Efficacy and Safety of Ravidasvir + Danoprevir/r 12-week Oral Therapy in Treatment-Naive Non Cirrhotic G1 CHC Taiwan: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Efficacy and Safety of Ravidasvir + Danoprevir/r 12-week Oral Therapy in Treatment-Naive Non Cirrhotic G1 CHC Taiwan (NCT03020095), a na phase 2 study. The primary outcome is Percentage of Subjects With Sustained Virologic Response (SVR12) 12 Weeks Post-treatment.

2. Clinical Question

3. Trial Design

This is a Phase 2, single-group study of an oral combination regimen for chronic hepatitis C genotype 1. The registry describes a treatment-naive, non-cirrhotic Taiwanese population and records enrollment of 38. The listed study status is completed. The study start is recorded as 2015-08 and primary completion as 2016-08.

Participants in the single listed group received ravidasvir, ritonavir-boosted danoprevir and ribavirin daily for 12 weeks. The arm description gives the doses as ravidasvir 200mg, danoprevir/ritonavir 200/200mg and ribavirin 1000/1200mg. The record does not explain the ribavirin dose notation, so it should be read as written rather than interpreted as a dose schedule for particular participants.

Allocation is recorded as not applicable, masking as none, and the model as single group. This is not a randomized comparison: no concurrent control arm is listed. The design can describe outcomes observed in participants who received the regimen, but it does not provide a randomized estimate of how those outcomes differ from another treatment or from an untreated course.

The registry lists one outcome measure, the percentage of subjects with SVR12, assessed 12 weeks after treatment. The endpoint definition is undetectable HCV RNA 12 weeks after the last day of study drug administration. Although the study is marked completed, the primary outcome result is not reported in the registry record. The protocol, detailed statistical plan, sample-size justification, interim analyses and detailed analysis populations are not reported in the registry record either.

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.

Overall Study

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.

6. Primary Endpoint

The registry lists the primary outcome as Percentage of Subjects With Sustained Virologic Response (SVR12) 12 Weeks Post-treatment, measured over 12 weeks.

The primary endpoint is the percentage of participants with sustained virologic response 12 weeks after treatment, abbreviated SVR12. The registry defines a response as undetectable HCV RNA 12 weeks after the last day of study drug administration. This is a binary outcome at the participant level: each participant either meets the stated definition or does not, based on the assessment described in the record.

SVR12 is used as a virologic endpoint because it captures whether viral RNA remains undetectable at a specified post-treatment assessment. It is distinct from a measurement taken during treatment: the endpoint is tied to the period after study drug administration has ended. In general, a defined follow-up time makes the outcome interpretable by specifying when response is assessed.

The registry does not report the number of participants who achieved SVR12, the percentage, or an uncertainty interval. It also does not report details such as how missing assessments were handled or what analysis population was used. Consequently, the endpoint definition is available, but the posted record does not provide the observed result needed to estimate the response proportion or its precision.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies a binary primary endpoint: participants are classified according to whether HCV RNA is undetectable 12 weeks after the last day of study drug administration. A binary endpoint records whether a defined event or state occurred for each participant. For a single group, the basic descriptive result would ordinarily be the number meeting the definition and the proportion among the participants included in the specified analysis. The posted registry record gives neither that count nor that proportion.

What would an estimate describe?

In general, an observed proportion summarizes the participants assessed in a study; it does not automatically represent every person with the condition. Its interpretation depends on who entered the study, who completed follow-up and how the analysis population was defined. Here, the registry lists enrollment of 38 but does not report the primary-outcome denominator, the number with an available SVR12 assessment, or the analysis population. Enrollment should therefore not be substituted for the endpoint denominator.

In general, a confidence interval communicates the uncertainty around an estimate. It gives a range of values compatible with the data under the method used, rather than guaranteeing that the underlying value falls within that range. The record does not report a confidence interval for SVR12, and without the endpoint result and analysis details, its precision cannot be assessed from the posted information.

Why does the study design matter?

The study is recorded as single group, with allocation not applicable and no masking. A single-group analysis can describe outcomes observed after the listed regimen, but it does not provide a randomized between-group contrast. In general, random assignment helps make groups comparable with respect to measured and unmeasured factors, on average. Without a control group and random assignment, a within-group outcome cannot isolate the regimen’s effect from other influences on the observed outcome.

There is no sponsor-reported hypothesis test, adjusted estimate or statistical model listed for the primary endpoint. The number of analyses is recorded as zero. The statistical plan, handling of missing outcomes, any interim analyses and the rationale for the planned enrollment are not reported in the registry record. It is therefore not possible to say which inferential procedure was prespecified or how the investigators intended to address those issues.

How should the planning illustrations be read?

The page includes sample-size planning illustrations based on the observed effect, using a two-sided significance level of 0.05, equal allocation between two arms and a normal approximation. These are planning illustrations, not observed power and not the design of this single-group trial. The stated effect to detect is a fraction of the observed effect. The sample-size section should be understood as a hypothetical planning exercise; it does not turn the trial into a randomized comparison or supply the missing primary endpoint result.

In general, power calculations depend on the assumptions used, including the effect size selected, significance level, allocation and statistical method. Changing an assumption changes the planning result. Such calculations can help illustrate the sample size associated with a hypothetical comparison, but they cannot show that a completed study had a particular probability of detecting an effect after the results are known. The registry record does not report a trial-specific sample-size justification, so the planning illustration should not be presented as the investigators’ original rationale.

What can the safety counts establish?

The registry presents counts for participants at risk and participants affected in serious and other adverse-event categories. Counts describe the recorded events or affected participants as classified in the registry; they do not, by themselves, give event timing, severity beyond the category, causal attribution or a comparison with another group. In general, safety interpretation also depends on how events were collected and defined, details that are not reported in the registry record.

In sum, the registry supports a description of the planned endpoint, the treatment group and limited safety counts. It does not provide the primary response estimate, an inferential analysis or enough methodological detail to reconstruct the outcome analysis. General statistical concepts can explain what those missing elements would mean, but they cannot replace unreported study results.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Ravidasvir,Danoprevir/r,RBV")
n      <- c(38)
events <- c(38)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Ravidasvir,Danoprevir/r,RBV  38  38  100.0  90.7  100.0  90.8  100.0  91.0  99.9

11. Multiplicity, Missing Data and Analysis Populations

The registry lists one outcome measure, the primary SVR12 endpoint, and records zero analyses. It does not report a statistical analysis plan, a hierarchy of outcomes, adjustment for multiple testing or any interim analyses. The registry record therefore does not establish whether multiplicity was considered in the study’s analysis or whether other outcomes were evaluated outside the listed measure. It would be inappropriate to infer a prespecified testing strategy from the outcome listing alone.

Missing outcome data are important for a binary endpoint because the estimated proportion depends on which participants are included and how unavailable assessments are handled. The registry does not report the number with an SVR12 assessment, the number missing, reasons for missingness, imputation methods or sensitivity analyses. The listed enrollment of 38 cannot establish how many participants contributed to the endpoint result.

The record also does not describe the primary analysis population. It does not say whether the endpoint analysis included all enrolled participants, only those who completed treatment, or another defined group. These are not interchangeable choices in general: the target population and handling of departures from the planned treatment can affect the interpretation of an estimate.

No adjustment variables, model, confidence interval method or hypothesis test are reported for the primary endpoint. These omissions mean readers cannot assess the planned inferential framework or reproduce the analysis from the registry record. Most importantly, the primary outcome result itself is not reported in the registry record, so there is no posted estimate to interpret for multiplicity or missing-data sensitivity.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

Most frequent non-serious adverse event terms

The registry’s safety summary lists 38 participants at risk for serious adverse events and zero affected by serious adverse events. It also lists 38 participants at risk in the other adverse-event category and 14 affected participants. These are the counts recorded for the single listed treatment group.

The categories should be kept distinct: zero is the count in the serious adverse-event category, while 14 is listed in the other adverse-event category. The registry does not provide detailed terms for the serious adverse-event category; no top serious terms are listed. The count in the other category should not be relabeled as serious events or interpreted as a complete description of all safety experiences.

These registry counts do not describe event timing, duration, severity within the other category, clinical course or the investigator’s assessment of whether an event was related to study drugs. The record also supplies no comparator group, so the counts cannot support a between-treatment safety comparison. They are descriptive information from the posted record, not a complete safety profile or a causal assessment.

13. What the Result Does, and Does Not, Mean

The registry record describes a Phase 2 study of a 12-week oral combination regimen in treatment-naive, non-cirrhotic Taiwanese participants with chronic hepatitis C genotype 1. It identifies SVR12 as the primary endpoint and defines the assessment as undetectable HCV RNA 12 weeks after the last day of study drug administration. It also reports limited adverse-event counts for the listed treatment group.

The posted record does not report the primary endpoint result. It therefore does not show how many participants achieved SVR12, what percentage they represented, or how precise an estimate would be. The completion status and enrollment count do not fill this gap. A numerical efficacy conclusion cannot be drawn from the information recorded.

Even if an outcome proportion were available, the single-group design would make it descriptive rather than a randomized comparison. With no comparator group listed, the study cannot directly establish how outcomes differed from another treatment. The posted registry information also does not describe missing endpoint assessments or the analysis population, further limiting interpretation of any estimate that might appear elsewhere.

The serious adverse-event count is zero among 38 at risk, and the other adverse-event category lists 14 affected among 38 at risk. Those counts are not a complete account of event details or a comparison of safety between treatments. They do not establish cause or provide information about outcomes beyond the categories reported.

The sample-size material on the page is a planning illustration, not observed power. It should not be mistaken for a result of the clinical study or for evidence that a treatment effect was detected. Overall, the record describes the study question and design, but leaves the primary efficacy result and important analysis details not reported in the registry record.

14. Why This Trial Matters Statistically

This trial is statistically informative as an example of the difference between a clearly defined endpoint and a reported endpoint result. The registry states what SVR12 means and when it is assessed, but does not report the number or percentage of participants who met that definition. A well-specified outcome can make a study question understandable; without the result, readers still cannot estimate the outcome observed in the trial.

The single-group design also makes the distinction between description and comparison especially important. The study can be framed around outcomes among participants receiving the listed regimen, but no randomized control group is present in the registry record. A descriptive result, if reported, would not on its own quantify a comparative treatment effect. This distinction is central when interpreting studies without a concurrent comparator.

The entry also illustrates why enrollment is not necessarily the endpoint denominator. The registry records enrollment of 38, but does not report how many participants had an SVR12 assessment or how missing data were handled. Readers need the analysis population and missing-data approach to understand what a response proportion represents and how robust it may be.

Finally, the planning illustrations on the page should be kept separate from the observed clinical findings. Planning assumptions can illustrate sample sizes for hypothetical comparisons, but they are neither the result of this single-group study nor observed power. The record’s limited safety counts likewise require careful category-specific reading. Together, these features show how design, endpoint reporting and analysis transparency determine what conclusions a registry entry can support.

15. 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 important limitation for interpreting this record is that the primary SVR12 result is not reported in the registry record. The endpoint is defined, but no response count, percentage, confidence interval or analysis result is available. The study’s completed status does not supply those missing results.

The single-group design has no listed comparator and no randomized allocation. Any outcome reported for this group would be descriptive and would not provide a randomized estimate of the difference from another treatment. The masking entry is none, and the record does not provide additional detail about outcome assessment procedures.

The registry lists enrollment of 38 but does not report the primary endpoint denominator, the number of missing assessments, the analysis population or the handling of missing outcomes. This prevents assessment of how endpoint availability could affect a response estimate. The statistical analysis plan, sample-size justification, interim analyses and inferential methods are also not reported in the registry record.

The safety summary is limited to counts by category. It does not provide event terms for the other category, details about timing or severity, attribution to study drugs, or a comparator for interpreting the counts. No top serious terms are listed. The population described is specifically treatment-naive, non-cirrhotic Taiwanese participants with genotype 1, so the record does not itself establish how results would apply outside that described group.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Efficacy and Safety of Ravidasvir + Danoprevir/r 12-week Oral Therapy in Treatment-Naive Non Cirrhotic G1 CHC Taiwan — NCT03020095.
• Registry record last updated 2020-10-22; status last verified 2017-01.
• Results first posted 2020-10-22.
• 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.

19. Record Summary

This completed Phase 2 study is recorded as a single-group investigation of ravidasvir with ritonavir-boosted danoprevir and ribavirin in treatment-naive, non-cirrhotic Taiwanese participants with chronic hepatitis C genotype 1. Enrollment is 38, and the regimen is described as daily treatment for 12 weeks.

The primary endpoint is SVR12, defined as undetectable HCV RNA 12 weeks after the last day of study drug administration. The primary outcome result is not reported in the registry record. The record lists zero serious adverse events among 38 at risk and 14 affected participants in the other adverse-event category among 38 at risk.

No comparator group is listed. The statistical plan, analysis population, missing-data handling and sample-size justification are not reported in the registry record. The available information describes the study design and endpoint but does not provide a numerical efficacy estimate or comparative treatment effect.