Design Details

1. Reject Reason

Skip if not rejecting. Don't fill out rest if you are rejecting


Reason	Not CKD (at all) Not CKD stage or disease of interest Not HCV-related N<10 per extractable arm (all arms) Not primary study or SR Included in 2018 CPG (ignore 2020 letter update) Duplicate article No unique data (vis a vis included publication) Other Not intervention of interest No outcome of interest Conference abstract (pre-2019) Multi-organ transplant Viral co-infection Too short duration follow-up Publication pre-2016 SR (references checked) Could not parse results by population or regimen with each group n≥10 (GL 2)
Confirmed by CG	Yes Question/Comment

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


	CKD 4-5 (GFR <30) CKD 5 dialysis CKD T (transplant, any stage) CKD, other (unclear stage or include more than CKD 4,5,T). Explain in f/up Q. Cryoglobulinemia, unknown/unclear GN Cryoglobulinemia with GN Other or unclear (explain)


	DAA(s) Interferon Ribavirin Immunosuppression (for cryoglobulinemia) Other (for cryoglobulinemia, not IS or HCV-treatment) Other


	GL 2: DAA G4-G5D/T GL 2: Other? (including non-DAA) GL 4: DAA for D+/R- KTxp GL 4: Other? GL 5: HCV treatment (DAA or IFN/Riba) GL 5: Immunosuppression GL 5: Other?


	GL 2: DAA G4-5 (non-dialysis) GL 2: DAA G4-G5 HD GL 2: DAA G4-G5 PD GL 2: DAA Txp GL 4: DAA D+/R- KTxp GL 5: DAA HCV-GN GL 5: IS HCV-GN Other/Comment

8. Study design


Design	RCT NRCS (comparison of treatment) Single group (single treatment) Unclear (one cohort, multiple treatments, unclear if comparison made) Case-control Systematic review Other/unclear
Direction	Prospective Retrospective Prospective and retrospective Unclear
Protocol	Protocol (only)

9. Study design


Design	RCT NRCS (planned comparisons of interventions [N≥10 per group]) NRCS (unplanned comparison of interventions [N≥10 per group]; designed as "cohort") Single group (planned single treatment [N≥10]) Single group (originally RCT or NRCS, but only single group of interest) Case-control Other
Direction	Prospective Retrospective Unclear

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	NR


	US Canada Europe, multiple countries France Germany Italy Spain UK Egypt India Pakistan China Japan S Korea Australia/New Zealand Other(s)

12. Note/Comment


	Rise in SCr omitted because not defined

Arms

Arm Name	Arm Description
PrO +- RBV (CKD 4)
PrO +- RBV (CKD 5HD)
SOF/DCV +- RBV (Txp)

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)

PrO +- RBV (CKD 4)


Rx 1	Paritaprevir 150 mg qD
Rx 2	Ritonavir 100 mg qD
Rx 3	Ombitasvir 25 mg qD
Rx 4	Ribavirin 200 mg qD (non-anemic, NR%)
Rx 5
Rx 6
Rx 7
Rx 8

PrO +- RBV (CKD 5HD)


Rx 1	Paritaprevir 150 mg qD
Rx 2	Ritonavir 100 mg qD
Rx 3	Ombitasvir 25 mg qD
Rx 4	Ribavirin 200 mg qOD (non-anemic, NR%)
Rx 5
Rx 6
Rx 7
Rx 8

SOF/DCV +- RBV (Txp)


Rx 1	Sofosbuvir 400 mg qD
Rx 2	Daclatasvir 60 mg qD
Rx 3	Ribavirin 900-1200 mg qD (non-anemic, NR%)
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)

PrO +- RBV (CKD 4)


	12 wk

PrO +- RBV (CKD 5HD)


	12 wk

SOF/DCV +- RBV (Txp)


	24 wk

3. (GL 4) Time to start of DAA (relative to Txp)

PrO +- RBV (CKD 4)

PrO +- RBV (CKD 5HD)

SOF/DCV +- RBV (Txp)

4. Comment/Note

PrO +- RBV (CKD 4)

PrO +- RBV (CKD 5HD)

SOF/DCV +- RBV (Txp)

Sample Characteristics

1. Population characteristics

Enter as per template in row headers

PrO +- RBV (CKD 4)


Male: n/N (%)	NR
Age: mean (SD or range)	NR
Genotype 1 (any subtype): %	NR
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: %	NR (U/S), 0 (F4)
IFN Tx-naive (skip)
IFN treated prev, %	NR

PrO +- RBV (CKD 5HD)


Male: n/N (%)	27/40 (68%)
Age: mean (SD or range)	48.2
Genotype 1 (any subtype): %
Genotype 1a: %	8%
Genotype 1b: %
Genotype 2 (any): %
Genotype 3 (any): %
Genotype 4 (any): %	92%
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: %	2% (U/S), 0 (F4)
IFN Tx-naive (skip)
IFN treated prev, %	5% (IFN)

SOF/DCV +- RBV (Txp)


Male: n/N (%)	91/125 (73%)
Age: mean (SD or range)	44.5
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	10%
Other or mixed gt_2
Other or mixed gt_3
Other or mixed gt_4	90%
Other or mixed gt_5
Liver cirrhosis: %	2% (U/S), 0 (F4)
IFN Tx-naive (skip)
IFN treated prev, %	8% (IFN)

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.

PrO +- RBV (CKD 4)

	All	Subset
CKD 4-5ND	All (100%)
HD	All (100%)
PD	All (100%)
Transplant	All (100%)

PrO +- RBV (CKD 5HD)

	All	Subset
CKD 4-5ND	All (100%)
HD	All (100%)
PD	All (100%)
Transplant	All (100%)

SOF/DCV +- RBV (Txp)

	All	Subset
CKD 4-5ND	All (100%)
HD	All (100%)
PD	All (100%)
Transplant	All (100%)

Total

	All	Subset
CKD 4-5ND	All (100%)
HD	All (100%)
PD	All (100%)
Transplant	All (100%)

3. Note/Comment

PrO +- RBV (CKD 4)


	Reported data combined with CKD 3 who received SOF/DCV

PrO +- RBV (CKD 5HD)

SOF/DCV +- RBV (Txp)

Total

Outcomes

Type	Domain	Populations	Timepoints
Categorical	SVR12	All Participants	12 (wk post-Tx)
Categorical	SVR24	All Participants	24 (wk post-Tx)
Continuous	eGFR	All Participants	Baseline 12 (wk post-Tx)
Categorical	Acute rejection	All Participants	EOT
Categorical	Dialysis, incident	All Participants	EOT
Categorical	Discontinuation due to AE	All Participants	EOT

Outcome Details

1. Comment/Note

SVR12

SVR24

eGFR

Acute rejection

Dialysis, incident

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:	Incomplete reporting specific to CKD 4

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):	all participants analyzed

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):	Some lack of clarity re: ribavirin dosing

14. ALL_Were the outcomes adequately defined?


Rating
Notes/Comments (add for no):	Except "Rise in SCr" omitted because it was undefined.

15. ALL_Were the harms PRE-DEFINED using standardized or precise definitions


Rating
Notes/Comments (add for no):	AE not reported clearly. Mostly omitted due to lack of sufficient information.

16. Other Bias:


Rating
Notes/Comments:

Results

Categorical

SVR12

All Participants
		Descriptive Statistics				Between Arm Comparisons
		PrO +- RBV (CKD 4)	PrO +- RBV (CKD 5HD)	SOF/DCV +- RBV (Txp)
12 (wk post-Tx)
	Total (N analyzed)				Odds Ratio (OR)
	Events				95% CI low (OR)
	Percentage				95% CI high (OR)
	Note				p value
		Within Arm Comparisons				Net Comparisons
		PrO +- RBV (CKD 4)	PrO +- RBV (CKD 5HD)	SOF/DCV +- RBV (Txp)

SVR24

All Participants
		Descriptive Statistics				Between Arm Comparisons
		PrO +- RBV (CKD 4)	PrO +- RBV (CKD 5HD)	SOF/DCV +- RBV (Txp)
24 (wk post-Tx)
	Total (N analyzed)				Odds Ratio (OR)
	Events				95% CI low (OR)
	Percentage				95% CI high (OR)
	Note				p value
		Within Arm Comparisons				Net Comparisons
		PrO +- RBV (CKD 4)	PrO +- RBV (CKD 5HD)	SOF/DCV +- RBV (Txp)

Acute rejection

All Participants
		Descriptive Statistics				Between Arm Comparisons
		PrO +- RBV (CKD 4)	PrO +- RBV (CKD 5HD)	SOF/DCV +- RBV (Txp)
EOT
	Total (N analyzed)				Odds Ratio (OR)
	Events				95% CI low (OR)
	Percentage				95% CI high (OR)
	Note				p value
		Within Arm Comparisons				Net Comparisons
		PrO +- RBV (CKD 4)	PrO +- RBV (CKD 5HD)	SOF/DCV +- RBV (Txp)

Dialysis, incident

All Participants
		Descriptive Statistics				Between Arm Comparisons
		PrO +- RBV (CKD 4)	PrO +- RBV (CKD 5HD)	SOF/DCV +- RBV (Txp)
EOT
	Total (N analyzed)				Odds Ratio (OR)
	Events				95% CI low (OR)
	Percentage				95% CI high (OR)
	Note				p value
		Within Arm Comparisons				Net Comparisons
		PrO +- RBV (CKD 4)	PrO +- RBV (CKD 5HD)	SOF/DCV +- RBV (Txp)

Discontinuation due to AE

All Participants
		Descriptive Statistics				Between Arm Comparisons
		PrO +- RBV (CKD 4)	PrO +- RBV (CKD 5HD)	SOF/DCV +- RBV (Txp)
EOT
	Total (N analyzed)				Odds Ratio (OR)
	Events				95% CI low (OR)
	Percentage				95% CI high (OR)
	Note				p value
		Within Arm Comparisons				Net Comparisons
		PrO +- RBV (CKD 4)	PrO +- RBV (CKD 5HD)	SOF/DCV +- RBV (Txp)

Continuous

eGFR

All Participants
		Descriptive Statistics				Between Arm Comparisons
		PrO +- RBV (CKD 4)	PrO +- RBV (CKD 5HD)	SOF/DCV +- RBV (Txp)
Baseline
	Total (N analyzed)				Mean Difference (MD)
	Mean				95% CI low (MD)
					95% CI high (MD)
					SD (MD)
					p value (MD)
12 (wk post-Tx)
	Total (N analyzed)				Mean Difference (MD)
	Mean				95% CI low (MD)
					95% CI high (MD)
					SD (MD)
					p value (MD)
		Within Arm Comparisons				Net Comparisons
		PrO +- RBV (CKD 4)	PrO +- RBV (CKD 5HD)	SOF/DCV +- RBV (Txp)
vs.
		Saved!	Saved!	Saved!	Net Mean Difference (NMD)
	p value (MD)	Saved!	Saved!	Saved!	95% CI low (NMD)
					95% CI high (NMD)
					SD (NMD)
					P value (NMD)

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

Design Details

1. Reject Reason

2. Secondary to other article?

3. Study or registry name

4. CKD stage

5. Treatment(s) investigated

6. KQ/Topic

7. KQ/Topic

8. Study design

9. Study design

10. Sample size

11. Country/ies

12. Note/Comment

Arms

Arm Details

1. Regimen

PrO +- RBV (CKD 4)

PrO +- RBV (CKD 5HD)

SOF/DCV +- RBV (Txp)

2. Duration of treatment

PrO +- RBV (CKD 4)

PrO +- RBV (CKD 5HD)

SOF/DCV +- RBV (Txp)

3. (GL 4) Time to start of DAA (relative to Txp)

PrO +- RBV (CKD 4)

PrO +- RBV (CKD 5HD)

SOF/DCV +- RBV (Txp)

4. Comment/Note

PrO +- RBV (CKD 4)

PrO +- RBV (CKD 5HD)

SOF/DCV +- RBV (Txp)

Sample Characteristics

1. Population characteristics

PrO +- RBV (CKD 4)

PrO +- RBV (CKD 5HD)

SOF/DCV +- RBV (Txp)

Total

2. Population

PrO +- RBV (CKD 4)

PrO +- RBV (CKD 5HD)

SOF/DCV +- RBV (Txp)

Total

3. Note/Comment

PrO +- RBV (CKD 4)

PrO +- RBV (CKD 5HD)

SOF/DCV +- RBV (Txp)

Total

Outcomes

Outcome Details

1. Comment/Note

SVR12

SVR24

eGFR

Acute rejection

Dialysis, incident

Discontinuation due to AE

Risk of Bias Assessment

1. RCT only_Random sequence generation

2. RCT only_Allocation concealment

3. RCT only_Blinding of participants

4. ALL_Blinding of outcome assessors

5. ALL_Incomplete outcome data (dropouts, missing data)

6. ALL_Selective Reporting (reporting bias)

7. ALL_Intention-to-treat-analysis

8. ALL_Was selection of participants into the study based on participant characteristics observed AFTER the start of intervention?

9. COMPARATIVE only_Cohorts comparable?

10. COMPARATIVE only_Were potential confounders properly accounted for?

11. ALL_Clear reporting with no discrepancies

12. ALL_Were eligibility criteria clear?

13. ALL_Were interventions adequately described?

14. ALL_Were the outcomes adequately defined?

15. ALL_Were the harms PRE-DEFINED using standardized or precise definitions

16. Other Bias:

Results

Categorical

SVR12

SVR24

Acute rejection

Dialysis, incident