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U.S. Government Funded Research Brings Shorter Tuberculosis Treatment Regimens to New York City

Contact: Elizabeth Lovinger, elizabeth.lovinger@treatmentactiongroup.org

May 16, 2022 – We applaud the New York City Department of Health and Mental Hygiene (DoHMH) for its leadership as one of the first TB programs in the U.S. and globally to introduce a new four-month regimen for the treatment of drug-susceptible tuberculosis (TB). This new regimen represents a long-awaited breakthrough, offering a shorter alternative to the six-to-nine-month treatment in use since the 1980s. That the Department of Health and Mental Hygiene is moving forward to make this regimen available to patients will make treatment more tolerable for people living with TB. As TB survivor and activist Kate O’Brien of We Are TB and co-chair of the TB Roundtable put it, “TB treatment can be such a miserable experience, with all sorts of side effects and logistical complications. Shorter regimens offer patients welcome relief and I’m thrilled to see important government investments delivering better cures for TB.”

Making treatment easier to endure will improve patient outcomes: “A four-month regimen makes it easier to coordinate care, and treat each person successfully,” said Dr. Joe Burzynski, TB Program Director at the Department of Health and Mental Hygiene. “We participated in the trial that tested this new regimen and are eager to be able to translate the outcomes of U.S. tax dollar supported research to benefit TB-affected communities in New York City.”

Two men looking at camera, one of left has a stethoscope around his neck
On May 9, 2022, Manuel Duchitanga Tepan (right) became the first patient in New York City (NYC) to take the new four-month regimen for treatment of drug-susceptible tuberculosis prescribed by Dr. Neil Vora (left) at the NYC Department of Health and Mental Hygiene Clinic in Corona, Queens.

The new regimen centers on rifapentine and moxifloxacin, two older but powerful medicines that can cure TB in just four months when used in place of rifampicin and ethambutol and in combination with isoniazid and pyrazinamide. The new four-month regimen is the result of a clinical trial conducted across 34 sites in 13 countries by two USG funded research networks – the Tuberculosis Trials Consortium (TBTC) of the U.S. Centers for Disease Control and Prevention (CDC) and the AIDS Clinical Trials Group (ACTG) of the U.S. National Institutes of Health (NIH). The TBTC is a collaboration between the CDC, academic institutions, and local health departments, with an emphasis on programmatic relevance. The mission of the TBTC to conduct research that can be applied by state and local TB programs is what drove the network to develop and evaluate the four-month regimen now being rolled out in New York City, and another landmark trial that validated a three-month rifapentine-based regimen (3HP) that is used widely across the U.S. and the world for TB prevention. The results of both trials were published in the New England Journal of Medicine and have informed domestic and international treatment guidelines.

As both this new four-month course of treatment and 3HP demonstrate, rifapentine is a key component of effective new regimens that make TB far easier to treat and prevent. Universal access to shorter regimens would result in less physical, emotional, economic suffering for people living with TB and their families, more patients being successfully cured, more cases prevented before developing into active disease, and less transmission within communities. Unfortunately, however, chronic and recurring shortages of rifapentine makes it difficult to implement these treatment innovations at scale, limiting the potential of initiatives like the one being rolled out by the Department of Health and Mental Hygiene to reach all the patients who could benefit. Although rifapentine is off patent, the U.S. market is only served by one company, Sanofi, which has limited production capacity. Two generics manufacturers will soon produce rifapentine for the global market, but these companies have not registered their products with the U.S. Food and Drug Administration. The short supply of rifapentine in the United States and a recent price increase on the drug threaten the ability of cash-strapped TB programs to make rifapentine-based shorter regimens available to all patients who could benefit from them. “State and local TB programs are eager to implement these effective new interventions, but we simply don’t have the resources – fiscal or human. TB program staff have been diverted to the COVID-19 response, leaving significant nursing and programmatic staff shortages to conduct TB activities. Federal funding has been stagnant for a decade. Successfully, and safely, implementing this new regimen requires a robust TB workforce and strengthened laboratory testing capacity, which increased funding could address,” said Donna Wegener, Executive Director of the National Tuberculosis Controllers Association (NTCA). “In addition, with greater investments in the CDC Division of TB Elimination (DBTE), we could advance even more research like the groundbreaking rifapentine regimens, and improved diagnostics, and put them to work saving patients’ lives.”

People living with and at risk of TB in the United States and around the world have a right to benefit from scientific progress in the fight against TB and to effective, shorter treatment regimens that minimize the negative impacts of TB on their lives. We need to guarantee domestic TB programs have the funding they need, more investment in research, and to secure domestic and global supplies of rifapentine so that the Department of Health and Mental Hygiene and other TB programs can fully implement the latest standards of care. In the words of TAG Executive Director Mark Harrington, “the global fight against TB has long relied on outdated tools. Now that we have better ones, the fruits of scientific innovation and decades of investment by the U.S. taxpayer must be accessible so that scientific advancement leads to positive change in the lives of people who need it most.”

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About Treatment Action Group
Treatment Action Group (TAG) is an independent, activist, and community-based research and policy think tank committed to racial, gender, and LGBTQ+ equity; social justice; and liberation, fighting to end HIV, tuberculosis (TB), and hepatitis C virus (HCV). TAG catalyzes open collective action by affected communities, scientists, and policymakers to ensure that all people living with or impacted by HIV, TB, or HCV — especially communities of color and other marginalized communities experiencing inequities — receive life-saving prevention, diagnosis, treatment, care, and information. We are science-based activists working to expand and accelerate vital research and effective community engagement with research and policy institutions for an end to the HIV, TB, and HCV pandemics. More information is available here: https://www.treatmentactiongroup.org/.

About We Are TB
We Are TB is a supportive community of TB survivors, people in treatment, and family members committed to the common goal of eliminating TB. We Are TB is a growing survivor network that is fighting to achieve change in TB diagnostics, treatment regimens, and funding to support US-based public health programs. The group specializes in connecting medical professionals and current TB patients to TB survivors. We Are TB brings an unparalleled depth of knowledge and provides compassionate support, including support group meetings in both Spanish and English, while using personal stories to empower survivors to break the stigma around TB. More information is available here: https://www.wearetb.com/.

About the National TB Controllers Association (NTCA)
The National TB Controllers Association (NTCA) brings together the leaders of tuberculosis control programs in all states and territories, as well as many counties and city health departments that organize their own TB control activities. The NTCA protects the public’s health by advancing the elimination of tuberculosis in the U.S. through the concerted action of state, local, and territorial programs. More information is available here: https://www.tbcontrollers.org/.

About the TB Roundtable
Tuberculosis Roundtable is a coalition of dozens of organizations advocating for the funding and policy necessary to end TB in the U.S. and across the globe. TB Roundtable consists of survivors, clinicians, program staff, researchers, caregivers, community activists, and other advocates who partner with policymakers and provide education about TB. Through appropriated funding and authorizing legislation, TB Roundtable seeks to support the many U.S. and global programs working to prevent, diagnose, and treat TB and develop innovative solutions to the TB pandemic that center those most directly affected.

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