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Prescription medicine

Abacavir and dolutegravir and lamivudine Brand names: Triumeq

Abacavir and dolutegravir and lamivudine (Triumeq) is a prescription medicine with an FDA approval on record since 2014. No generic is listed; pharmacies paid $130.01 per Triumeq 600-50-300 mg tablet in the October 7, 2026 NADAC survey.

  • No generic listed
  • Boxed warning

Check it at the source: the abacavir and dolutegravir and lamivudine FDA label on DailyMed (effective July 8, 2024, ViiV Healthcare Company); the NDA 205551 record on Drugs@FDA; every abacavir and dolutegravir and lamivudine label on DailyMed.

Highlights of the record

FDA label of July 8, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026

Boxed warning

HYPERSENSITIVITY REACTIONS, AND EXACERBATIONS OF HEPATITIS B.

Hypersensitivity Reactions Serious and sometimes fatal hypersensitivity reactions, with multiple organ involvement, have occurred with abacavir, a component of TRIUMEQ and TRIUMEQ PD (abacavir, dolutegravir, and lamivudine). 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 [see Warnings and Precautions ( 5.1 )]. TRIUMEQ and TRIUMEQ PD are contraindicated in patients with a prior hypersensitivity reaction to abacavir and in HLA ‑ B*5701-positive patients [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 )]. All patients should be screened for the HLA ‑ B*5701 allele prior to initiating therapy with TRIUMEQ or TRIUMEQ PD or reinitiation of therapy with TRIUMEQ or TRIUMEQ PD, unless patients have a previously documented HLA ‑ B*5701 allele assessment. Discontinue TRIUMEQ or TRIUMEQ PD immediately if a hypersensitivity reaction is suspected, regardless of HLA ‑ B*5701 status and even when other diagnoses are possible [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 )]. […]

Used for

From the label: indications and usage

TRIUMEQ and TRIUMEQ PD are indicated for the treatment of HIV-1 infection in adults and in pediatric patients aged at least 3 months and weighing at least 6 kg.

Forms and strengths

  • 600 mg / 50 mg / 300 mg

Film-coated tablet; kit.

On the market

Earliest approval on file
August 22, 2014 Triumeq, Viiv Hlthcare; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals
No generic approved
Labelers listed (NDC)
1 of which 0 under generic applications, 1 under brand applications, repackagers included
Last listed patent
June 8, 2030 Triumeq tablets; not a generic launch date

Supply and safety

Pharmacy cost (NADAC)
$130.01 per tablet Triumeq 600-50-300 mg tablet
Shortage (FDA)
No current entry
Recalls by its makers (FDA)
1 since 2021 0 Class I among all firms' recalls; latest March 15, 2021
FAERS reports
6,307 through July 30, 2026

What is abacavir and dolutegravir and lamivudine used for?

From the label: indications and usage

TRIUMEQ and TRIUMEQ PD are indicated for the treatment of HIV-1 infection in adults and in pediatric patients aged at least 3 months and weighing at least 6 kg. Limitations of Use: TRIUMEQ and TRIUMEQ PD alone are not recommended in patients with resistance‑associated integrase substitutions or clinically suspected integrase strand transfer inhibitor (INSTI) resistance because the dose of dolutegravir in TRIUMEQ and TRIUMEQ PD is insufficient in these subpopulations. See full prescribing information for TIVICAY (dolutegravir). […]

Conditions named in the indications of abacavir and dolutegravir and lamivudine's FDA labels, with every medicine labeled for each:

FDA pharmacologic class: Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor, Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor and Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor.

Source: FDA drug label (Triumeq), ViiV Healthcare Company, effective July 8, 2024 (SPL set 2997739a-aa91-42aa-a206-a70e2db7b84f), via openFDA; the full label on DailyMed

What does the patient leaflet for abacavir and dolutegravir and lamivudine say first?

The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.

From the patient leaflet: What is the most important information I should know about TRIUMEQ and TRIUMEQ PD?

TRIUMEQ and TRIUMEQ PD can cause serious side effects, including: • Serious allergic reactions (hypersensitivity reaction) that can cause death have happened with TRIUMEQ or TRIUMEQ PD and other abacavir-containing products. Your risk of this allergic reaction to abacavir is much higher if you have a gene variation called HLA‑B*5701. Your healthcare provider can determine with a blood test if you have this gene variation. If you get a symptom from 2 or more of the following groups while taking TRIUMEQ or TRIUMEQ PD, call your healthcare provider right away to find out if you should stop taking TRIUMEQ or TRIUMEQ PD. Symptom(s) Group 1 Fever Group 2 Rash Group 3 Nausea, vomiting, diarrhea, abdominal (stomach area) pain Group 4 Generally ill feeling, extreme tiredness, or achiness Group 5 Shortness of breath, cough, sore throat A list of these symptoms is on the Warning Card your pharmacist gives you. Carry this Warning Card with you at all times. If you stop TRIUMEQ or TRIUMEQ PD because of an allergic reaction, never take TRIUMEQ, TRIUMEQ PD (abacavir, dolutegravir and lamivudine), or any other medicine that contains abacavir or dolutegravir (DOVATO, EPZICOM, JULUCA, TIVICAY, TIVICAY PD, TRIZIVIR, or ZIAGEN) again. • If you have an allergic reaction, dispose of any unused TRIUMEQ or TRIUMEQ PD. Ask your pharmacist how to properly dispose of medicines. • If you take TRIUMEQ, TRIUMEQ PD or any other abacavir‑containing medicine again after you have had an allergic reaction, within hours you may get life‑threatening symptoms that may include very low blood pressure or death. • If you stop TRIUMEQ or TRIUMEQ PD for any other reason, even for a few days, and you are not allergic to TRIUMEQ or TRIUMEQ PD, talk with your healthcare provider before taking it again. […]

From the patient leaflet: How should I store TRIUMEQ or TRIUMEQ PD?

Store TRIUMEQ and TRIUMEQ PD at room temperature between 68°F to 77°F (20°C to 25°C) in the original bottle. Keep the bottle tightly closed and protect it from moisture. • The bottle of TRIUMEQ and TRIUMEQ PD contains a desiccant packet to help keep your medicine dry (protect it from moisture). Do not remove the desiccant packet from the bottle. Keep TRIUMEQ, TRIUMEQ PD, and all medicines out of the reach of children.

Source: FDA drug label (Triumeq), ViiV Healthcare Company, effective July 8, 2024 (SPL set 2997739a-aa91-42aa-a206-a70e2db7b84f), via openFDA; the full label on DailyMed

Is there a generic for abacavir and dolutegravir and lamivudine (Triumeq)?

No generic abacavir and dolutegravir and lamivudine is approved (Drugs@FDA, October 8, 2026). Drugs@FDA also holds 3 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.

The Orange Book lists 2 patents for Triumeq tablets: the compound patent runs to December 8, 2029 (pediatric exclusivity to June 8, 2030). A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

  • 2014 earliest approval on file
  • 2030 last listed patent
  • red ticks recalls

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do pharmacies pay for abacavir and dolutegravir and lamivudine (Triumeq)?

In CMS's NADAC survey of October 7, 2026, pharmacies paid $130.01 per Triumeq 600-50-300 mg tablet, up 3% from $126.10 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.

  • Triumeq 600-50-300 mg tablet (brand)
$130.13
$121.12
January 2024October 2026
NADAC per unit, October 7, 2026
Strength and formBrand or genericPharmacy cost30 tablets, or one pen or vial12-month change
Triumeq 600-50-300 mg tabletBrand$130.01 per tablet$3,900.19+3%

Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price

Has abacavir and dolutegravir and lamivudine been recalled?

The FDA's Enforcement Report lists 1 recall naming abacavir and dolutegravir and lamivudine since 2021: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.

StartedClassCompanyReason
March 15, 2021Class IICardinal Health Inc.CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026

What does the abacavir and dolutegravir and lamivudine label say about other medicines?

The abacavir and dolutegravir and lamivudine label names 24 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Medicine namedSectionWhat the label says
Atazanavirdrug interactionsConcomitant Drug Class/Drug Name: Non-nucleoside reverse transcriptase inhibitor: Etravirine a; Effect on Concentration: ↓Dolutegravir; Clinical Comment: Use of TRIUMEQ or TRIUMEQ PD with etravirine without coadministration of atazanavir/ritonavir, darunavir/ritonavir, or lopinavir/ritonavir is not recommended.
Carbamazepinedrug interactionsConcomitant Drug Class/Drug Name: Carbamazepine a; Effect on Concentration: ↓Dolutegravir; Clinical Comment: In adults and in pediatric patients weighing at least 25 kg, adjust dolutegravir dose to 50 mg twice daily. An additional TIVICAY 50-mg dose should be taken, separated by 12 hours from TRIUMEQ. …
Dalfampridinedrug interactionsDolutegravir may increase plasma concentrations of drugs eliminated via OCT2 or MATE1 (dofetilide, dalfampridine, and metformin) [see Contraindications ( 4 ), Drug Interactions ( 7.3 )].
Darunavirdrug interactionsConcomitant Drug Class/Drug Name: Non-nucleoside reverse transcriptase inhibitor: Etravirine a; Effect on Concentration: ↓Dolutegravir; Clinical Comment: Use of TRIUMEQ or TRIUMEQ PD with etravirine without coadministration of atazanavir/ritonavir, darunavir/ritonavir, or lopinavir/ritonavir is not recommended.
Dofetilidecontraindications• receiving dofetilide due to the potential for increased dofetilide plasma concentrations and the risk for serious and/or life-threatening events with concomitant use of dolutegravir [see Drug Interactions ( 7 )].
Efavirenzdrug interactionsConcomitant Drug Class/Drug Name: Non-nucleoside reverse transcriptase inhibitor: Efavirenz a; Effect on Concentration: ↓Dolutegravir; Clinical Comment: In adults and in pediatric patients weighing at least 25 kg, adjust dolutegravir dose to 50 mg twice daily. …
Etravirinedrug interactionsConcomitant Drug Class/Drug Name: Non-nucleoside reverse transcriptase inhibitor: Etravirine a; Effect on Concentration: ↓Dolutegravir; Clinical Comment: Use of TRIUMEQ or TRIUMEQ PD with etravirine without coadministration of atazanavir/ritonavir, darunavir/ritonavir, or lopinavir/ritonavir is not recommended.
Fosamprenavirdrug interactionsConcomitant Drug Class/Drug Name: Protease inhibitor: Fosamprenavir/ritonavir a Tipranavir/ritonavir a; Effect on Concentration: ↓Dolutegravir; Clinical Comment: In adults and in pediatric patients weighing at least 25 kg, adjust dolutegravir dose to 50 mg twice daily. …
Lopinavir and ritonavirdrug interactionsEtravirine significantly reduced plasma concentrations of dolutegravir, but the effect of etravirine was mitigated by coadministration of lopinavir/ritonavir or darunavir/ritonavir and is expected to be mitigated by atazanavir/ritonavir ( Table 6 ) [see Drug Interactions ( 7.3 ), Clinical Pharmacology ( 12.3 )].
Metformindrug interactionsDolutegravir may increase plasma concentrations of drugs eliminated via OCT2 or MATE1 (dofetilide, dalfampridine, and metformin) [see Contraindications ( 4 ), Drug Interactions ( 7.3 )].
Methadonedrug interactionsMethadone Abacavir: In a trial of 11 HIV-1–infected subjects receiving methadone-maintenance therapy with 600 mg of abacavir twice daily (twice the currently recommended dose), oral methadone clearance increased [see Clinical Pharmacology ( 12.3 )].
Midazolamdrug interactionsIn drug interaction trials, dolutegravir did not have a clinically relevant effect on the pharmacokinetics of the following drugs: tenofovir, methadone, midazolam, rilpivirine, and oral contraceptives containing norgestimate and ethinyl estradiol.
Nevirapinedrug interactionsConcomitant Drug Class/Drug Name: Non-nucleoside reverse transcriptase inhibitor: Nevirapine; Effect on Concentration: ↓Dolutegravir; Clinical Comment: Avoid coadministration with TRIUMEQ or TRIUMEQ PD because there are insufficient data to make dosing recommendations.
Omeprazoledrug interactionsDarunavir/ritonavir, lopinavir/ritonavir, rilpivirine, tenofovir, boceprevir, prednisone, rifabutin, and omeprazole had no clinically significant effect on the pharmacokinetics of dolutegravir.

Every other medicine the abacavir and dolutegravir and lamivudine label names

Medicine namedSectionWhat the label says
Oxcarbazepinedrug interactionsConcomitant Drug Class/Drug Name: Oxcarbazepine Phenytoin Phenobarbital St. John’s wort ( Hypericum perforatum); Effect on Concentration: ↓Dolutegravir; …
Phenobarbitaldrug interactionsConcomitant Drug Class/Drug Name: Oxcarbazepine Phenytoin Phenobarbital St. John’s wort ( Hypericum perforatum); Effect on Concentration: ↓Dolutegravir; …
Phenytoindrug interactionsConcomitant Drug Class/Drug Name: Oxcarbazepine Phenytoin Phenobarbital St. John’s wort ( Hypericum perforatum); Effect on Concentration: ↓Dolutegravir; …
Prednisonedrug interactionsDarunavir/ritonavir, lopinavir/ritonavir, rilpivirine, tenofovir, boceprevir, prednisone, rifabutin, and omeprazole had no clinically significant effect on the pharmacokinetics of dolutegravir.
Rifabutindrug interactionsDarunavir/ritonavir, lopinavir/ritonavir, rilpivirine, tenofovir, boceprevir, prednisone, rifabutin, and omeprazole had no clinically significant effect on the pharmacokinetics of dolutegravir.
Rifampindrug interactionsConcomitant Drug Class/Drug Name: Rifampin a; Effect on Concentration: ↓Dolutegravir; Clinical Comment: In adults and in pediatric patients weighing at least 25 kg, adjust dolutegravir dose to 50 mg …
Rilpivirinedrug interactionsDarunavir/ritonavir, lopinavir/ritonavir, rilpivirine, tenofovir, boceprevir, prednisone, rifabutin, and omeprazole had no clinically significant effect on the pharmacokinetics of dolutegravir.
Riociguatdrug interactionsRiociguat Abacavir: Coadministration with TRIUMEQ resulted in increased riociguat exposure, which may increase the risk of riociguat adverse reactions [see Clinical Pharmacology ( 12.3 )].
Ritonavirdrug interactions… TRIUMEQ PD with etravirine without coadministration of atazanavir/ritonavir, darunavir/ritonavir, or lopinavir/ritonavir is not recommended.
Sucralfatedrug interactionsConcomitant Drug Class/Drug Name: Medications containing polyvalent cations (e.g., Mg or Al): Cation-containing antacids a or laxatives Sucralfate Buffered medications; …

Check abacavir and dolutegravir and lamivudine against other medicines

Source: FDA drug label (Triumeq), ViiV Healthcare Company, effective July 8, 2024 (SPL set 2997739a-aa91-42aa-a206-a70e2db7b84f), via openFDA; the full label on DailyMed

What do FAERS reports show for abacavir and dolutegravir and lamivudine?

The FDA Adverse Event Reporting System holds 6,307 reports that list abacavir and dolutegravir and lamivudine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 325 are coded as a death and 1,185 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

Reports received each year

The most reported reactions

  • Product Dose Omission Issue (a use or a product term, not a reaction)826
  • Pain807
  • Anxiety (named in the label)756
  • Emotional Distress697
  • Anhedonia628
  • Chronic Kidney Disease473
  • Fatigue (named in the label)335
  • Depression315

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What else is labeled for the same conditions as abacavir and dolutegravir and lamivudine?

33 other medicines are given the same way (oral) and in the same FDA class as abacavir and dolutegravir and lamivudine or labeled mainly for the same use (HIV), the same class first. HIV lists all 47 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.

MedicineShared indicationGeneric labelers (oral)Pharmacy costShortage
Emtricitabine and tenofovir disoproxilHIV25 labelers$0.529 per tablet 200-300 mg tabletNo current entry
Tenofovir disoproxilHIV15 labelers$0.294 per tablet 300 mg tabletNo current entry
RaltegravirHIV1 labeler$34.54 per tablet 400 mg tabletNo current entry
Efavirenz and emtricitabine and tenofovir disoproxilHIV7 labelers$1.12 per tablet 600-200-300 mg tabletNo current entry
ZidovudineHIV3 labelers$0.464 per tablet 300 mg tabletNo current entry
Bictegravir and emtricitabine and tenofovir alafenamideHIVnone listed$136.73 per tablet 50-200-25 mg tabletNo current entry
EmtricitabineHIV2 labelers$12.69 per capsule 200 mg capsuleA presentation being discontinued
Emtricitabine and rilpivirine and tenofovir disoproxilHIV2 labelers$114.50 per tablet 200-25-300 mg tabletNo current entry

Every medicine labeled for the same conditions as abacavir and dolutegravir and lamivudine

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

What next?

Abacavir and dolutegravir and lamivudine side effects
the label's list beside FAERS reports
Check an interaction
what two or more labels say about each other