This is a fixed-dose combination of three antiretroviral medicines — dolutegravir, lamivudine, and tenofovir disoproxil fumarate (often abbreviated TLD) — used together as a complete, once-daily regimen to treat HIV-1 infection. It combines a highly effective integrase inhibitor with two nucleoside/nucleotide reverse transcriptase inhibitors and is widely used as a preferred first-line HIV regimen globally. It is a prescription-only medicine.

• Therapeutic Class: Antiretroviral combination therapy for HIV-1.

• Pharmacological Class: Integrase strand transfer inhibitor (dolutegravir) plus two nucleos(t)ide reverse transcriptase inhibitors (lamivudine, tenofovir disoproxil fumarate).

• Drug Family: Combination antiretroviral therapy (cART).

• ATC Classification: J05AR21 (Tenofovir disoproxil, lamivudine and dolutegravir).

Approved: HIV-1 infection in treatment-naive and certain treatment-experienced adults and adolescents, as a complete once-daily regimen.

Commonly used for: People newly diagnosed with HIV starting first-line therapy, given its inclusion as a preferred regimen in WHO and many national HIV treatment guidelines.

Off-label use (only under medical guidance): Not typically used off-label; dosing and use are governed by established HIV treatment guidelines.

● Oral tablets (fixed-dose combination): dolutegravir 50 mg/lamivudine 300 mg / tenofovir disoproxil fumarate 300 mg (tenofovir disoproxil fumarate equivalent to 245 mg tenofovir disoproxil).

Dolutegravir blocks an HIV enzyme called integrase, which the virus needs to insert its genetic material into human cells — this is a highly effective mechanism with a high barrier to resistance. Lamivudine and tenofovir disoproxil fumarate block a different HIV enzyme, reverse transcriptase, by acting as faulty building blocks that stop the virus's genetic material from being copied. Together, these three drugs attack HIV replication at complementary points, helping keep the virus suppressed.

• Standard dose: One tablet taken orally once daily, with or without food.

• Condition-wise dose: Not recommended in patients with a creatinine clearance below 50 mL/min, as individual dose adjustment of the components is not possible in this fixed combination.

• Route: Oral, once daily.

• Missed dose: Take the missed dose as soon as remembered; if close to the next dose, skip it and continue as scheduled — don't double up.

• Overdose: May cause increased side effects related to the individual components; requires medical attention.

• Common: Headache, nausea, diarrhoea, fatigue, and insomnia.

• Serious: Immune reconstitution inflammatory syndrome (a temporary worsening of symptoms as the immune system recovers), liver toxicity, kidney function decline, and reduced bone mineral density linked to tenofovir disoproxil fumarate; weight gain has also been associated with dolutegravir-based regimens.

• Emergency symptoms: Yellowing of the skin/eyes, signs of an allergic/hypersensitivity reaction (fever, rash, severe fatigue, along with respiratory or gastrointestinal symptoms), or a marked drop in urine output.

• Recovery advice: Most common side effects like headache or nausea are mild and often improve within the first few weeks; any new rash accompanied by fever or fatigue should be reported promptly, as it could indicate a hypersensitivity reaction to dolutegravir.

• Pregnancy: Current guidance supports dolutegravir-based regimens in pregnancy in most circumstances; review specific guidance with the treating doctor, particularly around the time of conception.

• Breastfeeding: Discussed with the treating doctor, in line with broader HIV-in-pregnancy/breastfeeding guidance to prevent transmission.

• Liver disease: Use with caution; monitor liver function, particularly given the hepatitis B interaction risk.

• Kidney disease: Not recommended in patients with reduced kidney function, as described above.

• Elderly: Limited specific data; used with routine monitoring.

• Children: Fixed-dose combination use is generally approved for adults and adolescents meeting weight criteria; younger children typically require separate weight-based dosing of the individual components.

● Polyvalent cation-containing products (antacids, calcium, iron supplements): can significantly reduce dolutegravir absorption; these should be separated by several hours or, where appropriate, taken with food.

● Other integrase inhibitors, lamivudine-, or tenofovir-containing products: should not be combined with this medicine to avoid duplicate dosing.

● Certain anti-seizure and anti-tuberculosis medicines (e.g., carbamazepine, rifampin): can reduce dolutegravir levels, sometimes requiring dose adjustment.

● Other nephrotoxic drugs (e.g., NSAIDs, certain antibiotics): may increase the risk of kidney effects when combined with tenofovir disoproxil fumarate.

● Hepatitis B virus testing before starting and monitoring if the medicine is stopped.

● Kidney function tests (serum creatinine, estimated creatinine clearance) periodically.

● HIV viral load and CD4 count to monitor treatment response.

● Weight monitoring, given the association between dolutegravir-based regimens and weight gain in some studies.

Bictegravir/emtricitabine/tenofovir alafenamide, Dolutegravir/lamivudine (a two-drug regimen), efavirenz-based combinations (older regimens, generally less preferred due to side-effect profile).

This is itself a fixed triple combination intended as a complete regimen; not combined with other products containing the same three drugs. Used alongside other antiretrovirals only in specific treatment-experienced situations, under specialist guidance.

● HIV / Antiretroviral Medicines

● Fixed-Dose Combination ART

● Integrase Strand Transfer Inhibitors

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1. https://list.essentialmeds.org/recommendations/1007

2. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12157303/

The information on this page is for educational purposes only and is not a substitute for medical advice. Please consult your doctor to know if this treatment is appropriate for your condition.