FDA Approves Tivicay PD for HIV Treatment in Children Weighing at Least 2 kg
The U.S. Food and Drug Administration (FDA) has approved Tivicay PD (dolutegravir) for use in combination with other antiretroviral medicines to treat HIV-1 infection in pediatric patients weighing at least 2 kilograms (kg). The approval expands access to a modern HIV treatment option for very young children, including eligible newborns.
ViiV Healthcare, a global specialist HIV company majority owned by GSK, announced the FDA decision on August 26, 2026. The new indication applies to children who are either treatment-naïve or treatment-experienced but have not previously received an integrase strand transfer inhibitor (INSTI).
A New HIV Treatment Option for Newborns
The FDA decision is significant because Tivicay PD is now the first second-generation integrase inhibitor approved in the United States for children living with HIV who weigh at least 2 kg.
This includes certain term newborns who meet the treatment criteria.
Dolutegravir is an INSTI that works by blocking HIV integrase, an enzyme the virus needs to insert its genetic material into human cells. By preventing this process, dolutegravir helps limit HIV replication when used as part of an appropriate combination antiretroviral therapy regimen.
The availability of a pediatric formulation is particularly important for infants because medicines and doses need to be adapted to a child's age, weight and ability to take medication.
According to Diana F. Clarke, Pharm.D., Assistant Professor of Paediatrics at Boston University School of Medicine and lead investigator of the IMPAACT 2023 study, the approval provides an important new option for babies born at term who weigh at least 2 kg. Early access to effective HIV treatment can be particularly important because HIV can progress rapidly in untreated infants.
Why Early HIV Treatment Matters
HIV treatment has advanced considerably over the past several decades. However, infants and young children can still face significant challenges when it comes to timely diagnosis and access to age-appropriate medicines.
Without early diagnosis and treatment, HIV infection can progress quickly in infants. UNICEF and UNAIDS have reported that approximately half of infants with untreated HIV may die by the age of two.
This highlights the importance of identifying HIV infection as early as possible and connecting affected children with appropriate medical care.
For newborns exposed to HIV during pregnancy or childbirth, healthcare providers can use established testing and prevention protocols to determine whether infection has occurred. When HIV infection is confirmed, treatment decisions are based on factors including age, weight, previous antiretroviral exposure and other clinical considerations.
The availability of a formulation specifically designed for young children may help healthcare professionals manage treatment during the earliest stages of life.
Evidence Behind the FDA Approval
The FDA approval was supported by findings from the NIH-funded IMPAACT 2023 study, together with pharmacokinetic modelling that incorporated additional pediatric data.
Pharmacokinetics, commonly abbreviated as PK, refers to how a medicine is absorbed, distributed, metabolized and eliminated by the body. PK data are particularly important when developing treatments for newborns and young children because drug exposure can change substantially as children grow and their organ systems mature.
According to ViiV Healthcare, the available data showed that dolutegravir achieved therapeutic drug concentrations in term neonates. The safety profile observed in the study was also consistent with the established safety profile of dolutegravir in older pediatric patients and adults.
Dolutegravir is a second-generation INSTI and has a higher barrier to resistance than earlier generations of integrase inhibitors. Resistance is an important consideration in HIV treatment because changes in the virus can reduce the effectiveness of certain medicines.
What Is Tivicay PD?
Tivicay PD contains dolutegravir and is designed as tablets for oral suspension. It is used alongside other antiretroviral medicines as part of combination treatment for HIV-1 infection.
The FDA-approved indication covers pediatric patients weighing at least 2 kg who are treatment-naïve or treatment-experienced but INSTI-naïve.
Tivicay and Tivicay PD are also approved for certain adult patients. However, the products have different formulations and are not interchangeable.
Parents and caregivers should therefore follow the specific instructions provided by the child's healthcare professional and the product's prescribing information.
Important Safety Information
Like all medicines, dolutegravir can cause side effects and may not be appropriate for every patient.
Tivicay and Tivicay PD should not be used by people who have previously experienced a hypersensitivity reaction to dolutegravir. They are also contraindicated with dofetilide because of the potential for a clinically important drug interaction.
Serious hypersensitivity reactions have been reported. These reactions may involve skin rash, general symptoms and, in some cases, organ problems including liver injury. Patients who develop symptoms suggestive of a hypersensitivity reaction should receive immediate medical assessment.
Liver toxicity has also been reported with dolutegravir-containing treatment. People with underlying hepatitis B or hepatitis C may require particular attention because they can have an increased risk of liver-related complications.
Dolutegravir can also interact with several other medicines and supplements. Certain metabolic inducers can reduce dolutegravir concentrations. Products containing calcium or iron, as well as some antacids, laxatives and other medications, may also affect how dolutegravir is taken.
Healthcare professionals should review a patient's complete medication list before treatment begins.
Pregnancy and Breastfeeding Considerations
The prescribing information also contains important considerations concerning pregnancy.
An alternative treatment should be considered at the time of conception through the first trimester because of concerns regarding possible neural tube defects. Adolescents and adults who could become pregnant should discuss pregnancy testing and effective contraception with their healthcare provider.
Breastfeeding is not recommended because of the potential risk of HIV-1 transmission.
These considerations are particularly relevant when treating adolescents and adults of reproductive potential rather than newborn patients.
IMPAACT's Role in Pediatric HIV Research
The IMPAACT Network, which supported the clinical research behind the expanded indication, is an international collaboration focused on improving health outcomes among infants, children, adolescents and pregnant and postpartum populations affected by HIV, tuberculosis and related conditions.
The network brings together researchers, healthcare institutions, community representatives and other partners to conduct clinical trials and evaluate new approaches to treatment and prevention.
The IMPAACT 2023 study contributed evidence supporting the use of dolutegravir in very young patients, helping address an important gap in pediatric HIV treatment research.
What the Approval Could Mean for Pediatric HIV Care
The expanded FDA indication represents another step toward providing HIV treatments that are suitable for children from the earliest stages of life.
For healthcare professionals, the availability of an approved dolutegravir formulation for children weighing at least 2 kg may provide another option when developing individualized treatment plans.
For families affected by pediatric HIV, access to age-appropriate treatment can be an important part of managing the condition and supporting long-term health.
However, treatment decisions should always be individualized. HIV therapy involves selecting appropriate medicines based on factors such as viral resistance, previous treatment, age, weight, other medical conditions and potential drug interactions.
The FDA approval does not mean that Tivicay PD is appropriate for every child with HIV. A qualified healthcare professional should determine the most suitable treatment.
Conclusion
The FDA's approval of Tivicay PD for pediatric patients weighing at least 2 kg expands the available treatment options for children living with HIV-1, including eligible newborns.
Supported by data from the IMPAACT 2023 study and pharmacokinetic modelling, the decision adds a second-generation integrase inhibitor option for a population that has historically faced limited age-appropriate treatment choices.
As pediatric HIV care continues to evolve, expanding access to effective medicines for infants and children remains an important public health priority. The new indication for Tivicay PD represents progress toward closing treatment gaps and ensuring that children living with HIV can access appropriate therapy as early as possible.
Sources
- ViiV Healthcare. FDA approval announcement for Tivicay PD, August 26, 2026.
- UNICEF and UNAIDS. The Cost of Inaction: Children and Adolescents Living with HIV in Eastern and Southern Africa.
- U.S. Food and Drug Administration. Tivicay and Tivicay PD prescribing information.
- National Institutes of Health, IMPAACT Network. Pediatric HIV clinical research information
Medical Disclaimer
This article is intended for general educational and informational purposes only. It does not constitute medical advice, diagnosis or treatment recommendations. FDA approvals, prescribing information and safety guidance can change over time. Patients, parents and caregivers should consult a qualified healthcare professional before starting, stopping or changing HIV treatment. Always refer to the current official prescribing information for Tivicay and Tivicay PD for complete indications, contraindications, warnings, precautions, drug interactions and dosing information.