Does Dovato cause kidney damage?
Dovato (dolutegravir and lamivudine) is not known to cause kidney damage. However, Dovato is not recommended for people with severe kidney problems due to the risk of too much medication building up in the body.
In 96-week clinical trials, only two kidney-related side effects were reported among 716 patients taking Dovato. Dolutegravir (one of the active ingredients in Dovato) blocks a waste product called creatinine from leaving the kidneys, which leads to a reversible increase in serum creatinine levels. This typically happens during the first 4 weeks of treatment, and doesn’t usually affect glomerular filtration rate (GFR) or cause structural kidney damage. Creatinine clearance is a test that helps healthcare providers assess your kidney function. While too much creatinine can indicate a problem with the kidneys, in this case it is due to certain effects of the medication that do not harm the kidneys.
In studies of dolutegravir, serum creatinine stabilized after the first 4 weeks and remained about the same through 144 weeks. The change in serum creatinine was minor and not considered to be a problem. Another small placebo-controlled study looking at the effect of dolutegravir on kidney function found that the medication did not affect GFR in healthy people.
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Can I take Dovato if I have kidney problems?
Your healthcare provider can test your kidney function and determine if Dovato is safe for you to take. This medication is cleared from the body by the kidneys, and people with poor kidney function might not be able to process it as well as people with healthy kidneys. This could lead to the medication building up in the body, which could cause more side effects.
Dovato is not recommended for people with creatinine clearance less than 30 mL/min. This is because it is a fixed dose combination, and the dose of lamivudine cannot be adjusted in people with poor kidney function. Patients with creatinine clearance between 30 and 49 mL/min taking Dovato have been shown to have up to about 3 times more lamivudine in the body than patients with creatinine clearance of 50 mL/min or higher. Talk to your healthcare provider if you experience any side effects from Dovato.
This is not all the information you need to know about Dovato (dolutegravir and lamivudine) for safe and effective use and does not take the place of your doctor’s directions. Review the full product information and discuss this information and any questions you have with your doctor or other health care provider.
References
Cahn, P., et. al. 2019. Durable Efficacy of Dolutegravir Plus Lamivudine in Antiretroviral Treatment–Naive Adults With HIV-1 Infection: 96-Week Results From the GEMINI-1 and GEMINI-2 Randomized Clinical Trials. In: Journal of Acquired Immune Deficiency Syndromes. DOI: https://doi.org/10.1097/QAI.0000000000002275
Dovato [package insert]. Updated April 2024. ViiV Healthcare Company. Accessed 03/04/2025 at https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=68e45422-43ed-4cfb-9356-fae88d14a53a
Milburn, J., et. al. 2016. Renal effects of novel antiretroviral drugs. In: Nephrology Dialysis Transplantation. DOI: https://doi.org/10.1093/ndt/gfw064
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Drug information
- Dovato Information for Consumers
- Dovato prescribing info & package insert (for Health Professionals)
- Side Effects of Dovato (detailed)
- Dovato user reviews (49)
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