ViiV Healthcare seeks EMA and FDA approval to expand Dovato (dolutegravir/lamivudine) to younger children, supported by the Phase I/II D3/Penta‑21 study in paediatric HIV.
Written By: Fariha Sameen, PharmD
Reviewed By: Pharmacally Editorial Team
ViiV Healthcare is working to address a major gap in paediatric HIV care by seeking regulatory approval from the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) to expand the use of Dovato (dolutegravir/lamivudine) for younger children. The European Medicines Agency has validated the company’s marketing application for this paediatric extension, while a New Drug Application has also been submitted to the FDA. The applications are supported by the Phase I/II D3/Penta‑21 study (NCT04337450; ISRCTN17157458; EudraCT 2020‑001426‑57), an open‑label, randomized non‑inferiority trial in virologically suppressed children with HIV aged 2 to <15 years, evaluating once‑daily DTG/3TC fixed‑dose formulations against standard three‑drug regimens.
By filing these applications, the company aims to provide younger patients with simplified, age‑appropriate HIV treatment options comparable to those available for adults. Despite major advances in HIV treatment, it remains a pressing challenge that approximately 1.4 million children are living with HIV globally, with an estimated 620,000 still not receiving life‑saving antiretroviral therapy.
The submissions include a new dispersible tablet formulation for children aged ≥3 months and weighing ≥6 kg to <25 kg, using WHO‑based weight‑band dosing, along with an extension of the film‑coated tablet indication for paediatric patients weighing at least 20 kg. If approved, the two‑drug regimen could help reduce lifelong cumulative antiretroviral drug exposure for children who may require decades of continuous HIV treatment.
Dovato combines the integrase inhibitor dolutegravir with the nucleoside reverse transcriptase inhibitor lamivudine, offering a simplified, once‑daily, single‑tablet treatment approach designed to maintain effective viral suppression with fewer antiretroviral agents.
Dr. Jean van Wyk, Chief Medical Officer at ViiV Healthcare, emphasised that supporting children living with HIV has remained a core priority for the company. Guided by the Rome Action Plan, ViiV Healthcare continues to focus on developing innovative, age‑appropriate treatment options for even the youngest patients. According to Dr. van Wyk, the latest EMA and FDA applications represent an important step towards supporting lifelong HIV care and ensuring no child is left behind.
The applications are backed by findings from the D3/Penta‑21 study, conducted in collaboration with the PENTA Foundation. The research leveraged adult clinical data to support use in paediatric populations and highlighted the potential of simplified two‑drug regimens such as DTG/3TC to effectively treat children while potentially reducing lifelong antiretroviral exposure.
Currently, Dovato is approved in Europe as a once‑daily, single‑tablet regimen for adolescents and adults aged 12 years and older weighing at least 40 kg, and in the United States for adults and adolescents aged 12 years and older weighing at least 25 kg, provided there is no known resistance to dolutegravir or lamivudine and, in previously treated patients, they are virologically suppressed on a stable regimen with no history of treatment failure. ”
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About the Writer
Fariha Sameen, PharmD (LinkedIn), is a clinical pharmacy professional with hands-on experience in patient counselling, medication review, therapeutic monitoring, and clinical documentation across multiple departments. She has experience identifying and assessing drug-related problems and supporting medication safety practices. Her interests include pharmacovigilance, ADR reporting, clinical research, and medical writing focused on clear, evidence-based communication.