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FDA approved Tivicay (dolutegravir) for HIV-1 Infection in Adults and Pediatric PatientsFDA approved new HIV drug Tivicay for adults and children

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Key Takeaway
Consider dolutegravir for HIV-1 treatment in adults and children, but adjust dose for inducers or INSTI resistance.

The FDA has approved Tivicay (dolutegravir), an integrase strand transfer inhibitor (INSTI), for the treatment of HIV-1 infection. The drug is indicated in combination with other antiretroviral agents for adults (treatment-naïve or -experienced) and pediatric patients (treatment-naïve or -experienced but INSTI-naïve) aged at least 4 weeks and weighing at least 3 kg. Additionally, Tivicay is approved in combination with rilpivirine as a complete regimen for virologically suppressed adults (HIV-1 RNA <50 copies/mL) on a stable regimen for at least 6 months with no history of treatment failure or resistance-associated substitutions.

This approval provides a new option for both adult and pediatric populations, including those who have experienced prior antiretroviral therapy. The label specifies dosing adjustments for patients with certain resistance patterns or when coadministered with metabolic inducers. Clinicians should note that Tivicay tablets and Tivicay PD tablets for oral suspension are not bioequivalent and cannot be substituted on a milligram-per-milligram basis.

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 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 INSTI-naïve) aged at least 4 weeks and weighing at least 3 kg. TIVICAY is also 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 <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.

Dosing & Administration

May be taken without regard to food. For adults: Treatment-naïve or treatment-experienced INSTI-naïve or virologically suppressed adults switching to dolutegravir plus rilpivirine: 50 mg once daily. When coadministered with certain UGT1A or CYP3A inducers: 50 mg twice daily. INSTI-experienced with certain INSTI-associated resistance substitutions or clinically suspected INSTI resistance: 50 mg twice daily. For pediatric patients weighing 3 to less than 6 kg: 5 mg once daily (TIVICAY PD); 6 to <10 kg: 15 mg once daily; 10 to <14 kg: 20 mg once daily; 14 to <20 kg: 25 mg once daily; 20 kg and greater: 30 mg once daily. Alternative dosing with TIVICAY tablets for patients weighing at least 14 kg: 14 to <20 kg: 40 mg once daily; 20 kg and greater: 50 mg once daily. TIVICAY and TIVICAY PD are not bioequivalent and are not substitutable on a milligram-per-milligram basis.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Not reported in label.

Place in Therapy

Dolutegravir provides an INSTI option for treatment-naïve and -experienced patients, including those with INSTI resistance (at higher dose). It is also useful as a switch regimen with rilpivirine for virologically suppressed adults. The availability of a pediatric formulation (TIVICAY PD) extends treatment options to children as young as 4 weeks and weighing at least 3 kg. Dosing adjustments are required with certain inducers and in INSTI-experienced patients.

The U.S. Food and Drug Administration has approved a new drug called Tivicay (dolutegravir) for the treatment of HIV-1 infection. Tivicay is an integrase strand transfer inhibitor, which works by blocking an enzyme the virus needs to multiply. It is meant to be taken in combination with other antiretroviral drugs, not alone.

Tivicay is approved for adults who are new to treatment or who have been treated before. It is also approved for children at least 4 weeks old and weighing at least 3 kilograms (about 6.6 pounds), provided they have not taken an INSTI before. Additionally, Tivicay can be used with another drug called rilpivirine as a complete regimen for certain adults whose virus is already suppressed (below 50 copies/mL) and who have been on a stable treatment for at least 6 months without a history of treatment failure or resistance.

This approval gives doctors and patients another option for managing HIV. It is especially important because it includes pediatric patients, offering a treatment for younger children. However, the drug is not a cure, and it must be taken exactly as prescribed. Also, note that Tivicay tablets and Tivicay PD tablets for oral suspension are not interchangeable, so dosing must be carefully managed.

If you or a loved one are considering Tivicay, talk to your doctor. They can help determine if this drug is right for you, based on your medical history, current medications, and any resistance patterns. Always follow your healthcare provider's guidance.

What this means for you:
Tivicay is a new HIV treatment option, but it is not a cure. Talk to your doctor to see if it's right for you.

Study Details

Study typeFda approval
PublishedAug 2013
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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