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lamivudine + zidovudine + abacavir (abacavir + Combivir / Combivir + abacavir / Trizivir)

✓ Approved

Shire · · Small Molecule

What is lamivudine + zidovudine + abacavir?

lamivudine + zidovudine + abacavir is a small molecule developed by Shire. It is approved for therapeutic indications via oral (po).

Drug Profile

Brand Namesabacavir + Combivir, Combivir + abacavir, Trizivir
CompanyShire
Drug ClassSmall Molecule
RouteOral (PO)
StatusApproved
Sources: ClinicalTrials.gov, Shire

Mechanism of Action

Molecular Targets

lamivudine + zidovudine + abacavir acts on 1 molecular target:

gag-pol, HIV-1 (gag-pol)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

lamivudine + zidovudine + abacavir is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Infections and infestationsAcquired immunodeficiency syndrome✓ Approved

Related Research Articles

PubMedHealth science reports2026-11-11

Low Level Viremia in Early HIV RNA Kinetics in Naïve People Living With HIV Treated With Bictegravir/Emtricitabine/Tenofovir Alafenamide or Dolutegravir/Abacavir/Lamivudine: An Observational Multicenter Retrospective Study.

Bonadiman Nicola N, Basso Monica M, Rossi Maria Cristina MC, Giobbia Mario M et al.

Integrase inhibitors have a pivotal role in antiviral therapyA quarter of PLWH had LLV after 3 months of treatmentPLWH with LLV had immunological parameters lower than PLWH with virological suppression but comparable to those with partial response.

PMID 43011739
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PubMedAntimicrobial agents and chemotherapy2026-11-10

Population pharmacokinetic analysis of lamivudine (3TC) in HIV-exposed neonates and pediatric participants living with HIV-1 from the IMPAACT 2019 and PETITE studies.

Costa Ana Carolina Conchon ACC, Lin Yu-Wei Y-W, Chandasana Hardik H, Collins Jon J et al.

Lamivudine is a nucleoside reverse transcriptase inhibitor widely used in combination antiretroviral therapy for the treatment of human immunodeficiency virus infection. Accurate dose selection in neonates and young children remains challenging because of rapid developmental changes in renal clearance. We updated an existing pediatric population pharmacokinetic (PopPK) model, previously developed using data from 210 participants across five studies, by incorporating a maturation function and integrating pharmacokinetic data from two additional studies, IMPAACT 2019 (n = 55) and PETITE (n = 24, all neonates), for a total of 289 participants aged 0.0137 (~5 days) to 19.1 years. Unlike the prior model, which did not include a maturation function, the refined PopPK model incorporates a sigmoid Emax maturation function on clearance (postmenstrual age at which clearance reaches 50% of its mature [adult] value (TM50) 51.4 weeks postmenstrual age; Hill coefficient 4.81), reflecting developmental immaturity of clearance mechanisms in early life. The PopPK model retained a one-compartment structure with first-order absorption and linear elimination. Estimation of allometric exponents for body weight further improved model fit, and inter-individual and inter-occasion variability were included in clearance, volume, and absorption rate constant. Model performance was assessed using standard goodness-of-fit diagnostics and visual predictive checks, which demonstrated good agreement between observed and model-predicted concentrations across the pediatric age and weight range. In conclusion, incorporation of a maturation function on clearance successfully extended the pediatric lamivudine PopPK model to term neonates and infants, with parameter estimates remaining consistent with the original model, supporting model-informed dose selection in this understudied population.

PMID 43007007
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PubMedCurrent HIV research2026-11-05

Abacavir-Containing Versus Abacavir-Free Dolutegravir-Based Regimens: A Cardiovascular Pharmacovigilance Analysis.

Hasebe Shigeru S, Tanaka Masayuki M, Iwane Shiori S, Tsuji Toshikazu T et al.

To address the long-standing debate over the cardiovascular safety of Abacavir (ABC) in Human Immunodeficiency Virus (HIV) medicine, we directly compared two contemporary regimens sharing a dolutegravir (DTG)/lamivudine (3TC) backbone: DTG/ABC/3TC and DTG/3TC. We assessed whether the ABC-containing regimen was associated with disproportionate reporting signals for Major Adverse Cardiovascular Events (MACE). We analyzed reports from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database covering 2020 Q1-2025 Q2, after consolidation by case identifier. Outcome-specific populations were created by excluding reports suggestive of pre-existing outcome-related conditions. Propensity score matching balanced measured covariates, and conditional logistic regression estimated Odds Ratios (ORs). For 3-point MACE, 1,642 matched pairs were analyzed. The ABC-containing regimen showed higher reporting odds (OR, 2.82; 95% confidence interval [CI], 1.62-4.91). Hypertension, dyslipidemia, and diabetes mellitus signals were also elevated. Age-only multiple imputation yielded a similar estimate; complete-case estimates were attenuated. These hypothesis-generating findings indicate cardiovascular and cardiometabolic reporting signals with the ABC-containing regimen; residual confounding and uncertain exposure-event timing preclude causal interpretation.

PMID 42983939
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PubMedThe Journal of clinical investigation2026-11-05

Cellular senescence mediates facioscapulohumeral muscular dystrophy.

Jung Usuk U, Wei Erdong E, Mitanoska Ana A, Heher Philipp P et al.

Facioscapulohumeral muscular dystrophy (FSHD) is driven by aberrant expression of the early embryonic transcription factor Double Homeobox 4 (DUX4), yet the mechanisms linking low, sporadic DUX4 activity to progressive muscle degeneration remain unclear. Here, we identify cellular senescence as a central and early mechanism in FSHD pathogenesis. Analysis of patient muscle transcriptomes revealed strong enrichment of senescence and senescence-associated secretory phenotype (SASP) programs that correlated with DUX4 activity, clinical severity, and histopathological changes. Notably, these signatures were detectable even in STIR-negative muscles, defining a prodystrophic state characterized by early molecular alterations preceding overt MRI-detectable inflammation and highlighting their potential utility as early biomarkers of disease activity. Using an FSHD mouse model, we show that DUX4-induced muscle injury rapidly triggers senescence, which then progressively expands. Fibroadipogenic progenitors and macrophages emerged as the principal senescent populations and key sources of pro-inflammatory and profibrotic SASP signals. Importantly, senescence was therapeutically modifiable. Treatment with the nucleoside reverse transcriptase inhibitor lamivudine (3TC), which inhibits LINE-1 reverse transcriptase activity, significantly reduced senescence, inflammation, and fibrosis while promoting muscle regeneration. These findings identify cellular senescence as a tractable driver of FSHD and warrant senotherapeutic strategies, particularly lamivudine, for clinical intervention in FSHD.

PMID 42986690
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PubMedAntimicrobial agents and chemotherapy2026-11-03

Population pharmacokinetic modeling of abacavir in HIV-exposed neonates and children with HIV-1 using data from the IMPAACT 2019 and PETITE studies.

Kang Won-Ho W-h, Lin Yu-Wei Y-W, Chandasana Hardik H, Collins Jon J et al.

Abacavir (ABC) is one of the primary HIV nucleoside reverse transcriptase inhibitors used in pediatric antiretroviral therapy, yet optimal dosing in neonates and infants is challenging because of rapid developmental changes that influence its pharmacokinetics (PK). In this work, a previously developed pediatric population pharmacokinetic (PopPK) model for ABC was refined to extend its applicability to neonates and young infants by incorporating maturation-related processes and newly available clinical data. PK data from the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) 2019 and PETITE studies, which included term neonates (<28 days of life) and infants (<2 years), were integrated into a historical pooled data set of five pediatric studies. Multiple maturation functions and body weight scaling approaches were systematically evaluated to describe developmental changes in ABC disposition. Model performance was assessed using standard goodness-of-fit diagnostics and prediction-corrected visual predictive checks. The final PopPK model incorporated a sigmoid Emax maturation function on oral clearance together with an age-dependent absorption rate constant, providing an accurate description of ABC PK across the full pediatric age range. The updated model successfully captured the higher systemic exposures observed in neonates and infants with immature metabolic capacity during early life. The ABC PK model supports evidence-based dosing guidance for term neonates and young infants.

PMID 42975412
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PubMedNature communications2026-11-02

First-line dolutegravir/lamivudine in HIV-1 infection: lymph node penetration and reservoir decline in a randomized open-label clinical trial.

Rosen Elias P EP, Bondoc Stephen S, Bailón Lucía L, Blay Lidia L et al.

Dual antiretroviral therapy with dolutegravir and lamivudine (DTG/3TC) is a recommended first-line regimen for people with HIV, but whether reduced-drug therapy maintains adequate antiviral pressure within lymph node (LN) reservoirs remains uncertain. In the DUALITY clinical trial (EudraCT number 2019-002733-10), the prespecified primary endpoint-change in proviral HIV-1 DNA in peripheral blood CD4 + T cells from baseline to week 48-was similar between participants initiating DTG/3TC or dolutegravir-based triple therapy. Here, we investigated prespecified secondary endpoints comprising viral persistence and antiretroviral drug penetration and distribution in LN using multimodal imaging. In 39 participants undergoing inguinal LN excision at baseline or during the first year of treatment, HIV-1 DNA and RNA were detected by DNAscope/RNAscope and antiretroviral spatial distribution was mapped by mass spectrometry imaging. HIV-1-infected cells declined rapidly after treatment initiation across both treatment groups. Antiretrovirals were widely detected within LN tissue regions containing or adjacent to HIV-positive cells. These findings provide spatial evidence that DTG/3TC reaches LN tissue and HIV-positive cells, extending peripheral blood observations to a key anatomical HIV reservoir.

PMID 42967902
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