Conclusion of the national transition to dolutegravir (DTG) formulations for adult first-line (1L) recipients of care in Malawi: early outcomes and practical lessons for low- and middle-income (LMIC) settings

BACKGROUND: Since its inception in 2001, Malawi Department of HIV & AIDS (DHA) has strived to provide optimized antiretroviral regimens for all people living with HIV (PLHIV). By 2017, over 630,000 adults were accessing the WHO-preferred 1L regimen TLE600, with an average national viral load (VL) suppression rate of 89%. Given the anticipated availability of new generic formulations, Malawi considered adopting DTG-based regimens, such as fixed-dose combination TLD given their clinical superiority over efavirenz-based regimens.
DESCRIPTION: DTG transition planning started in 2017. Through multi-stakeholder consensus, TLD was adopted as the preferred adult 1L regimen by end 2018. DHA recommended VL testing as best practice but not a requirement before switching to DTG, due to VL access challenges. DHA initially adopted a conservative approach for women of childbearing potential (WOCBP), given the May 2018 safety signal. A prescribing algorithm to translate TLD guidance into clinical practice was developed and at least two healthcare workers from Malawi's 750 ART facilities were trained. Pharmacovigilance tools were also developed to ensure timely and appropriate response to adverse events. The national projection was >95% of eligible patients will be transitioned to TLD by Q4 2019, staring January 2019.
LESSONS LEARNED: Early implementation monitoring conducted in 30 facilities showed low uptake among WOCBP (5%) highlighting influence of policy guidance on product adoption. When WHO updated TLD guidance in 2019, Malawi leveraged the early insights to catalyze development of a contextual, women-centered approach for TLD. Key stakeholder coordination minimized inefficiencies and facilitated uptake. Rapid guideline adaptation at onset of COVID-19 ensured sustained product access and showed the importance of swift coordination mechanisms for implementation. Routine quarterly supervision and site-level data collection systems enabled timely troubleshooting and course-correction. Analysis of programmatic TLD data between Q1 2019 and Q1 2021 shows Malawi transitioned 817,320 (~97%) patients to TLD, achieving viral suppression rates of ~98% in 1L adults. TLD uptake has been sustained at 97%.
CONCLUSIONS: Malawi is one of the first LMICs to finish national transition to TLD. National HIV programs can learn from Malawi's implementation experience as best practice for ensuring rapid adoption to optimal products, even in light of COVID-19.