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FDA approved Tivicay PD (dolutegravir) for Pediatric HIV-1 InfectionFDA approved new HIV drug for children as young as 4 weeks

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Key Takeaway
Consider Tivicay PD for pediatric HIV-1 patients aged ≥4 weeks and ≥3 kg, but adjust dose with UGT1A/CYP3A inducers.

The FDA has approved Tivicay PD (dolutegravir) tablets for oral suspension for the treatment of HIV-1 infection in pediatric patients aged at least 4 weeks and weighing at least 3 kg. This new formulation is intended for children who are treatment-naïve or treatment-experienced but have not previously received an integrase strand transfer inhibitor (INSTI). The approval expands treatment options for a vulnerable population, offering a weight-based dosing regimen that can be administered without regard to food.

Tivicay PD is not bioequivalent to Tivicay tablets and cannot be substituted on a milligram-per-milligram basis. The recommended dose varies by body weight, ranging from 5 mg once daily for infants weighing 3 to less than 6 kg, up to 30 mg once daily for children weighing 20 kg or more. For children weighing at least 14 kg, alternative dosing with Tivicay tablets is also available.

The approval is based on pharmacokinetic and safety data from pediatric studies, though specific efficacy trial data were not included in the label. Clinicians should note that dosing adjustments are required when Tivicay PD is coadministered with certain UGT1A or CYP3A inducers, and that the drug is not recommended for INSTI-experienced patients with certain resistance substitutions.

Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Mechanism of Action

Dolutegravir is an HIV-1 integrase strand transfer inhibitor (INSTI). It inhibits the strand transfer step of HIV-1 integration, which is essential for viral replication.

Indication & Patient Population

Tivicay PD is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients aged at least 4 weeks and weighing at least 3 kg, who are treatment-naïve or treatment-experienced but INSTI-naïve. It is not indicated for INSTI-experienced patients.

Dosing & Administration

Tivicay PD tablets for oral suspension may be taken without regard to food. The recommended weight-based dose for pediatric patients weighing 3 to less than 6 kg is 5 mg once daily; 6 to less than 10 kg: 15 mg once daily; 10 to less than 14 kg: 20 mg once daily; 14 to less than 20 kg: 25 mg once daily; 20 kg and greater: 30 mg once daily. If coadministered with certain UGT1A or CYP3A inducers, the dose should be given twice daily. Tivicay PD is not bioequivalent to Tivicay tablets and should not be substituted on a milligram-per-milligram basis. For patients weighing at least 14 kg, alternative dosing with Tivicay tablets is available (14 to less than 20 kg: 40 mg once daily; 20 kg and greater: 50 mg once daily).

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

No specific warnings or contraindications were provided in the label text. However, dosing adjustments are required with certain UGT1A or CYP3A inducers. Tivicay PD is not recommended for INSTI-experienced patients with certain INSTI-associated resistance substitutions.

Place in Therapy

Tivicay PD provides a pediatric-friendly formulation of dolutegravir for young children with HIV-1 infection. It is an option for treatment-naïve or INSTI-naïve patients, allowing for weight-based dosing. Clinicians should consider this formulation when treating children who cannot take tablets, and should be aware of the need for dose adjustment with concomitant inducers.

The U.S. Food and Drug Administration has approved a new medicine called Tivicay PD (dolutegravir) for children with HIV. This drug comes as a powder that can be mixed with liquid, making it easier for young kids to take. It is approved for children who are at least 4 weeks old and weigh at least 3 kilograms (about 6.6 pounds). Tivicay PD is for children who have not taken HIV medicines before, or who have taken them but have not used a type of drug called an integrase strand transfer inhibitor (INSTI).

This approval gives doctors a new tool to treat HIV in a group that can be hard to treat. The dose is based on the child's weight, and it can be given with or without food. However, Tivicay PD is not the same as the regular Tivicay tablet, so they cannot be swapped milligram for milligram. For children who weigh at least 14 kg, the tablet form may also be an option.

The approval is based on studies that looked at how the drug works in the body and its safety in children. It is important to know that this drug is not recommended for children who have already taken an INSTI and have certain drug resistance. Also, if a child takes other medicines that affect certain liver enzymes, the dose may need to be adjusted.

If you are a parent or caregiver, talk to your child's doctor about whether Tivicay PD is right for them. This approval does not mean a cure for HIV, but it offers a new way to manage the infection in young children.

What this means for you:
Tivicay PD is a new liquid HIV medicine for young children, but always ask your doctor if it's right for your child.

Study Details

Study typeFda approval
PublishedJun 2020
View Original Abstract ↓
1 INDICATIONS AND USAGE TIVICAY and TIVICAY PD are indicated in combination with other antiretroviral agents for the treatment of HIV‑1 infection in adults (treatment-naïve or -experienced) and in pediatric patients (treatment-naïve or -experienced but integrase strand transfer inhibitor [INSTI]-naïve) aged at least 4 weeks and weighing at least 3 kg [see Microbiology ( 12.4 )]. TIVICAY is indicated in combination with rilpivirine as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/ mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure or known substitutions associated with resistance to either antiretroviral agent. TIVICAY and TIVICAY PD are an HIV-1 integrase strand transfer inhibitor (INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults (treatment-naïve or -experienced) and in pediatric patients (treatment-naïve or -experienced but INSTI- naïve) aged at least 4 weeks and weighing at least 3 kg. ( 1 ) TIVICAY is indicated in combination with rilpivirine as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure or known substitutions associated with resistance to either antiretroviral agent. ( 1 )
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