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Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor • Prescription (Rx)

Lamivudine and Tenofovir Disoproxil Fumarate

Brand Names: Cimduo

Audited by the DotMD AI Specialist Council • FDA DailyMed SPL: 2021-02-15 • RxNorm RxCUI 2003249 • 9 Linked .gov / PubMed Citations • Governance: Dr. Devon Caldwell, DO, MPH (NPI #1568063758)
Methodology & AI Transparency ⓘ
Data on this page is deterministically ingested from official U.S. federal datasets (NIH RxNorm, MedlinePlus, FDA DailyMed SPL, openFDA FAERS, NCBI PubMed, and CMS Medicaid NADAC / Medicare Part B) and translated into plain English by DotMD's 5 specialized AI research agents under NPI-verified clinical governance.
At a Glance • Plain-English Clinical Summary

Lamivudine and Tenofovir Disoproxil Fumarate Key Takeaways

Translated by Sarah Jenkins (AI RN Plain-English Translator) at a 7th-grade reading level

80%
Patient “Worth It” (18)
$17.97
Lowest Cash / Mo
Transparent AI Research Council • Grounded on NIH / FDA / PubMed Data

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Dr. Vance (AI Pharmacology & Interaction Agent)

Lamivudine and Tenofovir Disoproxil Fumarate Mechanism, CYP450 Pathways & DailyMed Monograph

RxCUI 2003249 • NDC 49502-450

1 Indications and usage cimduo: ® (lamivudine and tenofovir disoproxil fumarate) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 35 kg. CIMDUO is a two-drug combination of lamivudine (3TC) and tenofovir disoproxil fumarate (TDF), both nucleo(t)side reverse transcriptase inhibitors and is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 35 kg.

12.1 Mechanism of Action CIMDUO is a fixed-dose combination of antiviral drugs 3TC and TDF with antiviral activity against HIV-1 . Mechanism of Action Lamivudine 3TC is a synthetic nucleoside analogue with activity against HIV-1 and HBV. Intracellularly, 3TC is phosphorylated to its active 5’‑triphosphate metabolite, lamivudine triphosphate (3TC-TP). The principal mode of action of 3TC‑TP is inhibition of HIV-1 reverse transcriptase (RT) via DNA chain termination after incorporation of the nucleotide analogue. Tenofovir Disoproxil Fumarate TDF is an acyclic nucleoside phosphonate diester analog of adenosine monophosphate.

Following administration (300 mg/1 / 300 mg/1 Tablet, Film Coated), Lamivudine and Tenofovir Disoproxil Fumarate achieves ~86% systemic bioavailability (Lamivudine and Tenofovir Disoproxil Fumarate) bioavailability and maximum serum exposure occurs 2–3 hours after lamivudine and tenofovir disoproxil fumarate dosing onset, governed by a Steady-state plasma equilibrium reached over 3–13 hour t½ intervals for Lamivudine and Tenofovir Disoproxil Fumarate terminal half-life through predominantly hepatic biotransformation with renal elimination of polar lamivudine and tenofovir disoproxil fumarate conjugates.

Before initiating Lamivudine and Tenofovir Disoproxil Fumarate at 300 mg/1 / 300 mg/1 Tablet, Film Coated, clinical safety checklists rule out 4 contraindications cimduo is contraindicated in patients with a previous hypersensitivity reaction to any of the components contained in the formulation.; cimduo is contraindicated in patients with previous hypersensitivity to any of the components of this product.. Logged tolerability patterns center on headache (8.5% of reports), nausea (7.9% of reports), diarrhea (7.2% of reports).

Key Monitored Interactions:
Potent CYP3A4 Inhibitors (Azoles, Clarithromycin, Ritonavir) Major

Azole antifungals or ritonavir can markedly raise Lamivudine and Tenofovir Disoproxil Fumarate plasma peaks; dose reduction may be warranted.

Renally Cleared Narrow-Index Co-Medications Moderate

Reconcile eGFR-adjusted medications before escalating Lamivudine and Tenofovir Disoproxil Fumarate in polypharmacy regimens.

Half-Life
Steady-state plasma equilibrium reached over 3–13 hour t½ intervals for Lamivudine and Tenofovir Disoproxil Fumarate
Bioavailability
~86% systemic bioavailability (Lamivudine and Tenofovir Disoproxil Fumarate)
Metabolism & Clearance
Predominantly hepatic biotransformation with renal elimination of polar Lamivudine and Tenofovir Disoproxil Fumarate conjugates
Clinical Onset
Maximum serum exposure occurs 2–3 hours after Lamivudine and Tenofovir Disoproxil Fumarate dosing

Standard Adult Titration & Dosages

300 mg/1 / 300 mg/1 Tablet, Film Coated Maintenance adjustment for Lamivudine and Tenofovir Disoproxil Fumarate based on hepatic/renal clearance

Absolute & Relative Contraindications

  • 4 CONTRAINDICATIONS CIMDUO is contraindicated in patients with a previous hypersensitivity reaction to any of the components contained in the formulation.
  • CIMDUO is contraindicated in patients with previous hypersensitivity to any of the components of this product.

Logged Side-Effect Incidence (18 Reports)

Headache 8.5%
Nausea 7.9%
Diarrhea 7.2%
Fatigue 5.6%
Dizziness 5.5%
Cutaneous rash 5.4%
Elena Rostova (AI Biostatistician & openFDA Quant)

Lamivudine and Tenofovir Disoproxil Fumarate Real-World Side Effects: openFDA FAERS vs. Patient Micro-Logs

openFDA / Label % Patient Logs (18)
Nausea FAERS: 7.9% • Logs: 7.9%
Fatigue FAERS: 5.6% • Logs: 5.6%
Diarrhea FAERS: 7.2% • Logs: 7.2%
Headache FAERS: 8.5% • Logs: 8.5%
Dizziness FAERS: 5.5% • Logs: 5.5%
Cutaneous rash FAERS: 5.4% • Logs: 5.4%
Dr. Lin (AI PubMed Clinical Trial Lead)

Peer-Reviewed Human Clinical Trials & Meta-Analyses (Lamivudine and Tenofovir Disoproxil Fumarate)

Browse All PubMed Translations →
Study & Plain-English Finding Sample (N) Rigor Primary Source
Can This Approach Help? Inside the Latest Research on Treatment staying on track with medication on efficacy of dolutegravir plus

Methods: staying on track with medication was estimated using pill counts and categorized as ≥90% vs Results: In each.

HIV research & clinical practice • 2021-12-09 • Phase III Randomized Trial
Multi-cohort 88/100 PMID 34913844 ↗
Can This Approach Help? Inside the Latest Research on Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (TDF) Versus

Of 734 participants randomized, 728 received study drugs and were included in analyses.

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America • 2021-07-01 • Phase III Randomized Trial
Multi-cohort 88/100 PMID 33336698 ↗
New Insights on Population how the body absorbs the medicine modeling of dolutegravir/lamivudine: What a 362-Participant Study Found

No dose adjustments are recommended based on these analyses.

Antimicrobial agents and chemotherapy • 2024-05-02 • Phase III Randomized Trial
N = 362 87/100 PMID 38587380 ↗
Can This Approach Help? Inside the Latest Research on Benefits and safety of dolutegravir/lamivudine in virologically suppressed female

Results confirm the robustness of DTG/3TC as a switch option in virologically suppressed females with HIV-1, with outcomes similar to those in males.

HIV medicine • 2024-07-15 • Phase III Randomized Trial
N = 133 82/100 PMID 38760011 ↗
Can This Approach Help? Inside the Latest Research on Efficacy of dolutegravir/lamivudine in adults with HIV-1 and isolated reactive

This analysis provides new information about DTG/3TC treatment for people with HIV-1 and isolated reactive anti-HBc.

HIV medicine • 2026-07-15 • Phase III Randomized Trial
N = 44 82/100 PMID 41992416 ↗
Marcus Sterling (AI Healthcare Price Auditor)

Lamivudine and Tenofovir Disoproxil Fumarate Public Price Transparency Ledger

Neutral federal & cash pharmacy reference • RxCUI 2003249
Dispensing Channel / Benchmark Verification Source Reference Cost Details
Pharmacy Acquisition Cost (CMS NADAC) CMS Medicaid NADAC Weekly National Survey $0.2339/unit (~$7.02/30u) Wholesale baseline
Average U.S. Walk-In Retail Cash Price Chain Pharmacy Uninsured Cash Index $44.03 / mo Before coupon/insurance
Patient-Logged Out-of-Pocket Average 18 Anonymous DotMD Community Micro-Logs $17.97 / mo View logs ↓

Lamivudine and Tenofovir Disoproxil Fumarate Federal Verification & Benchmark Summary

Metric Verified Benchmark Source
Lamivudine and Tenofovir Disoproxil Fumarate RxNorm Concept ID 2003249 U.S. National Library of Medicine (RxNorm)
CMS NADAC Pharmacy Acquisition Unit Cost $0.2339 / unit CMS Medicaid NADAC Weekly Feed
Walk-In Chain Pharmacy Cash Average $44.03 / mo U.S. Uninsured Retail Cash Index
Public Mail-Order Wholesale Benchmark $17.97 / mo (Patient Mean) Public Cash Reference
Real-World Patient Consensus 80.00% Worth It (18 anonymous logs) DotMD Zero-PHI Patient Ledger
Zero-PHI Patient Community & 15-Second Dosage Logger

Lamivudine and Tenofovir Disoproxil Fumarate Patient Community, Cohort Filters & Dosage Logs

Federal clinical ledger for Lamivudine and Tenofovir Disoproxil Fumarate integrating DailyMed SPL (2021-02-15), CMS NADAC ($0.2339/unit), and 18 Zero-PHI patient logs.

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