This page shows what was measured, who it was measured in, and what that does not settle.
What Glecaprevir does in the body
Long-standing hepatitis C infection across all six genetic forms.
Hepatitis C builds all its proteins as one long strip and then cuts the strip into separate working parts using its own scissors. Glecaprevir jams the scissors. The strip never gets cut, none of the parts are released, and the virus cannot assemble the machinery it needs to copy itself. Its partner pibrentasvir blocks a second, unrelated viral protein at the same time, so escaping one is not enough.
What happened in people
Paired with pibrentasvir, eight weeks cured about 99 in 100 people with the most common form.
✓ Reviewed first-read answer
Where this came from
A person wrote this and a reviewer approved it against this exact record. It carries no effect size.
A reviewer approved this against this record. The reviewed-claim record carrying the exact population and effect size does not exist yet.
No source is stored against this line.
The limit that matters most
The shortened course for one harder-to-treat form was not assigned by chance.
Where it acts
Hepatocyte cytoplasm, at the endoplasmic reticulum membrane where the viral polyprotein is processed
Kind of result
The kind of result is not recorded
Supervision
RNAWiki has not recorded a supervision or regulatory status for this substance.
What the registries record it as
The substance registry classes this as chemical.
FDA substance registry · K6BUU8J72P · read 2026-08-29
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.
The limit a reviewer approved as the one that matters most here.
The four opening statements run to 96 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 people◇Read 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.
Sustained virologic response 12 weeks after end of treatment, genotype 1
ENDURANCE-1: 8 against 12 weeks in genotype 1 (NCT02604017) · a recorded source, not a stored snapshot
Sustained virologic response 12 weeks after end of treatment, genotype 3
✓ The study showed what it set out to show
Who was studied
ENDURANCE-3 (NCT02640157)
How many people
505
Study design
Phase 3, randomised 2:1 against an active comparator, plus a non-randomised arm
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
95% (222/233) at 12 weeks against 97% (111/115) on sofosbuvir-daclatasvir; 95% (149/157) in the non-randomised 8-week cohort
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. The 8-week genotype 3 cohort was enrolled after randomisation had closed and assigned without randomisation, so it has no concurrent comparator.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral fixed-dose combination tablet with pibrentasvir, and oral pellets for children
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
98% (102 of 104; 95% CI 95 to 100), with no on-treatment failures and no relapses
Repeated elsewhere
Unreplicated
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. Serious adverse events in 24% of patients. Single-arm and open-label in a population with high background morbidity, so the serious event rate cannot be attributed either way.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral fixed-dose combination tablet with pibrentasvir, and oral pellets for children
Interval reported. 95% CI 95 to 100), with no on-treatment failures and no relapses
Written into the record, not signed off as a reviewed claim.
ENDURANCE-1: 8 against 12 weeks in genotype 1 (NCT02604017) · a recorded source, not a stored snapshot
What we know
RNAWiki holds 3 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 body◇Read 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.
Start
Glecaprevir
What a person takes: Oral fixed-dose combination tablet with pibrentasvir, and oral pellets for children.
The measurement behind this step
Three tablets once daily with food; absorption falls substantially when taken fasting. Glecaprevir is not sold separately. Pellets exist for children from age 3.
Getting in
Three tablets a day, taken with food
Glecaprevir is never given alone. It comes fixed together with pibrentasvir, and the tablets are taken with food because absorption is much lower on an empty stomach.
╌╌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
Fixed-dose combination of 100 mg glecaprevir with 40 mg pibrentasvir per tablet, three tablets once daily. Both are substrates of P-glycoprotein and BCRP and inhibitors of them, which is the origin of most of the interaction list, including the outright contraindications with rifampin and atazanavir.
Transport proteins on the liver-cell surface pull the drug in, and it leaves again in bile rather than urine. That is why failing kidneys do not cause it to build up.
╌╌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
Uptake is mediated by OATP1B1 and OATP1B3; elimination is biliary with negligible renal clearance, which is the pharmacological basis for the stage 4 and 5 chronic kidney disease indication established in EXPEDITION-4.
The virus makes all its proteins as one long strip that must be cut into separate pieces. Glecaprevir sits in the cutting groove so the cut never happens.
╌╌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
A macrocyclic acylsulfonamide that binds the NS3/4A serine protease active site, inhibiting recombinant enzyme from genotypes 1a through 6a with IC50 values of 3.5 to 11.3 nM and replicons with median EC50 values of 0.08 to 4.6 nM. The macrocycle pre-organises the molecule into the bound conformation, which is what buys potency across subtypes.
The polyprotein is never cut and the replication machinery is never built
None of the individual viral proteins are released, so the virus cannot assemble the copying apparatus at all. Blocking NS3/4A also restores part of the cell’s own antiviral alarm.
╌╌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
NS3/4A cleaves the polyprotein at the NS3-NS4A, NS4A-NS4B, NS4B-NS5A and NS5A-NS5B junctions. It also cleaves the host adaptor MAVS, blunting RIG-I-mediated interferon induction, so protease inhibition removes both the maturation step and the virus’s suppression of innate sensing.
Eight weeks is the standard course for most previously untreated patients, whatever their genotype and whatever their kidney function.
╌╌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
SVR12 was 99.1% at 8 weeks in genotype 1 without cirrhosis, 95% at 12 weeks and 95% at 8 weeks in genotype 3 without cirrhosis, and 98% at 12 weeks in stage 4 or 5 chronic kidney disease across genotypes 1 to 6.
Because the drug is cleared by the liver, a badly damaged liver lets it accumulate. It is contraindicated in moderate or severe liver impairment, and cases of liver failure with fatal outcomes have been reported.
╌╌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
Contraindicated in Child-Pugh B or C and in any history of prior hepatic decompensation. Glecaprevir exposure rises steeply with worsening hepatic function because clearance is hepatic and uptake is transporter-mediated.
No suggested links are held for this record, so nothing is hidden from this path.
What we know
The record describes 6 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 unclear◇Read 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.
Adults and children aged 3 and over with any genotype, at any level of kidney function. It must not be used in anyone with moderate or severe liver impairment or with any history of hepatic decompensation.
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.
Where the result stopped carrying
Hepatic decompensation and failure, including fatal outcomes, reported after approval in patients with moderate or severe liver impairment
Contraindicated outright in Child-Pugh B or C and in any history of prior decompensation, excluding the sickest livers from a pan-genotypic option
Genotype 3 accounted for 20 of 24 virologic failures across the registrational programme
Two genotype 2 failures had no treatment-emergent resistance substitution at all, so the failure has no molecular explanation
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 take◇Read 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.
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 (11)
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.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. 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 take◇Read 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 fixed-dose combination tablet with pibrentasvir, and oral pellets for children
✎ 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
RNAWiki has not recorded a supervision or regulatory status for this substance.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
No register row and no identity class settled the question.
No source is stored against this line.
What is in the pack
Three tablets once daily with food; absorption falls substantially when taken fasting. Glecaprevir is not sold separately. Pellets exist for children from age 3.
✎ 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 and what that means for what is in the pack.
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 take◇Read 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
Contraindicated in Child-Pugh B or C hepatic impairment and in any history of prior hepatic decompensation, and contraindicated with atazanavir or rifampin. Boxed warning for hepatitis B virus reactivation, as for the whole class. Warnings and Precautions record hepatic decompensation and failure including fatal outcomes, mostly in patients with cirrhosis and baseline moderate or severe impairment. Adverse events led to discontinuation in no more than 1% of ENDURANCE patients; in the dialysis population of EXPEDITION-4 serious adverse events were reported in 24%, with pruritus, fatigue and nausea the commonest events.
Nobody counted how many people took this and were fine, so this cannot be turned into a rate.
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 unclear◇Read 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 fixed-dose combination tablet with pibrentasvir, and oral pellets for children
✎ 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
Glecaprevir is not sold separately. Pellets exist for children from age 3.
✎ 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 and how they compare.
No source is stored against this line.
What is recorded as being sold
5 products list this as an active ingredient in the United States drug directory. 1 of them contain it and nothing else.
FDA National Drug Code directory · 12613-3048 · read 2026-08-29
They are sold as pellet and tablet, film coated, taken oral.
FDA National Drug Code directory · 12613-3048 · read 2026-08-29
1 published label names it as an active ingredient. None of them describes this substance alone, so no label text on this page can be attributed to it rather than to a combination.
US prescribing information · 7bf99777-0401-9095-8645-16c6e907fcc0 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 7bf99777-0401-9095-8645-16c6e907fcc0 · read 2026-08-29
Mavyret is oral at 3 DOSAGE FORMS AND STRENGTHS MAVYRET is available as tablets or pellets for oral use., recorded as fda label in effect 2025-06-25 in the United States.
US prescribing information · 7bf99777-0401-9095-8645-16c6e907fcc0 · read 2026-08-30
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 take◇Read 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.
RNAWiki could not confidently classify this substance, so no self-experiment plan is offered.
Questions worth asking
Which of the trials of Glecaprevir 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 unclear◇Read 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 eight weeks in genotype 3 rests on the same evidence as twelve weeks — the eight-week cohort was assigned without randomisation
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 98% cure rate in advanced kidney disease has been shown to change renal or survival outcomes; the trial measured virus in blood
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 pan-genotypic label means uniform potency: replicon EC50 spans 0.08 to 4.6 nM, a nearly sixtyfold range across subtypes
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 the 24% serious adverse event rate in EXPEDITION-4 is attributable to the drug; the trial was single-arm in a dialysis population
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 unclear◇Read 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 Glecaprevir 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 people◇Read 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.
ENDURANCE-1: 99.1% cured in eight weeks in genotype 1
In plain words
Eight weeks of treatment cured essentially everyone with genotype 1 and no cirrhosis, and twelve weeks added nothing measurable. Fewer than one in a hundred patients in any group stopped because of side effects.
What was measured
Sustained virologic response 12 weeks after end of treatment
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
ENDURANCE-1 and ENDURANCE-3 together treated 1,208 patients without cirrhosis. Genotype 1 patients were randomised 1:1 to glecaprevir 300 mg with pibrentasvir 120 mg for 8 or 12 weeks: SVR12 was 99.1% (95% CI 98 to 100) at 8 weeks and 99.7% (95% CI 99 to 100) at 12 weeks. Adverse events led to discontinuation in no more than 1% of patients in any group.
Written into the record, not signed off as a reviewed claim
EXPEDITION-4: 98% cured in stage 4 and 5 kidney disease, with no failures at all
In plain words
A hundred and four people with failing kidneys or on dialysis were treated. A hundred and two were cured. Not one had the virus break through during treatment, and not one relapsed afterwards.
What was measured
Sustained virologic response at 12 weeks in stage 4 or 5 chronic kidney disease
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
EXPEDITION-4 was an open-label phase 3 trial in adults with genotype 1 to 6 hepatitis C, compensated liver disease with or without cirrhosis, and stage 4 or 5 chronic kidney disease including dialysis dependence. Of 104 patients, 52% had genotype 1, 16% genotype 2, 11% genotype 3, 19% genotype 4 and 2% genotype 5 or 6. SVR12 was 98% (102 of 104; 95% CI 95 to 100). No patient had virologic failure on treatment and none relapsed after it. Serious adverse events were reported in 24% of patients, and four discontinued early for adverse events, three of whom were still cured.
Written into the record, not signed off as a reviewed claim
Contraindicated in the sickest livers after fatal decompensation reports
In plain words
This regimen must not be given to anyone whose liver is moderately or severely impaired, or who has ever had a liver decompensation. Cases of liver failure, some fatal, were reported after approval in exactly those patients.
What was measured
Not recorded
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
The label contraindicates the combination in Child-Pugh B or C hepatic impairment and in any patient with a history of prior hepatic decompensation. Warnings and Precautions 5.2 records that hepatic decompensation and failure, including fatal outcomes, have been reported mostly in patients with cirrhosis and baseline moderate or severe liver impairment, and directs discontinuation on any evidence of decompensation. Protease inhibitors as a class are cleared hepatically and accumulate as liver function falls, which is the mechanistic reason. This is a contraindication rather than a warning, and it excludes the population in which sofosbuvir-velpatasvir with ribavirin remains usable.
Source
MAVYRET United States prescribing information, Contraindications 4 and Warnings and Precautions 5.2 (NDA 209394)
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
Twenty of the twenty-four registrational failures were genotype 3
In plain words
Across the whole approval programme only twenty-four people failed treatment. Twenty of them had genotype 3. Nobody with genotype 4, 5 or 6 failed at all.
What was measured
Distribution of virologic failures by genotype across the registrational programme
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
In pooled resistance analyses of protease-inhibitor-naive and NS5A-inhibitor-naive subjects treated for 8, 12 or 16 weeks in the registrational phase 2 and 3 programme, 24 subjects had virologic failure: 2 genotype 1, 2 genotype 2 and 20 genotype 3. No genotype 4, 5 or 6 subject failed. Both genotype 1 failures were subtype 1a and both had treatment-emergent NS5A substitutions; one also had NS3 A156V. Neither genotype 2 failure had any treatment-emergent NS3 or NS5A substitution, meaning the failure was not explained by resistance at all.
Source
MAVYRET United States prescribing information, Microbiology 12.4, pooled registrational resistance analysis (NDA 209394)
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 eight-week genotype 3 result came from a non-randomised add-on cohort
In plain words
The twelve-week genotype 3 comparison was randomised. The eight-week genotype 3 group was not: those patients were enrolled afterwards and assigned to eight weeks without randomisation.
What was measured
That eight weeks is established in genotype 3 to the same standard as twelve weeks — the twelve-week arm was randomised against an active comparator, the eight-week arm was not randomised against anything
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
In ENDURANCE-3, genotype 3 patients were randomised 2:1 to 12 weeks of glecaprevir-pibrentasvir or sofosbuvir-daclatasvir, giving SVR12 of 95% (222 of 233; 95% CI 93 to 98) against 97% (111 of 115; 95% CI 93 to 99.9). Additional genotype 3 patients were then, in the paper’s own words, subsequently enrolled and nonrandomly assigned to 8 weeks, reaching 95% (149 of 157; 95% CI 91 to 98). The eight-week number is as high as the randomised twelve-week number, and it comes from a cohort that was not randomised, was recruited later, and has no concurrent comparator.
Written into the record, not signed off as a reviewed claim
The Q80K substitution that killed the previous protease inhibitor does nothing here
In plain words
An earlier protease inhibitor failed in a large fraction of genotype 1a patients because of one common natural variant. Glecaprevir is unaffected by it, which is a genuine structural advance and not a marketing claim.
What was measured
Fold-change in glecaprevir susceptibility by NS3 substitution
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Q80 substitutions in genotypes 1a and 1b, including the genotype 1a Q80K polymorphism that reduced simeprevir efficacy enough to require baseline testing, do not reduce glecaprevir susceptibility. Substitutions at NS3 positions 36, 43, 54, 55, 56, 155, 166 or 170 associated with resistance to other protease inhibitors generally do not reduce it either. The exceptions are real and specific: A156 substitutions cost more than 100-fold, D/Q168 substitutions more than 30-fold in genotypes 1a (D168F/Y), 3a (Q168R) and 6a, a genotype 3a Q80R costs 21-fold, and Y56H combined with a D/Q168 change costs more still.
Source
MAVYRET United States prescribing information, Microbiology 12.4, resistance in cell culture (NDA 209394)
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
Every endpoint in the programme is a blood test
In plain words
ENDURANCE and EXPEDITION measured virus in blood twelve weeks after treatment. Neither counted deaths, liver cancers, transplants or dialysis outcomes.
What was measured
That curing hepatitis C in advanced kidney disease changes renal or survival outcomes — the reason the trial was run, and not something the trial measured
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The 2017 Cochrane review of 138 randomised direct-acting antiviral trials in 25,232 participants found no usable randomised data on hepatitis C-related morbidity or on hepatocellular carcinoma, and mortality data from only 11 trials. EXPEDITION-4 is where the gap is most visible: its population is defined by stage 4 or 5 kidney disease, the outcome that matters to them is renal and cardiovascular, and the trial was open-label with a 12-week virological endpoint and no comparator.
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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.
What was measured, goal by goal — found nothing in the sources checked.
How close this is to real life — found nothing in the sources checked.
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.
Other ways to the same goal — found nothing in the sources checked.
What changed on this page — found nothing in the sources checked.
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 pan-genotypic NS3/4A protease inhibitor that, paired with pibrentasvir, cured 99.1% of genotype 1 patients in eight weeks in ENDURANCE-1 and 98% of 104 patients with stage 4 or 5 kidney disease in EXPEDITION-4 — and that is contraindicated outright in Child-Pugh B or C liver disease after reports of hepatic decompensation and failure, including deaths.
Recorded evidence blocks (6)
Q1
51 registered trials of Glecaprevir — at which phases?
Registered studies posting no result
16 of 51
51 registered studies of Glecaprevir: 28 phase3, 12 phase2, 8 phase4, 5 na or unstated, 3 phase1, 2 na, 1 early phase1. CLINICALTRIALS_SNAPSHOT · 2026-09-01
60 with a PubMed record
Show the evidence
phase3
28
phase2
12
phase4
8
na or unstated
5
phase1
3
na
2
8 more recorded rows
early phase1
1
completed
40
unknown
4
recruiting
2
terminated
2
active not recruiting
1
approved for marketing
1
withdrawn
1
recorded 2026-09-01 · last checked 2026-09-04
Q2
3 of Glecaprevir's trials stopped: accrual/recruitment, funding/business, other?
NCT02296905, NCT02442258, NCT04047680, NCT03492112, NCT05108935 and NCT04682509, and 1 more
Completion dates
oldest 2015-09; newest 2024-04-15
Show the evidence
Trial
NCT02296905
2015-09
NCT02442258
2015-12
NCT04047680
2019-06
NCT03492112
2021-11-30
NCT05108935
2023-03-30
NCT04682509
2024-02-28
1 further recorded trialNCT05446857
2024-04-15
Q5
At the median, Glecaprevir's trials enrolled 102.5 people — anything larger?
Median enrolment
102.5
Largest enrolment
800
Registered trials counted
50
Q6
What do 4027 spontaneous reports say about Glecaprevir — 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.
Glecaprevir appears in spontaneous reports to regulators. Across the 6 most-reported reaction terms, 4027 reaction mentions were counted: fatigue 1515; headache 1384; nausea 675; pruritus 414. FAERS via Open Targets · CHEMBL3545363 · 2026-06-24
Show the evidence
fatigue
1515
headache
1384
nausea
675
pruritus
414
viral load increased
28
drug hypersensitivity
11
recorded 2026-06-24 · last checked 2026-09-04
Where it is registeredIdentifiers, relations and other names
ChEMBL 37 — CC BY-SA 3.0 Unported · ClinicalTrials.gov — US Government work · Open Targets 26.06 — CC0 · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md
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✓ public claims reviewed: 0 reviewed claim(s); drafts are never rendered
✓ source coverage passed: 5 source rows
✓ no critical contamination: no quarantine open
✓ canonical metadata passed: slug and display name present
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