Newly approved TB drug needs equitable access and transparency to save lives

The USA Food and Drug Administration (FDA) has approved a new drug as part of a novel regimen to combat extremely drug resistant tuberculosis (XDR TB), the most deadly form of the world’s leading infectious killer.  TB overall is responsible for 1.6 million deaths annually. 

The new drug, pretomanid, is only the third TB drug to be approved in decades. The all-oral regimen consisting of linezolid, bedaquiline, and pretomanid was piloted among a small group of patients with XDR TB in South Africa as part of the Nix-TB trial. Patients receiving the drug experienced remarkably higher cure rates compared to those of previous regimens whose success rates hover around 30%. The new treatment course is also significantly shorter and more tolerable for patients. Previous treatments for drug-resistant TB involved dozens of pills per day, painful daily injections, toxicity and severe side effects, and a treatment duration spanning two years or more. This breakthrough represents an opportunity to save more lives if equity, pricing, and access are prioritized by all stakeholders.

Pretomanid and the “BPaL” regimen are the latest exciting development to improve treatment and access to high-quality medicines for patients with drug-resistant TB. This comes on the heels of other notable shifts in the global TB landscape as new attention and energy builds to confront TB. In 2018, the WHO released updated guidelines for DR TB treatment that recommend an all-oral regimen including bedaquiline over more toxic, injectable drugs. Also in 2018, the UN hosted the first-ever High Level Meeting on TB, where global leaders committed to more aggressive targets to eliminate the disease that include the successful treatment of 1.5 million people with drug resistant TB by 2022.

Pretomanid, called a second-line drug, is used to treat patients whose TB is resistant to standard, first-line drugs. It has been approved for adult patients with XDR, treatment-intolerant or non-responsive multidrug resistant (MDR) TB, and trials are underway to determine correct dosages for prescribing practices. 

Building on the momentum that this breakthrough regimen has garnered, TB researchers and experts are calling on policymakers as well as the TB Alliance, who conducted the Nix-TB trial, and Mylan, the manufacturer, for equitable access and transparency in pricing and licensing for the drug. Another drug in the BPaL regimen, bedaquiline, was similarly heralded as a game-changing pharmaceutical with less toxicity and better treatment outcomes. However, only a small fraction of people who need bedaquiline for their TB have access to it. Policymakers must commit to fast-tracking the approval of novel drugs to facilitate delivery to countries and areas with high burdens of TB. Multilateral institutions like the WHO that inform national treatment guidelines must create and disseminate evidence-based recommendations urgently and effectively. Moreover, and in keeping with the WHO’s End TB Strategy goal for no TB-affected families to face catastrophic costs due to TB by 2035, pharmaceuticals must be made affordable for patients. This change must involve a variety of developments including the production of generic drugs to competitively drive down prices as well as improved procurement models.  

Exciting developments with new drugs for XDR TB need to be accompanied by transparent and equity-oriented measures to ensure that pretomanid has its maximum impact on the global TB epidemic. Such measures must be comprehensive and emphasize access for the most vulnerable patients if we are to reach zero TB.  

Nobel Peace Prize Laureate Nadia Murad to Speak at Duke

Nobel Peace Prize Laureate Nadia Murad is set to speak as a Crown Lecturer at Duke University on October 29.

As a member of the ethno-religious Yazidi community from Northern Iraq, she has been lauded for her work to end genocide and sexual violence, especially as a means of war. The Yazidi community has faced historic persecution and violence that has intensified in recent years. Her own experience of violence at the hands of ISIS has fueled her work to start a nonprofit, Nadia’s Initiative, as a platform to advocate for women’s and minorities’ rights, especially in emergency and crisis settings.

This event coincides with Advance Access & Delivery’s newly established project with researchers at UNC and Garmian University to  understand mental health needs and maternal and child health challenges among the Yazidi in Iraq. This consortium hopes that this event will foster growing attention and action to address this urgent humanitarian crisis. AA&D, in its partnership with Duke, started the push to bring Nobel Laureate Murad to the Triangle.

She will give the 2018 Crown Lecture in Ethics at Penn Pavilion from 5:30-7:00pm on Monday, October 29, followed by a reception and book signing. More event details can be found here.

AA&D partners with interdisciplinary team to support displaced families in Iraq

AA&D is among a team of researchers and global health practitioners who have partnered across North Carolina and Iraq to improve the delivery of critical health services for internally displaced persons (IDP) in Iraq.

This research project, “Closing the Delivery Gap for Internally Displaced Mothers and Children in Fragile Contexts: Perinatal Mental Health, Infant Feeding Practices and Malnutrition in Iraq,” seeks to understand and improve mental health services for Yazidi mothers and children who have been displaced by conflict in the country. Yazidis are an ethno-religious minority who have suffered extensively in past and ongoing conflicts in Iraq. Currently, most of the population is in displacement camps in Iraqi Kurdistan, and they lack access to basic services including medical care. The immediate and lasting effects of trauma are well-documented among the Yazidis, especially among women and mothers, yet there is little work being done to address this urgent need.

Alongside AA&D and included in this team are Dr. Aunchalee Palmquist, a UNC Chapel Hill assistant professor of maternal and child health and member of the Carolina Breastfeeding Institute, and Dr. Dilshad Jaff, adjunct assistant professor of maternal and child health and program coordinator for solutions to complex emergencies in the UNC Gillings School’s Research Innovation and Global Solutions Office. In Iraq, Dr. Pegah Seidi and Nazdar Qudrat Abas, both of the University of Garmian College of Education’s Department of Psychology, will collaborate in this project’s research and in-country implementation among IDP camps.

The goal of this project is to gather evidence of the ongoing trauma and mental health concerns among this population while prioritizing maternal and infant health in a complex emergency setting. This research will translate to more inclusive health delivery pathways that integrate maternal and child health with important, but overlooked, mental health support for severely traumatized mothers and infants.

“We are honored to take part in this work with UNC and Garmian University, to understand how to support these communities that have been through so much suffering and strife in recent years. This is a modest first step to identify how to assist in the provision of health care and social services to these Iraqi communities, in a spirit of solidarity and respect,” says Tom Nicholson, AA&D executive director.

A news announcement for this project from UNC Gillings School of Public Health can be found here, and an announcement from the Duke Center for International Development here.

AA&D launches new project in South Africa linking TB services with NCD care

Durban, South Africa -- On July 9th, over 350 individuals from government, civil society, and the international community joined the Kwamakutha community in the South-Central sub-district of eThekwini to launch a 5-year linkage to care project for tuberculosis (TB) and noncommunicable diseases (NCDs). The event highlighted the importance of integrating screening and treatment for NCDs within the existing TB and HIV services in eThekwini. The event was attended by several high level officials from the National, Provincial, District Departments of Health as well as from the Municipal Health Office, including a keynote speech from Sibongiseni Dholo, MEC KwaZulu Natal.

This 5-year project, called NCD-LINK, is supported by Lilly Global Health and will be implemented in 10 public facilities across Umlazi, a sub-district of Durban. The project will be carried out by Advance Access & Delivery (AA&D) and its partners at Interactive Research & Development-South Africa (IRD-SA) and the South African Medical Research Council will lead the project’s monitoring and evaluation arm. NCD-LINK will build on TB and HIV infrastructure in KwaZulu Natal as a platform for screening and treating NCDs. The goal of the project is to expand access to these important medical services and hasten the delivery of care that people need.

Participants of this event were offered screening for TB, HIV, diabetes, and hypertension. Screening was provided by local teams from IRD-SA, the District Department of Health, and the Municipal Health Office. Project activities will begin later this year and will support the National Service Integration agenda as well as the National Wellness Campaign in which eThekwini is one of the high-burden sub-districts identified.