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Dolutegravir, abacavir, and lamivudine: Drug information

Dolutegravir, abacavir, and lamivudine: Drug information
(For additional information see "Dolutegravir, abacavir, and lamivudine: Patient drug information" and see "Dolutegravir, abacavir, and lamivudine: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
ALERT: US Boxed Warning
Hypersensitivity reactions:

Serious and sometimes fatal hypersensitivity reactions, with multiple organ involvement, have occurred with abacavir. Patients who carry the HLA-B*5701 allele are at a higher risk of a hypersensitivity reaction to abacavir; although, hypersensitivity reactions have occurred in patients who do not carry the HLA-B*5701 allele.

Abacavir/dolutegravir/lamivudine is contraindicated in patients with a prior hypersensitivity reaction to abacavir and in HLA-B*5701-positive patients. All patients should be screened for the HLA-B*5701 allele prior to initiating therapy with abacavir/dolutegravir/lamivudine or reinitiation of therapy with abacavir/dolutegravir/lamivudine unless patients have a previously documented HLA-B*5701 allele assessment. Discontinue abacavir/dolutegravir/lamivudine immediately if a hypersensitivity reaction is suspected, regardless of status and even when other diagnoses are possible.

Following a hypersensitivity reaction to abacavir/dolutegravir/lamivudine, never restart abacavir/dolutegravir/lamivudine or any other abacavir-containing product because more severe symptoms, including death, can occur within hours. Similar severe reactions have also occurred rarely following reintroduction of abacavir-containing products in patients who have no history of abacavir hypersensitivity.

Exacerbations of hepatitis B:

All patients with HIV-1 should be tested for the presence of hepatitis B virus (HBV) prior to or when initiating abacavir/dolutegravir/lamivudine. Emergence of lamivudine-resistant HBV variants associated with lamivudine-containing antiretroviral regimens has been reported. If abacavir/dolutegravir/lamivudine is used in patients coinfected with HIV-1 and HBV, additional treatment should be considered for appropriate treatment of chronic HBV; otherwise, consider an alternative regimen.

Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued lamivudine, a component of abacavir/dolutegravir/lamivudine. Closely monitor hepatic function in these patients and, if appropriate, initiate anti-HBV treatment.

Brand Names: US
  • Triumeq;
  • Triumeq PD
Brand Names: Canada
  • Triumeq
Pharmacologic Category
  • Antiretroviral, Integrase Inhibitor (Anti-HIV);
  • Antiretroviral, Reverse Transcriptase Inhibitor, Nucleoside (Anti-HIV)
Dosing: Adult
HIV-1 infection, treatment

HIV-1 infection, treatment: Oral: One tablet (abacavir 600 mg/dolutegravir 50 mg/lamivudine 300 mg) once daily. Note: Do not use in the setting of hepatitis B virus (HBV) coinfection or unknown HBV status (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

CrCl ≥30 mL/minute: No dosage adjustment necessary. Patients with CrCl consistently between 30 and <50 mL/minute should be monitored for lamivudine-associated hematologic toxicities. If new or worsening neutropenia or anemia develop, requiring dose adjustment of lamivudine, then use dose-adjusted individual components of abacavir, dolutegravir, and lamivudine.

CrCl <30 mL/minute: Use is not recommended (use dose-adjusted individual component drugs).

Dosing: Hepatic Impairment: Adult

Mild impairment (Child-Pugh class A): Use is not recommended (use dose-adjusted individual component drugs).

Moderate to severe impairment (Child-Pugh class B or C): Use is contraindicated.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Dolutegravir, abacavir, and lamivudine: Pediatric drug information")

Note: Tablets (Triumeq) and tablets for oral suspension (Triumeq PD) are not interchangeable on a mg-per-mg basis due to different pharmacokinetic profiles of the dolutegravir component. Triumeq PD (tablets for oral suspension) should not be used in patients ≥25 kg; suboptimal dosing may occur.

HIV-1 infection, treatment

HIV-1 infection, treatment: Note: Evaluate gene mutation and antiretroviral resistance patterns (refer to https://www.iasusa.org and https://hivdb.stanford.edu for more information).

Infants ≥3 months and Children, weighing 6 to <25 kg: Triumeq PD tablets for oral suspension (abacavir 60 mg/dolutegravir 5 mg/lamivudine 30 mg per tablet):

6 to <10 kg: Oral: 3 tablets once daily.

10 to <14 kg: Oral: 4 tablets once daily.

14 to <20 kg: Oral: 5 tablets once daily.

20 to <25 kg: Oral: 6 tablets once daily.

Children and Adolescents weighing ≥25 kg: Triumeq tablets (abacavir 600 mg/dolutegravir 50 mg/lamivudine 300 mg per tablet): Oral: One tablet once daily.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

Infants ≥3 months, Children, and Adolescents, weighing ≥6 kg:

CrCl ≥30 mL/minute: No dosage adjustment necessary. Patients with CrCl consistently between 30 and <50 mL/minute should be monitored for lamivudine-associated hematologic toxicities. If new or worsening neutropenia or anemia develops, requiring dose adjustment of lamivudine, then use individual components of abacavir, dolutegravir, and lamivudine with dose adjustments as appropriate.

CrCl <30 mL/minute: Use is not recommended.

Dosing: Hepatic Impairment: Pediatric

Infants ≥3 months, Children, and Adolescents, weighing ≥6 kg:

Mild impairment: Use of fixed-dose combination is not recommended; see individual agents.

Moderate to severe impairment: Use is contraindicated; safety, efficacy, and pharmacokinetic properties have not been established.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reaction incidences reported in adults. Also see individual agents.

>10%: Gastrointestinal: Increased serum lipase (grade 2: 11%; grades 3/4: 5%)

1% to 10%:

Dermatologic: Pruritus (<2%)

Endocrine & metabolic: Hyperglycemia (grade 2: 9%; grade 3: 2%), hypertriglyceridemia (<2%)

Gastrointestinal: Abdominal distention (<2%), abdominal distress (<2%), abdominal pain (<2%), anorexia (<2%), dyspepsia (<2%), flatulence (<2%), gastroesophageal reflux disease (<2%), upper abdominal pain (<2%), vomiting (<2%)

Hematologic & oncologic: Decreased neutrophils (grade 2: 4%; grades 3/4: 3%)

Hepatic: Hepatitis (<2%), increased serum alanine aminotransferase (grade 2: 3%; grades 3/4: 1%), increased serum aspartate aminotransferase (grade 2: 3%; grades 3/4: 1%)

Nervous system: Depression (1%), drowsiness (<2%), fatigue (2%), headache (2%), insomnia (3%), lethargy (<2%), nightmares (<2%), sleep disorder (<2%), suicidal ideation (<2%), suicidal tendencies (<2%)

Neuromuscular & skeletal: Arthralgia (<2%), increased creatine phosphokinase in blood specimen (grade 2: 5%; grades 3/4: 7%), myositis (<2%)

Renal: Renal insufficiency (<2%)

Miscellaneous: Fever (<2%)

<1%:

Dermatologic: Skin rash

Gastrointestinal: Diarrhea, nausea

Nervous system: Abnormal dreams, dizziness

Frequency not defined:

Hepatic: Exacerbation of hepatitis B

Hypersensitivity: Hypersensitivity reaction (including severe hypersensitivity reaction)

Postmarketing: Immunologic: Immune reconstitution syndrome

Contraindications

Hypersensitivity to abacavir, dolutegravir, lamivudine, or any component of the formulation; patients with HLA-B*5701 allele; concomitant dofetilide; moderate or severe hepatic impairment.

Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Canadian labeling: Additional contraindications (not in US labeling): Concurrent use with organic cation transporter 2 substrates with narrow therapeutic windows (eg, fampridine).

Warnings/Precautions

Concerns related to adverse effects:

• Hepatotoxicity: Hepatic adverse events, including elevated transaminases, hepatitis, and acute liver failure (sometimes requiring liver transplant), have been reported with regimens containing dolutegravir. Risk may be increased in patients with significant transaminase elevations or hepatitis B or C prior to treatment; however, hepatotoxicity has been reported in patients with no preexisting hepatic disease or other risk factors. In some patients receiving dolutegravir-containing regimens, elevations in transaminases may be concurrent with development of immune reconstitution syndrome or hepatitis B reactivation (especially if antihepatitis therapy has been discontinued).

• Hypersensitivity reactions: Hypersensitivity reactions have been reported with use of abacavir or dolutegravir. Serious, sometimes fatal, hypersensitivity reactions, including multiorgan failure and anaphylaxis, have occurred with abacavir. Reactions usually occur within 6 weeks of starting abacavir (median time to onset: 9 days), although these reactions may occur at any time during therapy. Patients who carry the HLA-B*5701 allele are at higher risk for abacavir hypersensitivity reactions, although patients without the allele have also developed hypersensitivity reactions. Hypersensitivity reactions reported with dolutegravir include rash, constitutional findings (eg, fatigue, fever, malaise, muscle/joint aches), and organ dysfunction (eg, liver injury). Monitor clinical status, including LFTs, and initiate supportive therapy as appropriate. If hypersensitivity occurs or is suspected, immediately discontinue therapy and do not reinitiate. Because it is not possible to clinically determine whether a hypersensitivity reaction is caused by abacavir or dolutegravir, do not restart therapy or any other abacavir- or dolutegravir-containing product in patients who have stopped therapy due to a hypersensitivity reaction; life-threatening hypotension and death have occurred within hours of restarting abacavir. If a hypersensitivity reaction is ruled out, may restart therapy. Rarely, patients who have stopped abacavir for reasons other than hypersensitivity have also reported life-threatening reactions within hours of reinitiating. Reintroduction of therapy or any other abacavir-containing product is only recommended if medical care is readily accessible.

• Immune reconstitution syndrome: Patients may develop immune reconstitution syndrome resulting in the occurrence of an inflammatory response to an indolent or residual opportunistic infection during initial HIV treatment or activation of autoimmune disorders (eg, Graves disease, polymyositis, Guillain-Barré syndrome) later in therapy; further evaluation and treatment may be required.

• Lactic acidosis/hepatomegaly: Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with nucleoside analogues, including abacavir and lamivudine. Female gender and obesity may increase the risk for development. Suspend treatment in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or hepatotoxicity (transaminase elevation may/may not accompany hepatomegaly and steatosis).

• Pancreatitis: Pancreatitis has been observed with lamivudine and abacavir. Discontinue use if pancreatitis is suspected and resume only after pancreatitis has been ruled out.

Disease-related concerns:

• Coronary heart disease: Use has been associated with an increased risk of MI in some cohort studies (Elion 2018; HHS [adult] 2019). Consider using with caution in patients with risks for coronary heart disease and minimizing modifiable risk factors (eg, hypertension, hyperlipidemia, diabetes mellitus, smoking) prior to use.

• Emergence of lamivudine-resistant hepatitis B: HIV/HBV coinfected patients receiving lamivudine-containing antiretroviral regimens have developed lamivudine resistant HBV variants.

• Hepatic impairment: Abacavir/dolutegravir/lamivudine, as a fixed-dose combination tablet, should not be used in patients with mild hepatic impairment; use is contraindicated in moderate to severe hepatic impairment.

• Renal impairment: Abacavir/dolutegravir/lamivudine, as a fixed-dose combination tablet, should not be used in patients with CrCl <30 mL/minute.

Dosage form specific warnings:

• Interchangeability: Tablets and tablets for oral suspension are not interchangeable on a milligram-per-milligram basis; differing pharmacokinetic profiles for the dolutegravir component exist.

• Tablets for oral suspension: Tablets for oral suspension are only recommended for use in pediatric patients weighing 6 to <25 kg; suboptimal dosing may occur if used in patients ≥25 kg.

Other warnings/precautions:

• Changes in serum creatinine: Dolutegravir may increase serum creatinine due to inhibition of tubular secretion of creatinine without affecting renal glomerular function or effective renal plasma flow (Gutierrez 2014). Increased serum creatinine occurred within the first 4 weeks of treatment with dolutegravir and remained stable through 144 weeks of treatment.

Warnings: Additional Pediatric Considerations

The major clinical toxicity of lamivudine in pediatric patients is pancreatitis, which was reported in 14% of patients in one open-label, dose-escalation trial; discontinue lamivudine therapy if clinical signs, symptoms, or laboratory abnormalities suggestive of pancreatitis occur. Use with extreme caution and only if there is no satisfactory alternative therapy in pediatric patients with a history of pancreatitis or other significant risk factors for the development of pancreatitis (Epivir prescribing information).

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Triumeq: Abacavir 600 mg, dolutegravir 50 mg, and lamivudine 300 mg

Tablet Soluble, Oral:

Triumeq PD: Abacavir 60 mg, dolutegravir 5 mg, and lamivudine 30 mg

Generic Equivalent Available: US

No

Pricing: US

Tablet,Dispersible (Triumeq PD Oral)

60-5-30 mg (per each): $14.99

Tablets (Triumeq Oral)

600-50-300 mg (per each): $149.90

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Triumeq: Abacavir 600 mg, dolutegravir 50 mg, and lamivudine 300 mg

Administration: Adult

Oral:

Tablet: Administer with or without food. If patient is on concomitant therapy with efavirenz, fosamprenavir/ritonavir, tipranavir/ritonavir, carbamazepine, or rifampin an additional daily single-component dolutegravir tablet should be administered 12 hours after Triumeq. Administer 2 hours before or 6 hours after cation-containing antacids or laxatives, sucralfate, oral supplements containing iron or calcium, or buffered medications. Alternatively, may be administered with supplements containing calcium or iron at the same time if administered together with food.

Tablet for oral suspension: Do not use in adults.

Administration: Pediatric

Oral: Administer with or without food. Do not chew, cut, or crush. Administer 2 hours before or 6 hours after cation-containing antacids or laxatives, sucralfate, oral supplements containing iron or calcium, or buffered medications. Alternatively, may be administered with supplements containing calcium or iron at the same time if administered together with food.

Tablet for oral suspension (Triumeq PD): Volume used to prepare dose depends on number of tablets. If dose is 3 tablets, use 15 mL of clean drinking water; if dose is 4 to 6 tablets, use 20 mL. Pour appropriate volume of clean drinking water into the provided dosing cup. Add the appropriate number of tablets to achieve dose to the water; swirl cup gently for 1 to 2 minutes to disperse tablets; swirl until no lumps remain. Administer mixture within 30 minutes of preparation using cup or an oral dosing syringe; following administration, add another 15 mL of drinking water to the cup, swirl, and administer. If any remnants of the dose remain in the dosing cup or syringe, repeat the addition of 15 mL of drinking water and administer. If a spill occurs during preparation, or if >30 minutes pass between preparation and administration, discard and prepare a new dose. Only use water to prepare oral suspension; do not use other liquids. Clean cup with water following use.

Hazardous Drugs Handling Considerations

Hazardous agent (NIOSH 2016 [group 2]).

Abacavir is a hazardous agent. Use appropriate precautions for receiving, handling, administration, and disposal. Gloves (single) should be worn during receiving, unpacking, and placing in storage. NIOSH recommends single gloving for administration of intact tablets or capsules (NIOSH 2016).

Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and at https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205551s31,215413s02lbl.pdf#page=56, must be dispensed with this medication.

Use: Labeled Indications

HIV infection, treatment: Treatment of HIV-1 infection in adult and pediatric patients ≥3 months of age and weighing ≥6 kg.

Limitations of use: Not recommended for use in patients with resistance-associated integrase substitutions or clinically suspected integrase strand transfer inhibitor resistance because the dose of dolutegravir is insufficient in these subpopulations.

Metabolism/Transport Effects

Refer to individual components.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Aluminum Hydroxide: May decrease the serum concentration of Dolutegravir. Management: Administer dolutegravir at least 2 hours before or 6 hours after oral aluminum hydroxide. Administer the dolutegravir/rilpivirine combination product at least 4 hours before or 6 hours after oral aluminum hydroxide. Risk D: Consider therapy modification

Antidiabetic Agents: Hyperglycemia-Associated Agents may diminish the therapeutic effect of Antidiabetic Agents. Risk C: Monitor therapy

Betibeglogene Autotemcel: Antiretroviral Agents may diminish the therapeutic effect of Betibeglogene Autotemcel. Risk X: Avoid combination

Cabozantinib: MRP2 Inhibitors may increase the serum concentration of Cabozantinib. Risk C: Monitor therapy

Calcium Salts: May decrease the serum concentration of Dolutegravir. Management: Administer dolutegravir at least 2 hours before or 6 hours after oral calcium. Administer dolutegravir/rilpivirine at least 4 hours before or 6 hours after oral calcium salts. Alternatively, dolutegravir and oral calcium can be taken together with food. Risk D: Consider therapy modification

CarBAMazepine: May decrease the serum concentration of Dolutegravir. Management: Increase dolutegravir to 50 mg twice/day in adults. Increase weight-based dose to twice daily in pediatric patients. Specific recommendations vary for combination products; see interaction monograph for details. Risk D: Consider therapy modification

Cladribine: Agents that Undergo Intracellular Phosphorylation may diminish the therapeutic effect of Cladribine. Risk X: Avoid combination

Clofarabine: OCT2 Inhibitors may increase the serum concentration of Clofarabine. Risk C: Monitor therapy

Dalfampridine: OCT2 Inhibitors may increase the serum concentration of Dalfampridine. Management: Consider alternatives to this combination. Carefully weigh the risk of seizures against the benefit of combining OCT2 inhibitors with dalfampridine. Risk D: Consider therapy modification

Dofetilide: Dolutegravir may increase the serum concentration of Dofetilide. Risk X: Avoid combination

Efavirenz: May decrease the serum concentration of Dolutegravir. Management: Increase dolutegravir to 50 mg twice/day in adults. Increase weight-based dose to twice daily in pediatric patients. Recommendations vary for combo products; see interaction monograph for details. Not recommended with Dovato or Juluca brand combos. Risk D: Consider therapy modification

Elivaldogene Autotemcel: Antiretroviral Agents may diminish the therapeutic effect of Elivaldogene Autotemcel. Management: Avoid use of antiretroviral medications for at least one month, or for the amount of time required for elimination of the retroviral medication, prior to stem cell mobilization and until the all apheresis cycles are finished Risk X: Avoid combination

Erdafitinib: May increase the serum concentration of OCT2 Substrates (Clinically Relevant with Inhibitors). Management: Consider alternatives to this combination when possible. If combined, monitor for increased effects/toxicities of OCT2 substrates and consider OCT2 substrate dose reductions when appropriate. Risk D: Consider therapy modification

Etravirine: May decrease the serum concentration of Dolutegravir. Management: Avoid etravirine with dolutegravir unless with atazanavir/ritonavir, darunavir/ritonavir or lopinavir/ritonavir; avoid use with Dovato brand combination. Canada recommends using dolutegravir 50 mg twice daily when with etravirine. Risk D: Consider therapy modification

Fexinidazole: May increase the serum concentration of MATE1/2-K Substrates (Clinically Relevant with Inhibitors). Management: Avoid use of fexinidazole with MATE1/2-K substrates when possible. If combined, monitor for increased MATE1/2-K substrate toxicities. Risk D: Consider therapy modification

Fexinidazole: May increase the serum concentration of OCT2 Substrates (Clinically Relevant with Inhibitors). Management: Avoid use of fexinidazole with OCT2 substrates when possible. If combined, monitor for increased OCT2 substrate toxicities. Risk D: Consider therapy modification

Fosamprenavir: May decrease the serum concentration of Dolutegravir. Specifically, Fosamprenavir/Ritonavir may decrease the serum concentration of Dolutegravir. The individual contributions of Fosamprenavir and Ritonavir to this effect are unknown. Management: Increase dolutegravir to 50 mg twice/day in adults. Increase weight-based dose to twice daily in pediatric patients. Recommendations vary for combo products; see interaction monograph for details. Not recommended with Dovato or Juluca brand combos. Risk D: Consider therapy modification

Foslevodopa: May increase the serum concentration of MATE1/2-K Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy

Fosphenytoin-Phenytoin: May decrease the serum concentration of Dolutegravir. Risk X: Avoid combination

Gilteritinib: May increase the serum concentration of OCT1 Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy

Iron Preparations: May decrease the serum concentration of Dolutegravir. Management: Administer dolutegravir at least 2 hours before or 6 hours after oral iron. Administer dolutegravir/rilpivirine at least 4 hours before or 6 hours after oral iron. Alternatively, dolutegravir and oral iron can be taken together with food. Risk D: Consider therapy modification

Isoniazid: Dolutegravir may enhance the adverse/toxic effect of Isoniazid. Dolutegravir may increase the serum concentration of Isoniazid. Risk C: Monitor therapy

Levomethadone: May diminish the therapeutic effect of Abacavir. Abacavir may decrease the serum concentration of Levomethadone. Risk C: Monitor therapy

Lovotibeglogene Autotemcel: Antiretroviral Agents may diminish the therapeutic effect of Lovotibeglogene Autotemcel. Risk X: Avoid combination

Magnesium Salts: May decrease the serum concentration of Dolutegravir. Management: Administer dolutegravir at least 2 hours before or 6 hours after oral magnesium salts. Administer the dolutegravir/rilpivirine combination product at least 4 hours before or 6 hours after oral magnesium salts. Risk D: Consider therapy modification

MetFORMIN: Dolutegravir may increase the serum concentration of MetFORMIN. Management: Consider alternatives to this combination or use of lower metformin doses. Carefully weigh the risk of metformin toxicities (including lactic acidosis) against the benefit of combining dolutegravir with metformin. Risk D: Consider therapy modification

Methadone: May diminish the therapeutic effect of Abacavir. Abacavir may decrease the serum concentration of Methadone. Risk C: Monitor therapy

Mitapivat: May decrease the serum concentration of UGT1A1 Substrates. Risk C: Monitor therapy

Multivitamins/Minerals (with ADEK, Folate, Iron): May decrease the serum concentration of Dolutegravir. Management: Administer dolutegravir at least 2 hours before or 6 hours after multivitamins. Administer the dolutegravir/rilpivirine product at least 4 hours before or 6 hours multivitamins. Alternatively, dolutegravir and multivitamins can be taken together with food Risk D: Consider therapy modification

Multivitamins/Minerals (with AE, No Iron): May decrease the serum concentration of Dolutegravir. Management: Administer dolutegravir at least 2 hours before or 6 hours after multivitamins. Administer the dolutegravir/rilpivirine product at least 4 hours before or 6 hours multivitamins. Alternatively, dolutegravir and multivitamins can be taken together with food Risk D: Consider therapy modification

Nevirapine: May decrease the serum concentration of Dolutegravir. Risk X: Avoid combination

Orlistat: May decrease the serum concentration of Antiretroviral Agents. Risk C: Monitor therapy

OXcarbazepine: May decrease the serum concentration of Dolutegravir. Risk X: Avoid combination

Pacritinib: May increase the serum concentration of OCT1 Substrates (Clinically Relevant with Inhibitors). Risk X: Avoid combination

PHENobarbital: May decrease the serum concentration of Dolutegravir. Risk X: Avoid combination

Primidone: May decrease the serum concentration of Dolutegravir. Specifically, the Primidone metabolite phenobarbital may decrease Dolutegravir serum concentrations. Risk X: Avoid combination

Rifabutin: May decrease the serum concentration of Dolutegravir. Risk C: Monitor therapy

RifAMPin: May decrease the serum concentration of Dolutegravir. Management: Increase dolutegravir to 50 mg twice/day in adults. Increase weight-based dose to twice daily in pediatric patients. Specific recommendations vary for combination products; see interaction monograph for details. Risk D: Consider therapy modification

Rifapentine: Dolutegravir may enhance the adverse/toxic effect of Rifapentine. Rifapentine may decrease the serum concentration of Dolutegravir. Risk C: Monitor therapy

Riociguat: Abacavir may increase the serum concentration of Riociguat. Risk C: Monitor therapy

Risdiplam: May increase the serum concentration of MATE1/2-K Substrates (Clinically Relevant with Inhibitors). Management: Avoid use of risdiplam with MATE substrates if possible. If the combination cannot be avoided, monitor closely for adverse effects. Consider a reduced dose of the MATE substrate according to that substrate's labeling if appropriate. Risk D: Consider therapy modification

Selenium: May decrease the serum concentration of Dolutegravir. Management: Administer dolutegravir at least 2 hours before or 6 hours after oral selenium. Administer the dolutegravir/rilpivirine combination product at least 4 hours before or 6 hours after oral selenium. Risk D: Consider therapy modification

Sorbitol: May decrease the serum concentration of LamiVUDine. Management: When possible, avoid chronic coadministration of sorbitol-containing solutions with lamivudine, but if this combination cannot be avoided, monitor patients more closely for possible therapeutic failure associated with decreased lamivudine exposure. Risk D: Consider therapy modification

St John's Wort: May decrease the serum concentration of Dolutegravir. Risk X: Avoid combination

Sucralfate: May decrease the serum concentration of Dolutegravir. Management: Administer dolutegravir at least 2 hours before or 6 hours after sucralfate. Administer the dolutegravir/rilpivirine combination product at least 4 hours before or 6 hours after sucralfate. Risk D: Consider therapy modification

Tafenoquine: May increase the serum concentration of MATE1/2-K Substrates (Clinically Relevant with Inhibitors). Management: Avoid use of MATE substrates with tafenoquine, and if the combination cannot be avoided, monitor closely for evidence of toxicity of the MATE substrate and consider a reduced dose of the MATE substrate according to that substrate's labeling. Risk D: Consider therapy modification

Tafenoquine: May increase the serum concentration of OCT2 Substrates (Clinically Relevant with Inhibitors). Management: Avoid use of OCT2 substrates with tafenoquine, and if the combination cannot be avoided, monitor closely for evidence of toxicity of the OCT2 substrate and consider a reduced dose of the OCT2 substrate according to that substrate's labeling. Risk D: Consider therapy modification

Tipranavir: May decrease the serum concentration of Dolutegravir. Specifically, Tipranavir/Ritonavir may decrease the serum concentration of Dolutegravir. The individual contributions of Tipranavir and Ritonavir to this effect are unknown. Management: Increase dolutegravir to 50 mg twice/day in adults. Increase weight-based dose to twice daily in pediatric patients. Recommendations vary for combo products; see interaction monograph for details. Not recommended with Dovato or Juluca brand combos. Risk D: Consider therapy modification

Trimethoprim: May increase the serum concentration of LamiVUDine. Risk C: Monitor therapy

Valproate Products: May decrease the serum concentration of Dolutegravir. Risk C: Monitor therapy

Zinc Salts: May decrease the serum concentration of Dolutegravir. Management: Administer dolutegravir at least 2 hours before or 6 hours after oral zinc salts. Administer the dolutegravir/rilpivirine combination product at least 4 hours before or 6 hours after oral zinc salts. Risk D: Consider therapy modification

Reproductive Considerations

Evaluate pregnancy status prior to use in patients who can become pregnant. The manufacturer recommends consistent use of effective contraception during therapy.

The Health and Human Services (HHS) perinatal HIV guidelines consider this fixed-dose combination a preferred regimen for patients with HIV who are not yet pregnant but are trying to conceive. HLA-B*5701 allele status should be evaluated and documented as negative prior to use (HHS [perinatal] 2023).

Refer to individual monographs for additional information.

Pregnancy Considerations

HLA-B*5701 allele status should be evaluated and documented as negative prior to use; abacavir is contraindicated in all patients who are positive for the HLA-B*5701 allele, including patients who are pregnant.

The Health and Human Services (HHS) perinatal HIV guidelines consider this fixed-dose combination a preferred regimen in pregnant patients with HIV who are antiretroviral naive, who have had antiretroviral therapy (ART) in the past but are restarting, and who require a new ART regimen (due to poor tolerance or poor virologic response of current regimen). In addition, patients who become pregnant while taking this regimen may continue if viral suppression is effective and the regimen is well tolerated (HHS [perinatal] 2023).

Refer to individual monographs for additional information.

Breastfeeding Considerations

Abacavir, dolutegravir, and lamivudine are present in breast milk.

Refer to individual monographs for additional information.

Monitoring Parameters

Baseline HLA-B*5701 allele screening, hypersensitivity reactions, renal and hepatic function, hepatotoxicity, treatment-associated toxicities including hepatic decompensation, hepatitis exacerbation, or lamivudine resistance in coinfected patients; monitor for new onset or worsening hematologic toxicity (eg, neutropenia or anemia) in patients with CrCl <50 mL/minute (periodically and as clinically indicated). Evaluate pregnancy status prior to use in patients who can become pregnant.

Mechanism of Action

Dolutegravir inhibits HIV integrase by binding to the integrase active site and blocking the strand transfer step of retroviral DNA integration. Abacavir is converted by cellular enzymes to the active metabolite, carbovir triphosphate (CBV-TP), an analogue of deoxyguanosine-5′-triphosphate (dGTP). CBV-TP inhibits the activity of HIV-1 reverse transcriptase (RT) both by competing with the natural substrate dGTP and by its incorporation into viral DNA. Intracellularly, lamivudine is phosphorylated to its active 5′-triphosphate metabolite, lamivudine triphosphate (3TC-TP). The principal mode of action of 3TC-TP is inhibition of reverse transcriptase via DNA chain termination after incorporation of the nucleotide analogue.

Pharmacokinetics (Adult Data Unless Noted)

Pharmacokinetic studies of Triumeq show no difference in values when compared to dolutegravir as a single agent given with abacavir and lamivudine as a combination product. Tablets and tablets for oral suspension are bioequivalent for the abacavir and lamivudine components, but not the dolutegravir component. The relative dolutegravir bioavailability of the tablet formulation is ~1.7-fold higher than the tablet for oral suspension; therefore, the 2 dosage forms are not interchangeable. See individual agents.

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Altered kidney function: Patients taking abacavir/dolutegravir/lamivudine with CrCl between 30 and 49 mL/minute may experience a 1.6- to 3.3-fold higher lamivudine AUC compared to patients with CrCl ≥50 mL/minute.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Triumeq;
  • (AR) Argentina: Triumeq | Zevuvir abc pack;
  • (AT) Austria: Triumeq;
  • (AU) Australia: Trelavue | Triumeq;
  • (BE) Belgium: Triumeq;
  • (BG) Bulgaria: Triumeq;
  • (BR) Brazil: Triumeq;
  • (CH) Switzerland: Triumeq;
  • (CO) Colombia: Triumeq;
  • (CZ) Czech Republic: Triumeq;
  • (DE) Germany: Triumeq;
  • (EC) Ecuador: Triumeq;
  • (EE) Estonia: Triumeq;
  • (ES) Spain: Triumeq;
  • (ET) Ethiopia: Triumeq;
  • (FI) Finland: Triumeq;
  • (FR) France: Triumeq;
  • (GB) United Kingdom: Triumeq;
  • (GR) Greece: Triumeq;
  • (HK) Hong Kong: Triumeq;
  • (HR) Croatia: Triumeq;
  • (HU) Hungary: Triumeq;
  • (IE) Ireland: Triumeq;
  • (IT) Italy: Triumeq;
  • (JP) Japan: Triumeq;
  • (KE) Kenya: Triumeq;
  • (KR) Korea, Republic of: Triumeq;
  • (KW) Kuwait: Triumeq;
  • (LB) Lebanon: Triumeq;
  • (LT) Lithuania: Triumeq;
  • (LU) Luxembourg: Triumeq;
  • (LV) Latvia: Triumeq;
  • (MX) Mexico: Triumeq;
  • (NG) Nigeria: Triumeq;
  • (NL) Netherlands: Triumeq;
  • (NO) Norway: Triumeq;
  • (PE) Peru: Triumeq;
  • (PK) Pakistan: Triumeq;
  • (PT) Portugal: Triumeq;
  • (QA) Qatar: Triumeq;
  • (RO) Romania: Triumeq;
  • (SA) Saudi Arabia: Triumeq;
  • (SE) Sweden: Triumeq;
  • (SG) Singapore: Triumeq;
  • (SI) Slovenia: Triumeq;
  • (SK) Slovakia: Triumeq;
  • (TH) Thailand: Triumeq;
  • (TR) Turkey: Triumeq;
  • (TW) Taiwan: Triumeq;
  • (UG) Uganda: Triumeq;
  • (UY) Uruguay: Triumeq;
  • (ZA) South Africa: Damicava | Dolab | Inbec | Kavideza | Triumeq
  1. Elion RA, Althoff KN, Zhang J, et al; North American AIDS Cohort Collaboration on Research and Design of IeDEA. Recent abacavir use increases risk of type 1 and type 2 myocardial infarctions among adults with HIV. J Acquir Immune Defic Syndr. 2018;78(1):62-72. doi: 10.1097/QAI.0000000000001642. [PubMed 29419568]
  2. Epivir (lamivudine) [prescribing information]. Research Triangle Park, NC: ViiV Healthcare; September 2020.
  3. Gutierrez F, Fulladosa X, Barril G, Domingo P. Renal tubular transporter-mediated interactions of HIV drugs: implications for patient management. AIDS Rev. 2014;16(4):199-212. [PubMed 25350530]
  4. Triumeq and Triumeq PD (abacavir/dolutegravir/lamivudine) [prescribing information]. Durham, NC: GlaxoSmithKline; October 2022.
  5. Triumeq and Triumeq PD (abacavir/dolutegravir/lamivudine) [prescribing information]. Durham, NC: ViiV Healthcare; June 2023.
  6. Triumeq (abacavir/dolutegravir/lamivudine) [product monograph]. Montreal, Quebec, Canada: ViiV Healthcare ULC; July 2023.
  7. US Department of Health and Human Services; Centers for Disease Control and Prevention; National Institute for Occupational Safety and Health. NIOSH list of antineoplastic and other hazardous drugs in healthcare settings 2016. https://www.cdc.gov/niosh/docs/2016-161/default.html. Updated September 2016. Accessed October 5, 2016.
  8. US Department of Health and Human Services (HHS). Guidelines for the use of antiretroviral agents in adults and adolescents with HIV. https://aidsinfo.nih.gov/contentfiles/lvguidelines/adultandadolescentgl.pdf. Updated January 20, 2022. Accessed April 13, 2022.
  9. US Department of Health and Human Services (HHS) Panel on Treatment of HIV During Pregnancy and Prevention of Perinatal Transmission. Recommendations for the use of antiretroviral drugs during pregnancy and interventions to reduce perinatal HIV transmission in the United States. https://clinicalinfo.hiv.gov/en/guidelines/perinatal/whats-new. Updated January 31, 2023. Accessed February 23, 2023.
  10. Ziagen (abacavir) [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline; September 2013.
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