This page shows what was measured, who it was measured in, and what that does not settle.
What Bictegravir does in the body
HIV infection, as one tablet containing three drugs
HIV cannot survive in a cell until it pastes its own genetic code into one of your chromosomes. The enzyme that does the pasting is called integrase, and it needs two magnesium ions held in exactly the right place to cut and join DNA. Bictegravir grabs both of those magnesium ions and holds the enzyme in a pose where the joining step cannot happen. The virus's DNA is left floating in the cell, unspliced, and that cell is never turned into a virus factory.
What happened in people
92.4% of 314 previously untreated adults below 50 copies per millilitre at week 48, against 93.0% of 315 on dolutegravir-abacavir-lamivudine
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The recorded finding that sits closest to something a person would notice. Written into the record, not signed off, and it carries no population or interval.
That bictegravir is superior to dolutegravir — no trial was designed to test it and the direct comparison favoured dolutegravir numerically
Where it acts
Cytoplasm and nucleus of infected CD4-positive T lymphocytes
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
6 registered substances share the start of this name, which is why a search for it can return more than one thing.
FDA substance registry · TD2G64J9XN · 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.
A limit recorded against this substance. Not signed off as a reviewed claim.
The four opening statements run to 116 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.
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.
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.
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.
Proportion with plasma HIV-1 RNA below 50 copies per millilitre at week 48 (FDA snapshot), versus dolutegravir, abacavir and lamivudine
2% versus 2%, difference 0.0% (95.002% CI -2.5 to 2.5)
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. Open-label. Drug-related adverse events were reported by 19% of those who switched against 2% of those who changed nothing, a gap that an unblinded design cannot separate from expectation.
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, taken once daily with or without food
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
Proportion below 50 copies per millilitre at week 48 with dolutegravir plus tenofovir alafenamide or tenofovir disoproxil, versus efavirenz-based standard care
✓ The study showed what it set out to show
Who was studied
ADVANCE (NCT03122262) — partner-drug evidence, not a bictegravir trial
84%, 85% and 79% respectively; both dolutegravir regimens non-inferior at a -10 percentage-point margin
Repeated elsewhere
Replicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. Weight increase was greatest on tenofovir alafenamide and among women: mean 6.4 kg versus 3.2 kg versus 1.7 kg. This row is here because tenofovir alafenamide is the partner drug in every bictegravir product and no bictegravir trial made weight a primary endpoint.
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, taken once daily with or without food
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
RNAWiki holds 5 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
Bictegravir
What a person takes: Oral fixed-dose combination tablet, taken once daily with or without food.
The measurement behind this step
Bictegravir is not marketed on its own. It exists only inside a single tablet with emtricitabine and tenofovir alafenamide, which is the product studied in every trial on this page. Polyvalent cations in antacids, iron and calcium supplements bind it in the gut and reduce absorption.
Getting in
One tablet, three drugs, taken by mouth
The tablet carries bictegravir alongside two other antiviral drugs that block a different step of the same viral life cycle. All three are absorbed together and act inside the same infected cells.
╌╌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 fixed-dose combination of bictegravir 50 mg, emtricitabine 200 mg and tenofovir alafenamide 25 mg. Bictegravir is metabolised by CYP3A4 and UGT1A1 in roughly equal measure, which is the basis of its relatively quiet interaction profile compared with boosted regimens; polyvalent cations chelate it in the gut, so antacid and mineral timing is a real interaction and not a theoretical one.
It reaches the cells the virus is trying to infect
The drug spreads through the blood into the immune cells HIV targets. It has to be inside the cell before the virus finishes copying itself, not after.
╌╌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
Bictegravir is highly protein-bound and distributes into CD4-positive T lymphocytes and macrophages. Its window of action is the interval between reverse transcription completing and the pre-integration complex docking on host chromatin — a matter of hours after a cell is infected.
The viral enzyme that pastes HIV into your chromosome uses two magnesium ions as its cutting tools. Bictegravir clamps onto both of them, and the tools stop working.
╌╌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
The hydroxypyridinone oxygens chelate the two Mg2+ ions held by the aspartate-aspartate-glutamate triad in the integrase catalytic core, within the assembled intasome. This is the two-metal-binding pharmacophore shared by the whole strand-transfer inhibitor class.
With the drug in place, the end of the virus DNA that was lined up to be joined is displaced. The joining reaction simply 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
The trifluorobenzyl arm occupies the pocket left by the displaced 3′-adenine of the processed viral DNA end, ejecting the reactive 3′-hydroxyl from the active site. Strand transfer is blocked while 3′-processing, the earlier step, is largely spared — which is why this class is named for strand transfer specifically.
Unspliced viral DNA is degraded or circularised, and the cell is never infected
DNA that never gets pasted in has nowhere to go. The cell breaks it down or seals it into a dead loop, and no new virus is made from that cell.
──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
Unintegrated linear viral DNA is degraded or ligated by host repair enzymes into 1-LTR and 2-LTR circles, which are transcriptionally near-silent and are diluted out as cells divide. Measured as plasma HIV-1 RNA, this appears as suppression below 50 copies per millilitre — the endpoint of every trial on this page. It does not touch cells already carrying integrated provirus, which is why treatment is lifelong.
No suggested links are held for this record, so nothing is hidden from this path.
What we know
The record describes 5 steps from taking it to an effect in a person.
How we know it
Each step names the study behind it in the technical detail beside it.
What this does not prove
A change inside the body is a reason to look. It is not a result in a person.
Why it matters
A reader can see exactly where the chain stops being measured in people.
What we still do not know
No reviewed claim binds any of these steps to a named population.
What is missing or 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 over 14 kg starting HIV treatment for the first time, and people already suppressed on another regimen who switch to a single daily tablet. It is one of the most prescribed HIV regimens in high-income countries.
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
Trial 1490 produced a lower point estimate for bictegravir than for dolutegravir (89% versus 93%) and cleared non-inferiority only on the width of the margin
Tenofovir alafenamide, introduced as the bone- and kidney-sparing prodrug, was found in ADVANCE to produce the largest weight gain of the three regimens tested, concentrated in women
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.
The product may not be what it says
Contents of a sold product are not always what the label states.
On this record: This is sold as a supplement, so no agency checked what is in a given tub before it was sold.
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.
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.
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, taken once daily with or without food
✎ 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
Bictegravir is not marketed on its own. It exists only inside a single tablet with emtricitabine and tenofovir alafenamide, which is the product studied in every trial on this page. Polyvalent cations in antacids, iron and calcium supplements bind it in the gut and reduce absorption.
✎ 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
The US label carries a boxed warning for post-treatment acute exacerbation of hepatitis B: people co-infected with hepatitis B who stop the regimen can have severe hepatic flares, and hepatic function is monitored for months afterwards. Bictegravir inhibits the renal transporters OCT2 and MATE1, which raises serum creatinine without reducing actual glomerular filtration — a laboratory change that is not kidney injury and is regularly mistaken for it. Reported effects include headache, diarrhoea, nausea and weight gain; the weight signal is a class and partner-drug question, addressed in the audit points above.
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, taken once daily with or without food
✎ 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
It exists only inside a single tablet with emtricitabine and tenofovir alafenamide, which is the product studied in every trial on this page. Polyvalent cations in antacids, iron and calcium supplements bind it in the gut and reduce absorption.
✎ 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
12 products list this as an active ingredient in the United States drug directory. 5 of them contain it and nothing else.
FDA National Drug Code directory · 47234-2501 · read 2026-08-29
They are sold as powder and tablet, taken oral.
FDA National Drug Code directory · 47234-2501 · read 2026-08-29
2 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 · 664cb8f0-1f65-441b-b0d9-ba3d798be309 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 664cb8f0-1f65-441b-b0d9-ba3d798be309 · read 2026-08-29
Biktarvy is oral at 3 DOSAGE FORMS AND STRENGTHS BIKTARVY tablets are available in two dose strengths: 50 mg/200 mg/25 mg tablets: 50 mg of bictegravir (BIC) (equivalent to 52.5 mg of bictegravir sodium), 200 mg of emtricitabine (FTC), and…, recorded as fda label in effect 2026-07-07 in the United States.
US prescribing information · 664cb8f0-1f65-441b-b0d9-ba3d798be309 · 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 Bictegravir 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 bictegravir is superior to dolutegravir — no trial was designed to test it and the direct comparison favoured dolutegravir numerically
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 "high barrier to resistance" is a measured clinical property rather than an in-vitro selection result plus an absence of events in a selected, adherent, one-year 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.
✗Goes past the evidence
That 48-week suppression rates predict durability over decades, which is the timescale on which this drug is actually taken
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 tolerability advantage generalises beyond the specific comparators used — the nausea difference in 1489 is against abacavir-containing therapy, not against dolutegravir as such
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 Bictegravir 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.
92.4% suppressed at 48 weeks, and no treatment-emergent resistance in either arm
In plain words
In the first registration trial, 92 out of every 100 previously untreated adults had virus below the limit of detection at 48 weeks. Nobody in either group developed a virus resistant to any of the study drugs.
What was measured
Proportion below 50 copies per millilitre at week 48 by FDA snapshot algorithm
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
GS-US-380-1489 randomised 631 previously untreated HIV-1 infected adults at 122 outpatient centres in nine countries to coformulated bictegravir, emtricitabine and tenofovir alafenamide (n=314 dosed) or coformulated dolutegravir, abacavir and lamivudine (n=315 dosed). At week 48, plasma HIV-1 RNA below 50 copies per millilitre was achieved in 290 of 314 (92.4%) against 293 of 315 (93.0%), difference -0.6% (95.002% CI -4.8 to 3.6, p=0.78), meeting the prespecified -12% non-inferiority margin. No individual in either arm developed treatment-emergent resistance to any study drug. Nausea occurred in 10% (n=32) on bictegravir against 23% (n=72) on the comparator (p<0.0001).
Written into the record, not signed off as a reviewed claim
Non-inferiority is the only thing ever demonstrated, in all four registration trials
In plain words
Every trial that got this drug approved was designed to show it was not worse than something else, and none was designed to show it was better. In the trial that compared it most directly with dolutegravir, its number was lower.
What was measured
That bictegravir is a better integrase inhibitor than dolutegravir — an inference from tolerability secondaries and pill count, not from any virological comparison that favoured it
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
All four phase 3 trials used a non-inferiority design. GS-US-380-1490 held both partner drugs constant and swapped only the integrase inhibitor: at week 48, 286 of 320 (89%) on bictegravir were below 50 copies per millilitre against 302 of 325 (93%) on dolutegravir, difference -3.5% (95.002% CI -7.9 to 1.0, p=0.12). GS-US-380-1844 switched 563 suppressed adults from dolutegravir-abacavir-lamivudine and found 3 of 282 (1%) versus 1 of 281 (<1%) at 50 copies or above, difference 0.7% (p=0.62). GS-US-380-1878 switched 577 suppressed adults from boosted protease inhibitors and found 5 of 290 (2%) versus 5 of 287 (2%), difference 0.0%. Not one of these is a superiority result, and none was powered to be. The commercial case rests on secondary adverse-event counts and on the tablet being one tablet.
Written into the record, not signed off as a reviewed claim
The "high barrier to resistance" is an in-vitro property extended to people
In plain words
The claim that this drug is hard for the virus to escape comes from laboratory experiments on cultured virus. In people, the evidence is that no resistance appeared over 48 weeks in trials that had already excluded the people most likely to develop it.
What was measured
That bictegravir has a clinically high barrier to resistance — an in-vitro selection result plus an absence of events in a selected population, presented as a measured clinical property
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The barrier claim originates in in-vitro resistance selection, where more accumulated integrase substitutions were required to lose activity than with earlier strand-transfer inhibitors. The clinical evidence is an absence: no treatment-emergent resistance in either arm of GS-US-380-1489 or GS-US-380-1490 through 48 weeks. Both trials required screening genotypes showing sensitivity to the partner nucleosides and enrolled participants under trial-grade adherence support; 1489 additionally required an estimated glomerular filtration rate of 50 mL/min or more and excluded hepatitis B co-infection. An absence of observed resistance in roughly 1,300 selected, adherent participants over one year does not measure the height of a barrier, and the populations in whom integrase resistance actually emerges — people with interrupted supply, advanced disease and prior treatment failure — are the ones these trials did not enrol.
Written into the record, not signed off as a reviewed claim
Tenofovir alafenamide was introduced as the safer prodrug, and traded bone and kidney effects for weight
In plain words
The newer form of tenofovir in this tablet was brought in because it is easier on bones and kidneys than the older form. Trials then found that people on it gain substantially more weight, and that women gain the most.
What was measured
Mean weight change at 48 weeks by tenofovir prodrug and by sex, in a randomised comparison
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
ADVANCE (NCT03122262) randomised 1,053 participants in South Africa to dolutegravir plus emtricitabine with either tenofovir alafenamide or tenofovir disoproxil fumarate, or to standard-of-care efavirenz-tenofovir disoproxil-emtricitabine. At week 48, suppression below 50 copies per millilitre was 84%, 85% and 79% respectively, with the dolutegravir regimens non-inferior. The tenofovir alafenamide regimen had less effect on bone density and renal function than the others. Weight increase, in both lean and fat mass, was greatest in the tenofovir alafenamide group and among female participants: mean increases of 6.4 kg (tenofovir alafenamide), 3.2 kg (tenofovir disoproxil) and 1.7 kg (standard care). ADVANCE studied dolutegravir, not bictegravir, so this is a partner-drug and class finding rather than a bictegravir result — but tenofovir alafenamide is the partner drug in every bictegravir product, and no bictegravir trial was designed with weight as a primary endpoint.
Written into the record, not signed off as a reviewed claim
Switching from a suppressive regimen kept people suppressed, in two trials
In plain words
Two trials took people whose virus was already undetectable on a different regimen and moved them onto this one. Almost nobody lost control of the virus in either group.
What was measured
Proportion with HIV-1 RNA at or above 50 copies per millilitre at week 48 after switching
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
GS-US-380-1844 (NCT02603120) enrolled 563 adults suppressed for at least three months on dolutegravir, abacavir and lamivudine, randomised double-blind to switch or remain: at week 48, 3 of 282 (1%) on bictegravir and 1 of 281 (<1%) on the continued regimen had HIV-1 RNA of 50 copies or more, difference 0.7% (95.002% CI -1.0 to 2.8, p=0.62). Treatment-related adverse events were recorded in 8% versus 16%. GS-US-380-1878 (NCT02603107) enrolled 577 adults suppressed for at least six months on boosted atazanavir or darunavir, randomised open-label: 5 of 290 (2%) and 5 of 287 (2%) at 50 copies or above, difference 0.0% (95.002% CI -2.5 to 2.5). In the open-label switch trial, drug-related adverse events were reported in 19% of the bictegravir group against 2% of the group that changed nothing, which is what an unblinded switch does to symptom reporting.
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What is not here
7 questions this page could not answer
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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.
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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.
An integrase inhibitor that jams the enzyme HIV uses to splice itself into human chromosomes, which held 92.4% of previously untreated adults below 50 copies per millilitre at 48 weeks in its first registration trial — a result that was non-inferior to dolutegravir and has never, in any trial, been shown to be better than it.
Recorded evidence blocks (6)
Q1
76 registered trials of Bictegravir — at which phases?
accrual/recruitment (4), funding/business (1), sponsor decision unspecified (3) and other (1): Bictegravir's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01
"Difficulties enrolling participants"; 9 of 76 registered studies
Show the evidence
Trial
NCT03532425
terminated; "Difficulties enrolling participants"
NCT03986697
withdrawn; "COVID19 emergency. No patients randomised"
NCT04249037
terminated; "Insufficient enrollment"
NCT04518228
terminated; "The study was closed to accrual early based on Study Monitoring Committee review indicating that the study objectives had either been achieved or could not be met within a reasonable timeframe for the then-open arms."
NCT04853524
withdrawn; "Sponsor Decision"
NCT04944654
terminated; "Trial set up was delayed, funding support no longer available"
3 further recorded trials
NCT05457530
withdrawn; "Due to No/Low enrollment"
NCT06613685
terminated; "Sponsor decision to terminate study."
NCT07115368
terminated; "Sponsor decision to terminate study."
recorded 2026-09-01 · last checked 2026-09-04
Q3
Human studies of Bictegravir used Bictegravir 50mg+Tenofovir AF 25 mg+emtricitabine 200 mg — over how long?
Human studies of Bictegravir used "Bictegravir 50mg+Tenofovir AF 25 mg+emtricitabine 200 mg". ClinicalTrials.gov · 2026-09-01
5 recorded entries; human; also "BIKTARVY 50Mg-200Mg-25Mg Tablet", "50mg bictegravir/200mg emtricitabine/25mg tenofovir alafenamide", "Biktarvy 50Mg-200Mg-25Mg Tablet"
Show the evidence
human
NCT03711253
Bictegravir 50mg+Tenofovir AF 25 mg+emtricitabine 200 mg
NCT03502005, NCT03499483, NCT04009057, NCT04416906, NCT04653194 and NCT04805944, and 4 more
Completion dates
oldest 2019-12-30; newest 2024-06-03
Show the evidence
Trial
NCT03502005
2019-12-30
NCT03499483
2020-03-31
NCT04009057
2022-03-21
NCT04416906
2023-05-11
NCT04653194
2023-07-31
NCT04805944
2023-12-31
4 further recorded trials
NCT06629480
2024-02-28
NCT04950530
2024-02-29
NCT05243602
2024-03-18
NCT03580668
2024-06-03
Q5
At the median, Bictegravir's trials enrolled 100 people — anything larger?
Median enrolment
100
Largest enrolment
700
Registered trials counted
76
Q6
What do 10 spontaneous reports say about Bictegravir — 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.
Bictegravir appears in spontaneous reports to regulators. Across the 3 most-reported reaction terms, 10 reaction mentions were counted: drug resistance 5; kaposi's sarcoma 3; autoimmune pancreatitis 2. FAERS via Open Targets · CHEMBL3989866 · 2026-06-24
Show the evidence
drug resistance
5
kaposi's sarcoma
3
autoimmune pancreatitis
2
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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