This page shows what was measured, who it was measured in, and what that does not settle.
What Velpatasvir does in the body
Long-standing hepatitis C infection across all six genetic forms.
Hepatitis C builds itself a private workshop out of folded cell membrane, and a viral protein called NS5A runs it. Velpatasvir jams NS5A. What makes it different from the NS5A blocker that came before it is shape tolerance: the same molecule fits the version of NS5A carried by all six genetic families of the virus, so nobody needs to find out which family a patient has before starting treatment.
What happened in people
Combined with sofosbuvir, it cured 622 of 624 people and outperformed an older combination in a harder-to-treat 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
One cirrhosis subgroup with a resistance change had a 40% treatment failure rate.
Where it acts
Hepatocyte cytoplasm — the membranous web where NS5A assembles the viral replication complex
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 · KCU0C7RS7Z · read 2026-08-29
Where each sentence above came from
The recorded explanation is written in label language rather than for a beginner. 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 98 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 therapy
✓ The study showed what it set out to show
Who was studied
ASTRAL-1 (NCT02201940)
How many people
740
Study design
Phase 3, double-blind, placebo-controlled
Compared against
A dummy treatment
Kind of result
A number that stands in for health
What was found
99% (95% CI 98 to >99) on treatment against 0% in 116 placebo patients; two relapses, both genotype 1
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. Genotype 5 patients were assigned to the active arm without randomisation because of low regional prevalence, so the placebo comparison does not cover that genotype.
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 sofosbuvir, and oral pellets for children
Interval reported. 95% CI 98 to >99) on treatment against 0% in 116 placebo patients; two relapses, both genotype 1
Written into the record, not signed off as a reviewed claim.
83% at 12 weeks, 94% at 12 weeks with ribavirin, 86% at 24 weeks; post hoc analysis found no significant difference among the three groups
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 16% to 19% across arms, and anaemia in 31% of those given ribavirin. Open-label with no untreated comparator in a population whose clinical course changes on its own.
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 sofosbuvir, and oral pellets for children
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
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 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
Velpatasvir
What a person takes: Oral fixed-dose combination tablet with sofosbuvir, and oral pellets for children.
The measurement behind this step
One tablet daily with or without food. Velpatasvir is not sold separately, so every claim on this page is a claim about the combination. Velpatasvir is delivered as an amorphous solid dispersion because the crystalline form does not dissolve well enough to absorb reliably.
Getting in
One tablet, once a day, whatever the genotype
The same tablet is used for all six families of the virus, so the laboratory test that used to come first is no longer needed to choose treatment.
╌╌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 velpatasvir with 400 mg sofosbuvir. Velpatasvir is formulated as an amorphous solid dispersion because the crystalline free base is too poorly soluble to absorb reliably.
Into the liver cell, where the viral workshop is built
Hepatitis C folds a piece of the cell’s own membrane into a private compartment and copies itself inside it, hidden from much of the cell’s surveillance.
╌╌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
HCV remodels endoplasmic reticulum into the membranous web. NS5A is a membrane-anchored phosphoprotein with no catalytic activity, organising the replication complex and later directing genome packaging.
It grips a part of the protein that all six families share
The six genetic families of the virus differ in most of their proteins. Velpatasvir was designed against the part of NS5A that varies least, which is why one molecule fits all of them.
╌╌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
Velpatasvir binds domain I of the NS5A dimer. Unlike the symmetric ledipasvir, its two arms are chemically different, which relaxes the geometric requirement on the binding surface. Replicon EC50 values sit between 0.002 and 0.016 nM across genotypes 1a, 1b, 2a, 2b and 3a.
The workshop stops working and copying is blocked as well
With NS5A jammed and the copying enzyme separately blocked by sofosbuvir, the virus loses the place it copies itself and the machine it copies itself with in the same dose.
╌╌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
NS5A inhibition blocks replication complex formation and virion assembly; sofosbuvir’s triphosphate metabolite terminates nascent RNA chains. The two mechanisms have no shared resistance pathway, which is why the combination is durable.
Undetectable at twelve weeks in about 99 of every 100 people
Twelve weeks of treatment, one duration for everyone without cirrhosis or with compensated cirrhosis, whatever the genotype.
╌╌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% in ASTRAL-1 across genotypes 1, 2, 4, 5 and 6, 99% in genotype 2 in ASTRAL-2 and 95% in genotype 3 in ASTRAL-3, against 0% on placebo in the one placebo-controlled arm.
One combination of circumstances defeats it: genotype 3, with cirrhosis, in someone whose virus already carries a specific change at position 93. Two in five of those failed.
╌╌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
Baseline NS5A Y93H is present in 6% of genotype 3 isolates. With Y93H and compensated cirrhosis, 40% (6 of 15) failed 12 weeks of treatment, against 7% (2 of 28) with Y93H and no cirrhosis. Baseline polymorphisms did not affect outcome in genotypes 2, 4, 5 or 6.
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 of chronic hepatitis C, including those with compensated cirrhosis, and with decompensated cirrhosis when ribavirin is added. Velpatasvir is not sold on its own.
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
Two of 624 patients in ASTRAL-1 relapsed, both genotype 1
Twelve weeks without ribavirin in decompensated cirrhosis reached only 83%, the lowest figure in the programme
Anaemia in 31% of the decompensated-cirrhosis patients given ribavirin, in a group least able to tolerate it
Genotype 3 with cirrhosis and Y93H failed at 40%, the one documented hole in the pan-genotypic claim
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 sofosbuvir, 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
One tablet daily with or without food. Velpatasvir is not sold separately, so every claim on this page is a claim about the combination. Velpatasvir is delivered as an amorphous solid dispersion because the crystalline form does not dissolve well enough to absorb reliably.
✎ 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
Class boxed warning for hepatitis B virus reactivation, including fulminant hepatitis, hepatic failure and death. Serious adverse events were 2% on treatment and 0% on placebo in ASTRAL-1; in decompensated cirrhosis they ran 16% to 19% across arms, reflecting the population rather than the drug. Commonest events are fatigue, headache, nausea and insomnia. Adding ribavirin brings anaemia, seen in 31% of ASTRAL-4 patients who received it. The amiodarone bradycardia warning applies, as it does to every sofosbuvir-containing regimen.
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 sofosbuvir, 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
Velpatasvir is not sold separately, so every claim on this page is a claim about the combination. Velpatasvir is delivered as an amorphous solid dispersion because the crystalline form does not dissolve well enough to absorb reliably.
✎ 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
13 products list this as an active ingredient in the United States drug directory. 6 of them contain it and nothing else.
FDA National Drug Code directory · 48087-0124 · read 2026-08-29
They are sold as pellet, powder and tablet, film coated, taken oral.
FDA National Drug Code directory · 48087-0124 · read 2026-08-29
3 published labels name 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 · 7f30631a-ee3b-4cfe-866b-964df3f0a44f · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 7f30631a-ee3b-4cfe-866b-964df3f0a44f · read 2026-08-29
Epclusa is oral at 3 DOSAGE FORMS AND STRENGTHS EPCLUSA is available as tablets or pellets for oral use., recorded as fda label in effect 2024-06-05 in the United States.
US prescribing information · 7f30631a-ee3b-4cfe-866b-964df3f0a44f · 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 Velpatasvir 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 the genotype 5 and 6 evidence is as strong as the genotype 1, 2 and 3 evidence — those arms had tens of patients and genotype 5 was not randomised
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 ribavirin adds efficacy in decompensated cirrhosis; ASTRAL-4 found no significant difference between its three arms on its own post hoc analysis
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 99% sustained virologic response has been shown to reduce deaths, decompensations or liver cancers — no trial here measured any of those
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 "pan-genotypic" means uniform: it does not cover genotype 3 with cirrhosis and baseline Y93H, where the label reports 40% failure
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 Velpatasvir 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.
ASTRAL-1: 99% cured against 0% on placebo, across five genotypes at once
In plain words
Six hundred and twenty-four people with five different genetic families of hepatitis C took the drug; six hundred and twenty-two were cured. One hundred and sixteen took a dummy tablet; none were cured. Two relapses in total, both genotype 1.
What was measured
Sustained virologic response 12 weeks after end of therapy, against matching placebo
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
ASTRAL-1 was a phase 3, double-blind, placebo-controlled trial in untreated and previously treated patients with genotype 1, 2, 4, 5 or 6, including compensated cirrhosis. Genotypes 1, 2, 4 and 6 were randomised 5:1 to sofosbuvir-velpatasvir or matching placebo for 12 weeks; genotype 5 was assigned to active treatment because of low regional prevalence. Of 624 treated, 34% had genotype 1a, 19% 1b, 17% genotype 2, 19% genotype 4, 6% genotype 5 and 7% genotype 6; 19% had cirrhosis and 32% had been treated before. SVR12 was 99% (95% CI 98 to greater than 99), with two virologic relapses, both genotype 1. None of the 116 placebo patients achieved SVR. Serious adverse events occurred in 15 patients (2%) on treatment and none on placebo.
Written into the record, not signed off as a reviewed claim
ASTRAL-3: superior to the previous standard in genotype 3, 95% against 80%
In plain words
Genotype 3 was the family the earlier drugs handled worst. Against the regimen it replaced, this one cured fifteen percentage points more people, and in half the time.
What was measured
Sustained virologic response at 12 weeks against active comparator, superiority tested
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
ASTRAL-3 randomised 552 patients with genotype 3, previously treated and untreated including compensated cirrhosis, 1:1 to sofosbuvir-velpatasvir for 12 weeks (277 patients) or sofosbuvir plus weight-based ribavirin for 24 weeks (275 patients). SVR12 was 95% (95% CI 92 to 98) against 80% (95% CI 75 to 85), superiority p<0.001. In the parallel ASTRAL-2 trial in genotype 2, 134 patients on sofosbuvir-velpatasvir reached 99% (95% CI 96 to 100) against 94% (88 to 97) on sofosbuvir-ribavirin in 132 patients, superiority p=0.02. Commonest adverse events across both were fatigue, headache, nausea and insomnia.
Written into the record, not signed off as a reviewed claim
Genotype 3 with cirrhosis and a baseline Y93H: two in five failed
In plain words
The pan-genotypic claim has one documented hole. About one genotype 3 patient in sixteen starts with a particular change in the target protein. If they also have cirrhosis, twelve weeks of treatment fails four times in ten.
What was measured
Virologic failure rate in genotype 3 with baseline NS5A Y93H, stratified by cirrhosis
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
In a pooled analysis of genotype 3 trials the baseline NS5A Y93H polymorphism was present in 6% (104 of 1,842) of subjects. Among genotype 3 subjects with Y93H treated with sofosbuvir-velpatasvir for 12 weeks, 7% (2 of 28) without cirrhosis relapsed, while 40% (6 of 15) with compensated cirrhosis had virologic failure — five relapses and one on-treatment failure. In ASTRAL-3 itself, 4 of the 56 genotype 3 subjects with any baseline NS5A resistance-associated polymorphism relapsed (3 with Y93H, 1 with A30K), and 20% (3 of 15) of all genotype 3 subjects carrying Y93H relapsed. By contrast, baseline polymorphisms did not affect relapse in genotypes 2, 4, 5 or 6, where every such subject achieved SVR12, and all 77 subjects with baseline NS5B nucleoside-inhibitor polymorphisms achieved SVR12.
Source
EPCLUSA United States prescribing information, Microbiology 12.4, effect of baseline HCV polymorphisms on treatment response (NDA 208341)
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
Adding ribavirin in decompensated cirrhosis rests on a difference that was not significant
In plain words
In the decompensated-cirrhosis trial, twelve weeks with ribavirin cured 94% and twelve weeks without cured 83%. That eleven-point gap is the reason ribavirin is added. The trial itself found no significant difference between the three arms.
What was measured
That ribavirin adds efficacy in decompensated cirrhosis — an eleven-point numerical gap in a three-arm trial whose own post hoc analysis found no significant difference, bought at 31% anaemia
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
ASTRAL-4 randomised 267 patients with Child-Pugh-Turcotte class B decompensated cirrhosis 1:1:1 to sofosbuvir-velpatasvir for 12 weeks, the same plus ribavirin for 12 weeks, or sofosbuvir-velpatasvir for 24 weeks. SVR12 was 83% (95% CI 74 to 90), 94% (87 to 98) and 86% (77 to 92) respectively. The paper states that post hoc analysis did not detect any significant differences among the three groups. Serious adverse events occurred in 19%, 16% and 18%. Anaemia occurred in 31% of the patients receiving ribavirin. The trial was open-label with no untreated comparator, in a population where spontaneous clinical change is common.
Written into the record, not signed off as a reviewed claim
"Pan-genotypic" is a statement about laboratory potency plus uneven trial numbers
In plain words
The word means the drug works against all six families. That is well established for genotypes 1, 2 and 3, which had hundreds of patients each. Genotype 5 had thirty-five patients and was not randomised at all.
What was measured
That the evidence for genotypes 5 and 6 is the same strength as for genotypes 1, 2 and 3 — the potency data are comparable, the clinical data are not
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
ASTRAL-1 enrolled genotype 5 patients into the active arm without randomisation because of low prevalence in the study regions, and genotype 5 made up 6% of the 624 treated, roughly 35 people. Genotype 6 made up 7%. The laboratory basis is uniform — replicon EC50 values of 0.014, 0.016, 0.005 to 0.016, 0.002 to 0.006 and 0.004 nM for genotypes 1a, 1b, 2a, 2b and 3a — and the clinical basis is not uniform, because the rarer genotypes are rare. This is not a criticism of the drug; it is a statement of which parts of the claim rest on hundreds of randomised patients and which rest on tens of unrandomised ones.
Written into the record, not signed off as a reviewed claim
Every ASTRAL endpoint is a blood test, not a clinical outcome
In plain words
All four trials measured whether virus could be detected twelve weeks after the last tablet. None of them counted deaths, liver cancers or transplants. The link between the two is inferred.
What was measured
That a 99% sustained virologic response rate translates into fewer deaths, decompensations and liver cancers — plausible, supported by cohort follow-up, and not measured in these trials
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The 2017 Cochrane review of direct-acting antivirals pooled 138 randomised trials in 25,232 participants and found no usable randomised data on hepatitis C-related morbidity, hepatocellular carcinoma, ascites, variceal bleeding or hepatic encephalopathy, and mortality data from only 11 trials. ASTRAL-4 is the trial where this matters most, because its population — Child-Pugh class B cirrhosis — is the one whose clinical trajectory a cure would most plausibly change, and it was open-label with no untreated arm and a 12-week virological endpoint.
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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 NS5A inhibitor active at single-digit picomolar concentrations against every genotype tested, which combined with sofosbuvir cured 99% of 624 patients against 0% of 116 on placebo in ASTRAL-1 and beat sofosbuvir-ribavirin outright in genotype 3 (95% against 80%, p<0.001) — with one documented hole, genotype 3 with cirrhosis and a baseline Y93H substitution, where 40% failed.
Recorded evidence blocks (7)
Q1
86 registered trials of Velpatasvir — at which phases?
Registered studies posting no result
36 of 86
86 registered studies of Velpatasvir: 26 phase2, 21 phase3, 17 phase4, 13 na or unstated, 8 phase1, 3 na, 1 early phase1. CLINICALTRIALS_SNAPSHOT · 2026-09-01
80 with a PubMed record
Show the evidence
phase2
26
phase3
21
phase4
17
na or unstated
13
phase1
8
na
3
9 more recorded rows
early phase1
1
completed
59
unknown
13
terminated
6
active not recruiting
4
enrolling by invitation
1
not yet recruiting
1
recruiting
1
withdrawn
1
recorded 2026-09-01 · last checked 2026-09-04
Q2
7 of Velpatasvir's trials stopped: accrual/recruitment, funding/business, other?
"The study stopped early because the study objectives were met."; 7 of 86 registered studies
Show the evidence
Trial
NCT02292706
terminated; "The study stopped early because the study objectives were met."
NCT02510300
terminated; "The study stopped early because the study objectives were met."
NCT03207399
terminated; "Enrollment terminated due to not having any other eligible participants."
NCT03313414
withdrawn; "No participant enrollment, funding withdrawn."
NCT03625687
terminated; "Lack of funding, transitioned to standard of care"
NCT03820258
terminated; "SOF/VEL/VOX will not be evaluated in younger age groups."
1 further recorded trialNCT05717400
terminated; "PI Request"
recorded 2026-09-01 · last checked 2026-09-04
Q3
Human studies of Velpatasvir used Sofosbuvir-velpatasvir (400 mg/100 mg) — over how long?
Human studies of Velpatasvir used "Sofosbuvir-velpatasvir (400 mg/100 mg)". ClinicalTrials.gov · 2026-09-01
6 recorded entries; human; also "SOF/VEL- sofosbuvir 400mg and velpatasvir 100mg", "Sofosbuvir/Velpatasvir 400 MG-100 MG Oral Tablet", "Sofosbuvir 400 Mg and Velpatasvir 100 Mg Oral Capsules"
Show the evidence
human
NCT03112044
Sofosbuvir-velpatasvir (400 mg/100 mg)
NCT03570112
SOF/VEL- sofosbuvir 400mg and velpatasvir 100mg
NCT05140941
Sofosbuvir/Velpatasvir 400 MG-100 MG Oral Tablet
NCT05248919
Sofosbuvir 400 Mg and Velpatasvir 100 Mg Oral Capsules
NCT05264558
Epclusa 400Mg-100Mg Tablet
NCT05503979
Sofosbuvir 400 MG / Velpatasvir 100 MG [Epclusa]
recorded 2026-09-01 · last checked 2026-09-04
Q4
Which running trial of Velpatasvir could settle lifespan?
NCT03520660 measures Phase II: Liver-related clinical outcome, HCC, or liver-related mortality, reading out 2032-12-31.
1 open trial; n 121; "People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents"
Show the evidence
TrialNCT03520660
"People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents"; n 121; "Phase II: Liver-related clinical outcome, HCC, or liver-related mortality"; 2032-12-31
Q5
Which 12 trials of Velpatasvir posted no result?
Posted no result
12 of 12 completed trials
Registrations
NCT01817985, NCT02333292, NCT03032666, NCT03513393, NCT04664894 and NCT04047680, and 6 more
Completion dates
oldest 2013-08; newest 2023-09-30
Show the evidence
Trial
NCT01817985
2013-08
NCT02333292
2017-06-30
NCT03032666
2018-08-06
NCT03513393
2018-12-01
NCT04664894
2019-05-30
NCT04047680
2019-06
6 further recorded trials
NCT04695769
2021-10-21
NCT03492112
2021-11-30
NCT03377478
2022-04-01
NCT02836925
2022-11
NCT03570112
2023-02-27
NCT05264558
2023-09-30
Q6
At the median, Velpatasvir's trials enrolled 105 people — anything larger?
Median enrolment
105
Largest enrolment
10000
Registered trials counted
86
Q7
What do 4949 spontaneous reports say about Velpatasvir — 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.
Velpatasvir appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 4949 reaction mentions were counted: fatigue 1611; headache 1360; nausea 769; insomnia 326. FAERS via Open Targets · CHEMBL3545062 · 2026-06-24
Show the evidence
fatigue
1611
headache
1360
nausea
769
insomnia
326
hepatitis c
275
treatment failure
257
4 more recorded rows
dyspepsia
143
hepatocellular carcinoma
86
genotype drug resistance test positive
64
hepatic cirrhosis
58
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
✗ 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: 5 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
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