Tivicay (Dolutegravir): Uses, Dosage & Side Effects
Integrase strand transfer inhibitor (INSTI) for HIV-1 treatment
Quick Facts About Tivicay
Key Takeaways
- Tivicay (dolutegravir) is a preferred first-line HIV treatment recommended by the WHO due to its high efficacy, high barrier to resistance, and favorable side effect profile.
- It must always be taken in combination with other antiretroviral medicines – never as monotherapy.
- Do not take Tivicay with fampridine (dalfampridine). Antacids and mineral supplements can reduce absorption and must be timed carefully.
- Common side effects include headache, diarrhea, and nausea. Psychiatric symptoms such as depression and insomnia should be reported to your healthcare provider.
- Approved for adults and children from 4 weeks of age (weighing at least 3 kg), with weight-based dosing in pediatric patients.
What Is Tivicay and What Is It Used For?
Tivicay contains the active substance dolutegravir, which belongs to a group of antiretroviral medicines called integrase strand transfer inhibitors (INSTIs). Integrase is an enzyme that HIV uses to insert its DNA into the DNA of human CD4+ T-cells. By blocking this step, dolutegravir prevents the virus from replicating and producing new viral particles.
Tivicay is approved for the treatment of HIV-1 infection in adults, adolescents, and children from 4 weeks of age who weigh at least 3 kg. It is always used as part of combination antiretroviral therapy (cART), meaning it must be taken together with at least one other antiretroviral medicine. Combination therapy is essential because using multiple drugs that target different stages of the HIV lifecycle dramatically reduces the chance of the virus developing resistance.
While Tivicay does not cure HIV infection, it effectively suppresses the virus to undetectable levels in the blood when taken consistently. This not only prevents the progression of HIV to AIDS but also preserves and restores the immune system by allowing CD4+ T-cell counts to recover. Evidence from large clinical trials, including the SPRING-2, SINGLE, and FLAMINGO studies, demonstrated that dolutegravir achieves virological suppression rates above 80% at 48 weeks, comparable to or exceeding other first-line regimens.
The World Health Organization (WHO) recommends dolutegravir-based regimens as the preferred first-line treatment for all people living with HIV, including adults, pregnant women, adolescents, and children. This recommendation is based on dolutegravir's superior efficacy, high genetic barrier to resistance, once-daily dosing convenience, and generally well-tolerated side effect profile.
Not everyone responds to treatment in the same way. Your healthcare provider will monitor your viral load and CD4 count regularly to assess the effectiveness of your treatment regimen. It is critical to take all your medicines exactly as prescribed and not to stop any of them unless instructed by your doctor, as interrupting treatment can lead to viral rebound and the development of drug resistance.
What Should You Know Before Taking Tivicay?
Contraindications
Tivicay is contraindicated in individuals who have a known hypersensitivity to dolutegravir or any of the excipients in the formulation. Hypersensitivity reactions can be serious and may include skin rash, fever, fatigue, swelling (including facial or oral angioedema), muscle pain, and joint pain. If you experience any of these symptoms, seek immediate medical attention.
Tivicay must not be taken together with fampridine (also known as dalfampridine), a medicine used to treat multiple sclerosis. Co-administration of these two drugs is strictly contraindicated due to the risk of serious adverse effects. If either of these contraindications applies to you, inform your healthcare provider before starting treatment.
Warnings and Precautions
Some people taking antiretroviral medicines for HIV infection may develop additional conditions that can be serious. These include:
- Immune reconstitution inflammatory syndrome (IRIS): When treatment begins, the recovering immune system may mount an inflammatory response against previously undetected infections. This can cause symptoms such as fever, headache, stomach pain, or breathing difficulties. In rare cases, the immune system may also attack healthy tissue (autoimmune disorders), which can present as palpitations, tremors, or weakness starting in the hands and feet.
- Hypersensitivity reactions: Although uncommon, allergic reactions to dolutegravir can occur. Signs include rash, high temperature, lack of energy, swelling (sometimes of the face and mouth causing breathing difficulties), and muscle or joint pain.
- Psychiatric symptoms: Depression, anxiety, suicidal thoughts, and suicidal behavior have been reported, particularly in patients with a pre-existing history of psychiatric illness. Report any changes in mood or behavior to your healthcare provider immediately.
- Liver problems: Hepatitis (inflammation of the liver) and, rarely, liver failure have been reported. Your doctor may order liver function tests during treatment.
- Osteonecrosis: Some patients receiving combination antiretroviral therapy develop osteonecrosis (death of bone tissue), particularly in the hips, knees, or shoulders. Risk factors include long-term combination therapy, corticosteroid use, alcohol consumption, severe immunosuppression, and higher body weight.
Pregnancy and Breastfeeding
If you are pregnant, think you may be pregnant, or are planning to have a baby, discuss the risks and benefits of Tivicay with your healthcare provider. Early observational data from the Tsepamo birth surveillance study in Botswana raised a possible signal regarding neural tube defects with periconceptional dolutegravir exposure. However, subsequent larger analyses have shown the absolute risk is very low (approximately 0.19%), close to background rates. Based on this updated evidence, the WHO now includes dolutegravir as a preferred first-line option for all populations, including women of childbearing potential and pregnant women.
Do not stop taking Tivicay without consulting your healthcare provider, as this could harm both you and your unborn child by allowing HIV to rebound. Breastfeeding is generally not recommended for women living with HIV because the virus can be transmitted through breast milk. Small amounts of dolutegravir have also been detected in breast milk. Discuss infant feeding options with your doctor.
Driving and Operating Machinery
Tivicay can cause dizziness and other side effects that may reduce your alertness. Do not drive or operate machinery if you feel that your ability to do so is impaired while taking this medicine.
Tivicay is approved for children from 4 weeks of age weighing at least 3 kg. It should not be given to younger infants, children weighing less than 3 kg, or children with integrase inhibitor-resistant HIV. Pediatric dosing is weight-based and must be determined by the prescribing physician. Regular follow-up appointments are essential for children taking Tivicay, as the dose needs to be adjusted as the child grows.
How Does Tivicay Interact with Other Drugs?
Drug interactions are an important consideration with any antiretroviral regimen. Some medications can decrease the blood levels of dolutegravir, reducing its effectiveness, while dolutegravir can increase the levels of certain other drugs, raising the risk of adverse effects. Always tell your healthcare provider about all prescription medicines, over-the-counter products, and herbal supplements you take.
Major Interactions
The following drugs have clinically significant interactions with Tivicay and may require dose adjustment, alternative therapy, or close monitoring:
| Drug | Used For | Effect | Action Required |
|---|---|---|---|
| Fampridine (dalfampridine) | Multiple sclerosis | Increased fampridine levels – risk of seizures | Contraindicated – do not co-administer |
| Rifampicin | Tuberculosis, bacterial infections | Significantly reduces dolutegravir levels | Increase Tivicay dose to 50 mg twice daily |
| Phenytoin / Phenobarbital | Epilepsy | Reduces dolutegravir levels via enzyme induction | Dose adjustment required – consult physician |
| Carbamazepine / Oxcarbazepine | Epilepsy, bipolar disorder | Reduces dolutegravir levels via enzyme induction | Dose adjustment required – consult physician |
| St. John's Wort | Herbal remedy for mild depression | Significantly reduces dolutegravir levels | Avoid co-administration |
| Etravirine (without boosted PI) | HIV infection | Reduces dolutegravir levels | Avoid unless given with atazanavir/r, darunavir/r, or lopinavir/r |
| Tipranavir/ritonavir | HIV infection | Reduces dolutegravir levels | Dose adjustment required |
Minor Interactions and Timing Considerations
Several commonly used products can interfere with the absorption of dolutegravir if taken at the wrong time:
- Antacids (containing aluminum or magnesium): Do not take within 6 hours before or 2 hours after Tivicay, as they significantly reduce absorption.
- Calcium, iron, or magnesium supplements: If taking Tivicay with food, these supplements can be taken at the same time. Without food, maintain a 6-hour gap before and 2-hour gap after Tivicay.
- Metformin: Dolutegravir increases metformin levels. Your doctor may need to adjust the metformin dose when starting or stopping Tivicay, and monitor blood glucose more closely.
- Other acid-suppressing medicines such as ranitidine and omeprazole can be taken at the same time as Tivicay without any dose adjustment.
Multivitamins and mineral supplements containing calcium, iron, or magnesium are commonly used and can interfere with dolutegravir absorption. The simplest approach is to take Tivicay with food and your supplements at the same time. If you take Tivicay without food, separate them by at least 6 hours before or 2 hours after your dose.
What Is the Correct Dosage of Tivicay?
Always take Tivicay exactly as your healthcare provider has instructed. Do not change your dose or stop taking the medicine without medical advice. Tivicay is available as film-coated tablets (10 mg, 25 mg, 50 mg) and dispersible tablets (5 mg) for patients who cannot swallow standard tablets.
Adults
Standard Dosing
50 mg once daily for treatment-naive and treatment-experienced, integrase inhibitor-naive patients. Take with or without food.
Twice-Daily Dosing
50 mg twice daily is required in the following situations:
- When co-administered with rifampicin, carbamazepine, oxcarbazepine, phenytoin, phenobarbital, or St. John's Wort
- When co-administered with efavirenz, fosamprenavir/ritonavir, nevirapine, or tipranavir/ritonavir
- For patients with suspected or confirmed integrase inhibitor resistance (based on resistance testing)
Children and Adolescents
The dose for children must be determined by the prescribing physician based on the child's weight and age. Children and adolescents weighing 20 kg or more may take the adult dose of 50 mg once daily (or 25 mg twice daily if required). For children from 4 weeks of age weighing between 3 kg and 20 kg, the dose is calculated individually.
| Body Weight | Once-Daily Dose | Tablets per Dose |
|---|---|---|
| 3 to <6 kg | 5 mg | 1 dispersible tablet |
| 6 to <10 kg | 10 mg | 2 dispersible tablets |
| 10 to <14 kg | 15 mg | 3 dispersible tablets |
| 14 to <20 kg | 20 mg | 4 dispersible tablets |
| ≥20 kg | 30 mg or adult dose | 6 dispersible tablets or film-coated tablet |
It is essential that children attend their scheduled medical appointments, as the dose must be adjusted as the child grows. For dispersible tablets: they may be swallowed whole with water or dispersed in drinking water before administration. When dispersing, use the appropriate volume of water as directed, gently swirl the cup for 1–2 minutes until fully dispersed, and administer within 30 minutes. Do not chew, crush, or split the tablets. Children should not swallow more than one tablet at a time when swallowing whole, to reduce the risk of choking.
Elderly Patients
No dose adjustment is required for elderly patients. However, clinical data in patients over 65 years of age is limited. Elderly patients may have reduced hepatic or renal function, and close monitoring is recommended.
Missed Dose
If you miss a dose, take it as soon as you remember. However, if your next scheduled dose is due within 4 hours, skip the missed dose and take the next one at the usual time. Do not take a double dose to make up for a forgotten one. Consistent adherence to your antiretroviral regimen is essential for maintaining viral suppression and preventing the emergence of drug resistance.
Overdose
If you take too many Tivicay tablets, contact your healthcare provider or go to the nearest emergency department immediately. Bring the medicine packaging with you if possible. There is no specific antidote for dolutegravir overdose. Treatment is supportive and symptomatic. Since dolutegravir is highly protein-bound, dialysis is unlikely to significantly remove the drug from the blood.
Take Tivicay for as long as your healthcare provider recommends. Do not stop taking it unless instructed by your doctor. Stopping antiretroviral treatment can cause the virus to rebound, reduce treatment options in the future, and may lead to the development of drug-resistant HIV. If you have concerns about your treatment, speak with your healthcare provider.
What Are the Side Effects of Tivicay?
Like all medicines, Tivicay can cause side effects, although not everyone experiences them. Most side effects are mild to moderate in severity and tend to improve over the first few weeks of treatment. However, some side effects can be serious and require immediate medical attention.
Very Common
May affect more than 1 in 10 people
- Headache
- Diarrhea
- Nausea
Common
May affect up to 1 in 10 people
- Skin rash
- Itching (pruritus)
- Vomiting
- Abdominal pain and discomfort
- Weight gain
- Insomnia (difficulty sleeping)
- Dizziness
- Abnormal dreams
- Depression
- Anxiety
- Fatigue
- Flatulence
- Elevated liver enzymes
- Elevated creatine phosphokinase (CPK)
Uncommon
May affect up to 1 in 100 people
- Hepatitis (liver inflammation)
- Suicidal attempt*
- Suicidal ideation*
- Panic attack
- Joint pain (arthralgia)
- Muscle pain (myalgia)
Rare
May affect up to 1 in 1,000 people
- Liver failure (signs may include yellowing of skin/eyes, dark urine)
- Elevated bilirubin levels
- Suicide*
- Sideroblastic anemia (frequency not known)
* Particularly in patients with a prior history of depression or psychiatric disorders.
Contact your healthcare provider or go to the emergency department immediately if you experience signs of a severe allergic reaction (rash with fever, fatigue, swelling of the face or mouth, difficulty breathing), yellowing of the skin or eyes (possible liver failure), or any thoughts of self-harm or suicide. Tell your doctor immediately about any psychiatric symptoms.
Immune Reconstitution Inflammatory Syndrome (IRIS)
People with advanced HIV infection (AIDS) have weakened immune systems that may have allowed opportunistic infections to go undetected. When antiretroviral treatment strengthens the immune system, it may begin to fight these previously silent infections, causing symptoms of infection or inflammation. These symptoms typically include fever along with headache, stomach pain, or breathing difficulties.
In rare cases, an overactive immune response may also attack the body's own healthy tissues (autoimmune disorders). Symptoms of autoimmune conditions can develop several months after starting HIV treatment and may include rapid or irregular heartbeat, hyperactivity, tremor, or weakness that starts in the hands and feet and moves upward. If you develop any symptoms of infection or inflammation after starting treatment, inform your healthcare provider immediately. Do not take additional medicines for an infection unless your doctor recommends it.
Osteonecrosis
Some patients taking combination antiretroviral therapy develop osteonecrosis, a condition where bone tissue dies due to reduced blood supply. This condition most commonly affects the hips, knees, and shoulders. Risk factors include long-term use of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severely weakened immune system, and obesity. Signs of osteonecrosis include joint stiffness, pain in the joints (especially hips, knees, or shoulders), and difficulty moving. Report these symptoms to your healthcare provider.
Metabolic Changes
During HIV treatment, weight gain and increased levels of blood lipids and blood glucose can occur. This is partly related to restored health and lifestyle changes, but there may also be a link to the HIV medicines themselves. Dolutegravir-based regimens have been associated with greater weight gain compared to some other antiretroviral classes, particularly in treatment-naive patients and in certain demographic groups. Your healthcare provider will monitor your metabolic parameters regularly and may recommend lifestyle modifications or additional treatment if needed.
How Should You Store Tivicay?
Proper storage of Tivicay is essential to maintain its effectiveness and safety. Follow these storage guidelines:
- Keep out of sight and reach of children.
- Do not use after the expiry date printed on the carton and bottle after "EXP."
- Store in the original packaging to protect from moisture.
- Keep the bottle tightly closed at all times.
- Do not remove the desiccant (moisture-absorbing sachet) from the bottle. Do not swallow the desiccant.
- No special temperature storage conditions are required – store at room temperature.
- Do not dispose of medicines via household waste or wastewater. Ask your pharmacist how to dispose of medicines you no longer need. These measures help protect the environment.
For the dispersible tablet formulation, once prepared (dispersed in water), the solution must be administered within 30 minutes. If more than 30 minutes have passed, discard the prepared dose and prepare a new one.
What Does Tivicay Contain?
Understanding what is in your medicine is important, particularly if you have allergies or sensitivities to specific ingredients.
Active Ingredient
Each tablet contains dolutegravir sodium, equivalent to the labeled amount of dolutegravir (5 mg, 10 mg, 25 mg, or 50 mg depending on the formulation and strength).
Inactive Ingredients – Dispersible Tablets (5 mg)
Mannitol (E421), microcrystalline cellulose, povidone, sodium starch glycolate, colloidal silicon dioxide, crospovidone, sodium stearyl fumarate, calcium sulfate dihydrate, sucralose, strawberry cream flavor, titanium dioxide (E171), hypromellose, and macrogol.
Inactive Ingredients – Film-Coated Tablets (10 mg, 25 mg, 50 mg)
The film-coated tablets contain mannitol (E421), microcrystalline cellulose, povidone K29/32, sodium starch glycolate, and sodium stearyl fumarate as core ingredients, with a film coating of polyvinyl alcohol, titanium dioxide (E171), macrogol/PEG, and talc.
Tivicay contains less than 1 mmol (23 mg) sodium per tablet, meaning it is essentially sodium-free. This is relevant for patients on a sodium-restricted diet.
Appearance and Packaging
The 5 mg dispersible tablets are white, round, biconvex tablets imprinted with "SV H7S" on one side and "5" on the other. They are supplied in bottles containing 60 tablets, along with a dosing cup and oral syringe for accurate administration to infants and young children. Film-coated tablets are also supplied in bottles with a desiccant to protect against moisture.
Tivicay is manufactured by GlaxoSmithKline Manufacturing S.p.A. and marketed by ViiV Healthcare, a specialist HIV company majority-owned by GSK with Pfizer and Shionogi as shareholders.
Frequently Asked Questions About Tivicay
Tivicay (dolutegravir) is used to treat HIV-1 infection. It belongs to the integrase inhibitor class and works by preventing the virus from inserting its DNA into human cells. It is always used in combination with other antiretroviral medicines and is approved for adults, adolescents, and children from 4 weeks of age weighing at least 3 kg. The WHO recommends dolutegravir-based regimens as preferred first-line therapy for all populations living with HIV.
The most common side effects (affecting more than 1 in 10 people) are headache, diarrhea, and nausea. Common side effects (up to 1 in 10) include rash, itching, vomiting, abdominal pain, weight gain, insomnia, dizziness, abnormal dreams, depression, anxiety, and fatigue. Most of these are mild to moderate and tend to improve over time. Serious but rare side effects include liver problems and psychiatric symptoms – report any concerns to your doctor.
Antacids and supplements containing calcium, iron, or magnesium can reduce the absorption of Tivicay. Do not take antacids within 6 hours before or 2 hours after your dose. If you take Tivicay with food, you can take your calcium, iron, or magnesium supplements at the same time. If you take Tivicay without food, maintain the 6-hour/2-hour separation. Proton pump inhibitors (like omeprazole) and H2 blockers (like ranitidine) can be taken at the same time without any issue.
Current evidence and updated WHO guidelines support the use of dolutegravir during pregnancy. While early observational data suggested a possible small risk of neural tube defects, larger follow-up studies have shown the risk is very low and close to background rates. The WHO now recommends dolutegravir-based regimens as preferred first-line treatment for all populations, including pregnant women. Never stop your HIV treatment without consulting your healthcare provider, as this could put both you and your baby at risk.
Take the missed dose as soon as you remember. If your next dose is due within 4 hours, skip the missed dose and continue with your regular schedule. Do not take two doses at once. Adherence to your HIV treatment is very important for keeping the virus suppressed and preventing drug resistance. If you frequently miss doses, discuss strategies with your healthcare provider – tools like pill organizers, phone reminders, or simplified regimens may help.
Fampridine (dalfampridine), used for multiple sclerosis, is the only drug that is strictly contraindicated with Tivicay. Several other medicines require dose adjustments or careful monitoring when used with Tivicay, including rifampicin, certain anticonvulsants (phenytoin, phenobarbital, carbamazepine, oxcarbazepine), efavirenz, tipranavir/ritonavir, and St. John's Wort. Always tell your doctor and pharmacist about all the medicines and supplements you take.
References
This article is based on the following peer-reviewed sources and authoritative medical guidelines:
- World Health Organization (WHO). Updated recommendations on first-line and second-line antiretroviral regimens and post-exposure prophylaxis and recommendations on early infant diagnosis of HIV. WHO, 2018 (updated 2022). Available at: who.int
- European Medicines Agency (EMA). Tivicay (dolutegravir) – Summary of Product Characteristics. EMA, 2025. Available at: ema.europa.eu
- Walmsley SL, Antela A, Clumeck N, et al. Dolutegravir plus abacavir-lamivudine for the treatment of HIV-1 infection. N Engl J Med. 2013;369(19):1807–1818. doi:10.1056/NEJMoa1215541
- Zash R, Holmes LB, Diseko M, et al. Update on neural tube defects with antiretroviral exposure in the Tsepamo study, Botswana. 23rd International AIDS Conference (AIDS 2020). Abstract OAXLB0102.
- DHHS Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV. Department of Health and Human Services, 2024. Available at: clinicalinfo.hiv.gov
- British HIV Association (BHIVA). BHIVA guidelines for the treatment of HIV-1-positive adults with antiretroviral therapy. HIV Medicine. 2022;23(S5):3–220.
- Cahn P, Madero JS, Arribas JR, et al. Dolutegravir plus lamivudine versus dolutegravir plus tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naive adults with HIV-1 infection (GEMINI-1 and GEMINI-2): week 144 results from two multicentre, double-blind, randomised, non-inferiority, phase 3 trials. Lancet HIV. 2022;9(1):e31–e43.
- Venter WDF, Moorhouse M, Sokhela S, et al. Dolutegravir plus two different prodrugs of tenofovir to treat HIV. N Engl J Med. 2019;381(9):803–815. doi:10.1056/NEJMoa1902824
About the Editorial Team
This article has been written and reviewed by the iMedic Medical Editorial Team, which includes licensed physicians with specialist training in infectious disease, clinical pharmacology, and internal medicine. All content follows the GRADE evidence framework and is reviewed according to guidelines from the WHO, EMA, FDA, BHIVA, and DHHS.
Medical Review Process
- All claims verified against peer-reviewed literature
- Drug information cross-referenced with EMA SmPC and FDA labeling
- Dosing information validated against current clinical guidelines
- Content updated to reflect latest evidence and recommendations
Editorial Standards
- Evidence Level 1A (systematic reviews, RCTs)
- No pharmaceutical industry funding
- Independent editorial decisions
- Regular updates based on new evidence