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Lamivudine

  • Prescription medicine
  • Prescription only
  • Identity checked
  • Sources last checked 2026-09-04

This page shows what was measured, who it was measured in, and what that does not settle.

What Lamivudine does in the body

HIV-1 infection and chronic hepatitis B

Lamivudine is a counterfeit version of one of the four chemical letters DNA is built from, and it is built back to front compared with the real thing. Human copying enzymes are fussy and mostly reject it. The copying enzymes of HIV and hepatitis B are not, and they stitch it in, at which point the chain cannot be extended and the copy stops. That mismatch in fussiness is why the drug is so well tolerated, and the same loose active site is why one small change to the enzyme is enough to make it reject the drug too.

What happened in people

Progression to AIDS or death of 20% against 9% with lamivudine added to zidovudine, relative hazard 0.42 (95% CI 0.32 to 0.57), with a separate survival benefit

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The recorded finding that sits closest to something a person would notice. Written into the record, not signed off, and it carries no population or interval.

The limit that matters most

That the E-184V result justifies retaining lamivudine in failing regimens generally, when it randomised 29 patients per arm against complete treatment interruption rather than against an active regimen

Where it acts
Cytoplasm of CD4-positive T cells and of hepatocytes, where the drug is phosphorylated to its active triphosphate
Kind of result
Living longer, or avoiding a major event
Supervision
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.

What the registries record it as

  • The substance registry classes this as chemical.

    FDA substance registry · 2T8Q726O95 · read 2026-08-29

  • Its recorded molecular formula is C8H11N3O3S, weighing 235.66 g/mol.

    US prescribing information · 6fd4d6b9-65ea-4988-8d6f-dd220ec5052d · read 2026-08-30

Where each sentence above came from

No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.

Shown as the opening line on this page.

A limit recorded against this substance. Not signed off as a reviewed claim.

The four opening statements run to 137 words.

Words this page uses

Four words worth knowing first

Chosen from what this page shows, with each one explained before the word it depends on.

Comparator

A comparator is whatever the treatment was measured against.

A picture of it, and where the picture fails

It is like the other runner in a race.

Where that stops being true. A race has one winner. A study can show both arms improved.

What people get wrong. Results are read without asking what the other group got. Beating nothing is not beating a treatment.

The control condition against which the experimental intervention is assessed.

Randomisation

Randomisation means chance decides who gets which treatment.

A picture of it, and where the picture fails

It is like a coin toss deciding the groups.

Where that stops being true. A coin toss is fair once. Fairness here comes from doing it for everyone.

What people get wrong. It is thought to make groups identical. It makes them similar on average, including on things nobody measured.

Allocation of participants to arms by a chance process, so that unmeasured factors are balanced in expectation.

Absolute difference

An absolute difference is how many more people in a hundred were affected.

A picture of it, and where the picture fails

It is like counting heads in two rooms of a hundred.

Where that stops being true. Heads are easy to count. Study results carry a margin of error too.

What people get wrong. It is confused with a percentage change, which can look far larger.

The arithmetic difference in event rates between arms.

Confidence interval

A confidence interval is the range the true answer is likely to sit in.

A picture of it, and where the picture fails

It is like a weather forecast giving a range rather than one number.

Where that stops being true. A forecast range covers tomorrow. This one covers what the study could resolve.

What people get wrong. The middle number is read as the answer. A range crossing zero means no change is still possible.

An interval estimate that would contain the true parameter in a stated proportion of repeated studies.

What happened in peopleRead from sources, not yet reviewed

What happened in people

Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.

Progression to a new protocol-defined AIDS event or death, adding lamivudine to a zidovudine-containing regimen

The study showed what it set out to show

Who was studied
CAESAR
How many people
1840
Study design
Randomised, placebo-controlled, 52-week clinical-endpoint trial, stopped early at interim analysis
Compared against
A dummy treatment
Kind of result
Living longer, or avoiding a major event
What was found
20% versus 9% progression, p<0.0001, relative hazard 0.42 (95% CI 0.32 to 0.57); survival relative hazard 0.40 (95% CI 0.23 to 0.69), p=0.0007
Repeated elsewhere
Replicated

What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral tablet and oral solution, at two different strengths for the two indications, and in many fixed-dose combinations

Interval reported. 95% CI 0

Written into the record, not signed off as a reviewed claim.

Proportion with HIV-1 RNA below 50 copies per millilitre at week 48 by snapshot, dolutegravir with lamivudine against dolutegravir with tenofovir disoproxil and emtricitabine

The study showed what it set out to show

Who was studied
GEMINI-1 and GEMINI-2 (NCT02831673, NCT02831764)
How many people
1433
Study design
Two identically designed multicentre, double-blind, randomised, non-inferiority phase 3 trials, 48-week primary
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Pooled 91% versus 93%, adjusted difference -1.7% (95% CI -4.4 to 1.1), non-inferior at a -10% margin
Repeated elsewhere
Replicated

What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.

The limits of this study, and where it came from

Main limit. Enrolment was restricted to screening HIV-1 RNA at or below 500,000 copies per millilitre, so the regimen was not randomised against three drugs above that threshold.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral tablet and oral solution, at two different strengths for the two indications, and in many fixed-dose combinations

Interval reported. 95% CI -4

Written into the record, not signed off as a reviewed claim.

Immunological or clinical failure, lamivudine monotherapy against complete treatment interruption in patients carrying M184V

The study showed what it set out to show

Who was studied
E-184V study
How many people
58
Study design
Randomised, open-label pilot, 48 weeks
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
41% versus 69% discontinued for failure, time to failure significantly longer on lamivudine (p=0.018); grade 3-4 HIV-related events in 20.7% of the interruption group only (p=0.02)
Repeated elsewhere
Partially Replicated

What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.

The limits of this study, and where it came from

Main limit. Twenty-nine patients per arm, and the comparator was stopping all antiretroviral therapy rather than switching to an active regimen. This trial supports a practice that is now applied far more widely than what it tested.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral tablet and oral solution, at two different strengths for the two indications, and in many fixed-dose combinations

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

Incidence of hepatitis flares, hepatic decompensation and liver-disease-related serious adverse events during long-term lamivudine treatment

The study did not show it

Who was studied
Lamivudine long-term hepatitis B safety analysis
How many people
998
Study design
Pooled long-term analysis of HBeAg-positive patients treated for up to six years, median four, with a one-year placebo comparison
Compared against
A dummy treatment
Kind of result
A number that stands in for health
What was found
Documented resistance mutation in 23% at year 1 rising to 65% at year 5; flares significantly more common in patients with resistance in every year (p<0.005)
Repeated elsewhere
Replicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. Hepatic decompensation rose to 6% (p=0.03) and liver-disease-related serious adverse events to 20% (p=0.009) after four years of carrying resistance. This row records why lamivudine is no longer a first-line hepatitis B drug.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral tablet and oral solution, at two different strengths for the two indications, and in many fixed-dose combinations

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

What we know
RNAWiki holds 4 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.

What it changes in the bodyRead from sources, not yet reviewed

The path through the body

From what a person takes to what changes. A solid line is a step measured in people. A dashed line is a step nobody has measured that way.

  1. Start

    Lamivudine

    What a person takes: Oral tablet and oral solution, at two different strengths for the two indications, and in many fixed-dose combinations.

    The measurement behind this step

    Taken once daily with or without food in HIV regimens. Elimination is predominantly renal and largely unchanged, so dose reduction is required at reduced creatinine clearance. The hepatitis B product is a lower strength under a different brand name and is not appropriate for anyone with HIV-1, a distinction carried in the boxed warning of both products.

  2. Getting in

    Swallowed once a day, at one of two strengths that are not interchangeable

    A small tablet with or without food. The same molecule is sold at a lower strength for hepatitis B under a different name, and using the wrong one in someone who has both infections causes resistance.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    Oral bioavailability is around 86% and unaffected by food. Elimination is predominantly renal and largely unchanged, so dose adjustment is required at reduced creatinine clearance. It is not a cytochrome P450 substrate, inhibitor or inducer of consequence, which is why it appears in almost every combination without an interaction problem. The two-strength issue is carried in the boxed warning of both products.

  3. Reaching the cell

    It enters cells freely, and human enzymes mostly ignore it

    The drug crosses into cells without help. Because it is built as the mirror image of a natural building block, the enzymes that copy human DNA largely refuse to touch it, which is where the tolerability comes from.

    Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.

    The measurement behind this step

    Lamivudine enters cells by passive diffusion and by nucleoside transporters and is phosphorylated by deoxycytidine kinase and downstream kinases to the triphosphate. Human DNA polymerases alpha and beta and mitochondrial polymerase gamma discriminate against the L-configuration, so the mitochondrial toxicity that characterised stavudine, didanosine and zidovudine is largely absent.

  4. What it acts on

    Three phosphates make it look like the DNA letter C

    The cell adds three phosphate groups. The finished molecule closely resembles one of the four building blocks the copying enzyme is looking for.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    Lamivudine 5-prime-triphosphate is the active species and competes with deoxycytidine triphosphate for the reverse transcriptase active site. Its intracellular half-life supports once-daily dosing in HIV. The same triphosphate inhibits the reverse transcriptase domain of the hepatitis B polymerase, which is why one molecule treats two unrelated viruses.

  5. The change it makes

    Inserted, and then nothing more can be added

    The viral enzyme takes it for the real thing and stitches it in. The ring it is built on has a sulfur atom where the attachment point for the next letter should be, so the chain ends there.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    Chain termination follows incorporation because the oxathiolane ring has no 3-prime hydroxyl. The signature HIV resistance substitution is M184V, which introduces a beta-branched side chain that sterically clashes with the oxathiolane sulfur, conferring more than hundred-fold resistance. The homologous hepatitis B substitution is rtM204V or rtM204I with rtL180M. The same structural change occurs in both viruses at the same position, and the clinical consequences run in opposite directions.

  6. What that does for a person

    And when the mutation arrives, the drug usually stays in the regimen

    M184V makes lamivudine stop working and also makes the virus worse at replicating and more vulnerable to two other drugs. So the drug is often deliberately kept, to keep the crippled virus in place.

    Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.

    The measurement behind this step

    M184V reduces reverse transcriptase processivity and replicative fitness and partially resensitises virus to zidovudine and tenofovir. In the E-184V randomised pilot, patients with M184V kept on lamivudine alone had significantly slower viral rebound, slower CD4 decline and slower recovery of replication capacity than patients who stopped everything, with 41% against 69% reaching immunological or clinical failure by week 48 (p=0.018). In hepatitis B, where the drug was given alone, the same class of substitution produced flares, decompensation and 65% resistance by year five.

No suggested links are held for this record, so nothing is hidden from this path.

What we know
The record describes 5 steps from taking it to an effect in a person.
How we know it
Each step names the study behind it in the technical detail beside it.
What this does not prove
A change inside the body is a reason to look. It is not a result in a person.
Why it matters
A reader can see exactly where the chain stops being measured in people.
What we still do not know
No reviewed claim binds any of these steps to a named population.

What is missing or unclearRead from sources, not yet reviewed

Were people like you studied?

RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.

Who was studied

People similar to this profile were included.

  • Almost everyone treated for HIV-1, usually inside a fixed-dose combination; and, decreasingly, people with chronic hepatitis B, for whom it has been superseded by tenofovir and entecavir on resistance grounds.

Who is missing from the studies

  • Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

What the label states about particular groups

  • On pediatric, the label states: “The safety and effectiveness of lamivudine tablets in combination with other antiretroviral agents have been established in pediatric patients aged 3 months and older.”

    US prescribing information · 6fd4d6b9-65ea-4988-8d6f-dd220ec5052d · read 2026-08-30

  • On older people, the label states: “Clinical trials of lamivudine tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.”

    US prescribing information · 6fd4d6b9-65ea-4988-8d6f-dd220ec5052d · read 2026-08-30

  • On people who are pregnant, the label states: “Lamivudine pharmacokinetics were studied in pregnant women during 2 clinical trials conducted in South Africa.”

    US prescribing information · 6fd4d6b9-65ea-4988-8d6f-dd220ec5052d · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary The Centers for Disease Control and Prevention recommends that HIV-1-infected mothers in the United States not breastfeed their infants to avoid risking postnatal transmission of HIV-1 infection.”

    US prescribing information · 6fd4d6b9-65ea-4988-8d6f-dd220ec5052d · read 2026-08-30

Where the result stopped carrying

  • Lamivudine monotherapy for hepatitis B produced 65% resistance by year five, with rising rates of flares, decompensation and serious liver events, and lost its place as a first-line hepatitis B drug
  • The same molecule is marketed at two strengths under two brand names for two infections that frequently co-occur, and the regulatory response was a boxed warning rather than a redesign
  • This is a scope explorer, not a diagnosis engine.
  • It shows who was studied so you can see whether people similar to you were included.

RNAWiki cannot tell whether a study fits you. It can show who was in it.

What it would be like to takeRead from sources, not yet reviewed

Why it might seem to do nothing

A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.

It was studied in different people

The people in the studies were not much like the reader.

On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

There was nothing to correct

Where a level is already normal, topping it up may change nothing.

On this record: The nucleoside half of Dovato, the two-drug regimen that has changed how many antiretrovirals a person starting treatment actually needs

The evidence may simply be wrong

Small early studies often do not hold up.

On this record: RNAWiki has not yet published a reviewed conclusion for this use.

Other reasons RNAWiki checked and found nothing for (10)
It was studied for a different goal
The studies measured something else entirely. Nothing in this record points to this reason.
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.

None of these is a reason to take more. Taking more is not a step this page ever suggests.

What it would be like to takeRead from sources, not yet reviewed

What taking it involves

The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.

How it is supplied

Prescription only

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

Read from the recorded approval status.

No source is stored against this line.

Form and route

Oral tablet and oral solution, at two different strengths for the two indications, and in many fixed-dose combinations

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The form and route recorded on this substance.

No source is stored against this line.

Who oversees it

Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

Suppression classes recorded: S6.

No source is stored against this line.

What is in the pack

Taken once daily with or without food in HIV regimens. Elimination is predominantly renal and largely unchanged, so dose reduction is required at reduced creatinine clearance.

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

Recorded notes on how this is sold. The rest of the recorded wording: The hepatitis B product is a lower strength under a different brand name and is not appropriate for anyone with HIV-1, a distinction carried in the boxed warning of both products.

No source is stored against this line.

Where it is registered

Regulatory records are listed in the technical disclosure at the foot of this page.

Counted from records

Where this came from

A count of rows RNAWiki holds. It describes our records, not your body.

Register entries are stored per jurisdiction and shown with their dates.

No source is stored against this line.

Why people stop

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

No record of why people stopped taking it is stored for this substance.

No source is stored against this line.

What it would be like to takeRead from sources, not yet reviewed

What can go wrong

Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.

Worth asking a clinician aboutWritten into the record from the studies named on this page

Severe acute exacerbation of hepatitis B on discontinuation is boxed, with hepatic monitoring required for at least several months after stopping in co-infected patients. The second boxed item is the difference between the two lamivudine products. Lactic acidosis and severe hepatomegaly with steatosis are labelled class effects of nucleoside analogues, though lamivudine carries far less mitochondrial toxicity than the earlier drugs of its class because human polymerases discriminate against its unnatural stereochemistry. Pancreatitis is labelled with caution in paediatric patients with a relevant history. In CAESAR there was no difference in the frequency or severity of clinical or laboratory toxicity against placebo.

Nobody counted how many people took this and were fine, so this cannot be turned into a rate.

Where this came from

Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.

Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

What is missing or unclearRead from sources, not yet reviewed

Does the exact form matter?

Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.

The form that was studied

Oral tablet and oral solution, at two different strengths for the two indications, and in many fixed-dose combinations

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The form used in the studies cited on this page.

No source is stored against this line.

What is sold

Elimination is predominantly renal and largely unchanged, so dose reduction is required at reduced creatinine clearance.

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

Recorded notes on which forms are sold. The rest of the recorded wording: The hepatitis B product is a lower strength under a different brand name and is not appropriate for anyone with HIV-1, a distinction carried in the boxed warning of both products.

No source is stored against this line.

What is recorded as being sold

  • 80 products list this as an active ingredient in the United States drug directory. 49 of them contain it and nothing else.

    FDA National Drug Code directory · 53873-074 · read 2026-08-29

  • They are sold as powder, solution, tablet and tablet, film coated, taken oral.

    FDA National Drug Code directory · 53873-074 · read 2026-08-29

  • The regulator's established pharmacologic class for it is hepatitis b virus nucleoside analog reverse transcriptase inhibitor [epc], human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor [epc] and nucleoside analog [ext].

    FDA National Drug Code directory · 53873-074 · read 2026-08-29

  • 44 published labels name it as an active ingredient. 20 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · 6fd4d6b9-65ea-4988-8d6f-dd220ec5052d · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 6fd4d6b9-65ea-4988-8d6f-dd220ec5052d · read 2026-08-29

  • LAMIVUDINE is oral at 3 DOSAGE FORMS AND STRENGTHS Lamivudine tablets, USP 150 mg are white to off-white, diamond shaped, biconvex film-coated tablets, engraved “APO” on one side, “LMV” score “150” on the other side., recorded as fda label in effect 2026-03-13 in the United States.

    US prescribing information · 6fd4d6b9-65ea-4988-8d6f-dd220ec5052d · read 2026-08-30

  • Recorded price in US: 0.21763 USD per one millilitre, across 4 priced products whose strengths and pack forms differ, as of 2026-08-26, paid by retail pharmacies buying the product, as surveyed by the Centers for Medicare & Medicaid Services. It is not a list price, an insurance price, or what anyone pays at a counter..

    Recorded source · 2026-08-26 · read 2026-08-28

  • Recorded price in US: 0.48867–1.3719 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 9 priced products whose strengths and pack forms differ, as of 2026-08-26, paid by retail pharmacies buying the product, as surveyed by the Centers for Medicare & Medicaid Services. It is not a list price, an insurance price, or what anyone pays at a counter..

    Recorded source · 2026-08-26 · read 2026-08-28

Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.

What it would be like to takeRead from sources, not yet reviewed

What you could measure

This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.

Self-experiment planning is not offered for a prescription or clinician-supervised medicine. The questions below are for a clinician or pharmacist.

Questions worth asking

  • Which of the trials of Lamivudine studied people like me?
  • What was measured, and for how long?
  • Was the result a laboratory value or a health outcome?
  • What would we watch for, and when would we stop?

Tracking can show whether something changed for you. It cannot show what caused it.

RNAWiki records evidence. It does not say whether this substance is right for you.

What is missing or unclearRead from sources, not yet reviewed

Claims that go past the evidence

Things said about this substance that sound reasonable, and the exact step that is missing between the evidence and the claim.

Goes past the evidence

That the E-184V result justifies retaining lamivudine in failing regimens generally, when it randomised 29 patients per arm against complete treatment interruption rather than against an active regimen

Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.

The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.

What would change this

A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.

RNAWiki has not yet published a reviewed conclusion for this use.

Goes past the evidence

That GEMINI non-inferiority at or below 500,000 copies per millilitre extends above that threshold, which was an entry criterion rather than a finding

Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.

The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.

What would change this

A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.

RNAWiki has not yet published a reviewed conclusion for this use.

Goes past the evidence

That a two-drug regimen containing lamivudine is appropriate in hepatitis B co-infection, where it constitutes lamivudine monotherapy against the second virus

Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.

The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.

What would change this

A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.

RNAWiki has not yet published a reviewed conclusion for this use.

What is missing or unclearRead from sources, not yet reviewed

What nobody knows yet

Open questions, each with why it is open and what would close it.

Missing populations

Which groups were under-represented in the studies has not been recorded.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing long-term data

No completed tested study window is recorded.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

No reviewed conclusion

RNAWiki has not yet published a reviewed conclusion for this use.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing interaction studies

No interaction was found in the registers checked. Not finding one is not the same as showing there is none.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Formulation uncertainty

Several salts, forms or products of Lamivudine are recorded. Results from one form may not transfer to another.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Mechanism not reviewed

No reviewed mechanism story exists for this substance.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

What happened in peopleRead from sources, not yet reviewed

Check any of this yourself

Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.

Every line above can be traced to the study named beside it. Follow the link and read it.

CAESAR: progression halved and survival improved, on clinical endpoints
In plain words
Adding lamivudine to existing zidovudine treatment in 1,840 patients cut progression to AIDS or death from 20% to 9% and improved survival. The trial was stopped early at its second interim analysis because the difference was so clear.
What was measured
Progression to a new AIDS-defining event or death: 20% against 9%, relative hazard 0.42 (95% CI 0.32 to 0.57); survival relative hazard 0.40 (95% CI 0.23 to 0.69)
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
CAESAR randomised 1,840 patients with HIV-1 and CD4 counts of 25 to 250 per microlitre, already on zidovudine alone or with zalcitabine or didanosine, to add placebo, lamivudine, or lamivudine plus loviride for 52 weeks, with progression to a new protocol-defined AIDS event or death as the primary endpoint. The study was terminated at the second interim analysis for a highly significant reduction in progression. In the final analysis, progression occurred in 95 of 471 (20%) placebo patients, 86 of 907 (9%) lamivudine patients and 42 of 462 (9%) lamivudine-plus-loviride patients, p<0.0001, relative hazard 0.42 (95% CI 0.32 to 0.57). A significant survival benefit was seen separately, relative hazard 0.40 (95% CI 0.23 to 0.69), p=0.0007. Hospital admissions, unscheduled visits and prescriptions for HIV-related events were all significantly reduced, and there was no difference in the frequency or severity of clinical or laboratory toxicity between groups. This is a clinical-endpoint trial in an era when most antiretroviral trials were not, and it is the strongest single result on this page.
Source
CAESAR Coordinating Committee. Randomised trial of addition of lamivudine or lamivudine plus loviride to zidovudine-containing regimens for patients with HIV-1 infection: the CAESAR trial. Lancet 1997;349:1413-1421
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
One amino acid ends it, and in hepatitis B that reached 65% by year five
In plain words
A single change at one position defeats lamivudine in both viruses it treats. In hepatitis B, where lamivudine was used alone, the proportion of patients carrying that change rose from 23% in the first year to 65% by the fifth, and the patients who carried it had more liver flares and worse outcomes.
What was measured
Documented lamivudine-resistant mutation in 23% of patients at year 1 rising to 65% at year 5, with hepatitis flares in 18% to 21% of patients per year from year 2
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
A long-term safety analysis of 998 patients with HBeAg-positive compensated chronic hepatitis B treated with lamivudine for up to six years, median four, found the proportion with a documented lamivudine-resistant mutation rising from 23% in year 1 to 65% in year 5. Hepatitis flares occurred in 10% of patients in year 1 and 18% to 21% in years 2 to 5, and the temporal association between flares and resistance mutations rose from 43% in year 1 to more than 80% by year 3. Patients with resistant mutations had significantly more flares than those without, p<0.005, in every year. Hepatic decompensation and liver-disease-related serious adverse events stayed stable through the first four years with mutations and then rose to 6% (p=0.03) and 20% (p=0.009). The equivalent HIV substitution, M184V, arises just as readily but is not permitted to matter in the same way, because lamivudine is never used alone in HIV. Lamivudine is no longer a first-line hepatitis B treatment anywhere.
Source
Lok AS, Lai CL, Leung N, et al. Long-term safety of lamivudine treatment in patients with chronic hepatitis B. Gastroenterology 2003;125:1714-1722
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
The mutation that defeats it is a reason to keep taking it
In plain words
Normally a resistance mutation is a reason to stop a drug. For lamivudine the field concluded the opposite. M184V cripples the virus that carries it, so keeping the drug on keeps the crippled virus in place, and a randomised pilot showed that patients doing this fared better than patients stopping everything.
What was measured
That the fitness cost of M184V justifies retaining lamivudine in failing regimens generally — supported by mechanism and by a 58-patient pilot whose comparator was complete treatment interruption, and adopted into routine practice far beyond what that trial tested
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The E-184V study randomised 58 HIV-1 patients already carrying M184V on a lamivudine-containing regimen either to lamivudine monotherapy or to complete interruption of all antiretroviral drugs, open-label, over 48 weeks, with immunological failure defined as a CD4 count below 350 cells per microlitre or a CDC grade B or C event. By week 48, 20 of 29 (69%, 95% CI 51 to 83) in the interruption group and 12 of 29 (41%, 95% CI 26 to 59) in the lamivudine group had discontinued for immunological or clinical failure, and time to failure was significantly longer on lamivudine (p=0.018). Grade 3 to 4 clinical adverse events at least possibly related to HIV-1 occurred only in the interruption group, 6 of 29 (20.7%), p=0.02. Mean decline in CD4 percentage, viral rebound and recovery of HIV-1 replication capacity were all significantly lower on lamivudine. The mechanism is that M184V introduces a steric clash that both blocks the drug and reduces enzyme processivity, so maintaining drug pressure maintains the fitness cost. M184V also partially resensitises virus to zidovudine and tenofovir. Two cautions belong with this: the trial randomised 29 patients per arm, and its comparator was stopping everything rather than switching to an active regimen, which is not the choice most patients face.
Source
Castagna A, Danise A, Menzo S, et al. Lamivudine monotherapy in HIV-1-infected patients harbouring a lamivudine-resistant virus: a randomized pilot study (E-184V study). AIDS 2006;20:795-803
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
contested
Review state
Written into the record, not signed off as a reviewed claim
GEMINI: two drugs matched three in 1,433 patients starting treatment
In plain words
Two identical trials randomised 1,441 people starting HIV treatment to either dolutegravir plus lamivudine, or dolutegravir plus two other drugs. At 48 weeks 91% against 93% were suppressed, meeting non-inferiority, and the two-drug arm had fewer drug-related side effects.
What was measured
Proportion below 50 copies per millilitre at week 48, pooled adjusted difference -1.7% (95% CI -4.4 to 1.1)
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
GEMINI-1 (NCT02831673) and GEMINI-2 (NCT02831764) were identically designed, double-blind, randomised non-inferiority phase 3 trials at 192 centres in 21 countries, enrolling treatment-naive adults with screening HIV-1 RNA at or below 500,000 copies per millilitre. 1,441 participants were randomised, 719 to dolutegravir with lamivudine and 722 to dolutegravir with tenofovir disoproxil and emtricitabine. At week 48 by snapshot in the intention-to-treat-exposed population, GEMINI-1 gave 320 of 356 (90%) against 332 of 358 (93%), adjusted difference -2.6% (95% CI -6.7 to 1.5), and GEMINI-2 gave 335 of 360 (93%) against 337 of 359 (94%), adjusted difference -0.7% (95% CI -4.3 to 2.9). Pooled, 655 of 716 (91%) against 669 of 717 (93%), adjusted difference -1.7% (95% CI -4.4 to 1.1), non-inferior at a -10% margin. Drug-related adverse events were numerically fewer on two drugs, 126 of 716 (18%) against 169 of 717 (24%), with discontinuation for adverse events at 2% in each arm.
Source
Cahn P, Sierra Madero J, Arribas JR, et al. Lancet 2019;393:143-155 (GEMINI-1 NCT02831673 and GEMINI-2 NCT02831764)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
GEMINI excluded the patients the two-drug question is hardest for
In plain words
The trials that established the two-drug regimen enrolled only people whose viral load at screening was at or below 500,000 copies per millilitre. That is an entry criterion, not a finding, and it means the regimen has not been randomised against three drugs in the people who present with the most virus.
What was measured
That non-inferiority demonstrated at or below 500,000 copies per millilitre, in patients without hepatitis B co-infection, extends to patients above that threshold and to patients carrying hepatitis B
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
GEMINI-1 and GEMINI-2 both restricted enrolment to a screening HIV-1 RNA of 500,000 copies per millilitre or less. Two-drug regimens have less redundancy by construction: if one agent is compromised by transmitted resistance, the effective regimen is monotherapy, and lamivudine is the agent in this pair with the lowest genetic barrier. Baseline resistance genotyping is not available at the moment therapy starts in most of the world. A second consequence is unrelated to virology: a person co-infected with hepatitis B who takes dolutegravir with lamivudine is receiving lamivudine monotherapy for their hepatitis B, which is the exposure that produced 65% resistance by year five in the hepatitis literature. Neither point is a criticism of the trial result, which is solid within its enrolment criteria. Both are limits on how far that result travels, and both are read across in practice more freely than the trials support.
Source
Cahn P et al., Lancet 2019;393:143-155; Lok AS et al., Gastroenterology 2003;125:1714-1722
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
Two strengths of the same molecule under two brand names, and a boxed warning about it
In plain words
Lamivudine is sold at one strength for HIV and a lower strength for hepatitis B, under different brand names. Giving the hepatitis B strength to someone who also has undiagnosed HIV is effectively HIV monotherapy at a subtherapeutic dose, and it selects resistance. The FDA put that on the front of the label.
What was measured
Two marketed strengths of one molecule under separate brand names, with the difference carried in the boxed warning of both
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
The Epivir boxed warning has two parts. The first is the class warning about severe acute exacerbation of hepatitis B on discontinuation in co-infected patients, with hepatic monitoring required for at least several months after stopping. The second is specific to this molecule: patients with HIV-1 infection should receive only dosage forms of Epivir appropriate for treatment of HIV-1, because the hepatitis B product contains a lower dose of the same active ingredient. The Warnings section adds that emergence of lamivudine-resistant hepatitis B variants has been reported with lamivudine-containing antiretroviral regimens. The failure recorded here is a design one rather than a pharmacological one: an identical molecule marketed at two strengths under two names, for two infections that frequently occur together, in a population that is not always tested for both. The regulator response was a boxed warning, which is an instruction rather than a fix.
Source
EPIVIR (lamivudine) prescribing information, boxed warning and section 5.1, NDA 020564, Drugs@FDA; EPIVIR-HBV prescribing information
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
The tolerability is a consequence of stereochemistry, not of luck
In plain words
Lamivudine is built as the mirror image of a natural DNA letter. Human copying enzymes are picky about which mirror image they accept and reject it; viral ones are not. That single design decision is why a chain-terminating drug has almost no side effects, and it is also why one small change to the virus is enough to defeat it.
What was measured
No difference in frequency or severity of clinical or laboratory toxicity against placebo in a 1,840-patient randomised trial
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Lamivudine is the (-)-beta-L-2-prime,3-prime-dideoxy-3-prime-thiacytidine enantiomer, the unnatural configuration, with a sulfur atom replacing the 3-prime carbon of the sugar ring. Human DNA polymerases alpha and beta discriminate strongly against the L-configuration, and mitochondrial DNA polymerase gamma incorporates it poorly, which is why lamivudine lacks the mitochondrial toxicity, lipoatrophy and neuropathy that defined the earlier nucleoside analogues. In CAESAR there was no difference in the frequency or severity of clinical or laboratory toxicities between lamivudine and placebo arms, which for a chain-terminating antiviral is a striking result. The same permissiveness in the viral active site that admits an L-nucleotide is what makes M184V sufficient to exclude it: a single beta-branched side chain restores the discrimination the wild-type enzyme lacks.
Source
CAESAR Coordinating Committee, Lancet 1997;349:1413-1421; EPIVIR prescribing information, NDA 020564, Drugs@FDA
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim

How many documents were read

  • 20 documents were read for this substance.

    RNAWiki source record

  • 20 of them state the same bioavailability, and they agree.

    RNAWiki source record

  • 4 of them state the same tMax, and they agree.

    RNAWiki source record

  • 16 of them state the same volumeOfDistribution, and they agree.

    RNAWiki source record

Where else this substance is registered

FDA substance identifier (UNII)
2T8Q726O95
RxNorm concept
199147

Checks this page had to pass

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  • Not passed

    Trial roles classified for highlighted evidence

    No registered study is classified as testing this substance.

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  • Passed

    Safety mode resolved

    Suppression classes recorded: S6.

  • Passed

    Canonical metadata present

    slug and display name present

What is missing or unclearRead from sources, not yet reviewed

How this medicine reached us

Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.

What the approval register records

  • 138 approved applications cover products containing this substance. The earliest was NDA020564, approved 19951117 to VIIV HLTHCARE.

    Drugs@FDA application register · NDA020564 · read 2026-08-29

  • Marketing status on the register: discontinued, none (tentative approval) and prescription.

    Drugs@FDA application register · NDA020564 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 19951117.

    FDA National Drug Code directory · 53873-074 · read 2026-08-29

What is missing or unclearRead from sources, not yet reviewed

What to learn next

Ordered by what would most change how you read this page, starting with what is easiest to misunderstand.

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What is not here

7 questions this page could not answer

These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.

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  • Felt, measured, or meaningful — found nothing in the sources checked.
  • How long anything takes — found nothing in the sources checked.
  • What it may clash with — found nothing in the sources checked.
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The record as stored

The full record, for auditing

Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.

The older medicine-wide conclusion held in this record

Written for a clinical reader, and about the medicine as a whole rather than about one indication, population and set of trials. RNAWiki does not treat it as a programme conclusion and no reviewer has signed it off in that form. It is here word for word because it is what the record holds.

A mirror-image cytidine analogue that terminates the DNA chain of both HIV-1 and hepatitis B; added to zidovudine in 1,840 patients it cut progression to AIDS or death from 20% to 9% (relative hazard 0.42) and improved survival (relative hazard 0.40), and it is defeated by the single substitution M184V, which is also why it is deliberately kept in failing regimens and why it lost its place in hepatitis B, where resistance reached 65% by year five.

Recorded evidence blocks (10)

On the Lamivudine label: indicated for what?


"Lamivudine tablets (HBV) are indicated for the treatment of chronic hepatitis B virus (HBV) infection associated with evidence of hepatitis B viral replication and active liver inflammation [see Clinical Studies ( 14.1 , 14.2 )]. The following points should be considered when initiating therapy with lamivudine tablets…": indications and usage on Lamivudine's label. DailyMed label · 6bd6b9da-df69-46db-813e-4e7f3bdecf95 · 2026-07-29

321 registered trials of Lamivudine — at which phases?


Registered studies posting no result
265 of 321

321 registered studies of Lamivudine: 85 phase3, 83 phase2, 76 phase4, 38 phase1, 36 na, 13 na or unstated, 4 early phase1. CLINICALTRIALS_SNAPSHOT · 2026-09-01

1816 with a PubMed record

Show the evidence
  • phase3
    85
  • phase2
    83
  • phase4
    76
  • phase1
    38
  • na
    36
  • na or unstated
    13
10 more recorded rows
  • early phase1
    4
  • completed
    241
  • unknown
    35
  • terminated
    20
  • active not recruiting
    7
  • withdrawn
    7
  • not yet recruiting
    4
  • recruiting
    4
  • suspended
    2
  • enrolling by invitation
    1

recorded 2026-09-01 · last checked 2026-09-04

23 of Lamivudine's trials stopped: safety, futility/efficacy, accrual/recruitment, funding/business, sponsor decision unspecified, other?


safety (2), futility/efficacy (1), accrual/recruitment (8), funding/business (3), sponsor decision unspecified (1) and other (8): Lamivudine's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"as of 4/23/97"; 23 of 321 registered studies

Show the evidence

Trial

  • NCT00001080
    withdrawn; "as of 4/23/97"
  • NCT00120796
    terminated; "poor patient recrutment"
  • NCT00143728
    suspended; "Enrollment."
  • NCT00612898
    terminated; "Sponsor decision"
  • NCT00650637
    terminated; "The study was prematurely discontinued due to administrative reasons on August 18, 2003. There were no safety concerns that led to the decision to terminate."
  • NCT00710216
    withdrawn; "Sponsor withdraw"
14 further recorded trials
  • NCT00798460
    terminated; "could not enroll patients"
  • NCT00986778
    withdrawn; "Business Objectives Changed"
  • NCT01005238
    terminated; "unsufficient patient recruitment"
  • NCT01338025
    terminated; "Study was halted for lack of accrual"
  • NCT01528865
    withdrawn; "Funding was removed."
  • NCT01620944
    terminated; "Business objectives have changed"
  • NCT01627223
    terminated; "Slow progress in recruiting study patients"
  • NCT02116660
    terminated; "This study was terminated early due to poor recruitment."
  • NCT02470650
    withdrawn; "No participants enrolled"
  • NCT02566707
    terminated; "due to introduction of another integrase inhibitor, recruitement was not feasible anymore."
  • NCT02659761
    terminated; "Sponsor decision due to slow recruitment rates and no future recruitment foreseen"
  • NCT02894554
    terminated; "clinical myalgia"
  • NCT02924389
    terminated; "This study terminated early due to the ongoing covid-19 pandemic making it unsafe to recruit participants for in-person visits. Participants are living with HIV who are antiretroviral therapy-naive and are at high risk of COVID-19…"
  • NCT03333083
    terminated; "The reason for the premature termination was the failure to reach the required number of participants."

recorded 2026-09-01 · last checked 2026-09-04

Human studies of Lamivudine used Zeffix 100mg QD — over how long?


studies of Lamivudine used the recorded amount. ClinicalTrials.gov · 2026-09-01

16 recorded entries; human; tablet, oral; also "Zeffix 100mg QD", "Zeffix 100mg", "Lamivudine 100mg once daily; or Entecavir 0.5mg once daily."

Show the evidence

human

  • NCT00625339
    Zeffix 100mg QD
  • NCT00625560
    Zeffix 100mg
  • NCT01894269
    Lamivudine 100mg once daily; or Entecavir 0.5mg once daily.
  • NCT01894269
    lamivudine 100 mg tablets (GlaxoSmithKline);
  • NCT02384395
    Lamivudine 300 mg
  • NCT02738931
    tablet; Lamivudine 300 mg tablet
10 more recorded rows
  • human NCT02738931
    Dolutegravir/Lamivudine 50 mg/300 mg Tablet (Product Code AA)
  • human NCT02738931
    Dolutegravir/Lamivudine 50 mg/300 mg Tablet (Product Code AB)
  • human NCT02868580
    lamivudine (300mg)
  • human NCT03205566
    Lamivudine 150Mg Tablet
  • human NCT03360682
    Lamivudine 300 MG
  • human NCT04302896
    oral; lamivudine oral tablet 300mg
  • human NCT04781426
    Lamivudine (3TC) 300mg
  • human NCT04903847
    Dolutegravir/Lamivudine 50 MG-300 MG Oral Tablet [DOVATO]
  • human NCT04903847
    Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate 100 MG-300 MG-300 MG Oral Tablet [DELSTRIGO]
  • human NCT05030025
    Triumeq Dispersible Tablets 5 mg GSK1349572 [Dolutegravir]/ 60 mg Abacavir/ 30 mg Lamivudine

recorded 2026-09-01 · last checked 2026-09-04

Lamivudine's half-life is 72 hours — which schedules were studied?


72 hours, the half-life Lamivudine's label states: "In most single-dose trials with plasma sampling for up to 48 or 72 hours after dosing, the observed mean elimination half-life (t½) ranged from 13 to 19 hours." DailyMed label · 6bd6b9da-df69-46db-813e-4e7f3bdecf95 · 2026-07-29

tmax 0.5 to 1 hour; bioavailability 86 %.

Show the evidence
  • half life pharmacokinetics
    72 hours; In most single-dose trials with plasma sampling for up to 48 or 72 hours after dosing, the observed mean elimination half-life (t½) ranged from 13 to 19 hours.
  • tmax pharmacokinetics
    0.5 to 1 hour; Lamivudine T max was 0.5 to 1 hour.
  • bioavailability pharmacokinetics
    86 %; Absolute bioavailability in 12 adult subjects was 86% ± 16% (mean ± SD) for the 150-mg tablet and 87% ± 13% for the 10-mg-per mL oral solution.
  • metabolism pharmacokinetics
    Metabolism: Metabolism of lamivudine is a minor route of elimination.

recorded 2026-07-29 · last checked 2026-09-04

Which running trial of Lamivudine could settle lifespan?


NCT04696575 measures Progression-free survival, reading out 2027-07-01.

1 open trial; n 28; "Lamivudine in Combination With Chemoimmunotherapy for the Treatment of Extensive Stage Small Cell Lung Cancer"

Show the evidence
  • Trial NCT04696575
    "Lamivudine in Combination With Chemoimmunotherapy for the Treatment of Extensive Stage Small Cell Lung Cancer"; n 28; "Progression-free survival"; 2027-07-01

Which 133 trials of Lamivudine posted no result?


Posted no result
133 of 133 completed trials
Registrations
NCT00000841, NCT00001067, NCT00001084, NCT00002371, NCT00000838 and NCT00000865, and 127 more
Completion dates
oldest 1997-06; newest 2024-07-14
Show the evidence

Trial

  • NCT00000841
    1997-06
  • NCT00001067
    1997-11
  • NCT00001084
    1997-12
  • NCT00002371
    1997-12
  • NCT00000838
    1998-03
  • NCT00000865
    1998-04
14 further recorded trials
  • NCT00000831
    1998-05
  • NCT00001085
    1998-09
  • NCT00001068
    1998-10
  • NCT00002411
    1999-09
  • NCT00001095
    1999-10
  • NCT00001108
    2000-06
  • NCT00001087
    2000-07
  • NCT00000901
    2000-10
  • NCT00001091
    2000-10
  • NCT00001968
    2000-11
  • NCT00000888
    2001-04
  • NCT00001083
    2001-06
  • NCT00000878
    2001-10
  • NCT00000899
    2001-10

At the median, Lamivudine's trials enrolled 100 people — anything larger?


Median enrolment
100
Largest enrolment
3526
Registered trials counted
307

What do 9175 spontaneous reports say about Lamivudine — and not say?


These are reports people sent to a regulator. They do not show the medicine caused the reaction. Nobody counted how many people took the medicine and reported nothing. The same event can be reported more than once, and many reports are incomplete. News coverage, lawsuits and new warnings change how often people report. A count is not a rate and not a risk.

Lamivudine appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 9175 reaction mentions were counted: drug resistance 1595; virologic failure 1506; viral mutation identified 1234; pathogen resistance 1142. FAERS via Open Targets · CHEMBL141 · 2026-06-24

Show the evidence
  • drug resistance
    1595
  • virologic failure
    1506
  • viral mutation identified
    1234
  • pathogen resistance
    1142
  • abortion spontaneous
    879
  • immune reconstitution inflammatory syndrome
    706
4 more recorded rows
  • premature baby
    649
  • treatment failure
    646
  • lipodystrophy acquired
    430
  • blood hiv rna increased
    388

recorded 2026-06-24 · last checked 2026-09-04

Which 10 reactions does Lamivudine's label not list?


abortion spontaneous, blood hiv rna increased and drug resistance and 7 more reported for Lamivudine, absent from its label. FAERS via Open Targets · CHEMBL141 · 2026-06-24

3 label terms; 10 reported and unlisted; 6bd6b9da-df69-46db-813e-4e7f3bdecf95

Show the evidence
  • abortion spontaneous
    count not stated
  • blood hiv rna increased
    count not stated
  • drug resistance
    count not stated
  • immune reconstitution inflammatory syndrome
    count not stated
  • lipodystrophy acquired
    count not stated
  • pathogen resistance
    count not stated
4 more recorded rows
  • premature baby
    count not stated
  • treatment failure
    count not stated
  • viral mutation identified
    count not stated
  • virologic failure
    count not stated

recorded 2026-06-24 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL141
PubChem CID
60825
CAS number
134678-17-4
RxCUI
68244
InChIKey
JTEGQNOMFQHVDC-NKWVEPMBSA-N
Development code
3TC, BCH 189, (-)-, GR 109714X, GR109714X, NSC-760061
Trade name
Epivir, Epivir-hbv, Lamivudine component of cimduo, Lamivudine component of combivir, Lamivudine component of delstrigo, Lamivudine component of dovato, Lamivudine component of dutrebis, Lamivudine component of epzicom, Lamivudine component of kivexa, Lamivudine component of symfi, Lamivudine component of temixys, Lamivudine component of triumeq
Also called
Lamivudina, Lamivudine teva, Lamivudinum, Virolam, abc/3tc, emtricitabine, lam, lvd, 2(1H)-PYRIMIDINONE, 4-AMINO-1-(2-(HYDROXYMETHYL)-1,3-OXATHIOLAN-5-YL)-, (2R-CIS)-, COMBIVIR COMPONENT LAMIVUDINE, EMTRICITABINE IMPURITY C [WHO-IP], EPZICOM COMPONENT LAMIVUDINE
Salt form
LAMIVUDINE ORAL
Sources (6)

Sources

ChEMBL 37 — CC BY-SA 3.0 Unported · ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Open Targets 26.06 — CC0 · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work

How these records are assembled · Which registers were checked

Index-quality checks
  • identity passed: no open identity hold
  • required summary fields resolved: 4 required field(s) not terminal: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
  • public claims reviewed: 0 reviewed claim(s); drafts are never rendered
  • source coverage passed: 6 source rows
  • no critical contamination: no quarantine open
  • canonical metadata passed: slug and display name present
  • no raw internal fields: enforced by the copy-contract test over the rendered page

This is a record of evidence. It is not medical advice, and it does not say this substance suits you. Nothing here says any substance on RNAWiki is appropriate for a child.