Experiences and early lessons from adoption and introduction of the generic paediatric Dolutegravir 10mg dispersible, scored tablets (pDTG) in Malawi

BACKGROUND: Despite notable progress towards adult 95-95-95 targets in Malawi by end of 2020 (88-98-97), significant work remains for children (75-100-74). By end 2020, ~77% of all children living with HIV (CLHIV) on treatment were virally suppressed, suggesting treatment inequalities when compared to adults (96%). In 2021, Malawi prioritized pDTG adoption to expand paediatric access to the life-saving formulation, which was not available at a sustainable price until 2020.
DESCRIPTION: Malawi's treatment guidelines were revised in 2021 to include pDTG as the preferred first-line treatment for children between 3kg-19.9kg and aged above four weeks. Through Unitaid funding, CHAI procured pDTG for ~2,500 children to catalyse product access in 50 targeted high-volume sites, while large-scale resource mobilization took place. Enhanced monitoring was adopted from Phase I of implementation to provide rapid insights on patient safety, product experience, health care worker (HCW) capacity to introduce the product and to support troubleshooting ahead of national scaleup. Phase II followed with 48 additional sites by August 2021. Across the 98 Phase II sites, 3,631 children were on pDTG by the time Global Fund delivered pDTG in October 2021, enabling Phase III implementation across all 671 sites serving CLHIV.
LESSONS LEARNED: Relative to most countries, a high proportion of the 6,900 eligible children (~53%) were on pDTG by December 2021. Swift stakeholder coordination, site-level trainings, monitoring visits, distribution of HCW materials and a comprehensive package of community resources enabled an effective rollout. A phased transition ensured building of supply chain experience with a new product during the COVID-19 pandemic. Caregivers, CLHIV, and HCWs across the 50 Phase I sites cited a preference of pDTG over LPV/r due to improved tolerability, simpler administration and palatability for children. A highlighted challenge has been pDTG 90-pack sizes, which have clinical implications on prescribing practices and patient monitoring in early phases of initiation.
CONCLUSIONS: Malawi is one of the first countries to adopt and scale-up pDTG nationally. Given pDTG's superior clinical profile and tolerability, optimal viral suppression rates in children are anticipated. National HIV programs can learn from Malawi's experience as a best practice for rapid adoption of child-friendly treatment products.

Download the e-Poster (PDF)