Web Annex 3.2Adult hepatitis C virus treatment systematic review; supporting evidence

Publication Details

Purpose

This ‘Supporting Document’ lists the studies that informed the pooled SVR12 estimates in the ‘all comer’ analyses for:

  • Sofosbuvir + daclatasvir
  • Sofosbuvir + velpatasvir
  • Glecaprevir + pibrentasvir

Refer to Web Annex 3.1 (the complete report (v3)) for a summary of all SVR12 estimates and GRADE evidence summaries for all treatments and patient populations.

Results

This Supporting Document is to accompany the main report (v3). The summaries presented in this section include a list of the studies which informed each analysis.

Efficacy outcomes (SVR12) – All comers

For each treatment in the all-comer population, the pooled proportions of patients achieving SVR12 are presented by genotype and treatment-experience. The number of treatment arms may represent subgroups of treatment arms in a single study, such as where outcomes are reported separately by prior treatment experience. The all-treatment experience analysis pools outcomes from patients who are treatment-naïve, treatment-experienced, and where previous treatment status was unclear.

Trial evidence refers to evidence coming from RCTs and other non-randomized or single-arm trials. This analysis is supplemented with an all evidence analysis, which also incorporates outcomes from observational studies.

Comparative evidence is not available and inferences on relative treatment effect should be avoided.

Daclatasvir + Sofosbuvir

All-treatment experience

In the all-treatment experience analysis of patients treated with daclatasvir + sofosbuvir, evidence was available for patients across all genotypes. The percentage of patients achieving SVR12 varied from 88% to 98%. Across outcomes, GRADE assessments varied from very low to high. A summary of the analyses is presented in Table 1.

Table 1. SVR12 in all patients treated with daclatasvir + sofosbuvir, arranged by genotype.

Table 1

SVR12 in all patients treated with daclatasvir + sofosbuvir, arranged by genotype.

Treatment-naïve patients only

In the analysis of treatment-naïve only patients treated with daclatasvir + sofosbuvir, evidence was available for patients with genotypes 1-5 infection, as well as an unknown or mixed genotype population. The percentage of patients achieving SVR12 varied from 75% to 98%. Across outcomes, GRADE assessments varied from very low to high. A summary of the analyses is presented in Table 2.

Table 2. SVR12 in treatment-naive patients treated with daclatasvir + sofosbuvir, arranged by genotype.

Table 2

SVR12 in treatment-naive patients treated with daclatasvir + sofosbuvir, arranged by genotype.

Treatment-experienced patients only

In the analysis of treatment-experienced only patients treated with daclatasvir + sofosbuvir, evidence was available for patients with genotypes 1-4 infection, as well as an unknown or mixed genotype population. The percentage of patients achieving SVR12 varied from 75% to 98%. Across outcomes, GRADE assessments varied from very low to moderate. A summary of the analyses is presented in Table 3.

Table 3. SVR12 in treatment-experienced patients treated with daclatasvir + sofosbuvir, arranged by genotype.

Table 3

SVR12 in treatment-experienced patients treated with daclatasvir + sofosbuvir, arranged by genotype.

Glecaprevir + Pibrentasvir

All-treatment experience

In the all-treatment experience analysis of patients treated with glecaprevir + pibrentasvir, evidence was available for patients across all genotypes. The percentage of patients achieving SVR12 varied from 83% to 98%. Across outcomes, GRADE assessments varied from very low to high. A summary of the analyses is presented in Table 4.

Table 4. SVR12 in all patients treated with glecaprevir + pibrentasvir, arranged by genotype.

Table 4

SVR12 in all patients treated with glecaprevir + pibrentasvir, arranged by genotype.

Treatment-naïve patients only

In the analysis of treatment-naïve only patients treated with glecaprevir + pibrentasvir, evidence was available only for patients with genotype 3 infection (N=419). The percentage of patients achieving SVR12 was 95%, with a GRADE assessment of high. A summary of the analyses is presented in Table 5.

Table 5. SVR12 in treatment-naïve patients treated with glecaprevir + pibrentasvir, arranged by genotype.

Table 5

SVR12 in treatment-naïve patients treated with glecaprevir + pibrentasvir, arranged by genotype.

Treatment-experienced patients only

In the analysis of treatment-experienced only patients treated with glecaprevir + pibrentasvir, evidence was available only for patients with genotype 3 infection (N=24). The percentage of patients achieving SVR12 was 92%, with a GRADE assessment of very low. A summary of the analyses is presented in Table 6.

Table 6. SVR12 in treatment-experienced patients treated with glecaprevir + pibrentasvir, arranged by genotype.

Table 6

SVR12 in treatment-experienced patients treated with glecaprevir + pibrentasvir, arranged by genotype.

Sofosbuvir + Velpatasvir

All-treatment experience

In the all-treatment experience analysis of patients treated with sofosbuvir + velpatasvir, evidence was available for patients across all genotypes. The percentage of patients achieving SVR12 varied from 89% to 99%. GRADE assessments varied from low to high across outcomes. A summary of the analyses is presented in Table 7.

Table 7. SVR12 in all patients treated with sofosbuvir + velpatasvir, arranged by genotype.

Table 7

SVR12 in all patients treated with sofosbuvir + velpatasvir, arranged by genotype.

Treatment-naïve patients only

In the analysis of treatment-naïve only patients treated with sofosbuvir + velpatasvir, evidence was available for patients with genotypes 1-3 infection, as well as an unknown or mixed genotype population. The percentage of patients achieving SVR12 varied from 84% to 98%. GRADE assessments varied from very low to high across outcomes. A summary of the analyses is presented in Table 8.

Table 8. SVR12 in treatment-naïve patients treated with sofosbuvir + velpatasvir, arranged by genotype.

Table 8

SVR12 in treatment-naïve patients treated with sofosbuvir + velpatasvir, arranged by genotype.

Treatment-experienced patients only

In the analysis of treatment-experienced only patients treated with sofosbuvir + velpatasvir, evidence was available for patients with genotypes 1-3 infection. The percentage of patients achieving SVR12 varied from 85% to 97%. GRADE assessments varied from low to high across outcomes. A summary of the analyses is presented in Table 9.

Table 9. SVR12 in treatment-experienced patients treated with sofosbuvir + velpatasvir, arranged by genotype.

Table 9

SVR12 in treatment-experienced patients treated with sofosbuvir + velpatasvir, arranged by genotype.

Safety outcomes

The number of patients experiencing each adverse event outcome category was pooled across studies, arranged by treatment. When possible, outcomes were extracted from each study based on the safety analysis set (i.e. number of patients who received ≥1 dose). Comparative evidence is not available and inferences on relative treatment effect should be avoided.

Discontinuations due to adverse events

Evidence on the number of patients who experienced a DAE was available for every treatment. The analyses for daclatasvir + sofosbuvir + ribavirin and sofosbuvir + ribavirin was restricted to patients with cirrhosis and genotype 2 or 3 infection. Across treatments and studies, the number of DAEs was very low, with the pooled percentages varying from 0% to 0.04%. GRADE was assessed as moderate in all cases. As very few studies blinded patients or outcome assessors, GRADE was lowered by one level due to the perceived subjectivity of labelling a discontinuation as a DAE (Risk of Bias). A summary of the analyses is presented in Table 10.

Table 10. Discontinuations due to adverse events, arranged by treatment.

Table 10

Discontinuations due to adverse events, arranged by treatment.

Serious adverse events

Evidence on the number of patients who experienced a SAE was available for every treatment with the exception of daclatasvir + sofosbuvir + ribavirin, where inclusion in this review was restricted to patients with cirrhosis and genotype 2 or 3 infection. Across treatments and studies, the number of SAEs was very low, with the pooled percentage varying 1% to 5% and GRADE assessments varying from moderate to high. A summary of the analyses is presented in Table 11.

Table 11. Serious adverse events, arranged by treatment.

Table 11

Serious adverse events, arranged by treatment.

Mortality

Evidence on mortality was available for every treatment. Incidence was very low across treatments, with the pooled morality percentage varying from 0% to 4%. GRADE assessments were high for all treatments and evidence types. A summary of the analyses is presented in Table 12.

Table 12. Mortality, arranged by treatment.

Table 12

Mortality, arranged by treatment.

Appendix A. Included studies from all analyses

Table A1. List of included studies, with treatments and study design categorization.

Table A1

List of included studies, with treatments and study design categorization.

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