Evaluating the Impact Tuberculosis Preventive Treatment in HIV Treatment Programs

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The role of the US President’s Emergency Plan for AIDS Relief in combating tuberculosis (TB).

Tuberculosis bacteria | Image credits: Unsplash

The Centers for Disease Control and Prevention (CDC) reports the US President’s Emergency Plan for AIDS Relief (PEPFAR) provides a course of tuberculosis preventive treatment (TPT) to all eligible clients receiving antiretroviral treatment (ART). The effectiveness of PEPFAR's strategy in incorporating TPT into the standard care for people living with HIV is facilitated by its collaboration with national HIV programs. The study also points to expanding the use of shorter TPT courses, adopting patient-focused strategies, and implementing electronic health record systems to attain comprehensive TPT coverage. While TPT completion rates are high, securing access and adherence to TPT for individuals with HIV is a concern.

Data showed that TPT initiation rates hit their highest point in 2019, hinting at leveling off in expanding the program. The initiation rates for TPT among clients who had been on ART for less than 6 months reached 59%, and the reported overall completion rate was as high as 87%. Since 2017, around 13 million people living with HIV have successfully finished TPT.

“Trends in overall initiations provide insight into TPT scale-up over time because climbing initiation rates would be expected when programs are rolling out TPT to the existing patient population,” according to the CDC. “Declining overall TPT initiation rates over time might suggest programmatic saturation, in which all eligible ART clients have already received TPT.”1

Main Takeaways

  1. The US PEPFAR has successfully integrated TPT into the care of people living with HIV, with data showing high initiation and completion rates.
  2. The limitations highlight variability in data across different settings, reliance on self-reporting for TPT completion, and the need for more detailed analysis underscoring the complexity of implementing TPT at a global scale and the necessity for innovative solutions to overcome these hurdles.
  3. The development and phase 3 clinical trial commencement of the M72/AS01E TB vaccine candidate represents a potentially groundbreaking advancement in the fight against TB.

Despite high completion rates, the PEPFAR initiative faces limitations, including the variability of data across diverse environments and populations, reliance on self-reporting for TPT completion, and the absence of individual-level data for more granular analysis. These factors underscore the need for innovative approaches to ensure comprehensive TPT coverage and adherence.

In recent reporting from Contagion, the Bill & Melinda Gates Medical Research revealed the commencement of phase 3 clinical trial evaluating the M72/AS01E TB vaccine candidate. If M72/AS01E proves to be both safe and productive, it has the potential to be the inaugural vaccine aimed at preventing pulmonary TB in adolescents and adults, marking the introduction of the first new TB vaccine in more than 100 years. This vaccine could reduce the incidence of TB, particularly pulmonary TB, which is the most common and contagious form of the disease, contributing significantly to global health efforts to combat this deadly disease.

“The launch of this pivotal phase 3 trial demonstrates our commitment to harnessing the power of medical innovation to fight diseases like TB that are particularly devastating for low- and middle-income countries,” said Emilio A. Emini, PhD, CEO of the Gates MRI. “Clinical study of the vaccine will still require years, but our incredible partners in South Africa and elsewhere who have come together for the phase 3 study share our hope in the vaccine’s potential.”2

World Health Organization (WHO) recommended TPT regimens to reduce the risk of TB disease and TB-attributable deaths among persons with HIV. The WHO reports that approximately 10.6 million individuals contracted TB in 2022, with 1.3 million fatalities, translating to more than 3,500 deaths daily particularly affecting vulnerable populations in low- and middle-income countries.

Overall, the integration of TPT into HIV care by PEPFAR and the advancement of TB vaccine research represent significant strides in the global fight against TB. While challenges remain, the commitment to innovative treatment strategies, patient-focused care, and global collaboration offers hope for a future where TB and HIV can be effectively managed and prevented.

References

  1. CDC. Tuberculosis Preventive Treatment Update — U.S. President’s Emergency Plan for AIDS Relief, 36 Countries, 2016–2023. Published March 21, 2024. Accessed March 25, 2024. https://www.cdc.gov/mmwr/volumes/73/wr/mm7311a1.htm?s_cid=mm7311a1_w
  2. Abene, S. Vaccine Targeting Tuberculosis (TB) Prevention Enters its Phase 3 Trial. Published March 19, 2024. Accessed March 25, 2024. https://www.contagionlive.com/view/vaccine-targeting-tuberculosis-tb-prevention-launches-phase-3-trail
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