Extraction form for project: Treatment of Hepatitis C in Chronic Kidney Disease. KDIGO 2022 update

Design Details

1. Reject Reason
Skip if not rejecting. Don't fill out rest if you are rejecting
Reason
Confirmed by CG
2. Secondary to other article?
List PMID(s) or other identifier for related article
3. Study or registry name
Skip if no identifying name available.
4. CKD stage
5. Treatment(s) investigated
6. KQ/Topic
7. KQ/Topic
8. Study design
Design
Direction
Protocol
9. Study design
Design
Direction
10. Sample size
Answer in one row only (but ok to leave data in both rows 1 and 2). Row 1 refers to N who meet all CKD criteria. Row 2 refers to total N when data for row 1 unclear (ie, in abstract). Similarly, row 3 is applicable only to abstract mapping phase. Across all arms. Ensure that each counted arm has N>=10.
N eligible (Specific Population)
N total (Broad population)
NR
11. Country/ies
Check citation title
12. Note/Comment

Arms

Arm NameArm Description
DAA treatment
SOF/LDV
SOF/DCV
SOF/SIM
SOF/RBV

Arm Details

1. Regimen
For each drug: Drug name dose frequency. Split up specific drugs, even if they are given in a combination pill. Include duration only if the specific drug is used for a different duration than the whole regimen. (If duration varied by gt, note in next question.) Std abbreviations: qD, BID, TID, QID, qOD, qW, BIW; gt = genotype (put in parentheses if drug used only a specific gt). Eg: Ombitasvir 25 mg qD Paritaprevir 150 mg qD Dasabuvir 250 mg BID (gt 1) Ritonavir 100 mg qD (gt 1a, 4, cirrhosis)
DAA treatment
Rx 1
Rx 2
Rx 3
Rx 4
Rx 5
Rx 6
Rx 7
Rx 8
SOF/LDV
Rx 1
Rx 2
Rx 3
Rx 4
Rx 5
Rx 6
Rx 7
Rx 8
SOF/DCV
Rx 1
Rx 2
Rx 3
Rx 4
Rx 5
Rx 6
Rx 7
Rx 8
SOF/SIM
Rx 1
Rx 2
Rx 3
Rx 4
Rx 5
Rx 6
Rx 7
Rx 8
SOF/RBV
Rx 1
Rx 2
Rx 3
Rx 4
Rx 5
Rx 6
Rx 7
Rx 8
2. Duration of treatment
If mean or median (with SD, IQR, etc.), specify explicitly. If duration (of whole regimen) varies by genotype or other factor, note it in parentheses. (If duration of one drug is different, note that in the prior question for that drug. Put the full duration of the regimen here.) Abbreviations: d, wk, mo (but try to convert to weeks). Eg, 12 wk 12 wk (gt 1b) 24 wk (gt 1a, 4, cirrhosis)
DAA treatment
SOF/LDV
SOF/DCV
SOF/SIM
SOF/RBV
3. (GL 4) Time to start of DAA (relative to Txp)
DAA treatment
SOF/LDV
SOF/DCV
SOF/SIM
SOF/RBV
4. Comment/Note
DAA treatment
SOF/LDV
SOF/DCV
SOF/SIM
SOF/RBV

Sample Characteristics

1. Population characteristics
Enter as per template in row headers
DAA treatment
Male: n/N (%)
Age: mean (SD or range)
Genotype 1 (any subtype): %
Genotype 1a: %
Genotype 1b: %
Genotype 2 (any): %
Genotype 3 (any): %
Genotype 4 (any): %
Genotype 5 (any): %
Genotype 6 (any): %
Other or mixed gt_1
Other or mixed gt_2
Other or mixed gt_3
Other or mixed gt_4
Other or mixed gt_5
Liver cirrhosis: %
IFN Tx-naive (skip)
IFN treated prev, %
SOF/LDV
Male: n/N (%)
Age: mean (SD or range)
Genotype 1 (any subtype): %
Genotype 1a: %
Genotype 1b: %
Genotype 2 (any): %
Genotype 3 (any): %
Genotype 4 (any): %
Genotype 5 (any): %
Genotype 6 (any): %
Other or mixed gt_1
Other or mixed gt_2
Other or mixed gt_3
Other or mixed gt_4
Other or mixed gt_5
Liver cirrhosis: %
IFN Tx-naive (skip)
IFN treated prev, %
SOF/DCV
Male: n/N (%)
Age: mean (SD or range)
Genotype 1 (any subtype): %
Genotype 1a: %
Genotype 1b: %
Genotype 2 (any): %
Genotype 3 (any): %
Genotype 4 (any): %
Genotype 5 (any): %
Genotype 6 (any): %
Other or mixed gt_1
Other or mixed gt_2
Other or mixed gt_3
Other or mixed gt_4
Other or mixed gt_5
Liver cirrhosis: %
IFN Tx-naive (skip)
IFN treated prev, %
SOF/SIM
Male: n/N (%)
Age: mean (SD or range)
Genotype 1 (any subtype): %
Genotype 1a: %
Genotype 1b: %
Genotype 2 (any): %
Genotype 3 (any): %
Genotype 4 (any): %
Genotype 5 (any): %
Genotype 6 (any): %
Other or mixed gt_1
Other or mixed gt_2
Other or mixed gt_3
Other or mixed gt_4
Other or mixed gt_5
Liver cirrhosis: %
IFN Tx-naive (skip)
IFN treated prev, %
SOF/RBV
Male: n/N (%)
Age: mean (SD or range)
Genotype 1 (any subtype): %
Genotype 1a: %
Genotype 1b: %
Genotype 2 (any): %
Genotype 3 (any): %
Genotype 4 (any): %
Genotype 5 (any): %
Genotype 6 (any): %
Other or mixed gt_1
Other or mixed gt_2
Other or mixed gt_3
Other or mixed gt_4
Other or mixed gt_5
Liver cirrhosis: %
IFN Tx-naive (skip)
IFN treated prev, %
Total
Male: n/N (%)
Age: mean (SD or range)
Genotype 1 (any subtype): %
Genotype 1a: %
Genotype 1b: %
Genotype 2 (any): %
Genotype 3 (any): %
Genotype 4 (any): %
Genotype 5 (any): %
Genotype 6 (any): %
Other or mixed gt_1
Other or mixed gt_2
Other or mixed gt_3
Other or mixed gt_4
Other or mixed gt_5
Liver cirrhosis: %
IFN Tx-naive (skip)
IFN treated prev, %
2. Population
Should sum to 100% for each arm. We will treat groups >=90% as if they were 100%, but do note the <10% groups.
DAA treatment
AllSubset
CKD 4-5ND
HD
PD
Transplant
SOF/LDV
AllSubset
CKD 4-5ND
HD
PD
Transplant
SOF/DCV
AllSubset
CKD 4-5ND
HD
PD
Transplant
SOF/SIM
AllSubset
CKD 4-5ND
HD
PD
Transplant
SOF/RBV
AllSubset
CKD 4-5ND
HD
PD
Transplant
Total
AllSubset
CKD 4-5ND
HD
PD
Transplant
3. Note/Comment
DAA treatment
SOF/LDV
SOF/DCV
SOF/SIM
SOF/RBV
Total

Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
CategoricalSVR12
  • All Participants
  • 12 (wk post-Tx)
CategoricalPatient death
  • All Participants
  • 12 (mo)
  • 15.3 (median) (mo)
CategoricalClinical responseCryoglobulinemia
  • All Participants
  • GN
  • 12 (wk post-Tx)
  • 15.3 (median) (mo)
CategoricalDiscontinuation due to AE
  • All Participants
  • EOT

Outcome Details

1. Comment/Note
SVR12
Patient death
Clinical response
Discontinuation due to AE

Risk of Bias Assessment

1. RCT only_Random sequence generation
Rating
Notes/Comments (add for high/unclear):
2. RCT only_Allocation concealment
Rating
Notes/Comments (add for high/unclear):
3. RCT only_Blinding of participants
Rating
Notes/Comments:
4. ALL_Blinding of outcome assessors
There is low risk of detection bias if the blinding of the outcome assessment was ensured and it was unlikely that the blinding could have been broken; or if there was no blinding or incomplete blinding, but the review authors judge that the outcome is not likely to be influenced by lack of blinding. WE SHOULD DISCUSS WHICH OUTCOMES (MAYBE ALL) THIS IS RELEVANT FOR.
Rating
Notes/Comments:
5. ALL_Incomplete outcome data (dropouts, missing data)
20% threshold (or imbalance between groups)
Rating
Notes/Comments (add for high/unclear):
6. ALL_Selective Reporting (reporting bias)
There is LOW risk of reporting bias ONLY if the study protocol is available and all of the study’s pre-specified (primary and secondary) outcomes that are of interest in the review have been reported in the pre-specified way. There is a HIGH risk of reporting bias if not all of the study’s pre-specified primary outcomes have been reported (pre-specified either in protocol or in methods section). Also HIGH risk of bias if one or more outcomes of interest in the review are reported incompletely so that they cannot be entered in a meta-analysis. Usually UNCLEAR risk of bias.
Rating
Notes/Comments:
7. ALL_Intention-to-treat-analysis
If self-describe ITT, confirm actually is ITT. If 100% reporting, then equivalent to ITT. Provide info about meaning of ITT or reason not ITT
Rating
Notes/Comments (add for high/unclear):
8. ALL_Was selection of participants into the study based on participant characteristics observed AFTER the start of intervention?
If yes, consider whether should reject. Try your best to select Y or N
Rating
Notes/Comments (add for Yes or Probably Yes):
9. COMPARATIVE only_Cohorts comparable?
E.g., based off of "Table 1". No statistically significant (or large) differences of a clinically important factor.
Rating
Notes/Comments (add for No):
10. COMPARATIVE only_Were potential confounders properly accounted for?
Comparative studies only (where we evaluate the analysis of the comparison)
Rating
Notes/Comments (add for unclear):
11. ALL_Clear reporting with no discrepancies
Rating
Notes/Comments (add for no):
12. ALL_Were eligibility criteria clear?
Rating
Notes/Comments (add for no):
13. ALL_Were interventions adequately described?
Rating
Notes/Comments (add for no):
14. ALL_Were the outcomes adequately defined?
Rating
Notes/Comments (add for no):
15. ALL_Were the harms PRE-DEFINED using standardized or precise definitions
Rating
Notes/Comments (add for no):
16. Other Bias:
Rating
Notes/Comments:

Results

Categorical


SVR12

All Participants
Descriptive StatisticsBetween Arm Comparisons
DAA treatmentSOF/LDVSOF/DCVSOF/SIMSOF/RBV
12 (wk post-Tx)
Complete clinical response
Odds Ratio (OR)
Partial clinical response
95% CI low (OR)
No clinical response
95% CI high (OR)
Total (N analyzed)
Odds Ratio, Adjusted (adjOR)
Events
95% CI low (adjOR)
Percentage
95% CI high (adjOR)
Note
p value
Within Arm ComparisonsNet Comparisons
DAA treatmentSOF/LDVSOF/DCVSOF/SIMSOF/RBV

Patient death

All Participants
Descriptive StatisticsBetween Arm Comparisons
DAA treatmentSOF/LDVSOF/DCVSOF/SIMSOF/RBV
12 (mo)
Cause
Odds Ratio (OR)
Complete clinical response
95% CI low (OR)
Partial clinical response
95% CI high (OR)
No clinical response
Odds Ratio, Adjusted (adjOR)
Total (N analyzed)
95% CI low (adjOR)
Events
95% CI high (adjOR)
Percentage
p value
Note
15.3 (median) (mo)
Cause
Odds Ratio (OR)
Complete clinical response
95% CI low (OR)
Partial clinical response
95% CI high (OR)
No clinical response
Odds Ratio, Adjusted (adjOR)
Total (N analyzed)
95% CI low (adjOR)
Events
95% CI high (adjOR)
Percentage
p value
Note
Within Arm ComparisonsNet Comparisons
DAA treatmentSOF/LDVSOF/DCVSOF/SIMSOF/RBV

Clinical response (Cryoglobulinemia)

All Participants
Descriptive StatisticsBetween Arm Comparisons
DAA treatmentSOF/LDVSOF/DCVSOF/SIMSOF/RBV
SOF/LDV
vs.
SOF/RBV

SOF/DCV
vs.
SOF/RBV

SOF/SIM
vs.
SOF/RBV
12 (wk post-Tx)
Complete clinical response
Odds Ratio, Adjusted (adjOR)
Partial clinical response
95% CI low (adjOR)
No clinical response
95% CI high (adjOR)
Total (N analyzed)
p value
Note
15.3 (median) (mo)
Complete clinical response
Odds Ratio, Adjusted (adjOR)
Partial clinical response
95% CI low (adjOR)
No clinical response
95% CI high (adjOR)
Total (N analyzed)
p value
Note
Within Arm ComparisonsNet Comparisons
DAA treatmentSOF/LDVSOF/DCVSOF/SIMSOF/RBV
SOF/LDV
vs.
SOF/RBV
SOF/DCV
vs.
SOF/RBV
SOF/SIM
vs.
SOF/RBV
GN
Descriptive StatisticsBetween Arm Comparisons
DAA treatmentSOF/LDVSOF/DCVSOF/SIMSOF/RBV
12 (wk post-Tx)
Complete clinical response
Odds Ratio (OR)
Partial clinical response
95% CI low (OR)
No clinical response
95% CI high (OR)
Total (N analyzed)
Odds Ratio, Adjusted (adjOR)
Note
95% CI low (adjOR)
95% CI high (adjOR)
p value
15.3 (median) (mo)
Complete clinical response
Odds Ratio (OR)
Partial clinical response
95% CI low (OR)
No clinical response
95% CI high (OR)
Total (N analyzed)
Odds Ratio, Adjusted (adjOR)
Note
95% CI low (adjOR)
95% CI high (adjOR)
p value
Within Arm ComparisonsNet Comparisons
DAA treatmentSOF/LDVSOF/DCVSOF/SIMSOF/RBV

Discontinuation due to AE

All Participants
Descriptive StatisticsBetween Arm Comparisons
DAA treatmentSOF/LDVSOF/DCVSOF/SIMSOF/RBV
EOT
Complete clinical response
Odds Ratio (OR)
Partial clinical response
95% CI low (OR)
No clinical response
95% CI high (OR)
Total (N analyzed)
Odds Ratio, Adjusted (adjOR)
Events
95% CI low (adjOR)
Percentage
95% CI high (adjOR)
Note
p value
Within Arm ComparisonsNet Comparisons
DAA treatmentSOF/LDVSOF/DCVSOF/SIMSOF/RBV