complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg： with no prior antiretroviral treatment history, OR to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of DELSTRIGO

Antiretrovials Antivirals

(Absorption) Tmax (h)：Doravirine (DOR)：2HR。Lamivudine (3TC)：1HR。Tenofovir DF (TDF)：1HR。 Absolute Bioavailability：Doravirine：約 64%。Lamivudine：約 86% 。Tenofovir DF：25%。 (Distribution) Vdss ：Doravirine：605L。Lamivudine：1.3 L/kg。Tenofovir DF：1.3 L/kg。 Plasma Protein Binding：Doravirine：約 76%。Lamivudine：< 36%。Tenofovir DF：< 0.7% (Metabolism) (Elimination) t1/2 (h)：Doravirine：約 15 hr。Lamivudine： 5-7 hr。Tenofovir DF：17hr。 CLrenal (mL/min)：Doravirine：Minor。Lamivudine：190–252 mL/min。Tenofovir DF：約 243 mL/min。

DELSTRIGO is contraindicated when co-administered with drugs that are strong cytochrome P450 (CYP)3A enzyme inducers as significant decreases in doravirine plasma concentrations may occur, which may decrease the effectiveness of DELSTRIGO.These drugs include, but are not limited to, the following: -the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, phenytoin -the androgen receptor inhibitor enzalutamide -the antimycobacterials rifampin, rifapentine -the cytotoxic agent mitotane -St. John's wort (Hypericum perforatum) DELSTRIGO is contraindicated in patients with a previous hypersensitivity reaction to lamivudine.

There is insufficient prospective pregnancy data from the APR to adequately assess the risk of birth defects and miscarriage.

Based on limited published data, both lamivudine and tenofovir are present in human milk. It is unknown whether doravirine is present in human milk, but doravirine is present in the milk of lactating rats (see Data). It is not known whether DELSTRIGO or the components of DELSTRIGO affects human milk production, or has effects on the breastfed infant. Potential risks of breastfeeding include: (1) HIV-1 transmission (in HIV-1-negative infants), (2) developing viral resistance (in HIV-1-positive infants), and (3) serious adverse reactions in a breastfed infant similar to those seen in adults.

Dizziness，Nausea，Abnormal Dreams，Headache，Insomnia，Diarrhea，Somnolence，Rash； Severe Skin Reactions[Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN)]； Severe Acute Exacerbation of Hepatitis B in People with Concomitant HIV-1 and HBV； New Onset or Worsening Renal Impairment； Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions； Bone Loss and Mineralization Defects； Immune Reconstitution Syndrome

Testing When Initiating and During Treatment with DELSTRIGO Prior to or when initiating DELSTRIGO, test patients for HBV infection. Prior to or when initiating DELSTRIGO, and during treatment with DELSTRIGO, on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, also assess serum phosphorus The recommended dosage of DELSTRIGO in adults and pediatric patients weighing at least 35 kg is one tablet taken orally once daily with or without food. If DELSTRIGO is co-administered with rifabutin, take one tablet of DELSTRIGO once daily, followed by one tablet of doravirine 100 mg (PIFELTRO) approximately 12 hours after the dose of DELSTRIGO for the duration of rifabutin co-administration.

Safety and efficacy of DELSTRIGO in pediatric patients weighing less than 35 kg have not been established.

Because DELSTRIGO is a fixed-dose combination tablet and the dosage of lamivudine and TDF cannot be adjusted, DELSTRIGO is not recommended in patients with estimated creatinine clearance less than 50 mL/min.

No dosage adjustment of DELSTRIGO is required in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment. DELSTRIGO has not been studied in patients with severe hepatic impairment (Child-Pugh Class C)

Store DELSTRIGO in the original bottle. Keep the bottle tightly closed to protect from moisture. Do not remove the desiccants. Store DELSTRIGO at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F)