MDR-TB Treatment & Prevention

Expert Panel Feb. 20-24: Management of Second Line anti-TB Drugs: Getting it right

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Practical and Ethical Challenges around GeneXpert MTB/RIF Scale up

Multi-drug resistant (MDR) and extensively drug resistant (XDR) tuberculosis arise in patients experiencing improper treatment regimens, and reveal weaknesses in health delivery systems both for diagnosis and treatment for tuberculosis. Fewer than 20% of MDR/XDR-TB cases have access to valuable diagnosis and treatment options (International Journal of Tuberculosis and Lung Disease, December 2012).

A new rapid diagnostic tool for detecting rifampicin resistance was endorsed by the World Health Organization in December 2010. The endorsement of GeneXpert MTB/RIF provided global sites with a way to detect markers for drug-resistant TB, and promised to be a game-changer to the diagnosis of drug-resistant TB. Three years later, the cost of GeneXpert cartridges have been reduced by 40% and PEPFAR and UNITAID both created projects to increase uptake and utilization of the test in high-burden countries and by public sector entities in 145 eligible countries. (World Health Organization, 2013)

The rapid roll-out and scale-up in countries with very different epidemiology and health systems has generated an immense need for timely technical guidance and collaboration. Under the guidance of Christopher Gilpin, PhD, MPH, GHDonline moderator and scientist in TB Diagnostics and Laboratory Strengthening Unit of the Stop TB Department at the WHO, and a member of the team leading the global roll-out and scale-up of the GeneXpert MTB/RIF assay, GHDonline is the host of a series of virtual expert panels and discussions to improve the uptake and usage of GeneXpert MTB/RIF worldwide and especially in countries with limited resources. This brief summarizes lessons learned from our second panel hosted in December 2012.

Discussion was dominated by an ethical dilemma: should the use of GeneXpert MTB/RIF be extended to locations without access to proper treatment drugs? Experiences and anecdotes from panelists and members in the Democratic Republic of the Congo, Belgium, Cambodia, Ethiopia, Kinshasa, and South Africa, as well as from Cepheid, the manufacturer, can be found in this expert panel.

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Implementation of GeneXpert MTB/RIF in Resource-Limited Settings

For many years, health implementers in high TB endemic areas with limited resources have been struggling with TB control primarily due to the lack of a rapid and reliable diagnostic test for HIV-associated TB and MDR-TB. The recent endorsement of the GeneXpert MTB/RIF, a fully-automated cartridge based nucleic acid amplification test (NAAT), by the World Health Organization in December 2010 was welcomed with enthusiasm by both implementers and donors. This novel tool reliably detects TB DNA in sputum specimens in less than two hours with 94.4 percent sensitivity for the simultaneous detection of rifampicin resistance with 98.3 percent specificity (Lancet, 2011).

But many questions have since arisen as to how best integrate this technology along with existing TB diagnostic tools in countries. Experts from the Stop TB Department of the WHO, the San Raffaele Scientific Institute, the Instituto de Medicina Tropical Alexander von Humboldt, and the Foundation for Innovative New Diagnostics (FIND) discuss the feasibility of implementing GeneXpert MTB/RIF in countries with limited resources with GHDonline members from around the globe.

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Psychosocial Support for MDR-TB Patients

Caring for patients with multidrug-resistant tuberculosis (MDR-TB) is a multifaceted enterprise, requiring effective planning for screening and diagnosis, complex drug management, individually supervised treatment, and extensive monitoring and evaluation. As organizations in resource-limited settings have scaled up their MDR-TB services, one challenge has been to provide adequate psychosocial support to patients and their families. Psychosocial support is a crucial component of treatment for MDR-TB in order to ensure completion of complicated treatment regimens and enable psychosocial rehabilitation after treatment (Acha J. et al).

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Reporting Sputum Conversion Rates for MDR-TB Monitoring

Monthly examination of sputum samples is an important aspect of treatment monitoring for MDR-TB patients. Reviewing the patient’s cultures and smears provides information about the patient’s treatment response, and culture conversion determines the overall duration of MDR treatment, which should continue for a minimum of 18 months after conversion. The World Health Organization offers standardized definitions for MDR-TB treatment outcomes, including culture and smear conversion. However, because the frequency of bacteriological monitoring varies across programs, reporting recommendations are difficult to implement across all settings. 

A GHDonline member in Taiwan presented several cases and asked if each patient would be considered to have sputum conversion at 6 months according WHO guidelines. In the dialogue that followed, moderators and members clarified the meaning of “culture conversion at 6 months,” date of sputum conversion and time to conversion, but also shared important distinctions between the use in clinical care versus evaluations of program performance.

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Using particulate respirators for TB Infection Control

The World Health Organization recommends that in addition to Administrative and Environmental Infection Control procedures such as proper cough etiquette and ventilation, personal protective equipment such as N95 and FFP2 respirators should be worn by health workers working with TB patients (Annex 7, 2009).

More than 100 resources and discussions have been posted so far by GHDonline members, raising important practical questions such as: Which respirators protect against TB and how effective are they? How should a respirator be worn? Can a respirator be re-used safely? How long can respirators be worn? What are the costs of various models and do members have recommendations for suppliers?

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Treating MDR-TB in Countries where Second-Line Drugs are not Available

Health providers who do not have access to second-line drugs (SLD) are deeply frustrated at their inability to offer adequate treatment to patients diagnosed with multidrug-resistant tuberculosis (MDR-TB). However, there are many factors besides access to drugs that are key to MDR-TB treatment, and providers should work with their National TB Programs (NTPs) in order to build a sustainable and effective delivery system that allows for better patient retention thus preventing more drug resistance and poor treatment outcome.

Members in Indonesia, the Philippines, Taiwan and the Netherlands confront this challenge, exchanging experience on their work with NTPs to develop a comprehensive MDR-TB delivery system.

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Minimum Volume of Testing for Maintaining Proficiency in TB Diagnosis

As stated by the World Health Organization, “lack of diagnostic capacity is a crucial barrier preventing an effective response to the challenges of TB-HIV and drug-resistant TB, with less than 5% of the estimated burden of MDR-TB patients currently being detected.”

In this discussion, members exchange recommendations and key references that inform the minimal volume of specimens for lab smear, culture and drug susceptibility testing needed in order to maintain lab proficiency.

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