This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Study to Evaluate the Pharmacokinetics of Tenofovir Alafenamide (TAF) in Adults With Normal Hepatic Function and Adults With Severe Hepatic Impairment (NCT02296853), a non-randomized phase 1 study. The primary outcome is Pharmacokinetic (PK) Parameter: AUCinf of Tenofovir Alafenamide (TAF), Its Metabolite Tenofovir (TFV) and Free (Unbound) TAF.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02296853 |
| Phase | Phase 1 |
| Condition | Hepatitis B Virus |
| Allocation | Non-Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 20 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Gilead Sciences |
| Results posted | Yes |
2. Clinical Question
Population
Adults with either normal hepatic function or severe hepatic impairment. The study enrolled 20 participants; the registry record describes a pharmacokinetic analysis population consisting of enrolled participants who received at least 1 dose and had at least 1 non-missing concentration result for the analyte being assessed.
Intervention
A single oral dose of TAF 25 mg on Day 1. The study also assessed tenofovir (TFV), a metabolite of TAF, and free (unbound) TAF in its pharmacokinetic outcomes.
Comparator
Participants with normal hepatic function formed a matched comparison group for participants with severe hepatic impairment. The study was non-randomized, and the registry cautions that the groups are not a like-for-like control comparison.
Primary question
How do the mean AUCinf pharmacokinetic measures for TAF, TFV, and free TAF compare between the hepatic-function groups after a single dose? Numerical endpoint results and a reported statistical comparison are not reported in the registry record.
The clinical question is pharmacokinetic rather than a test of treatment efficacy. AUCinf describes drug concentration exposure extrapolated to infinite time. Comparing this measure across the two groups can characterize whether exposure after the single dose differs by hepatic-function status. The registry lists hepatitis B virus as a condition, but the stated primary objective is to evaluate single-dose pharmacokinetics, not to assess an antiviral clinical outcome.
The record also lists treatment-emergent adverse events and treatment-emergent laboratory abnormalities as secondary outcomes. Their presence does not change the main question: the primary outcomes concern mean exposure to TAF and its measured forms or metabolite. The posted record does not give numerical results for those primary outcomes, so the direction, size, and precision of any group difference cannot be described from the recorded information.
3. Trial Design
This is a phase 1, open-label, parallel-group, non-randomized study. One group comprised participants with severe hepatic impairment, and the other was a matched group with normal hepatic function. Both groups were assigned a single oral dose of TAF 25 mg on Day 1. Because allocation was non-randomized, the groups should not be treated as if they were interchangeable groups created through random assignment. The registry explicitly cautions that the arms are not a like-for-like control comparison.
The registry reports enrollment of 20. It lists 10 participants at risk for serious adverse events in each group and 10 at risk for other adverse events in each group. Those safety denominators are reported separately from the pharmacokinetic analysis population. The latter included enrolled participants who received at least 1 dose and had at least 1 non-missing pharmacokinetic concentration result for the respective analyte. The number analyzed for each primary outcome is not reported in the registry record.
The study started on 2014-12-22, had primary completion on 2015-04-17, and is listed as completed. It was open-label, with no masking, and used a parallel-group model. The registry identifies Gilead Sciences as sponsor. These design features describe how the groups and observations were organized; they do not establish that differences in outcomes would be caused by hepatic-function status alone.
The study’s single-dose design supports a focused assessment of pharmacokinetic measurements following administration on Day 1. It does not, by itself, provide evidence about repeated dosing, longer-term outcomes, or clinical benefit. Details of how the normal-function participants were matched to those with severe impairment are not reported in the registry record. Randomization procedures, a detailed statistical analysis plan, and a sample-size justification are also not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: 28 participants were screened.
Overall Study
| Stage | Severe Hepatic Impairment Group | Matched Normal Hepatic Function Group |
|---|---|---|
| STARTED | 10 | 10 |
| COMPLETED | 10 | 10 |
| NOT COMPLETED | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: Participants in the PK Analysis Set (consisted of all enrolled participants who received at least 1 dose of the study drug and had at least 1 non-missing PK concentration data for each respective analyte) with available data were analyzed.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
| Characteristic | Unit | Severe Hepatic Impairment Group | Matched Normal Hepatic Function Group | Total |
|---|---|---|---|---|
| Participants analysed | 10 | 10 | 20 | |
| Age, Continuous | years | 57 (SD 7.3) | 55 (SD 9.3) | 56 (SD 8.2) |
| Sex: Female, Male: Female | Participants | 5 | 5 | 10 |
| Sex: Female, Male: Male | Participants | 5 | 5 | 10 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 3 | 4 | 7 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 7 | 6 | 13 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 1 | 1 |
| Race (NIH/OMB): White | Participants | 10 | 9 | 19 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Region of Enrollment: Germany | participants | 1 | 3 | 4 |
| Region of Enrollment: New Zealand | participants | 2 | 2 | 4 |
| Region of Enrollment: United States | participants | 7 | 5 | 12 |
6. Primary Endpoint
The registry lists the primary outcome as Pharmacokinetic (PK) Parameter: AUCinf of Tenofovir Alafenamide (TAF), Its Metabolite Tenofovir (TFV) and Free (Unbound) TAF, measured over Predose (≤5 minutes), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 12, 24, 36, 48, 60, 72, 96, 120, and 144 hours postdose on Day 1.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | h*ng/mL |
| Endpoint classification | Continuous Endpoint |
The primary endpoint family is mean AUCinf for TAF, its metabolite TFV, and free (unbound) TAF, measured in h*ng/mL. AUCinf is defined in the registry as the concentration of drug extrapolated to infinite time. It is a pharmacokinetic summary of exposure across the observed concentration profile and its extrapolated continuation, rather than a measure of a clinical event or symptom.
Exposure measures are used in pharmacokinetic studies to characterize how much drug or metabolite is present over time. Comparing group means can describe whether average exposure differs between participants with normal hepatic function and those with severe hepatic impairment after the study dose. The registry specifies the mean and standard deviation as the summary statistic and measure of dispersion. The listed sampling schedule extends from predose through 144 hours postdose on Day 1, with measurements at the stated intervening times.
These endpoint definitions explain what the study set out to measure, not what it found. Numerical means, standard deviations, group contrasts, confidence intervals, and p-values for the primary outcomes are not reported in the registry record. Therefore, the magnitude and precision of any observed exposure difference cannot be assessed from the recorded primary endpoint information. AUCinf also depends on the observed concentration data and extrapolation; the record’s definition alone does not show how much of any estimate would be extrapolated.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a study designed to compare mean single-dose pharmacokinetic exposure between participants with severe hepatic impairment and participants with normal hepatic function. Its primary outcomes are AUCinf for TAF, TFV, and free TAF. The record defines AUCinf and identifies the units, summary statistic, dispersion measure, and sampling schedule. However, it does not report the numerical results for these outcomes. There is consequently no basis in the record for saying whether mean exposure was higher, lower, or similar between the groups, or for describing the size or precision of a difference.
In a continuous-outcome comparison, means describe the group averages, while standard deviations describe variation among observations around those averages. A difference between means, if reported, would describe an unadjusted contrast unless the analysis were explicitly adjusted. The posted primary outcome information does not include group means or standard deviations, a contrast estimate, a confidence interval, or a p-value. The record therefore does not support a numerical interpretation of a group contrast or a claim about statistical significance.
The non-randomized design is important to interpretation. A comparison of the severe-impairment group with the matched normal-function group is not equivalent to a randomized comparison. Matching may make groups more comparable on some characteristics, but the variables used and the matching procedure are not reported in the registry record. Other differences between groups could therefore contribute to any observed contrast. The registry itself cautions that the arms are not a like-for-like control comparison.
The record lists 20 enrolled participants and identifies a pharmacokinetic analysis population based on receipt of at least 1 dose and availability of at least 1 non-missing concentration for the respective analyte. The number included in each endpoint analysis is not reported in the registry record. The enrolled count should not automatically be read as the analysis count for every measure: eligibility for the analysis set is defined by dose receipt and analyte-specific concentration availability.
The outcome schedule lists predose and postdose measurements through 144 hours on Day 1. AUCinf extrapolates concentration to infinite time, so it is not simply a direct reading at the final scheduled measurement. The extent of extrapolation and the handling of concentration data are not reported in the registry record. Without those details or the numerical estimates, it is not possible to judge the sensitivity of the reported AUCinf values to the extrapolation.
The safety summaries report one participant with a serious adverse event in the severe hepatic impairment group and none in the matched normal hepatic function group. The listed top serious term is hepatic failure, reported as 10.0%. The record also reports other adverse events for 4 participants in the severe-impairment group and 3 in the normal-function group. These are descriptive counts in small groups, not a randomized comparative safety estimate. The registry does not provide sufficient detail in the registry record recorded to infer causality or compare risks with precision.
The registry describes planning illustrations based on a stated fraction of the observed effect, using a two-sided significance level of 0.05, equal allocation, and a normal approximation. Such illustrations are planning calculations, not observed power and not evidence about the primary result. The specific illustration values and the underlying observed effect are not reported in the registry record. The sponsor’s own analysis would take precedence if a recalculation differed, but no recalculated primary outcome values are stated in the recorded details.
9. Statistical Methods Explained
The design and endpoint definitions help frame what statistical summaries would mean, but they do not replace the missing numerical outcome results. The study is a non-randomized, parallel-group comparison with no masking. Its primary measures are continuous pharmacokinetic outcomes summarized as means with standard deviations. The following concepts are general explanations of how such analyses are commonly interpreted; the registry record does not report a complete analysis plan for this study.
What does a mean describe?
For a continuous measure such as AUCinf, the mean is the arithmetic average of the observed values in the analysis group. It provides a summary of the group’s central level of exposure. It does not show the full distribution: two groups can have the same mean but different variability or patterns of individual values. The standard deviation describes the spread of individual observations around the mean. It is not the same as the uncertainty in the estimated mean, and it should not be read as a confidence interval.
The registry specifies mean and standard deviation for the primary outcomes. The actual means and standard deviations are not reported in the registry record. Without them, neither the average exposure in each group nor its observed variability can be described numerically. A group mean alone would also not establish that every participant had a similar exposure.
What would a group contrast show?
A contrast between group means would express the observed difference in average exposure between the severe hepatic impairment group and the matched normal hepatic function group. A confidence interval around a contrast would describe the range of values compatible with the data under the analysis assumptions, and its width would indicate precision. A p-value would quantify how unusual the data would be under a specified null hypothesis and statistical model; it would not measure the probability that the null hypothesis is true.
Neither a numerical contrast nor its confidence interval or p-value is reported for the primary outcomes in the registry record. Thus, statistical significance, precision, and the direction or size of the primary comparison cannot be assessed from this information. General statistical concepts should not be mistaken for results of this particular study.
Why does the non-randomized allocation matter?
Random assignment is one way to balance measured and unmeasured characteristics between groups on average. This study did not use random allocation. The matched normal-function group provides a comparison, but the registry’s own note says the arms are not a like-for-like control comparison. The criteria and process for matching are not reported in the registry record, and matching cannot be assumed to remove all differences between groups.
Consequently, a difference in AUCinf, if one were reported, would be an observed group association in this study. It would not automatically be a causal effect of hepatic impairment. Interpretation would depend on the group composition, matching details, measurement procedures, and analysis choices. Those details are not reported in the registry record beyond the stated group descriptions and analysis-population definition.
What does the analysis population mean?
The registry says the pharmacokinetic analysis set consisted of enrolled participants who received at least 1 dose and had at least 1 non-missing pharmacokinetic concentration for each respective analyte. This definition links inclusion to both treatment receipt and available measurement data. It also means the analyzable population may depend on the analyte under consideration. The number analyzed for each outcome and the handling of participants with incomplete concentration profiles are not reported in the registry record.
Missing observations can affect a pharmacokinetic summary if availability is related to exposure or to participant characteristics. General approaches include analyzing available observations under specified rules or modeling incomplete data, but the registry record does not describe the approach used. It would be inappropriate to assume that missing measurements were absent, ignored, imputed, or handled in any particular way.
Why is AUCinf extrapolated?
AUCinf represents exposure extrapolated to infinite time, as the registry defines it. In general, concentration measurements are collected over a finite observation period, and an extrapolation is used to estimate the remaining contribution after the last measurement. This makes the estimate dependent not only on observed concentrations but also on the extrapolation method and the data available near the end of the sampling period. The record lists sampling from predose through 144 hours postdose on Day 1, but the extrapolation method and the proportion of AUCinf attributable to extrapolation are not reported in the registry record.
Concentration profiles and AUC summaries can be variable, and the degree of variation affects how precisely group means and contrasts can be estimated. General statistical methods may account for distributional features or unequal variability, but the statistical model, transformations, and diagnostic procedures used for these endpoints are not reported in the registry record. There is therefore no basis to describe whether the analysis used such methods.
How should planning illustrations be read?
The registry describes planning illustrations based on the observed effect, a stated fraction of that effect, a two-sided significance level of 0.05, equal allocation, and a normal approximation. In general, a sample-size illustration estimates the number of participants that might be needed under specified assumptions to detect a target effect with a chosen power. It is not the number actually analyzed, and it is not observed power. The record says that non-time-to-event illustrations are expressed as participants per arm. The numerical illustrations and the observed effect used for them are not reported in the registry record.
These calculations depend on assumptions about the target effect, variability, allocation, and statistical model. They are not a substitute for the study’s own design rationale. The sample-size justification and a full statistical plan are not reported in the registry record. No conclusion about the adequacy of the study’s planned size can be drawn from the stated illustration assumptions alone.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 5 outcome measures and 9 analyses. It identifies the primary outcome family as mean AUCinf for TAF, TFV, and free TAF, and lists treatment-emergent adverse events and treatment-emergent laboratory abnormalities as secondary outcomes. The relationship between the listed analyses and outcomes, and any hierarchy or prespecified testing sequence, are not reported in the registry record.
Multiplicity arises when several outcomes, analytes, time points, or statistical comparisons are evaluated. In general, conducting multiple tests can increase the chance of at least one apparently unusual result if no adjustment or testing hierarchy is used. The registry record does not report whether multiplicity adjustments were made, whether particular outcomes were prioritized for formal inference, or which analyses were prespecified. It is therefore not possible to assess how multiplicity was handled or to interpret any unreported p-values in that context.
The pharmacokinetic analysis population required at least 1 dose and at least 1 non-missing concentration for each respective analyte. This is an analyte-specific availability criterion. The number analyzed for each endpoint, the amount and pattern of missing concentration data, and the method used to handle incomplete profiles are not reported in the registry record. The record also does not report whether missingness was assessed for relationships with group or measured exposure.
In general, missing data can affect both the estimated group means and their uncertainty, particularly if the observations that are absent differ systematically from those that remain. No particular missing-data mechanism or method should be assumed for this study. The analysis population definition is available, but further details on exclusions, imputation, sensitivity analyses, and analysis-set deviations are not reported in the registry record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Severe Hepatic Impairment Group | 1 | 10 | 10.0% |
| Matched Normal Hepatic Function Group | 0 | 10 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Severe Hepatic Impairment Group | 0 of 10 |
| Matched Normal Hepatic Function Group | 0 of 10 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Severe Hepatic Impairment Group | 4 of 10 |
| Matched Normal Hepatic Function Group | 3 of 10 |
Most frequent serious adverse event terms
| Event term | Organ system | Severe Hepatic Impairment Group | Matched Normal Hepatic Function Group |
|---|---|---|---|
| Hepatic failure | Hepatobiliary disorders | 1 of 10 | 0 of 10 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Severe Hepatic Impairment Group | Matched Normal Hepatic Function Group |
|---|---|---|---|
| Headache | Nervous system disorders | 1 of 10 | 2 of 10 |
| Nausea | Gastrointestinal disorders | 0 of 10 | 2 of 10 |
| Abdominal distension | Gastrointestinal disorders | 1 of 10 | 0 of 10 |
| Vomiting | Gastrointestinal disorders | 0 of 10 | 1 of 10 |
| Fatigue | General disorders | 0 of 10 | 1 of 10 |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | 1 of 10 | 0 of 10 |
| Cough | Respiratory, thoracic and mediastinal disorders | 1 of 10 | 0 of 10 |
| Pruritus | Skin and subcutaneous tissue disorders | 1 of 10 | 0 of 10 |
Serious events with the highest arm-level rate: hepatic failure (10.0%).
The registry reports serious adverse events for the severe hepatic impairment group and the matched normal hepatic function group separately. In the severe hepatic impairment group, 1 participant is listed as affected among 10 at risk; in the matched normal hepatic function group, 0 are listed as affected among 10 at risk. Hepatic failure is the listed top serious term, reported as 10.0%. The record does not establish from these figures alone whether that event was judged related to TAF.
For other adverse events, the registry lists 4 affected participants among 10 at risk in the severe hepatic impairment group and 3 among 10 at risk in the matched normal hepatic function group. Deaths are listed as 0 in both groups. These are descriptive summaries, not proof of a difference in risk. With a non-randomized design, the groups are not a like-for-like control comparison, and small-group counts provide limited precision. The registry record does not report uncertainty intervals for these figures in the registry record recorded. They should be read as the recorded event counts, not as a definitive comparative safety analysis or a causal attribution.
12. What the Result Does, and Does Not, Mean
This study addresses a focused pharmacokinetic question: it evaluates single-dose exposure to TAF, TFV, and free TAF in participants with normal hepatic function and participants with severe hepatic impairment. The registry provides the design, dose, endpoint definitions, sampling schedule, analysis-population rule, and selected safety counts. Those details explain what was intended to be measured and how the groups were described.
The numerical primary outcome results are not reported in the registry record. As a result, the record does not establish the mean AUCinf in either group, the direction or magnitude of a group contrast, or the precision of such a contrast. It does not support a statement that exposure was similar or different. Nor does an endpoint definition itself demonstrate a clinical effect or establish an outcome for repeated dosing.
The study is non-randomized and open-label. Its matched comparison group can provide descriptive context, but the registry cautions that the arms are not a like-for-like control comparison. Any observed contrast would need to be interpreted in light of potential group differences and the matching and analysis details. Those details are not fully reported in the registry record.
The safety figures are also descriptive. The recorded counts include a serious adverse event in the severe hepatic impairment group and none in the matched normal-function group, along with other adverse event counts in both groups. These figures do not, by themselves, show that TAF caused an event or that one group had a reliably different risk. The information does not establish a broad safety profile.
Overall, the registry record defines a clinical pharmacology question and reports the design framework, but it does not include the numerical primary endpoint findings needed to answer that question quantitatively. Conclusions should stay within that boundary: this record describes what was studied and selected safety observations, but it does not provide the primary exposure estimates or a definitive causal comparison.
13. Why This Trial Matters Statistically
Pharmacokinetic studies address a different kind of question from trials that compare clinical outcomes. Here, the focus is how TAF, TFV, and free TAF exposure is characterized after a single dose in groups defined by hepatic function. AUCinf is a compact measure of total exposure, and the registry’s endpoint definition makes clear that this measure includes extrapolation beyond the observed concentration period.
The comparison is statistically informative in principle because it places exposure measurements from participants with severe hepatic impairment alongside measurements from a matched normal-function group. At the same time, the non-randomized allocation matters: observed differences would not automatically be attributable to hepatic function. This makes careful reporting of group characteristics, matching procedures, analysis populations, and uncertainty especially important. Several of those details are not reported in the registry record.
The registry record also illustrates why an endpoint description is not a result. Knowing that the study measured mean AUCinf and standard deviation does not reveal the group means, variability, or precision of a contrast. Without those numerical results, readers cannot assess the magnitude or reliability of any exposure difference. Reporting those statistics would be central to a quantitative interpretation of the study’s main question.
The listed safety outcomes add descriptive context, while their small-group counts and non-randomized comparison limit what can be inferred from them. Taken together, the design and outcome definitions identify the statistical questions that matter: how exposure was summarized, how comparisons were made, how missing concentrations were handled, and how uncertainty and multiple analyses were addressed. The registry record does not report all of those analysis details or the primary numerical findings.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The most direct limitation for interpreting the primary question is that numerical AUCinf results are not reported in the registry record. Means, standard deviations, contrasts, confidence intervals, and p-values are not available in the recorded details. Therefore, readers cannot assess the size, direction, variability, or precision of the primary group comparisons.
The non-randomized design limits causal interpretation. Although the normal-function group is described as matched, the matching variables and procedures are not reported in the registry record. The record explicitly cautions that the arms are not a like-for-like control comparison. Potential differences between groups therefore remain relevant to any observed contrast.
The analysis population is defined by treatment receipt and availability of at least 1 non-missing concentration for each analyte, but the number analyzed for each endpoint is not reported. The extent and handling of missing concentration data, the approach to incomplete profiles, and the treatment of extrapolation in AUCinf are not reported in the registry record. These details matter to interpretation of a pharmacokinetic summary.
The record lists 5 outcome measures and 9 analyses, but does not describe the testing hierarchy or any multiplicity adjustment. It also does not report a complete statistical analysis plan, model specifications, or a sample-size justification. The planning assumptions are described, but the numerical planning illustrations are not reported in the registry record and should not be treated as observed power.
Finally, the single-dose design focuses on observations after TAF 25 mg on Day 1. It does not, on its own, answer questions about repeated dosing, longer-term outcomes, or clinical effects. The safety counts are descriptive and do not establish causation or a precise between-group safety comparison.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Study to Evaluate the Pharmacokinetics of Tenofovir Alafenamide (TAF) in Adults With Normal Hepatic Function and Adults With Severe Hepatic Impairment — NCT02296853.
- Registry record last updated 2020-12-09; status last verified 2020-11.
- Results first posted 2020-12-09.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT02296853 is a completed phase 1, open-label, non-randomized, parallel-group study sponsored by Gilead Sciences. It enrolled 20 participants with normal hepatic function or severe hepatic impairment. Both groups received a single oral dose of TAF 25 mg on Day 1.
The primary outcomes were mean AUCinf for TAF, TFV, and free TAF, with standard deviation, measured in h*ng/mL. The pharmacokinetic analysis population required receipt of at least 1 dose and at least 1 non-missing concentration for the respective analyte. Numerical primary outcome results are not reported in the registry record.
The registry lists treatment-emergent adverse events and laboratory abnormalities as secondary outcomes. It records serious and other adverse event counts by group and cautions that the non-randomized arms are not a like-for-like control comparison. Details of matching, missing-data handling, multiplicity, and a full statistical plan are not reported in the registry record.