DURBAN – All patients diagnosed with drug-resistant tuberculosis will now have access to a promising new drug bedaquiline, which is still undergoing trials, via a clinical access programme driven by the national health department.
Dr Francesca Conradie, President of the Southern African HIV Clinicians Society said although this access programme had already started in four pilot sites approved by the Medicines Control Council, it was now being rolled out in all nine provinces.
"We have trained nurses and doctors across the country to be able to administer bedaqualine to all multi-drug resistant (MDR) TB patients.
"Multi-drug resistant tuberculosis poses a serious threat in South Africa, bedaqualine provides much-needed treatment for patients who have don't have other options available," she added.
The current treatment for MDR-TB involves a two-year and often painful course of oral and injectable drugs, with some major side effects such as permanent hearing problems.
"Although the drug is still in clinical trials earlier trials have shown it is safe and more effective than the current drugs we use to treat MDR. Bedaquiline comes at a time when there is high pressure for better treatment options," said Conradie
She cautioned that because bedaqualine carries some significant risks, doctors should make sure they use it appropriately and only in patients who don't have other treatment options.
The World Health Organisation (WHO) recently gave conditional approval for the use of bedaqualine, but only in patients with pulmonary MDR TB where there were no other medical options and where there was informed consent from the patients. This follows a WHO Expert Group's evaluation of trial data from a Phase 2b trial, which found more deaths in the bedaqualine arm of the trial than the placebo arm, with a number of side effects including dizziness, nausea and liver impairment. However, many more patients in the bedaqualine arm (62%) were cured than in the placebo arm (44%), and also in a faster time (83 days vs 125 days). The WHO has urged the drug manufacturer to conduct a Phase 3 trial as soon as possible. It will re-evaluate the drug in 2015.
During a session yesterday (SUBS: WED) at the 6th South African Aids conference on decentralised MDR- TB management, Dr Norbet Ndjeka of the National Department of Health, emphasised the need for South Africa to find better technology, improve the response to drug resistant TB and to reduce the growing rates of TB deaths.
Bedaquilline is the first new drug used to treat MDR TB, but for it to be effective it should be used in combination with other TB treatment such as Linezolid.
Bedaquiline is also effective for those living with HIV. However those patients on the antiretroviral Efavirenz, will have to switch to Nevirapine.
Most of the sites approved to dispense Bedaquiline are at hospitals, including a primary health care site in Khayelitsha, where DR TB rates are high.
Patients will be initiated onto Bedaquiline at DR-TB centres in the hospitals where their tolerance to the drug will be monitored. They will then be referred to clinics where they will continue to receive their daily treatment.
Patients will also undergo a host of monthly tests, and trained staff will mentor clinic staff while keeping in close contact with patients and monitoring their results.
Conradie praised Njeka for showing great leadership for the speed at which he took the drug from clinical research into clinical practice.