lamivudine and tenofovir disoproxil
Regulatory sources consulted
Approved indications
- Treatment of HIV-1 in adults and patients weighing at least 35 kg, always with other antiretrovirals.
Contraindications
Absolute
- Hypersensitivity to lamivudine or tenofovir disoproxil.
Clinical warnings
- Withdrawal in HBV coinfection may cause severe exacerbation; monitor liver function for several months. — DailyMed, set_id a300f04d-118f-4136-aaf3-ddfd00197f86
- Tenofovir may cause renal injury, Fanconi syndrome, and bone toxicity; monitor renal function and phosphate. — DailyMed, set_id a300f04d-118f-4136-aaf3-ddfd00197f86
Drug interactions
- HighNephrotoxic drugs or products containing lamivudine, emtricitabine, TDF, or TAF
Mechanism: They increase renal toxicity or duplicate analogues.
Recommendation: Avoid duplication and monitor renal function.
DailyMed, set_id a300f04d-118f-4136-aaf3-ddfd00197f86
- HighBoosted atazanavir, darunavir, or lopinavir
Mechanism: Boosted protease inhibitors may increase tenofovir exposure and renal toxicity.
Recommendation: Atazanavir must be given with ritonavir; with atazanavir/ritonavir, darunavir/ritonavir, or lopinavir/ritonavir, closely monitor renal toxicity.
DailyMed, set_id a300f04d-118f-4136-aaf3-ddfd00197f86
- ModerateChronic sorbitol administration
Mechanism: Sorbitol reduces lamivudine exposure in a dose-dependent manner.
Recommendation: Avoid chronic coadministration when possible.
DailyMed, set_id a300f04d-118f-4136-aaf3-ddfd00197f86
Adverse events
Common (≥1%)
Headache, diarrhea, nausea, and fatigue
Rare but serious
Lactic acidosis, renal failure, Fanconi syndrome, and HBV exacerbation
Pregnancy and lactation
It may be used during pregnancy when indicated. Do not breastfeed during HIV treatment.
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
Dolutegravir (DTG)/lamivudine dual therapy (DT) has demonstrated noninferiority to triple therapy (TT) in the GEMINI trials. Although the population with ≤200 CD4 cells/mm3 had a lower response rate, this was unrelated to virological failure. This trial evaluated the antiviral activity of dolutegravir/lamivudine among antiretroviral therapy (ART)-naive patients with human immunodeficiency virus (HIV) with a CD4 count ≤200 cells/mm3. DOLCE is a randomized, hypothesis-based, open-label, multicenter study l, assessing the antiviral efficacy of DTG/3TC at week 48 in treatment-naive people with HIV (PWH) with CD4 counts ≤200 cells/mm3. Participants were randomly assigned in a 2:1 ratio to receive DTG/3TC as a single tablet regimen or DTG plus Tenofovir disoproxil fumarate (TDF)/XTC: Emtricitabine or lamivudine (FTC or 3TC). The primary endpoint was the proportion of participants with pVL <50 copies/mL at week 48 (Food and Drug Administration snapshot analysis intent-to-treat exposed population). This report presents results at week 48. Baseline characteristics were similar in both arms. In the DT arm, median CD4 cell count was 109 cells/mm (interquartile range [IQR]: 49-177) and median pVL was 180,000 copies/mL (IQR: 53 309-468 691); 45.4% had CD4 <100 cells/mm3, and 61.4% had pVL >100 000 copies/mL. CDC (Centers for Disease Control and Prevention) stage C: 31.4%. At week 48, virological suppression (pVL <50 copies/mL) was achieved 82.2% in the DT (125/152), and the CD4 count increased by +200 cells/mm3. Per-protocol analysis showed a response rate of 91.9%. Severe adverse events (n = 17) were reported in 15 of 152 participants (11.1%). Dolutegravir/3TC demonstrated high efficacy in a population with low CD4 counts and high viral load. This study adds information regarding the efficacy and safety of DTG/3TC, regardless of baseline CD4 counts and viral load. NCT04880395.
Nonoccupational postexposure prophylaxis (nPEP) for HIV is recommended when a nonoccupational (e.g., sexual, needle, or other) exposure to nonintact skin or mucous membranes that presents a substantial risk for HIV transmission has occurred, and the source has HIV without sustained viral suppression or their viral suppression information is not known. A rapid HIV test (also referred to as point-of-care) or laboratory-based antigen/antibody combination HIV test is recommended before nPEP initiation. Health care professionals should ensure the first dose of nPEP is provided as soon as possible, and ideally within 24 hours, but no later than 72 hours after exposure. The initial nPEP dose should not be delayed due to pending results of any laboratory-based testing, and the recommended length of nPEP course is 28 days. The recommendations in these guidelines update the 2016 nPEP guidelines (CDC. Updated guidelines for antiretroviral postexposure prophylaxis after sexual, injection drug use, or other nonoccupational exposure to HIV - United States, 2016. Atlanta, GA: US Department of Health and Human Services, CDC; 2017). These 2025 nPEP guidelines update recommendations and considerations for use of HIV nPEP in the United States to include newer antiretroviral (ARV) agents, updated nPEP indication considerations, and emerging nPEP implementation strategies. The guidelines also include considerations for testing and nPEP regimens for persons exposed who have received long-acting injectable ARVs in the past. Lastly, testing recommendations for persons who experienced sexual assault were updated to align with the most recent CDC sexually transmitted infection treatment guidelines. These guidelines are divided into two sections: Recommendations and CDC Guidance. The preferred regimens for most adults and adolescents are now bictegravir/emtricitabine/tenofovir alafenamide or dolutegravir plus (tenofovir alafenamide or tenofovir disoproxil fumarate) plus (emtricitabine or lami
The European AIDS Clinical Society (EACS) guidelines were revised for the 21st time in 2025, with updates covering all aspects of HIV care. The structure of the guidelines has been reorganized into two parts: Part I focuses on the management and prevention of HIV and related infections, and Part II addresses comorbidities and other relevant topics. In Part I, Version 13.0 recommends the following first-line regimens for adults with HIV-1: tenofovir disoproxil fumarate (TDF) or tenofovir alafenamide (TAF) with either lamivudine or emtricitabine (XTC), in combination with dolutegravir (DTG), bictegravir (BIC), or doravirine (DOR); or a dual therapy option consisting of XTC plus DTG. Version 13.0 introduces a completely new section on HIV-2. The preferred first-line regimens for HIV-2 include triple therapy with a second-generation integrase inhibitor: either TAF/FTC/BIC or TDF/XTC + DTG. The PrEP section has been updated to include the use of long-acting injectable antiretrovirals. Drug-drug interaction (DDI) tables have been updated to include long-acting antiretrovirals and considerations related to substance use, including drugs used to enhance or prolong sexual activity (chemsex). Tables for preferred and alternative ART regimens in children and adolescents have been updated, with particular attention to neonates. A new section on transition to adult care has also been included. The co-infections section has undergone extensive revision, especially regarding HBV, sexually transmitted infections, opportunistic infections (particularly tuberculosis, leishmaniasis, and cryptococcosis) and mpox, incorporating recent clinical trial data on tecovirimat. In Part II, Version 13.0 introduces major updates to the comorbidities section. In the cancer section, screening recommendations for anal and breast cancer have been updated. Cardiovascular and metabolic health sections have been significantly modified, reflecting recent advances and the use of statins in people with HIV
To assess efficacy and safety of dolutegravir (DTG) + lamivudine (3TC) vs. DTG + tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) in treatment-naive adults with HIV-1 in the prespecified 144-week secondary analyses of GEMINI-1 and GEMINI-2. Identical, multicenter, phase III, randomized, non-inferiority studies (double-blind through 96 weeks). Participants with HIV-1 RNA ≤500 000 copies/ml and no major viral resistance mutations to nucleoside reverse transcriptase inhibitors, nonnucleoside reverse transcriptase inhibitors, or protease inhibitors were randomized 1:1 to once-daily DTG + 3TC or DTG + TDF/FTC. At week 144, DTG + 3TC (N = 716) was noninferior to DTG + TDF/FTC (N = 717) in proportion of participants achieving HIV-1 RNA <50 copies/ml (Snapshot algorithm) in the pooled analysis (82% vs. 84%, respectively; adjusted treatment difference [95% confidence interval (CI)], -1.8% [-5.8, 2.1]), GEMINI-1 (-3.6% [-9.4, 2.1]), and GEMINI-2 (0.0% [-5.3, 5.3]). Twelve DTG + 3TC participants and nine DTG + TDF/FTC participants met protocol-defined confirmed virologic withdrawal (CVW) criteria; none developed treatment-emergent resistance. One DTG + 3TC participant who did not meet CVW criteria developed M184V at week 132 and R263R/K at week 144, conferring a 1.8-fold change in susceptibility to DTG; non-adherence to therapy was reported. Significantly fewer drug-related adverse events occurred with DTG + 3TC vs. DTG + TDF/FTC (20% vs. 27%; relative risk [95% CI], 0.76 [0.63-0.92]). Renal and bone biomarker changes favored DTG + 3TC. Three-year durable efficacy, long-term tolerability, and high barrier to resistance support first-line use of DTG + 3TC for HIV-1 treatment (see Supplemental Digital Content 1, http://links.lww.com/QAD/C297; video abstract).