Accelerating access to safer, simpler and more affordable antiretroviral treatment for individuals living with HIV

01 About OPTIMIZE

Antiretroviral treatment (ART) optimization ensures that people living with HIV receive the best-available ART in the most efficient and cost- effective manner possible.

  • Optimized antiretroviral (ARV) drugs and formulations are those that are:
  • Effective, safe, tolerable, and easy to use

  • Adapted to resource-constrained environments; affordable, heat-stable, and available in fixed- dose combinations (FDCs)

Over the next five years, the introduction of a new set of ARV drugs to a broader global market – including newer drugs and formulations with improved efficacy, tolerability, and safety such as dolutegravir (DTG), tenofovir alafenamide fumarate (TAF) and co-formulated darunavir/ ritonatir (DRV/r) – has the potential to transform the treatment landscape in low- and middle-income countries (LMICs).

ICAP at Columbia University is part of the OPTIMIZE project, a global consortium dedicated to rapidly improving treatment outcomes for people living with HIV by optimizing ARV drugs and formulations and accelerating their introduction in low- and middle-income countries (LMIC).

OPTIMIZE is supported by USAID and led by the Wits Reproductive Health and HIV Institute (Wits RHI) and founding members including ICAP at Columbia University‚ Mylan Laboratories‚ the University of Liverpool, and the UNITAID-funded Medicines Patent Pool. As an expanding partnership aimed at harnessing multiple stakeholders’ collective efforts, OPTIMIZE also includes the University of Cape Town (UCT) and contributions from private sector partners. USAID is a key implementing agency of the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) and is responsible for over half of all PEPFAR programs with activities focused in 35 priority countries and regions, mainly in sub- Saharan Africa and Asia. For more information, please visit: www.usaid.gov

02 Why is ART Optimization Important?

As momentum towards the UNAIDS 90-90-90 targets and implementation of the World Health Organization (WHO) Treat All recommendation grows, there will be an unprecedented demand for ARVs. Global ARV spending is expected to jump from $1.75 billion in 2014 to $3.8 billion in 2020 in response to growing numbers of people on ART. In the context of stagnant levels of donor funding, and limited LMIC country budgets, there is a need for simpler, better, safer, less toxic and more cost-effective HIV treatment.

  • 90% Diagnosed

  • ->
  • 90% on Treatment

  • ->
  • 90% Virally Supressed

Global ARV spending is expected to jump from $1.75 billion in 2014 to $3.8 billion in 2020.

The emergence of DTG, EFV400, TAF, and DRV/r as treatment options with improved tolerability, higher genetic barriers to resistance, and lower costs, may have substantial health and budgetary benefits. Previous ARV product innovations were marked by major delays to introduction in low-income, high HIV burden settings thus delaying treatment advancements for the populations that needed them most by several years. Similar delays at this critical juncture in the HIV epidemic would prevent the rapid uptake of gamechanging new drugs for the millions of patients hindering progress towards 90-90-90 targets.

Both health and budgetary benefits come from adopting optimized ARV products. Globally, the introduction of DTG, TAF, and EFV400 to the LMIC market is expected to yield USD $3 billion of savings by 2025, or up to USD $4 million for every 100,000 patients on treatment. In addition, countries can expect to see indirect savings due to lower rates of treatment failure and the need for more expensive second- and third-line regimens. Both direct and indirect savings will continue to grow over the long-term as market competition intensifies and countries simplify, standardize, and harmonize treatment protocols and ARV procurement practices.

Health benefits include:

  • Reduced quantities of active pharmaceutical ingredients (API), resulting in smaller tablet sizes that are easier to take

  • Higher tolerability, lower toxicity, and fewer side effects, resulting in improved adherence to treatment

  • Earlier and sustained viral suppression, leading to decreased HIV transmission and better treatment outcomes

  • Reduced regimen discontinuation, treatment failure, and drug resistance

03 What is ICAP Doing to Support ART Optimization?

Enabling environment (policy, advocacy, and finance)

Are national policies, advocacy platforms, and finances prepared for new product introduction?

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Enabling environment (policy, advocacy, and finance)

  • Define and promote public health value proposition
    • Advocate for optimized products (via Technical Working Groups (TWG), stakeholder meetings, and civil society networks)
  • Map and support expedited drug registration procedures
  • Conduct guidelines analysis and assess budget requirements/impact

Planning processes and tools

Do tools and processes for forecasting, tendering, procurement, target-setting, and transition monitoring require updating or adaptation?

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Planning processes and tools

  • Support national forecasting exercises incorporating optimized products
  • Develop phased implementation plans, including demand generation, communication, and monitoring and evaluation (M&E) plans:
    • Generate demand for optimized products among patients and providers
    • Communicate transition plan, roles, and responsibilities to stakeholders
    • Set national, sub-national, and facility targets & strengthen capacity for transition M&E
  • Revise tools and standard operating procedures (SOPs) for training and mentoring clinicians

Service delivery capacity

Are ART service delivery models and health care workers prepared to support the introduction of new ARV products and enhanced patient monitoring for post-marketing surveillance?

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Service delivery capacity

  • Conduct intensified patient monitoring, including cohort analyses
  • Support intensified stock monitoring
  • Increase stock visibility through “stop stockout” campaigns, publications, and web-based tracking tools
  • Conduct routine tracking of transition progress against established targets
  • Implement QA/QI activities focusing on regimen optimization, viral load suppression, and ARV drug resistance

Transition monitoring and visibility

Are rigorous monitoring and evaluation processes in place to ensure appropriate prescribing, monitor ARV stock levels, and evaluate overall transition progress?

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Transition monitoring and visibility

  • Adapt service delivery models to promote differentiated care, linkage, retention, and adherence
    • Institute innovative prescribing practices and differentiated care services for sub-populations
    • Integrate new treatment algorithms and treatment preparedness counseling into strategies for community-based ART delivery
  • Train and mentor clinicians in SOPs for patient management, regimen tracking, and stock monitoring
  • Increase demand among patients through community health days and community meetings

04 Countries

ICAP supports countries to accelerate the introduction of optimal ARVs using proven approaches to improve market access and strengthen health systems. Click on a country highlighted in grey to learn more.

Kenya

1,500,000Number of people living with HIV (all ages in 2015)1
826,097Number of adults living with HIV receiving ART in 20151
71,547Number of children living with HIV receiving ART in 20151
$USD 18,792,000Potential total cost savings for transition from TDF/3TC/EFV600 to TDF/3TC/DTG3
$USD 20.83Potential annual per patient cost savings for transition from TDF/3TC/EFV600 to TDF/3TC/DTG3
250,560Potential number of additional patients treated for transition from TDF/3TC/ EFV600 to TDF/3TC/DTG3

Kenya launched the use of DTG singles in June 2017. The country is currently planning for a broader rollout of DTG when a fixed dose combination tablet of tenofovir/lamivudine/dolutegravir (TLD) is available.

Mozambique

1,500,000Number of people living with HIV (all ages in 2015)1
738,386Number of adults living with HIV receiving ART in 20151
64,273Number of children living with HIV receiving ART in 20151
$USD 16,704,000Potential total cost savings for transition from TDF/3TC/EFV600 to TDF/3TC/DTG3
$USD 20.88Potential annual per patient cost savings for transition from TDF/3TC/EFV600 to TDF/3TC/DTG3
222,720Potential number of additional patients treated for transition from TDF/3TC/ EFV600 to TDF/3TC/DTG3

Mozambique is planning for future adoption of DTG when an FDC becomes available.

Zimbabwe

1,400,000Number of people living with HIV (all ages in 2015)1
817,397Number of adults living with HIV receiving ART in 20151
61,064Number of children living with HIV receiving ART in 20151
$USD 18,792,000Potential total cost savings for transition from TDF/3TC/EFV600 to TDF/3TC/DTG3
$USD 20.88Potential annual per patient cost savings for transition from TDF/3TC/EFV600 to TDF/3TC/DTG3
250,560Potential number of additional patients treated for transition from TDF/3TC/ EFV600 to TDF/3TC/DTG3

Zimbabwe is introducing TDF/3TC/EFV400 but considering a transition to DTG-containing regimens when an FDC becomes available.

South Africa*

7,000,000Number of people living with HIV (all ages in 2015)1
3,209,270Number of adults living with HIV receiving ART in 20151
174,891Number of children living with HIV receiving ART in 20151
$USD 111,720,000Potential total cost savings for transition from TDF/3TC/EFV600 to TDF/3TC/DTG3
$USD 31.92Potential annual per patient cost savings for transition from TDF/3TC/EFV600 to TDF/3TC/DTG3
1,489,600Potential number of additional patients treated for transition from TDF/3TC/ EFV600 to TDF/3TC/DTG3

South Africa is planning for the wide-scale introduction of DTG-based adult first line ART when an FDC becomes available.

*The current work in South Africa is being led by Wits Reproductive Health and HIV Institute and Clinton Health Access Initiative, however ICAP assisted with the development of the Needs Assessment that is available in the resources section of this website.

1. UNAIDS 2016 Prevention Gap Report

2. Calculation based on estimated savings from switching from TDF/3TC/EFV600 to TDF/3TC/DTG as the preferred 1L regimen using the estimated market introduction price for TDF/3TC/DTG of $75 pppy and RSA 2015-2018 tender weighted average price for TDF/3TC/EFV600 based on the CHAI ARV Market Report 2016.

3. Calculation based on estimated savings from switching from TDF/3TC/EFV600 to TDF/3TC/DTG as the preferred 1L regimen using the estimated market introduction price for TDF/TC/DTG of $75 pppy and Global Fund July 2016 Pricing for TDF/3TC/EFV600 based on the CHAI ARV Market Report 2016.

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