Tivicay

Generic name: dolutegravir

Trade name: Tivicay

All names: dolutegravir sodium tablets, Tivicay, DTG, Tivicay, dolutegravir

Indications:

Tivicay is used in combination with other antiretroviral drugs to treat adults and children over 12 years old infected with human immunodeficiency virus (HIV).

Usage and Dosage:

Adults:

Patients infected with HIV-1 who have not been diagnosed or clinically suspected of being resistant to integrase inhibitors

The recommended dose of Tevicay is 50 mg, taken orally, once daily.

Patients infected with HIV-1 who are diagnosed or clinically suspected to be resistant to integrase inhibitors

The recommended dose of Tyvica is 50 mg, taken orally, twice daily.

Adolescents 12 years of age and older:

In adolescent HIV-1 patients (12 to 17 years old, weighing not less than 40 kg) who are not resistant to integrase drugs, the recommended dose of Tevicay is 50 mg, taken orally, once daily.

Adverse reactions:

Headache, stomachache, belching, facial flushing, difficulty falling asleep or waking up, fatigue, muscle or joint pain, etc.

Contraindications:

Co-administration with dofetilide is contraindicated.

It is contraindicated in persons with known allergy to dolutegravir or to any component of Trivacay.

The combined use of dolutegravir and pixicanide is prohibited.

Precautions:

Rush, constitutive findings, and sometimes organ dysfunction, including liver damage, have been reported as features of hypersensitivity reactions. If signs or symptoms of a hypersensitivity reaction occur, immediately discontinue TIVICAY and other suspected drugs, as delayed discontinuation of treatment may result in a life-threatening reaction. Patients who have previously suffered a hypersensitivity reaction to TIVICAY should not use TIVICAY.

Patients with hepatitis B or C who use TIVICAY may be at increased risk for worsening or elevation of transaminases. Appropriate laboratory testing is recommended before initiating treatment and monitoring for hepatotoxicity during treatment with TIVICAY is recommended in patients with liver disease such as hepatitis B or C.

Body fat redistribution/accumulation and immune reconstitution syndrome have been reported in patients treated with combination antiretroviral therapy.

Storage:

Seal and store below 30℃.

Mechanism of action:

Dolutegravir sodium tablets are HIV integrase inhibitors that can prevent the HIV virus from entering cells. It can be used in combination with other antiretroviral drugs to treat adults and children over 12 years old infected with human immunodeficiency virus (HIV).

Safety and efficacy:

ING111762 (SAILING) is a 48-week phase 3 randomized double-blind controlled non-inferiority study (NCT01231516), which started in October 2010. The analysis in this study included 715 patients, including 354 in the dolutegravir group and 361 in the raltegravir group. Study results show that dolutegravir is more effective than raltegravir. At the same time, the researchers also found that fewer patients in the dolutegravir group suffered virological failure due to treatment-related immediate resistance to integrase inhibitors.