Dolutegravir and Lamivudine
Dolutegravir and lamivudine is a two-drug combination HIV-1 medicine, sold as Dovato, used as a complete regimen to treat HIV-1 infection in adults and adolescents.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Dovato is a once-daily, one-tablet complete regimen for HIV-1 that pairs dolutegravir and lamivudine, which block two different enzymes HIV needs to multiply (integrase and reverse transcriptase), and since arriving around 2019 it has become a widely recommended choice for starting treatment or switching from a well-controlled regimen. Most people tolerate it well, and when side effects show up they are usually mild headache, nausea, diarrhea or trouble sleeping. The boxed warning concerns hepatitis B, which lamivudine also acts on, so get tested before starting, and if you have hepatitis B, never stop Dovato without talking to your prescriber, because the infection can flare severely.
Clinical pearls
- Take Dovato 2 hours before or 6 hours after antacids or laxatives containing magnesium or aluminum, or sucralfate.
- Calcium or iron supplements can go with Dovato at a meal, but when fasting take Dovato 2 hours before or 6 after.
- Never combine it with dofetilide, a heart rhythm medicine, and avoid St. John's wort, which can weaken dolutegravir.
- Starting rifampin or carbamazepine means adding a separate dolutegravir tablet about 12 hours after Dovato, so tell every prescriber you take it.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
If you have both HIV-1 and hepatitis B (HBV), stopping Dovato can cause a severe flare-up of hepatitis B. The lamivudine in Dovato also acts on HBV. HBV can become resistant to lamivudine when it is used for HIV alone.
Everyone with HIV-1 should be tested for HBV before or when starting Dovato. If you have both infections, your doctor may add a hepatitis B treatment or choose a different regimen. After stopping, your liver should be closely monitored for several months.
Patient information guide A plain-language walkthrough of Dolutegravir and Lamivudine, written from its FDA label.
What Dolutegravir and Lamivudine is used for
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Dolutegravir and lamivudine, as Dovato, treats HIV-1 infection.
- Dovato is a complete regimen for adults and adolescents 12 and older weighing at least 25 kg who have never had HIV treatment.
- Dovato can replace a current regimen in people with suppressed virus (under 50 copies/mL) on a stable regimen, with no treatment failure and no known resistance to its components.
How Dolutegravir and Lamivudine works
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Dovato combines two HIV-1 medicines in one fixed-dose tablet. Dolutegravir is an integrase strand transfer inhibitor (INSTI). Lamivudine is a nucleoside analogue reverse transcriptase inhibitor (NRTI).
Dolutegravir and Lamivudine dosage
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Dovato is one tablet taken by mouth once a day, with or without food. Your doctor will test you for hepatitis B before or when you start.
- With carbamazepine or rifampin, an additional dolutegravir tablet is taken about 12 hours apart.
- Because it is a fixed-dose tablet, it cannot be adjusted for kidney impairment.
Follow your prescriber's directions and the label.
Dosing details from the FDA-approved label
From the Dolutegravir and Lamivudine prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Adults and adolescents 12 years of age and older weighing at least 25 kg
- One tablet (50 mg dolutegravir and 300 mg lamivudine) taken orally once daily with or without food
- Test patients for HBV infection prior to or when initiating DOVATO
- Coadministration with carbamazepine or rifampin
- One tablet of DOVATO once daily, followed by an additional dolutegravir 50-mg tablet approximately 12 hours from the dose of DOVATO
- The dolutegravir dose (50 mg) in DOVATO is insufficient when coadministered with these drugs
- Renal impairment
- Not recommended in patients with creatinine clearance less than 30 mL/min
- DOVATO is a fixed-dose tablet and cannot be dose adjusted
- Severe hepatic impairment (Child-Pugh Score C)
- Not recommended
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION • Prior to or when initiating DOVATO, test patients for hepatitis B virus (HBV) infection. ( 2.1 ) • One tablet taken orally once daily with or without food. ( 2.2 ) • The dolutegravir dose (50 mg) in DOVATO is insufficient when coadministered with carbamazepine or rifampin. If DOVATO is coadministered with carbamazepine or rifampin, take one tablet of DOVATO once daily, followed by an additional dolutegravir 50-mg tablet, approximately 12 hours from the dose of DOVATO. ( 2.3 ) 2.1 Testing Prior to or When Initiating Treatment with DOVATO Prior to or when initiating DOVATO, test patients for HBV infection [see Warnings and Precautions ( 5.1 )]. 2.2 Recommended Dosage DOVATO is a fixed-dose combination product containing 50 mg of dolutegravir and 300 mg of lamivudine. The recommended dosage regimen of DOVATO in adults and adolescents 12 years of age and older and weighing at least 25 kg is one tablet taken orally once daily with or without food [see Clinical Pharmacology ( 12.3 )] . 2.3 Recommended Dosage with Certain Coadministered Drugs The dolutegravir dose (50 mg) in DOVATO is insufficient when coadministered with drugs listed in Table 1 that may decrease dolutegravir concentrations; the following dolutegravir dosage regimen is recommended. Table 1. Dosing Recommendations for DOVATO with Coadministered Drugs Coadministered Drug Dosing Recommendation Carbamazepine, rifampin An additional dolutegravir 50-mg tablet, separated by 12 hours from DOVATO, should be taken. 2.4 Not Recommended in Patients with Renal Impairment Because DOVATO is a fixed-dose tablet and cannot be dose adjusted, DOVATO is not recommended in patients with creatinine clearance less than 30 mL/min [see Use in Specific Populations ( 8.6 )] . 2.5 Not Recommended in Patients with Severe Hepatic Impairment DOVATO is not recommended in patients with severe hepatic impairment (Child-Pugh Score C) [see Use in Specific Populations ( 8.7 )] .
Read the full Dosage and Administration section on DailyMed →
Dolutegravir and Lamivudine side effects
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The most common side effects in people taking Dovato were:
Common side effects
- Headache
- Nausea
- Diarrhea
- Trouble sleeping (insomnia)
- Fatigue
- Anxiety
When to get medical help
- Stop Dovato and get medical help right away if you develop a rash with feeling generally unwell or signs of liver problems. These can be signs of a serious allergic reaction.
- Call your doctor if you have a hepatitis B infection and plan to stop Dovato, or have stopped it. Hepatitis B can flare up severely.
- Report symptoms of liver problems, especially if you have hepatitis B or C.
- Seek care for signs of lactic acidosis (too much acid in the blood) or a severely enlarged liver. These are rare but can be fatal with this type of medicine.
- Tell your doctor about new symptoms after starting HIV treatment. Your recovering immune system can react to infections you already had (immune reconstitution syndrome).
- Tell your doctor about thoughts of suicide or worsening mood or anxiety.
Dolutegravir and Lamivudine warnings and precautions
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Biggest risk: hepatitis B. In people with both HIV-1 and hepatitis B, stopping Dovato can cause severe hepatitis flares, and hepatitis B can become resistant to lamivudine. Test for hepatitis B before starting.
- Stop immediately if signs of an allergic reaction appear, such as rash with feeling unwell.
- Liver toxicity has been reported, especially in people with hepatitis B or C.
- Lactic acidosis and severe liver enlargement have been reported with this type of medicine.
- Immune reconstitution syndrome can occur after starting therapy.
Dolutegravir and Lamivudine interactions
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Several medicines and supplements can change how Dovato works.
- Dofetilide: contraindicated because its levels can rise dangerously.
- Carbamazepine, rifampin: lower dolutegravir, so an extra dolutegravir dose is needed.
- Oxcarbazepine, phenytoin, phenobarbital, St. John's wort: lower dolutegravir; avoid.
- Antacids, laxatives, sucralfate with magnesium or aluminum: space Dovato 2 hours before or 6 hours after.
- Calcium or iron supplements: can be taken together with food; otherwise space them.
- Metformin and dalfampridine: levels may rise, and dalfampridine raises seizure risk.
- Sorbitol: lowers lamivudine; avoid when possible.
- Other HIV medicines: not recommended with Dovato.
Interactions listed in the FDA-approved label
From the Dolutegravir and Lamivudine prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Other antiretroviral drugs for HIV-1: DOVATO is a complete regimen for the treatment of HIV-1 infection. Coadministration with other antiretroviral drugs is not recommended.
- Dofetilide: Dofetilide concentrations increase. Coadministration is contraindicated with DOVATO.
- Carbamazepine: Dolutegravir concentrations decrease. An additional dolutegravir 50-mg dose should be taken, separated by 12 hours from DOVATO.
- Oxcarbazepine, phenytoin, phenobarbital: Dolutegravir concentrations decrease. Avoid coadministration with DOVATO because there are insufficient data to make dosing recommendations.
- Metformin: Metformin concentrations increase. Refer to the prescribing information for metformin for assessing the benefit and risk of concomitant use of DOVATO and metformin.
- Rifampin: Dolutegravir concentrations decrease. An additional 50-mg dose of dolutegravir should be taken, separated by 12 hours from DOVATO.
- St. John's wort (Hypericum perforatum): Dolutegravir concentrations decrease. Avoid coadministration with DOVATO because there are insufficient data to make dosing recommendations.
- Medications containing polyvalent cations (e.g., Mg or Al): cation-containing antacids or laxatives, sucralfate, buffered medications: Dolutegravir concentrations decrease. Administer DOVATO 2 hours before or 6 hours after taking medications containing polyvalent cations.
- Oral calcium and iron supplements, including multivitamins containing calcium or iron: Dolutegravir concentrations decrease. When taken with food, DOVATO and these supplements can be taken at the same time. Under fasting conditions, take DOVATO 2 hours before or 6 hours after taking supplements containing calcium or iron.
- Dalfampridine: Dalfampridine concentrations increase; elevated levels increase the risk of seizures. The potential benefits of taking dalfampridine concurrently with DOVATO should be considered against the risk of seizures in these patients.
Read the label’s full interactions text
7 DRUG INTERACTIONS • DOVATO is a complete regimen for the treatment of HIV-1 infection; therefore, coadministration with other antiretroviral drugs for the treatment of HIV-1 infection is not recommended. ( 7.1 ) • Refer to the full prescribing information for important drug interactions with DOVATO. ( 4 , 5.5 , 7 ) 7.1 Coadministration with Other Antiretroviral Drugs DOVATO is a complete regimen for the treatment of HIV-1 infection; therefore, coadministration with other antiretroviral drugs for the treatment of HIV-1 infection is not recommended [see Indications and Usage ( 1 )] . Information regarding potential drug-drug interactions with other antiretroviral drugs is not provided [see Contraindications ( 4 ), Warnings and Precautions ( 5.5 ), Clinical Pharmacology ( 12.3 )]. 7.2 Potential for DOVATO to Affect Other Drugs Dolutegravir, a component of DOVATO, inhibits the renal organic cation transporters (OCT)2 and multidrug and toxin extrusion transporter (MATE)1; thus, it may increase plasma concentrations of drugs eliminated via OCT2 or MATE1 such as dofetilide, dalfampridine, and metformin [see Contraindications ( 4 ), Drug Interactions ( 7.4 ), Clinical Pharmacology ( 12.3 )]. 7.3 Potential for Other Drugs to Affect the Components of DOVATO Dolutegravir is metabolized by uridine diphosphate (UDP)-glucuronosyl transferase (UGT)1A1 with some contribution from cytochrome P450 (CYP)3A. Dolutegravir is also a substrate of UGT1A3, UGT1A9, breast cancer resistance protein (BCRP), and P-glycoprotein (P-gp) in vitro. Drugs that induce those enzymes and transporters may decrease dolutegravir plasma concentrations and reduce the therapeutic effect of DOVATO [see Drug Interactions ( 7.4 ), Clinical Pharmacology ( 12.3 )] . Coadministration of DOVATO and other drugs that inhibit these enzymes may increase dolutegravir plasma concentrations.
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Dolutegravir and Lamivudine
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- Prior allergic reaction to dolutegravir or lamivudine: do not take.
- Taking dofetilide: do not take.
- Hepatitis B infection: tell your doctor; testing is required.
- Creatinine clearance under 30 mL/min: not recommended.
- Severe liver impairment (Child-Pugh C): not recommended.
- Pregnancy: a registry monitors outcomes. Studies of over 14,000 pregnancies showed similar neural tube defect rates with dolutegravir compared with other regimens, but data on Dovato itself are limited.
- Breastfeeding: both drugs pass into milk. Risks include passing HIV-1 to an HIV-negative infant, viral resistance in an infected infant, and side effects in the baby.
- Adolescents 12 and older weighing at least 25 kg have safety and efficacy data.
Dolutegravir and Lamivudine overdose
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There is no known specific treatment for a Dovato overdose. The person should be monitored and given standard supportive care. Dialysis is unlikely to remove dolutegravir, and it is unknown whether continuous hemodialysis would help with lamivudine.
What Dolutegravir and Lamivudine does in the body
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The combination has not been studied for effects on the QT interval (heart rhythm timing). Dolutegravir alone did not meaningfully prolong QTc at higher exposures. Dolutegravir did not show a clinically significant effect on kidney filtration in a study of healthy volunteers.
How your body processes Dolutegravir and Lamivudine
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Dolutegravir reaches its peak in about 2.5 hours, and lamivudine in about 1 hour. A high-fat meal did not cause clinically significant differences for either. Dolutegravir's half-life is about 14 hours and lamivudine's is 13 to 19 hours. Dolutegravir is mainly broken down by the UGT1A1 enzyme, while lamivudine is not significantly metabolized and leaves largely unchanged in urine.
How to store Dolutegravir and Lamivudine
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Store below 30°C (86°F).
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Dolutegravir and Lamivudine: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Dolutegravir and Lamivudine — the kind of thing our pharmacy team would talk through with you at the counter.
What is Dovato for?
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How do I take it?
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Why do I need a hepatitis B test?
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What side effects should I expect?
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Can I take it with antacids or supplements?
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Is it safe in pregnancy?
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Is Dolutegravir and Lamivudine available over the counter?
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When was Dolutegravir and Lamivudine first available?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Dolutegravir and Lamivudine on HelloPharmacist
Dolutegravir and Lamivudine forms and strengths (how it comes)
Dolutegravir and Lamivudine is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Dolutegravir and Lamivudine inactive ingredients by manufacturer.
Tablet
How this form is used
- Dovato is a complete regimen for HIV-1 infection in adults and adolescents 12 and older weighing at least 25 kg.
- Dovato can replace a current regimen in people whose virus is suppressed, with no treatment failure history or known resistance.
- Dovato is one tablet taken by mouth once daily, with or without food.
- Dovato users should be tested for hepatitis B before or when starting.
- With carbamazepine or rifampin, an extra dolutegravir tablet is taken about 12 hours after Dovato.
Dolutegravir and Lamivudine on the U.S. market: products, makers and brands
How Dolutegravir and Lamivudine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
1 company lists 1 Dolutegravir and Lamivudine product record with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2019. Brand names on the directory include Dovato; the rest are generics.
How widely Dolutegravir and Lamivudine is used (Medicaid data)
A general measure of how commonly Dolutegravir and Lamivudine is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Dolutegravir and Lamivudine is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Dolutegravir and Lamivudine prescribed? Of the 1,601 medications we measure, Dolutegravir and Lamivudine ranks #507 by Medicaid prescriptions — more than 68% of them.
Utilization by Dolutegravir and Lamivudine product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
dolutegravir 50 MG / lamivudine 300 MG Oral Tablet
Summed across the 2 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2122519
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Dolutegravir and Lamivudine, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 2 of 5 listed Dolutegravir and Lamivudine NDCs with Medicaid activity.
Compare Dolutegravir and Lamivudine products
A representative set of FDA-listed product records for Dolutegravir and Lamivudine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| DOLUTEGRAVIR SODIUM 50 mg/1; LAMIVUDINE 300 mg | Oral | ViiV Healthcare Company | NDA | View NDC → |
Showing 1 of 1 products — FDA National Drug Code Directory. See every product, package size and price: browse all 1 Dolutegravir and Lamivudine NDCs →
Dolutegravir and Lamivudine side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Dolutegravir and Lamivudine — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Dolutegravir and Lamivudine in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Dolutegravir and Lamivudine FDA approval history
How Dolutegravir and Lamivudine went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Dolutegravir and Lamivudine recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Dolutegravir and Lamivudine recalls since July 2021.
✅No Dolutegravir and Lamivudine recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one exact multiple-ingredient concept (MIN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). A product with a different ingredient combination belongs on a different page.
RxCUI 2122518 1 dose form · 1 strength
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Dose form (SCDF) Oral Tablet RxCUI 2122517In current FDA listingsClinical drug / strength (SCD) dolutegravir 50 MG / lamivudine 300 MGRxCUI 2122519
Look up RxCUI 2122518 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Dolutegravir and Lamivudine supply and shortage status
Whether Dolutegravir and Lamivudine is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 What Dolutegravir and Lamivudine costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Tablet, Film Coated · Oral | 50; 300 mg/1; mg | $105.23 per tablet | NDC details & price history |
| Tablet, Film Coated · Oral | DOLUTEGRAVIR SODIUM 50 mg/1; LAMIVUDINE 300 mg | $105.23 per tablet | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Dolutegravir and Lamivudine brand names
Dolutegravir and Lamivudine is sold under one brand name in the FDA directory — Dovato. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Dolutegravir and Lamivudine: manufacturers and labelers
One company lists Dolutegravir and Lamivudine products with the FDA. By number of product records, the largest are ViiV Healthcare Company. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Dolutegravir and Lamivudine drug class (RxNorm)
Dolutegravir and Lamivudine belongs to the Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Dolutegravir and Lamivudine page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. ViiV Healthcare Company is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →