24/03/2017 13:32 SAST | Updated 24/03/2017 13:46 SAST

Time For Otsuka To Step Up: Why South Africa's TB Patients Need Access To Delamanid And How To Get It

For a disease with more than 10 million people infected globally, treatment still largely involves using old, toxic drugs.

Finbarr O'Reilly / Reuters
Patients with HIV and tuberculosis (TB) wear masks while awaiting consultation at a clinic in Cape Town's Khayelitsha township, February 23, 2010.

Living in South Africa, most people are very familiar with HIV/AIDS. Our schools teach it, our clinics treat it, our media keeps us up to date on it, and it's rare to find someone whose life hasn't been touched by it in some way or other. But how many of us are as familiar with the problem of tuberculosis (TB) in South Africa?

TB kills more people in South Africa per year than HIV/AIDS, and is one of the most common opportunistic infections that affects people living with HIV. In fact, South Africa has the one of the highest burdens of TB in the world, with an incidence of around 450,000 cases per year. Of that number, at least 20,000 people are infected with some form of drug-resistant TB (DR-TB), which means that it is resistant to first lines of treatment. TB is a complex disease to treat, and drug-resistant strains even more so. DR-TB treatment regimens are really difficult for people to endure: they involve taking up to as many as 14,600 pills over the two years needed for a standard course of treatment, involve painful daily injections, and can include awful side effects, like the possibility of going deaf. Can you imagine going deaf as a result of treating your illness?

It seems impossible to imagine for a disease so deadly, but in the last half a century, only two new drugs have been approved to treat TB. You read that right. For a disease with more than 10 million people infected globally, treatment still largely involves using old, toxic drugs.

What about the new drugs? Called bedaquiline and delamanid, they've both shown promising results in improving health outcomes and the daily lives of patients, but access has been severely restricted.

The benefits of the new treatment are already being seen in this limited population, but the drug still reaches far fewer people than are in need.

South Africa has worked diligently to introduce bedaquiline as part of its treatment regimen for the sickest DR-TB patients, with around 2,000 people in South Africa receiving bedaquiline so far. The benefits of the new treatment are already being seen in this limited population, but the drug still reaches far fewer people than are in need.

But the other new drug delamanid is still not widely available in South Africa. At the Doctors Without Borders' (MSF) project in Khayelitsha, we are lucky enough to be able to treat almost 100 people with DR-TB using delamanid, and have seen extremely promising results.

Sinethemba Kuse, 17, was one of the first people to be initiated on delamanid in South Africa and was the first adolescent ever to receive it in Khayelitsha. She says, "I was very lucky, because I was one of the first people in Khayelitsha to get this medicine. I've been on treatment for 14 months now. I think that a lot of people should be given this treatment, and that it should not only be available in Khayelitsha and a few other places but in all places in all the provinces, because it works - I am doing so well now. A lot of people who don't have the chance to take these tablets are suffering - a lot of them die."

But, even though delamanid has been approved for treating TB since 2014, and even though some of its clinical trials were conducted in our own country, delamanid still has not been registered for use in South Africa. There is no excuse for this.

Otsuka, the company that makes delamanid, or its local partner in South Africa, must immediately file for registration and then ensure that the drug is fast-tracked through the Medicines Control Council (MCC). After the drug is registered, the government will be able to purchase the drug and to roll it out much more widely throughout South Africa, bringing hope and relief to an estimated 7,000 people who urgently need a more effective treatment.

While we wait for registration, Otsuka has offered 200 treatment courses to South Africa. That offer is a band-aid for a broken leg. With such a large number of people needing this treatment, the 200 courses won't last long. And what then? It's unethical to start treating people with this ground-breaking new medicine, only to have the donation run out and the drug still isn't registered, meaning that access is cut off again to those who need it.

So why hasn't Otsuka registered its lifesaving drug here? And why are they offering such a limited donation to get the country through the interim? No one knows for sure, but what we do know is that it's not good enough. We need Otsuka to publicly commit to filing for registration without delay, and that they will not allow their donation to run out and leave South Africans in the lurch without access. No more bureaucratic excuses when there are lives at stake, please.

Otsuka's delay in registering a drug that can save lives in a country with as high a TB burden as South Africa is deplorable. People are suffering, and in the worst cases dying, when they could be accessing a much more effective treatment.

So, Otsuka, if you want this World TB Day to mean anything to people living with TB in South Africa, and around the world, it's time to do the right thing. Register your drug now. Register it widely. Promise us that while we're waiting, you won't allow those who need access to delamanid to go untreated if the clinical access programme stock runs out. And finally, once registered, provide delamanid at an affordable price to ensure that the drug is affordable and accessible to all who need it. There are many, many more Sinethembas out there, and they won't stand a chance of getting the treatment they need if you don't step up, and soon.