Bedaquiline: New anti TB drug: Govt may allow usage by private health sector


 

Bedaquiline is  a TB drug which is also known by the trade name  Sirturo. Bedaquiline works by blocking an enzyme inside the Mycobacterium tuberculosis bacteria called ATP synthase. This enzyme is used by the bacteria to generate energy. Without the ability to generate energy, the TB bacteria  are killed.

Bedaquiline is used in combination with other TB drugs to treat pulmonary TB in adults when they have multi drug resistant TB (MDR-TB

It should only be used when effective  Tb treatment cannot otherwise be provided.

It should be always be used in combination with at least 3 other TB drugs which drug susceptibility testing has shown that the patient is susceptible to. If drug susceptibility testing is not available then bedaquiline should be used with at least 4 other drugs to which the patient is likely to be susceptible.

The safety and efficacy of the drug in the treatment of HIV positive patients with MDR-TB has also not yet been established.

side effects of bedaquiline                          

The most common side effects are headache, dizziness, feeling sick, being sick, joint pain and increases in liver enzymes. Side effects can be experienced by more than one in ten people.

Another  side effect is that QTc prolongation.

The US Food and Drug Administration (FDA) on 28th December 2012 granted approval for bedaquiline to be used to treat drug resistant TB.  FDA News Release, 31st December 2012 . In October 2013 the CDC issued new federal guidelines on the use of the drug, for the treatment of multi drug resistant TB.

Government may allow private sector to use key drug used for treating tuberculosis

Around 2.1 million people have TB in India, of which an estimated 30,000 people have MDR-TB. Only 6,500 patients are on the bedaquiline-based treatment regimen, which may cause severe side effects such as heart problems and hearing impairment.

The Union health ministry (India) is considering a proposal to allow bedaquiline, a controlled-access drug used in the treatment of multi-drug resistant tuberculosis (MDR-TB), to be open for prescription in the private sector.

Being a controlled-access drug, bedaquiline is dispensed only by the government to people with MDR-TB. At least four courses of treatment are needed. The drug costs Rs 28,000 per course, which means the cost per patient is Rs 1.12 lakh on medicine alone.

Around 2.1 million people have TB in India, of which an estimated 30,000 people have MDR-TB. Only 6,500 patients are on the bedaquiline-based treatment regimen, which may cause severe side effects such as heart problems and hearing impairment. “Technical opinion is being sought as there is no consensus among experts on opening access to the private sector,” said a senior health ministry official familiar with developments.

The health ministry, in collaboration with the departments of health research, biotechnology etc, is working out an institutional mechanism to give bedaquiline to patients in the private sector. “There is a huge pharma lobby that is building an argument for putting everyone on bedaquiline, but it doesn’t work like that. Even though it is being hailed as a wonder drug, it has side effects that include hearing loss. It’s a new drug, so we don’t really have adequate data on its long-term treatment outcome,” the official quoted above said.

“People generally assume bedaquiline is safer than other drugs but they forget that compared to a 6-8 months course for other medicines, a bedaquiline-based regimen could go up to 18-24 months. The longer duration could have its effects that our experts are looking at,” he added.

The ministry has begun compiling data on treatment outcome for all oral treatment regimens among Indians, which also includes the bedaquiline-related course. “About 20 patients in the private sector in Mumbai have been given conditional bedaquiline access by the government. But the entire private sector can be given access only if they strictly adhere to the drug-compliance regimen for complete cure and to stop the patient developing extremely drug-resistant TB,” the official said.

There will be strict vigilance. “Since it is a long-term regimen, it’s verifiable. A call will be taken soon,” said a second ministry official, requesting anonymity.

The United States Agency for International Development (USAID) has provided 22,000 doses to the government. “We don’t want to deny patients newer drugs if it benefits them, so we are considering the idea,” said the first health ministry official.

The United States Agency for International Development (USAID) has provided 22,000 doses to the government. “We don’t want to deny patients newer drugs if it benefits them, so we are considering the idea,” said the first health ministry official

 

 

 

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