise represent yourself as the authorized owner of our material to any third parties. This means that you cannot actively publish or submit our work for syndication to third party platforms or apps like Apple News or Google News. Health-e News understands that publishers cannot fully control when certain third parties automatically summarise or crawl content from publishers’ own sites.
-
You can’t republish our material wholesale, or automatically; you need to select stories to be republished individually.
-
If you share republished stories on social media, we’d appreciate being tagged in your posts. You can find us on Twitter @HealthENews, Instagram @healthenews, and Facebook Health-e News Service.
You can grab HTML code for our stories easily. Click on the Creative Commons logo on our stories. You’ll find it with the other share buttons.
If you have any other questions, contact info@health-e.org.za.
Delamanid clinical access programme expected
by lauralopez, Health-e News
March 29, 2016