lamivudine
Regulatory sources consulted
Approved indications
- Combination antiretroviral treatment of HIV infection in adults and children.
Contraindications
Absolute
- Hypersensitivity to lamivudine.
Clinical warnings
- In HBV coinfection, discontinuation may cause severe hepatitis exacerbation; monitor liver function and markers after stopping. — CIMA/AEMPS, ficha técnica 96015002
- It may cause pancreatitis, especially in pediatrics, and lactic acidosis/hepatomegaly with steatosis; discontinue if suspected. — CIMA/AEMPS, ficha técnica 96015002
Drug interactions
- ModerateOther lamivudine- or emtricitabine-containing medicines
Mechanism: They duplicate analogues with overlapping activity and resistance.
Recommendation: Do not combine or duplicate.
CIMA/AEMPS, ficha técnica 96015002
- HighTrimethoprim/sulfamethoxazole
Mechanism: Trimethoprim increases lamivudine exposure by 40%.
Recommendation: Avoid high doses used for PCP or toxoplasmosis; with standard doses monitor clinically and adjust in renal impairment.
CIMA/AEMPS, ficha técnica 96015002
- HighCladribine
Mechanism: Lamivudine may inhibit its phosphorylation and reduce efficacy.
Recommendation: The combination is not recommended.
CIMA/AEMPS, ficha técnica 96015002
Adverse events
Common (≥1%)
Headache, nausea, diarrhea, fatigue, and cough
Rare but serious
Pancreatitis, lactic acidosis, hepatomegaly with steatosis, and hepatitis B exacerbation
Pregnancy and lactation
It may be used during pregnancy within an antiretroviral regimen when indicated. The label advises against breastfeeding in treated people with HIV.
Recent literature (PubMed)
Although single-tablet, oral bictegravir, emtricitabine, and tenofovir alafenamide or dolutegravir and lamivudine are preferred regimens in several major guidelines and are widely used in many countries, they have not been compared in a fully powered trial. This study aimed to prospectively compare the 48-week results of dolutegravir and lamivudine versus bictegravir, emtricitabine, and tenofovir alafenamide as maintenance therapies for people with HIV. PASO-DOBLE is a randomised, multicentre, open-label, non-inferiority trial done over 48 weeks at 30 sites in Spain. Adults (aged ≥18 years) with HIV-1, without previous viral failure, who had reached virological suppression on oral regimens containing at least one pill a day, cobicistat, efavirenz, or tenofovir disoproxil fumarate and no previous use of dolutegravir or bictegravir, and plasma HIV-1 RNA <50 copies per mL for at least 24 weeks were eligible. Participants were randomly assigned (1:1) to switch regimens to dolutegravir 50 mg and lamivudine 300 mg or bictegravir 50 mg, emtricitabine 200 mg, and tenofovir alafenamide 25 mg once daily, using random block permutation, stratified by tenofovir alafenamide presence at baseline and sex assigned at birth. The primary endpoint was the proportion of participants with HIV RNA ≥50 copies per mL at week 48 in the intention-to-treat exposed population (ie, all participants who received at least one dose of study medication). The primary and safety analysis was done in the intention-to-treat exposed population. The non-inferiority margin was 4%. This trial is registered with ClinicalTrials.govNCT04884139 and is incomplete. Between July 14, 2021, and March 24, 2023, 553 participants initiated dolutegravir and lamivudine (n=277) or bictegravir, emtricitabine, and tenofovir alafenamide (n=276). The difference in the proportion of participants with HIV RNA ≥50 copies per mL between the dolutegravir and lamivudine group (six [2%] of 277) and bictegravir, emtricitabine, and t
Post-exposure prophylaxis (PEP) to prevent HIV acquisition has been recommended for over three decades, but remains underutilised. Over the past decade, clinical trials have established the safety and tolerability of newer PEP regimens, particularly those containing integrase strand transfer inhibitors (INSTIs) combined with a tenofovir and lamivudine or emtricitabine backbone. Several of these regimens were better tolerated than historical controls. Studies in macaques found that shorter courses of PEP with INSTIs were effective, particularly if dosing occurred close to the time of retroviral exposure. Despite the increase in well tolerated options, PEP seems to be underused globally and links to other prevention services are suboptimal. Interventions to increase provider and community awareness of PEP are needed. Lamivudine has been well studied in HIV-positive nursing mothers and appears to be well tolerated by their breastfed infants. It has not been studied in HIV-negative nursing mothers being treated for hepatitis B infection, but the low doses used would not be expected to cause any serious adverse effects in breastfed infants. The manufacturer estimates that a breastfed infant's dose would be about 6% of the infant dose for children over 2 years of age. Achieving and maintaining viral suppression with antiretroviral therapy decreases breastfeeding transmission risk to less than 1%, but not zero. Individuals with HIV who are on antiretroviral therapy with a sustained undetectable viral load and who choose to breastfeed should be supported in this decision. If a viral load is not suppressed, banked pasteurized donor milk or formula is recommended.[1,2] Extended postnatal prophylaxis of breastfed infants with lamivudine should continue until breastfeeding is stopped.[3] An expert review of available data concluded that there is currently no justification for contraindicating the use of lamivudine for hepatitis B therapy during breastfeeding.[4] Some profession
Diabetic macular edema (DME) affects millions worldwide. Intraocular injections of expensive anti-vascular endothelial growth factor (VEGF) inhibitors associated with complications are standard therapy. Lamivudine, an inexpensive oral drug, inhibits inflammasome activation, which is implicated in DME. This randomized, double-blind, placebo-controlled trial compared oral lamivudine to placebo for improving visual acuity in center-involved DME (CI-DME). Twenty-four adults enrolled between February 2022 and September 2023 with 1 or 2 eyes with CI-DME and a best-corrected visual acuity (BCVA) of less than 69 letters (Brazilian Registry of Clinical Trials RBR-87b6r5s) were randomized to lamivudine (150 mg twice daily; 10 participants; 16 eyes) or placebo (14 participants; 21 eyes) for 8 weeks. Participants were assigned intravitreous bevacizumab (1.25 mg) at week 4. Co-primary outcomes were mean changes in BCVA from baseline to weeks 4 and 8. Comparisons to anti-VEGF drugs used synthetic controls from DRCR.net Protocol T. Secondary outcomes included retinal thickness and adverse events. At 4 weeks, BCVA improved 9.8 letters with lamivudine and decreased 1.8 letters with placebo (p < 0.001). At 8 weeks, BCVA improved 16.9 letters with lamivudine and bevacizumab and 5.3 letters with placebo and bevacizumab (p < 0.001). Lamivudine was associated with greater BCVA improvement than bevacizumab or ranibizumab (p < 0.05) and was not different from aflibercept (p = 0.5). There was no significant difference in retinal thickness or adverse events between groups. Lamivudine, an oral inflammasome inhibitor, significantly improved vision in patients with CI-DME. This work was supported by Universidade Federal de São Paulo, Latinofarma, UVA SIF, and NIH. The antivirals are a large and diverse group of agents that are typically classified by the virus infections for which they are used, their chemical structure and their mode of action. Most antiviral agents have been developed in the