A Tale of Two Pills – How the TLD Transition Is Taking Shape within PEPFAR

A woman holds pills in both her hands. Three yellow ones in her left hand and 3 red ones in her right.
USAID’s Office of HIV/AIDS is working to support the transition to a new line of antiretroviral treatment, known as TLD.
Photo credit: Emily Harris/USAID
headshot of Emily Harris

By Emily Harris, Public Health Advisor
Emily Harris, MA, is a public health advisor in the Research Division in USAID's Office of HIV/AIDS. She leads multiple project teams dedicated to accelerating the introduction of innovative prevention and treatment products.

headshot of Meghan Majorowski

Meghan Majorowski, Senior Market Access Advisor
Meghan Majorowski, MSc, MSc, is a senior advisor in USAID's Center for Accelerating Innovation and Impact (CII) where she focuses on market-based strategies to accelerate adoption of priority health solutions, including strategic planning for product introductions and scaling.

 

Take a look at the photo above.

Do you recognize the large yellow pill on the right? It is TLE600, a fixed-dose, once-a-day medication containing a 600 mg dose of tenofovir disoproxil fumarate, lamivudine and efavirenz. TLE600 is currently the standard of care for most HIV treatment programs in low- and middle-income countries (LMICs).

How about the smaller pink pill on the left? That's a generic version of TLD, the single pill, once-a-day, fixed-dose combination of tenofovir disoproxil fumarate, lamivudine and dolutegravir. Although it is already a preferred treatment choice in the United States by the U.S. Department of Health and Human Services, TLD is relatively new in LMICs. Given its multitude of benefits, including TLD's improved tolerability and higher resistance barrier, a concentrated effort is underway to accelerate TLD's introduction in countries supported by the U.S. President's Emergency Plan for AIDS Relief (PEPFAR), where shifting drug regimens have sometimes proved challenging and time consuming.

Both pills are modeled by one of the many incredible country stakeholders we met in Johannesburg, South Africa, at the PEPFAR Regional Planning meetings (RPMs). At the RPMs, PEPFAR country teams worked intensely with key collaborators, including counterparts from government and civil society, to program and budget for the upcoming U.S. Government fiscal year.

A key part of these efforts was planning for a rapid transition to TLD.

Following on global market shaping efforts to accelerate TLD's access, country teams were asked to work toward an ambitious timeline of transitioning to TLD by the end of September 2019. Countries were provided with two key planning tools: (1) a supply plan focusing on existing stock, future orders and management of supply; and (2) a transition plan. The transition plan provided a streamlined version of this checklist, which helped countries report on the status of key activities needed for a successful transition to a new antiretroviral drug.

As part of an interagency task team supporting the TLD transition, we sat with PEPFAR country teams and their collaborators to discuss their plans and concerns:

  • Will TLD supply meet the increasing demand?
  • How should countries address pregnant women and patients with HIV-associated tuberculosis, given promising emerging data but a lack of World Health Organization guidance?
  • How long of a transition period will reduce risk of stock-outs and wastage, while accelerating access to TLD?
  • What kind of impact should simultaneous efforts to roll out viral load testing or to measure HIV drug resistance impact have on transition planning?

As we talked through these key concerns, we were also able to identify a number of key opportunities. Country teams were willing to consider shifting future orders, allowing for accelerated transition timelines. Some country teams who originally developed plans accounting for global supply shortages were even willing to make more ambitious plans, based on global coordination efforts that are underway between major manufacturers and procurers.

Currently, PEPFAR representatives are aggregating the supply and transition plans. This review will ensure PEPFAR can proactively address issues from a supply or broader transition plan perspective. These coordination efforts will also emphasize sharing existing tools and resources to avoid duplication of efforts and encourage shared learning across countries.

In April, PEPFAR country teams will gather in Washington, D.C., to finalize their budgets and plans for the upcoming fiscal year. Given TLD's rapid rate of viral suppression, improved side effect profile and decreased barrier to resistance, the rapid introduction of TLD in these plans holds the promise to transform HIV treatment programs. It's amazing to see how much promise can fit in the palm of your hand!

Last updated: September 16, 2019

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