ARTICLE

ARC ENGAGEMENT STORIES: EASING THE TRANSITIONING TO A NEW HIV THERAPY

IN KENYA AND SOUTH AFRICA, THE AFRICA RESOURCE CENTRE RECRUITED COMMERCIAL SUPPLY CHAIN EXPERTS TO SUPPORT THE PRODUCT LAUNCH OF A NEW FIRST-LINE ANTIRETROVIRAL THERAPY REGIMEN AND A TRANSITION PLAN FOR REPLACING THE EXISTING REGIMEN.

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The stories in this blog series illustrate the different ways ARC is helping countries engage private sector expertise to strengthen their health supply chains and design innovative new approaches that ensure medicines are available to the people who need them. Read the overview

Kenya is among the 82 countries that are transitioning to a new fixed-dose combination therapy as their first-line antiretroviral therapy (ART) regimen[1]. Dolutegravir (DTG) is an antiretroviral medicine that is “more effective, easier to take and has fewer side effects than alternative drugs that are currently used[2].” Patients are also less likely to develop drug resistance on DTG-based regimens, in contrast to the existing regimens containing efavirenz or nevirapine.

Launching new products into any marketplace is challenging. It requires deep understanding of market dynamics and consumer behaviour, past experience in launching similar products, complex demand planning, and supply chain agility to accommodate both slower and faster than expected uptake. Careful planning and close monitoring of supply and demand are essential for a successful launch and for managing and mitigating risks. The private sector knows this well and has learned from many successes and some famous failures. A recent example from the health sector is the 2016 introduction of the inactivated polio vaccine, where the global demand and pace at which countries chose to replace the oral polio vaccine was underestimated and resulted in a global shortage of the new vaccine version that manufacturers are still trying to overcome[3].

Advocating for an agile supply chain

Like many countries, Kenya has plenty of experience in launching new products in its HIV/AIDS programme, but these undertakings haven’t always gone as expected. When the National AIDS & STI Control Programme (NASCOP) transitioned from regimens containing stavudine to those with zidovudine or lamivudine, progress was significantly slower than expected[4], in part because doctors were uncertain about which patients should transition. Pharmacists were also concerned about wasting existing inventories of stavudine-based regimens and so continued to dispense them to patients. Demand forecasting and procurement plans relied on this consumption data rather than factoring in the goals of the transition plan, perpetuating the supply problem[5].

Kenya was an early adopter of a DTG-based regimen – tenofovir, lamivudine, and dolutegravir (TLD) – starting in 2016. The transition focused on updating clinical guidelines and orienting clinicians. Demand forecasts and procurement plans developed in coordination with supply chain implementing partners were based on assumptions about transitioning all of Kenya’s 1.1 million adult ART patients to DTG-based regimens by June 2018. But in May 2018, the World Health Organization issued an advisory about potential adverse effects on infants born to woman who conceived while on DTG[6] (this advisory was revised in July 2019[7]). With women of reproductive age representing roughly 70 per cent of Kenyan adults on ART[8], this caused a critical disruption in the transition, resulting in a significant decrease in demand for DTG. But procurement contracts were already in place based on the higher demand forecast and did not provide the flexibility to reduce the quantities in the pipeline. As result, Kenya was oversupplied with DTG, and the alternative regimens that were being phased out were in short supply.

HIV treatment programmes have experienced many product launches; such as the paediatric ART drug formulations introduced in the early 2000s, fixed-dose combination tablets, and rapid HIV test kits. As Kenya and other countries have found, the transition to a new regimen is fraught with compounding factors, so clear guidance, timely data, strong planning, and an agile supply chain are essential. Coordination is paramount, especially when there are many different donors and technical partners involved in treating HIV and procuring and distributing medicines. When NASCOP introduces a new ART regimen, it must coordinate with a multiplicity of partners working on different parts of the programme: clinical guidelines and treatment protocols, drug formularies, behaviour change communication, service delivery, and procurement and supply management.

ARC’s role

Recognising the challenges of past transitions, NASCOP, in consultation with its development partners, reached out to the Africa Resource Centre (ARC) for help in the TLD transition planning and implementation. ARC was already supporting South Africa’s TLD transition; in fact, Kenya’s early experience with single-dose DTG helped South Africa avoid similar challenges. In 2018, the ARC South Africa team placed a Transition Programme Manager with over 20 years’ experience in the commercial sector working on both supply chain and strategy development to sit within the South African National Department of Health (NDoH) and help coordinate and manage the different implementing partners and provincial teams working on the TLD transition. The transition plan assumes that the existing first-line regimen[9] will remain in use, as many patients will not transition due to eligibility criteria – a decision is still pending on whether TLD should be given to women of reproductive age who are not on contraception. A critical aspect of ARC’s focus is supporting the NDoH to create a robust demand model and working with suppliers to ensure adequate volumes of the existing regimen and TLD. A transition dashboard has been created to monitor the switch over and adjust supply plans, with specific outlines for each province.

In Kenya, ARC brokered a Novo Nordisk Transition Programme Manager with deep experience in product launches in the commercial sector to be embedded within NASCOP. ARC also arranged for Novo Nordisk to provide remote support from two subject matter experts for a nine-month period. The Transition Programme Manager worked with the NASCOP supply chain team to review the overall transition approach and the demand and supply planning tool that was developed for South Africa and adapt them for the Kenyan context. Kenya has begun its transition, developing detailed plans, including a supply chain lifecycle management playbook and traceability requirements for the supply planning tool. The Transition Programme Manager will coach her Ministry of Health colleagues on the transition team to use these tools. She will also document how these tools and processes can be used and shared globally for future product transitions, so they can support the launch of any new life-saving medicine, diagnostic or vaccine that a public health programme requires.

[1] WHO recommends dolutegravir as preferred HIV treatment option in all populations https://www.who.int/news-room/detail/22-07-2019-who-recommends-dolutegravir-as-preferred-hiv-treatment-option-in-all-populations

[2] Ibid

[3] https://www.statnews.com/2017/05/19/polio-vaccine-shortages/

[4] Experiences Transitioning to New Adult First-Line Antiretroviral Regimens: A Multi-Country Study https://optimize.icap.columbia.edu/wp-content/uploads/2017/12/First-line-antiretroviral-case-study.pdf

[5] Ministry of Health, Kenya HIV Estimates Report October 2018 https://nacc.or.ke/wp-content/uploads/2018/11/HIV-estimates-report-Kenya-20182.pdf

[6] Statement on DTG – Geneva 18 May 2018 https://www.who.int/medicines/publications/drugalerts/Statement_on_DTG_18May_2018final.pdf?ua=1

[7] See Footnote 1

[8] UNAIDS Country Factsheets 2018 https://www.unaids.org/en/regionscountries/countries/kenya

[9] Tenofovir, Lamivudine and Efavirenz (TDF+3TC+EFV600mg)