This page shows what was measured, who it was measured in, and what that does not settle.
What Daclatasvir does in the body
Long-standing hepatitis C infection in two genetic forms.
Hepatitis C cannot copy itself out in the open. It first folds the liver cell’s internal membranes into a sealed workshop, and one viral protein, NS5A, is what holds that workshop together and loads finished copies into new virus particles. Daclatasvir sticks to NS5A in vanishingly small amounts and stops both jobs. It was the first drug to prove this could be done at all, because NS5A has no chemistry of its own to interfere with — there is no pocket, no reaction, nothing to block in the usual sense. It is always given with sofosbuvir, which attacks the copying enzyme, because one drug alone lets the virus escape.
What happened in people
Combined with sofosbuvir, it cured 96 in 100 without cirrhosis but only 63 in 100 with cirrhosis.
✓ 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
It was never tested alone for approval, so its individual share of the cure is inferred.
Where it acts
Hepatocyte cytoplasm — the membranous web of remodelled endoplasmic reticulum where NS5A holds the replication complex together
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 · LI2427F9CI · read 2026-08-29
Its recorded molecular formula is C40H50N8O6, weighing 738.9.
PubChem record · 25154714 · 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 135 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.
Biomarker
A biomarker is a number from a test that stands in for something about health.
A picture of it, and where the picture fails
A biomarker is like a fuel gauge.
Where that stops being true. A gauge is wired to the tank. Many biomarkers are only loosely tied to health.
What people get wrong. A better number is read as a better life. Several medicines improved a number and helped nobody.
A measurable indicator used as a substitute for a clinical outcome of interest.
Placebo
A placebo is a dummy treatment given so the real one can be compared with it.
A picture of it, and where the picture fails
A placebo is like a blank control in an experiment.
Where that stops being true. A blank does nothing. People given a placebo often do get better.
What people get wrong. A placebo effect is read as imaginary. The improvement is measured and real.
An inactive intervention matched in appearance to the test intervention, used to control for non-specific effects.
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.
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.
Change in HCV RNA 24 hours after a single 100 mg dose
✓ The study showed what it set out to show
Who was studied
Phase 1 single-dose study reported in Gao 2010, Nature
How many people
2
Study design
Phase 1, single ascending dose in chronically infected patients
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Mean 3.3 log10 reduction at 24 hours, sustained for a further 120 hours in two patients with genotype 1b
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. Resistant variants carrying substitutions at the positions previously mapped in the replicon system were already detectable in patient samples at 24 and 144 hours after a single dose — the clearest possible demonstration that this drug could never be used alone.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral tablet, taken with a separate sofosbuvir tablet
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
Sustained virologic response 12 weeks after treatment, co-primary in treatment-naive and treatment-experienced patients
✓ The study showed what it set out to show
Who was studied
ALLY-3 (NCT02032901)
How many people
152
Study design
Phase 3, open-label, single-arm, genotype 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
90% (91/101) treatment-naive and 86% (44/51) treatment-experienced; 96% (105/109) without cirrhosis against 63% (20/32) with cirrhosis
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. Single-arm and open-label with no comparator. The cirrhotic subgroup of 32 patients drove the entire difference between the headline and the non-cirrhotic figure, and the authors state that further work to optimise efficacy in that group was under way.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral tablet, taken with a separate sofosbuvir tablet
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
RNAWiki holds 2 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
Daclatasvir
What a person takes: Oral tablet, taken with a separate sofosbuvir tablet.
The measurement behind this step
One 60 mg tablet once daily with or without food, alongside sofosbuvir 400 mg once daily, for 12 weeks. Never sold as a fixed-dose combination and never indicated as a single agent. No longer marketed in the United States.
Getting in
Two separate tablets, bought separately
Unlike the regimens that followed, daclatasvir was never combined into one tablet with its partner. Patients took one of each, and paid for each.
╌╌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
Daclatasvir 60 mg once daily with sofosbuvir 400 mg once daily, for 12 weeks, with or without ribavirin. The two are separate products from separate companies, which is one reason the combined course carried a US$147,000 wholesale acquisition cost.
The drug reaches the liver, where the virus lives, and is metabolised there rather than cleared by the kidney.
╌╌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
Daclatasvir is a substrate of P-glycoprotein and is metabolised by CYP3A4, which is the origin of its interaction profile. It reaches the hepatocyte cytoplasm where the viral replication complex is assembled on remodelled endoplasmic reticulum membrane.
NS5A has no reaction to block and no pocket built for a small molecule. Daclatasvir binds it anyway, at trillionths of a gram per litre, and that discovery opened a whole drug class.
╌╌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
Picomolar EC50 against replicons across a broad range of genotypes and against JFH-1 genotype 2a infectious virus. NS5A has no known enzymatic function; the binding surface is a protein-protein interface at domain I, near the dimer interface, rather than a catalytic site.
The replication complex collapses and assembly stops
Two things fail at once: the folded-membrane workshop is never properly built, and the genomes already made are never loaded into new particles.
╌╌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 is required both for replication complex formation on the membranous web and for virion assembly through domain III. Blocking it produces the fastest first-phase viral decline of any antiviral class — the 3.3 log10 fall in 24 hours after a single dose is the measurement that established this.
Twelve weeks instead of twenty-four, in the hardest genotype
Before this, genotype 3 needed six months of treatment with ribavirin. Two tablets for twelve weeks cured 96% of patients without cirrhosis.
──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
SVR12 was 90% (91/101) in treatment-naive and 86% (44/51) in treatment-experienced genotype 3 patients overall, and 96% (105/109) in those without cirrhosis. No virological breakthrough occurred during treatment.
In patients with cirrhosis the same regimen cured 20 of 32. That gap is why the drugs that came next were designed the way they were.
╌╌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 63% (20/32) with cirrhosis against 96% (105/109) without, on the identical 12-week regimen. Baseline viral load, IL28B genotype, age and sex did not affect the outcome; cirrhosis did.
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 with genotype 1 or 3, always with sofosbuvir. It was never sold as a single-drug treatment and is no longer marketed in the United States.
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
Cirrhosis cut the genotype 3 cure rate by 33 percentage points, and the authors flagged it as unresolved in their own conclusion
Extreme bradycardia including one cardiac asystole within two hours of the first dose in patients taking amiodarone, confirmed by rechallenge
Never available as a fixed combination, so patients bought and took two separate products
Two genotypes out of six on the United States label, at a time when pan-genotypic regimens were about to arrive
Resistant variants appeared in patients within 144 hours of a single dose, which permanently ruled out monotherapy
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 change is too small to feel
A real change can still sit below what a person notices.
On this record: Generic sofosbuvir-daclatasvir prices in low- and middle-income countries fell towards the modelled production floor within about two years, while the United States wholesale figure did not move
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.
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.
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 tablet, taken with a separate sofosbuvir tablet
✎ 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 60 mg tablet once daily with or without food, alongside sofosbuvir 400 mg once daily, for 12 weeks. Never sold as a fixed-dose combination and never indicated as a single agent. No longer marketed in the United States.
✎ 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
In ALLY-3 there were no adverse events leading to discontinuation and one on-treatment serious adverse event, unrelated to study medication; the commonest events were headache, fatigue and nausea. The serious risk is an interaction rather than a direct toxicity: extreme bradycardia, including cardiac asystole, has been reported within two hours of the first dose in patients taking amiodarone, confirmed by rechallenge in a published case. Amiodarone has a half-life measured in weeks, so recent discontinuation does not remove the risk. Daclatasvir is metabolised by CYP3A4 and is a P-glycoprotein substrate, so strong inducers reduce its exposure substantially.
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 tablet, taken with a separate sofosbuvir tablet
✎ 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
Never sold as a fixed-dose combination and never indicated as a single agent. No longer marketed in the United States.
✎ 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
1 product lists this as an active ingredient in the United States drug directory. 1 of them contain it and nothing else.
FDA National Drug Code directory · 66039-941 · read 2026-08-29
They are sold as powder.
FDA National Drug Code directory · 66039-941 · read 2026-08-29
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 Daclatasvir 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 ALLY-3 cure rates measure daclatasvir; no registrational arm separated it from sofosbuvir
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 12-week virological endpoint in cirrhotic genotype 3 patients predicts fewer cancers or transplants — the reason to treat them, and not what was measured
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 63% cirrhotic figure is a stable estimate; it rests on 32 patients in a single-arm trial
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 validating NS5A as a target implies all NS5A inhibitors behave alike; the successors differ by orders of magnitude in subtype coverage and resistance barrier
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 Daclatasvir 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.
One 100 mg dose, a thousandfold fall in virus, and a whole drug class validated
In plain words
A single tablet given to patients in a phase 1 study cut the amount of virus in their blood by a factor of about two thousand within 24 hours. Nobody had shown that a protein with no chemical activity of its own could be a drug target until then.
What was measured
Mean 3.3 log10 reduction in HCV RNA 24 hours after a single 100 mg dose in phase 1
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The discovery paper reports BMS-790052 as a small-molecule inhibitor of NS5A with picomolar EC50 values against replicons across a broad range of genotypes and against the JFH-1 genotype 2a infectious virus in cell culture. In a phase 1 trial in chronically infected patients, a single 100 mg dose produced a mean 3.3 log10 reduction in viral load at 24 hours, sustained for a further 120 hours in two patients with genotype 1b. Genotypic analysis of samples at baseline, 24 and 144 hours showed the major variants carried substitutions at the same amino acid positions the replicon system had already identified. The authors describe this as the first clinical validation of an NS5A inhibitor — a protein with no known enzymatic function — as an approach to suppressing viral replication.
Written into the record, not signed off as a reviewed claim
ALLY-3: 96% cured in genotype 3 without cirrhosis, in twelve weeks
In plain words
Genotype 3 had been the hardest form to treat, needing 24 weeks with ribavirin. Twelve weeks of two tablets cured 105 of 109 patients who did not have cirrhosis, and no one had the virus break through during treatment.
What was measured
Sustained virologic response at 12 weeks in genotype 3, treatment-naive and treatment-experienced
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
ALLY-3 was a phase 3 study of daclatasvir 60 mg with sofosbuvir 400 mg once daily for 12 weeks in 152 genotype 3 patients — 101 treatment-naive and 51 treatment-experienced. SVR12 was 90% (91/101) in treatment-naive and 86% (44/51) in treatment-experienced patients. No virological breakthrough occurred and at least 99% of patients had a virological response at end of treatment. Five of seven patients who had previously failed a sofosbuvir-containing regimen and both patients who had failed an alisporivir-containing regimen achieved SVR12. Gender, age, HCV RNA level and IL28B genotype did not affect the outcome. There were no adverse events leading to discontinuation and one on-treatment serious adverse event, unrelated to study medication.
Written into the record, not signed off as a reviewed claim
Cirrhosis cut the cure rate from 96% to 63% on the identical regimen
In plain words
The same twelve weeks of the same two drugs cured 105 of 109 patients without cirrhosis and 20 of 32 with it. Nothing else in the trial came close to mattering as much.
What was measured
SVR12 96% (105/109) without cirrhosis against 63% (20/32) with cirrhosis
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
SVR12 was 96% (105/109) in patients without cirrhosis against 63% (20/32) in those with cirrhosis. The authors’ own conclusion states the regimen achieved SVR12 in 96% of genotype 3 patients without cirrhosis and that additional evaluation to optimise efficacy in cirrhotic patients was under way — an unusually direct acknowledgement that the trial had not solved its hardest subgroup. The gap is not explained by baseline viral load, IL28B genotype, age or sex, all of which the paper reports as non-contributory. Genotype 3 with cirrhosis remained the acknowledged weak point of hepatitis C treatment for several years after this trial, and it is the population the later pan-genotypic regimens were explicitly designed around.
Written into the record, not signed off as a reviewed claim
Cardiac asystole thirty minutes after the first dose, in a patient on amiodarone
In plain words
Two patients taking the heart drug amiodarone had their hearts slow dangerously within two hours of the first dose. One stopped entirely for a period. When one patient was given the drugs again, it happened again — and it stopped happening once the amiodarone had been out of his system for eight weeks.
What was measured
Heart rate of 27 beats per minute and one cardiac asystole within two hours of the first dose, with positive rechallenge
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
A published case series reports extreme bradycardia within two hours of taking sofosbuvir with daclatasvir in two patients receiving amiodarone. The first had cardiac asystole 30 minutes after the dose; all three drugs were stopped and cardiac evaluation was normal after ten days. The second, on amiodarone and propranolol, had extreme sinus node dysfunction with a heart rate of 27 beats per minute two hours after dosing; bradycardia recurred each day for three days, resolved when the antivirals were stopped, recurred on rechallenge at day 13, and did not recur on a further rechallenge eight weeks after amiodarone had been stopped. Dechallenge and rechallenge in the same patient is about as strong as causal evidence gets outside a randomised trial. The regulators had warned about this interaction in 2015 before any case report had been published; these are the cases that followed.
Written into the record, not signed off as a reviewed claim
A 1,200-fold gap between the price of the course and the cost of making it
In plain words
The two-drug course was listed at US$147,000 in the United States. The published estimate of what it costs to manufacture at scale was US$122.
What was measured
US$147,000 wholesale acquisition cost against US$122 projected minimum production cost for the same 12-week two-drug course
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The published price comparison lists daclatasvir with sofosbuvir at a United States wholesale acquisition cost of US$147,000 per 12-week course, of which US$84,000 is the sofosbuvir component. The retrosynthesis-based cost analysis projected a minimum production cost of US$122 for the same 12-week two-drug course at a scale of at least five million patients per year, and an earlier analysis costed daclatasvir alone at US$10 to US$30 per course, ranking it second least complex to synthesise of the five hepatitis C drugs it assessed. Neither figure is a claim about what a company should charge; both are checkable statements about what the molecules cost to make.
Written into the record, not signed off as a reviewed claim
The company that invented the class stopped selling its own first-in-class drug
In plain words
Daclatasvir proved a whole new type of hepatitis C drug was possible. Four years after approval, the company that discovered it discontinued it in the United States, because the drugs it made possible had overtaken it.
What was measured
Not recorded
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Daclatasvir reached the United States market in 2015, after being approved in Japan and Europe earlier — it was already behind its own successors when it arrived. It requires a second, separately purchased tablet, covers two genotypes, and in its principal indication of genotype 3 falls to 63% in cirrhosis. Within eighteen months, sofosbuvir/velpatasvir and glecaprevir/pibrentasvir offered all six genotypes in a single fixed tablet with far better cirrhotic performance. Bristol-Myers Squibb subsequently discontinued Daklinza in the United States. The molecule itself did not fail: it is on the WHO Model List of Essential Medicines and remains in wide generic use internationally, where its low production cost matters more than its two-genotype label.
Written into the record, not signed off as a reviewed claim
No trial ever isolated daclatasvir from sofosbuvir
In plain words
Every cure rate here belongs to two drugs taken together. Daclatasvir was never given alone in a registrational trial, so its individual share of the result is inferred rather than measured.
What was measured
That the ALLY-3 cure rates measure daclatasvir — they measure a two-drug regimen, and the only single-agent human data are 144 hours of phase 1 with resistance already emerging
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
ALLY-3 and the other registrational studies tested daclatasvir with sofosbuvir; there was no daclatasvir monotherapy arm, and there could not have been, because the phase 1 data that validated the class also showed resistant variants emerging within 144 hours of a single dose. What is separately measured is the pharmacology — picomolar replicon EC50, the resistance positions, and the phase 1 viral load drop — and that phase 1 result is the one genuine single-agent measurement in the record. The clinical attribution, that daclatasvir supplies the second barrier that lets sofosbuvir cure in twelve weeks rather than twenty-four with ribavirin, is a mechanistic inference consistent with the data and not a finding from a trial that separated the two.
Written into the record, not signed off as a reviewed claim
Every endpoint is a blood test twelve weeks after the last tablet
In plain words
ALLY-3 measured virus in blood. It did not count deaths, liver cancers or transplants — including in the cirrhotic patients, for whom those outcomes are the reason to treat.
What was measured
That an undetectable blood test at twelve weeks in a cirrhotic genotype 3 patient predicts fewer cancers, transplants or deaths — plausible, and not what ALLY-3 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 evidence on hepatitis C-related morbidity or on hepatocellular carcinoma, and mortality data from only 11 trials. ALLY-3 is single-arm and open-label with a 12-week virological endpoint. The cirrhotic subgroup makes the gap sharpest: those 32 patients are the ones whose cancer and decompensation risk justifies treating at all, and the trial reports only whether their blood was clear twelve weeks afterwards.
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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
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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.
The first-in-class NS5A inhibitor, found by chemical genetics against a protein with no known enzymatic function, whose single 100 mg dose produced a 3.3 log10 fall in viral load within 24 hours in phase 1 and which with sofosbuvir cured 96% of 109 genotype 3 patients without cirrhosis in ALLY-3 — but only 63% of the 32 with cirrhosis, and which was priced at US$147,000 per 12-week course with sofosbuvir against a modelled production cost of US$122 before being discontinued in the United States.
Recorded evidence blocks (6)
Q1
99 registered trials of Daclatasvir — at which phases?
Registered studies posting no result
65 of 99
99 registered studies of Daclatasvir: 37 phase2, 36 phase3, 15 phase1, 10 na or unstated, 5 phase4, 2 na, 1 early phase1. CLINICALTRIALS_SNAPSHOT · 2026-09-01
128 with a PubMed record
Show the evidence
phase2
37
phase3
36
phase1
15
na or unstated
10
phase4
5
na
2
6 more recorded rows
early phase1
1
completed
77
unknown
10
withdrawn
7
terminated
3
no longer available
2
recorded 2026-09-01 · last checked 2026-09-04
Q2
5 of Daclatasvir's trials stopped: safety, funding/business, other?
NCT00904059, NCT01051414, NCT01497834, NCT01573351, NCT01012895 and NCT01842451, and 39 more
Completion dates
oldest 2009-07; newest 2021-08-04
Show the evidence
Trial
NCT00904059
2009-07
NCT01051414
2012-05
NCT01497834
2013-06
NCT01573351
2013-12
NCT01012895
2014-02
NCT01842451
2014-05
14 further recorded trials
NCT01309932
2014-09
NCT01581203
2014-09
NCT01616524
2014-09
NCT01795911
2014-09
NCT01718158
2014-10
NCT01973049
2014-11
NCT01718145
2014-12
NCT02323594
2015-02
NCT02107365
2015-04
NCT02282709
2015-07
NCT01455090
2015-07-31
NCT02123654
2015-08
NCT02470858
2015-12
NCT02675127
2015-12
Q5
At the median, Daclatasvir's trials enrolled 100 people — anything larger?
Median enrolment
100
Largest enrolment
50000
Registered trials counted
97
Q6
What do 84 spontaneous reports say about Daclatasvir — 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.
Daclatasvir appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 84 reaction mentions were counted: anaemia 12; renal failure 11; hyperbilirubinaemia 9; alanine aminotransferase increased 9. FAERS via Open Targets · CHEMBL2023898 · 2026-06-24
Show the evidence
anaemia
12
renal failure
11
hyperbilirubinaemia
9
alanine aminotransferase increased
9
drug interaction
9
hepatic encephalopathy
8
4 more recorded rows
ascites
7
aspartate aminotransferase increased
7
hepatocellular carcinoma
6
blood bilirubin increased
6
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 · 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
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✓ public claims reviewed: 0 reviewed claim(s); drafts are never rendered
✓ source coverage passed: 5 source rows
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