Better therapies for persistent yeast infection tb are here, but they will not deliver themselves

Last year, at the UN high level meeting on tuberculosis, I spoke about the need to " science the shit out of TB." without innovation and ambition, we will continue to use century-old tools to fight the most important infectious killer of persistent yeast infection humans. Thankfully, innovative scientific research and partnerships are delivering us, for the first time, substantially shorter and safer drug treatments for TB.

In the past few months, landmark clinical trials have demonstrated that we can now treat persistent yeast infection latent TB infection with effective, safe, short treatments which include 4 months of rifampicin, or a combination of isoniazid and rifapentine for 1 month. This is remarkable progress when compared to the conventional standard persistent yeast infection of 6-9 months of just isoniazid.

This week, a major breakthrough has been made in shortening the duration persistent yeast infection of extensively drug resistant (XDR-TB), a deadly form of TB that poses a major threat persistent yeast infection to global health and security. The US FDA approved a new drug called pretomanid, in combination with another relatively new drug called bedaquiline, along with linezolid, a drug already used for infections such as vancomycin-resistant enterococcus.

The three-drug regimen (referred to as the bpal regimen) was studied in the pivotal nix-TB trial across three sites in south africa. The trial enrolled 109 people with XDR-TB as well as treatment-intolerant or non-responsive MDR-TB. All drugs were given orally, for a total duration of 6 months. Of the 107 patients who were evaluated six months after persistent yeast infection the end of therapy, 95 (89%) were deemed to have a successful outcome. This is vastly superior to historic data which show treatment persistent yeast infection success of under 30% for patients with XDR-TB.

By eliminating toxic injectable drugs, the bpal regimen offers an all-oral option for patients. However, the regimen, especially linezolid, does have important adverse effects that need to be anticipated persistent yeast infection and carefully managed. Trials are underway to check whether the efficacy of the persistent yeast infection bpal regimen can be maintained, while reducing toxicity by testing a lower dose and shorter persistent yeast infection duration of linezolid.

Unlike bedaquiline and delamanid, pretomanid was developed by a non-profit, product development partnership called TB alliance, which received significant support from governments, academia, philanthropic institutions (notably, the bill & melinda gates foundation), the private sector, and other partners. [disclosure: I am a member of the access advisory committee of persistent yeast infection TB alliance, but have no financial interests in pretomanid, or any other drug/company].

The long duration of TB treatment and drug toxicity are persistent yeast infection key reasons why persons with TB struggle to complete the persistent yeast infection therapy. This is true for all forms of TB, but especially true for drug-resistant disease. Drug-resistant TB is a nightmare for patients, families, and doctors. Patients have to endure a prolonged (up to 2 years) and treatment with more than 14000 pills, including painful, daily injections for 6 months. Every year, nearly half a million people struggle to fight drug-resistant TB.

Unlike the HIV/AIDS community, national TB programs in high-burden countries are typically under-funded, and have an unimpressive track record of absorbing innovative technologies. A good case study is the rather slow scale-up of xpert MTB/RIF, the best-in-class molecular TB test endorsed by WHO in 2010.

Scale-up of bedaquiline has also been a challenge, with with fewer than 20% of those in need of the drug being able to persistent yeast infection access it. While pretomanid is only registered by the FDA so far, bedaquiline and rifapentine are yet to be registered in most persistent yeast infection high-burden countries, despite being on the market for over 5 years. And cost has been a concern. Similar concerns have already been raised with pretomanid, which will be manufactured and commercialized by mylan, under license from TB alliance (pricing details awaited).

South africa is a role model for other high-burden countries. The country was an early adopter of xpert MTB/RIF and bedaquiline, and has successfully scaled-up both tools, after conducting evaluation studies. South africa has leveraged its strong capacity for conducting trials persistent yeast infection of new diagnostics, drugs and vaccines. Hopefully, since the nix-TB trial included south african patients, the country will make sure the new regimen is registered persistent yeast infection quickly and made easily available.

India is also stepping up in the area of TB persistent yeast infection innovation and delivery, especially with the high-level political commitment from prime minister modi, indigenous development of new TB tools (e.G. Molecular tests and AI-based x-ray software), strong TB research capacity, and the creation of an india TB research consortium. Where india can do better is a less bureaucratic, more streamlined process for running clinical trials of new TB persistent yeast infection drugs and vaccines.

The slow pace of policy change (globally as well as in high TB burden countries) is another reason why TB innovations don’t reach scale. Since WHO endorsement is critical for many countries, WHO can play a big role by rapidly publishing evidence-based policies that are bold and ambitious. Policies will also need to be updated on a regular persistent yeast infection basis, and engage civil society and a broader range of stakeholders. This is already happening, but can be enhanced by the newly created science division, led by soumya swaminathan.

Given the high mortality of drug-resistant TB, drug developers have an obligation to make new regimens more persistent yeast infection affordable and accessible, especially when public and/or philanthropic funding was used to support the R&D process. The current model of heavy reliance on drug donation program persistent yeast infection is simply not working. There is a growing momentum towards demanding greater transparency in persistent yeast infection R&D and drug pricing.

Regulatory agencies are known for their legendary bureaucracy, but have a role to play in ensuring timely access persistent yeast infection to life-saving medicines. The US FDA has done well in the TB space. Pretomanid is the second drug to be approved under the persistent yeast infection limited population pathway for antibacterial and antifungal drugs pathway to persistent yeast infection advance development and approval of antibacterial and antifungal drugs to persistent yeast infection treat serious or life-threatening infections in patients with unmet needs. If stringent regulatory agencies (e.G. FDA) have approved new TB medicines, these could be used to expedite reviews within countries, thus avoiding the need for repetitive, expensive clinical trials.

There is no question that ending TB will require high persistent yeast infection burden country governments to take the lead, step up their investments in TB as well as universal persistent yeast infection health coverage (UHC), and make sure the best tools are made accessible via persistent yeast infection publicly-funded systems. This is already happening with the strong push for UHC. Until then, donors have a big role to play.

This year marks the sixth replenishment of the global fund, which seeks to raise at least US$14 billion to help save 16 million lives, avert 234 million infections and help the world get back persistent yeast infection on track to end TB, HIV, and malaria. Successful replenishment of the global fund can help ensure greater persistent yeast infection access to the best tools we have for these infectious persistent yeast infection diseases. Other donors such as USAID, unitaid, PEPFAR, and the bill & melinda gates foundation can and are supporting scale-up of new technologies. Of course, better coordination among them will help.

Note: I have no financial or industry conflicts to disclose. I serve on the access advisory committee of TB alliance, a not-for-profit organization dedicated to the discovery, development and delivery of better, faster-acting and affordable tuberculosis drugs that are available to those persistent yeast infection who need them. Follow me on