Data from observational cohorts

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Guidelines for the Screening Care and Treatment of Persons with Chronic Hepatitis C Infection: Updated Version. Geneva: World Health Organization; 2016 Apr.

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This publication is provided for historical reference only and the information may be out of date.

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Guidelines for the Screening Care and Treatment of Persons with Chronic Hepatitis C Infection: Updated Version.

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Appendix 7Data from observational cohorts

Acknowledgements

This document was prepared by Kuniaki Arai and Azumi Ishizaki.

Information on safety, efficacy and acceptability
Regimen: Telaprevir + PEG-Interferon + Ribavirin; TVR + PR

Acceptability

Factor	Comment
Treatment duration	24 or 48 weeks
Injections needed	Yes
Number of doses/day	TVR:3, R:2
Number of pills/dose (morning-noon-evening)	TVR:1-1-1, RBV:2/3-0-3

Safety

		Pooled risk						HCV-TARGET		HEPATHER / HEPAVIH
		GT 1 or 4		GT 2		GT 3		without RBV	with RBV	without RBV		with RBV
		Naive	Exper	Naive	Exper	Naive	Exper	without RBV	with RBV	NC	Cirrhosis	NC	Cirrhosis
All patients	Number	641	650
	Discontinuation rate (%)	9.3	8.3
	Number	641	650
	Serious Adverse Event (%)	7.1	10.2
HIV co-infected patients	Number
	Discontinuation rate (%)
	Serious Adverse Event (%)

Efficacy (SVR-12 %)

		Pooled efficacy		HCV-TARGET				HEPATHER / HEPAVIH
		with RBV		without RBV		with RBV		without RBV		with RBV
		SVR (%)	Evaluated number	SVR-12 (%)	Evaluated number	SVR-12 (%)	Evaluated number	SVR-4 (%)	Evaluated number	SVR-4 (%)	Evaluated number
GT1	Naive_NC	76.5	641
	Naive_C	76.5	641
	Exper_NC	59.4	650
	Exper_C	59.4	650
	HIV coinfected
GT1a	Naive_NC
	Naive_C
	Exper_NC
	Exper_C
	HIV coinfected
GT1b	Naive_NC
	Naive_C
	Exper_NC
	Exper_C
	HIV coinfected
GT2	Naive_NC
	Naive_C
	Exper_NC
	Exper_C
	HIV coinfected
GT3	Naive_NC
	Naive_C
	Exper_NC
	Exper_C
	HIV coinfected
GT4	Naive_NC	76.5	641
	Naive_C	76.5	641
	Exper_NC	59.4	650
	Exper_C	59.4	650
	HIV coinfected
GT5/6/7	Naive_NC
	Naive_C
	Exper_NC
	Exper_C
	HIV coinfected

: GT: genotype; Exper: experienced; Naive_NC: treatment naive and non cirrhosis; Exper_NC: treatment experienced and non cirrhosis; Exper_C: treatment experienced and cirrhosis; NE = No patients with available outcome data; Pooled risk/efficacy of network meta analysis was calculated combined with GT1 and GT4.

Information on safety, efficacy and acceptability
Regimen: Boceprevir + PEG-Interferon + Ribavirin; BOC + PR

Acceptability

Factor	Comment
Treatment duration	48 weeks
Injections needed	Yes
Number of doses/day	BOC:3, RBV:2
Number of pills/dose (morning-noon-evening)	BOC:2-1-1, RBV:2/3-0-3

Safety

		Pooled risk						HCV-TARGET		HEPATHER / HEPAVIH
		GT 1 or 4		GT 2		GT 3		without RBV	with RBV	without RBV		with RBV
		Naive	Exper	Naive	Exper	Naive	Exper	without RBV	with RBV	NC	Cirrhosis	NC	Cirrhosis
All patients	Number	901	457
	Discontinuation rate (%)	13.6	12.1
	Number	901	457
	Serious Adverse Event (%)	10.9	12.2
HIV co-infected patients	Number
	Discontinuation rate (%)
	Serious Adverse Event (%)

Efficacy (SVR-12 %)

		Pooled efficacy		HCV-TARGET				HEPATHER / HEPAVIH
		with RBV		without RBV		with RBV		without RBV		with RBV
		SVR (%)	Evaluated number	SVR-12 (%)	Evaluated number	SVR-12 (%)	Evaluated number	SVR-4 (%)	Evaluated number	SVR-4 (%)	Evaluated number
GT1	Naive_NC	66.4	901
	Naive_C	66.4	901
	Exper_NC	63.1	457
	Exper_C	63.1	457
	HIV coinfected
GT1a	Naive_NC
	Naive_C
	Exper_NC
	Exper_C
	HIV coinfected
GT1b	Naive_NC
	Naive_C
	Exper_NC
	Exper_C
	HIV coinfected
GT2	Naive_NC
	Naive_C
	Exper_NC
	Exper_C
	HIV coinfected
GT3	Naive_NC
	Naive_C
	Exper_NC
	Exper_C
	HIV coinfected
GT4	Naive_NC	66.4	901
	Naive_C	66.4	901
	Exper_NC	63.1	457
	Exper_C	63.1	457
	HIV coinfected
GT5/6/7	Naive_NC
	Naive_C
	Exper_NC
	Exper_C
	HIV coinfected

: GT: genotype; Exper: experienced; Naive_NC: treatment naive and non cirrhosis; Exper_NC: treatment experienced and non cirrhosis; Exper_C: treatment experienced and cirrhosis; NE = No patients with available outcome data; Pooled risk/efficacy of network meta analysis was calculated combined with GT1 and GT4.

Information on safety, efficacy and acceptability
Regimen: Simeprevir + PEG-Interferon + Ribavirin; SMV + PR

Acceptability

Factor	Comment
Treatment duration	24 or 48 weeks
Injections needed	Yes
Number of doses/day	SMV:1, RBV:2
Number of pills/dose (morning-noon-evening)	SMV:1-0-0, RBV:2/3-0-3

Safety

		Pooled risk						HCV-TARGET		HEPATHER / HEPAVIH
		GT 1 or 4		GT 2		GT 3		without RBV	with RBV	without RBV		with RBV
		Naive	Exper	Naive	Exper	Naive	Exper	without RBV	with RBV	NC	Cirrhosis	NC	Cirrhosis
All patients	Number	704	811
	Discontinuation rate (%)	2.1	0.6
	Number	811	918
	Serious Adverse Event (%)	4.9	4.7
HIV co-infected patients	Number
	Discontinuation rate (%)
	Serious Adverse Event (%)

Efficacy (SVR-12 %)

		Pooled efficacy		HCV-TARGET				HEPATHER / HEPAVIH
		with RBV		without RBV		with RBV		without RBV		with RBV
		SVR (%)	Evaluated number	SVR-12 (%)	Evaluated number	SVR-12 (%)	Evaluated number	SVR-4 (%)	Evaluated number	SVR-4 (%)	Evaluated number
GT1	Naive_NC	80.5	686
	Naive_C	80.5	686
	Exper_NC	64.9	830
	Exper_C	64.9	830
	HIV coinfected
GT1a	Naive_NC
	Naive_C
	Exper_NC
	Exper_C
	HIV coinfected
GT1b	Naive_NC
	Naive_C
	Exper_NC
	Exper_C
	HIV coinfected
GT2	Naive_NC
	Naive_C
	Exper_NC
	Exper_C
	HIV coinfected
GT3	Naive_NC
	Naive_C
	Exper_NC
	Exper_C
	HIV coinfected
GT4	Naive_NC	80.5	686
	Naive_C	80.5	686
	Exper_NC	64.9	830
	Exper_C	64.9	830
	HIV coinfected
GT5/6/7	Naive_NC
	Naive_C
	Exper_NC
	Exper_C
	HIV coinfected

: GT: genotype; Exper: experienced; Naive_NC: treatment naive and non cirrhosis; Exper_NC: treatment experienced and non cirrhosis; Exper_C: treatment experienced and cirrhosis; NE = No patients with available outcome data; Pooled risk/efficacy of network meta analysis was calculated combined with GT1 and GT4.

Information on safety, efficacy and acceptability
Regimen: Sofosbuvir + PEG-Interferon + Ribavirin; SOF + PR

Acceptability

Factor	Comment
Treatment duration	12 weeks
Injections needed	Yes
Number of doses/day	SOF:1, RBV:2
Number of pills/dose (morning-noon-evening)	SOF:1-0-0, RBV:2/3-0-3

Safety

		Pooled risk						HCV-TARGET		HEPATHER / HEPAVIH
		GT 1 or 4		GT 2		GT 3		without RBV	with RBV	without RBV		with RBV
		Naive	Exper	Naive	Exper	Naive	Exper	without RBV	with RBV	NC	Cirrhosis	NC	Cirrhosis
All patients	Number	504	NE			36	47		387			88	133
	Discontinuation rate (%)	6.8	NE			0.03	0.0		3.9			6.82	10.53
	Number	504	NE			11	47		387			88	133
	Serious Adverse Event (%)	2.6	NE			0.0	9.4		12.0			4.55	8.27
HIV co-infected patients	Number								15			8	5
	Discontinuation rate (%)								0.0			0	0
	Serious Adverse Event (%)								13.3

Efficacy (SVR-12 %)

		Pooled efficacy		HCV-TARGET				HEPATHER / HEPAVIH
		with RBV		without RBV		with RBV		without RBV		with RBV
		SVR (%)	Evaluated number	SVR-12 (%)	Evaluated number	SVR-12 (%)	Evaluated number	SVR-4 (%)	Evaluated number	SVR-4 (%)	Evaluated number
GT1	Naive_NC	90.2	464			90.4	135			100.0	13
	Naive_C	90.2	464			75.8	33			87.5	16
	Exper_NC	NE	NE			82.3	62			78.9	19
	Exper_C	NE	NE			60.9	64			46.4	28
	HIV coinfected					78.6	14				0
GT1a	Naive_NC					89.9	99			100.0	9
	Naive_C					72.7	22			100.0	5
	Exper_NC					81.8	33			75.0	12
	Exper_C					61.7	47			56.3	16
	HIV coinfected										0
GT1b	Naive_NC					90.6	32			100.0	4
	Naive_C					77.8	9			80.0	10
	Exper_NC					84.2	19			85.7	7
	Exper_C					40.0	10			33.3	12
	HIV coinfected										0
GT2	Naive_NC						0				0
	Naive_C						0				0
	Exper_NC					100.0	1			100.0	1
	Exper_C					100.0	1			100.0	1
	HIV coinfected						0				0
GT3	Naive_NC	93.3	36			100.0	4			100.0	4
	Naive_C	93.3	36			66.7	3			87.5	8
	Exper_NC	88.8	111			66.7	3			88.2	17
	Exper_C	88.8	111			88.9	9			74.3	35
	HIV coinfected						0			100.0	6
GT4	Naive_NC	90.2	464			100.0	6			100.0	1
	Naive_C	90.2	464			100.0	1			60.0	5
	Exper_NC	NE	NE			80.0	10			100.0	9
	Exper_C	NE	NE			66.7	6			68.8	16
	HIV coinfected						0			50.0	2
GT5/6/7	Naive_NC									100.0	1
	Naive_C										0
	Exper_NC										NE
	Exper_C									100.0	4
	HIV coinfected										0

: GT: genotype; Exper: experienced; Naive_NC: treatment naive and non cirrhosis; Exper_NC: treatment experienced and non cirrhosis; Exper_C: treatment experienced and cirrhosis; NE = No patients with available outcome data; Pooled risk/efficacy of network meta analysis was calculated combined with GT1 and GT4; HCV-TARGET: data obtained as of 18 June, 2015; HEPATHER: data obtained as of 2 June, 2015; HEPAVIH: data obtained as of 23 June, 2015.

Information on safety, efficacy and acceptability
Regimen: Sofosbuvir + Ribavirin; SOF + RBV

Acceptability

Factor	Comment
Treatment duration	12 weeks or 24 weeks
Injections needed	No
Number of doses/day	SOF:1, RBV:2
Number of pills/dose (morning-noon-evening)	SOF:1-0-0, RBV:2/3-0-3

Safety

		Pooled risk						HCV-TARGET		HEPATHER / HEPAVIH
		GT 1 or 4		GT 2		GT 3		without RBV	with RBV	without RBV		with RBV
		Naive	Exper	Naive	Exper	Naive	Exper	without RBV	with RBV	NC	Cirrhosis	NC	Cirrhosis
All patients	Number	411	69	141	237/47^*	250	49		772			122	191
	Discontinuation rate (%)	1.1	4.2	0.01	0.01/0.05^*	0.01	4.95		6.7			6.56	13.09
	Number	268	69	141	237/41^*	250	240		772			122	191
	Serious Adverse Event (%)	3.2	12.7	0.02	0.01/0.03^*	0.04	4.35		9.1			5.74	13.09
HIV co-infected patients	Number								19			9	23
	Discontinuation rate (%)								0.0			0	9
	Serious Adverse Event (%)								10.5

Efficacy (SVR-12 %)

		Pooled efficacy		HCV-TARGET				HEPATHER / HEPAVIH
		with RBV		without RBV		with RBV		without RBV		with RBV
		SVR (%)	Evaluated number	SVR-12 (%)	Evaluated number	SVR-12 (%)	Evaluated number	SVR-4 (%)	Evaluated number	SVR-4 (%)	Evaluated number
GT1	Naive_NC	77.3	39			77.8	9			100.0	4
	Naive_C	77.3	39			55.6	27			80.0	10
	Exper_NC	75.5	49			57.1	14			75.0	12
	Exper_C	75.5	49			44.9	49			46.2	26
	HIV coinfected					55.6	9			83.0	6
GT1a	Naive_NC					75.0	8			100.0	1
	Naive_C					55.6	18			75.0	4
	Exper_NC					60.0	10			60.0	5
	Exper_C					48.3	29			50.0	6
	HIV coinfected									67.0	3
GT1b	Naive_NC					100.0	1			100.0	3
	Naive_C					57.1	7			83.3	6
	Exper_NC						2			80.0	5
	Exper_C					35.3	17			46.7	15
	HIV coinfected									100.0	3
GT2	Naive_NC	94.5	346			90.4	188			90.0	20
	Naive_C	94.5	346			70.2	47			91.7	12
	Exper_NC	91.0/88.0^*	140/30^*			85.2	54			93.5	31
	Exper_C	91.0/88.0^*	140/30^*			81.0	58			70.0	30
	HIV coinfected					83.3	6			100.0	3
GT3	Naive_NC	92.2	193			80.5	41			100.0	4
	Naive_C	92.2	193			60.6	33			90.9	11
	Exper_NC	83	217			80.8	26			90.0	10
	Exper_C	83	217			40.7	59			51.1	45
	HIV coinfected					66.7	3			100.0	5
GT4	Naive_NC	77.3	390			66.7	3			100.0	3
	Naive_C	77.3	390				1			33.3	3
	Exper_NC	75.5	49			66.7	3			100.0	8
	Exper_C	75.5	49			40.0	5			41.2	17
	HIV coinfected									83.0	6
GT5/6/7	Naive_NC										0
	Naive_C										0
	Exper_NC										0
	Exper_C										NE
	HIV coinfected										0

: GT: genotype; Exper: experienced; Naive_NC: treatment naive and non cirrhosis; Exper_NC: treatment experienced and non cirrhosis; Exper_C: treatment experienced and cirrhosis; NE = No patients with available outcome data;
*: Data for: treatment duration 12 weeks/ 24 weeks; Pooled risk/efficacy of network meta analysis was calculated combined with GT1 and GT4; HCV-TARGET: data obtained as of 18 June, 2015; HEPATHER: data obtained as of 2 June, 2015; HEPAVIH: data obtained as of 23 June, 2015.

Information on safety, efficacy and acceptability
Regimen: Simeprevir + Sofosbuvir; SMV + SOF

Acceptability

Factor	Comment
Treatment duration	12 or 24 weeks
Injections needed	No
Number of doses/day	SOF:1, SMV:1, RBV:2
Number of pills/dose (morning-noon-evening)	SOF:1-0-0, SMV:1-0-0, RBV:2/3-0-3

Safety

		Pooled risk						HCV-TARGET		HEPATHER / HEPAVIH
		GT 1 or 4		GT 2		GT 3		without RBV	with RBV	without RBV		with RBV
		Naive	Exper	Naive	Exper	Naive	Exper	without RBV	with RBV	NC	Cirrhosis	NC	Cirrhosis
All patients	Number	87	167					910	275	162	206	17	45
	Discontinuation rate (%)	1.5	1.5					2.7	2.9	2.47	1.94	5.88	17.78
	Number	87	167					910	275	162	206	17	45
	Serious Adverse Event (%)	2.2	0.8					5.6	8.4	1.23	7.28	5.88	8.89
HIV co-infected patients	Number							11	8	1	8	2	0
	Discontinuation rate (%)							0.0	0.0	0	0	0
	Serious Adverse Event (%)							9.1	12.5

Efficacy (SVR-12 %)

		Pooled efficacy		HCV-TARGET				HEPATHER / HEPAVIH
		with RBV		without RBV		with RBV		without RBV		with RBV
		SVR (%)	Evaluated number	SVR-12 (%)	Evaluated number	SVR-12 (%)	Evaluated number	SVR-4 (%)	Evaluated number	SVR-4 (%)	Evaluated number
GT1	Naive_NC	97.3	40	92.7	136	88.9	27	97.3	37	100.0	1
	Naive_C	97.3	40	84.0	175	84.0	50	92.9	28	100.0	7
	Exper_NC	94	127	90.7	182	82.9	41	94.9	78	100.0	9
	Exper_C	94	127	80.2	278	78.7	94	88.5	113	85.0	20
	HIV coinfected			87.5	8	80.0	5	50.0	2		0
GT1a	Naive_NC			90.2	82	90.0	20	100.0	11		0
	Naive_C			84.4	109	84.2	38	100.0	9	100.0	4
	Exper_NC			89.6	96	74.1	27	88.9	27	100.0	5
	Exper_C			76.4	157	81.8	66	83.8	37	75.0	8
	HIV coinfected							50.0	2		0
GT1b	Naive_NC			97.7	43	100.0	4	95.8	24	100.0	1
	Naive_C			86.7	45	100.0	5	88.9	18	100.0	2
	Exper_NC			95.4	65	100.0	9	97.9	47	100.0	4
	Exper_C			84.6	91	68.8	16	90.4	73	90.9	11
	HIV coinfected								0		0
GT2	Naive_NC				0		0		0		0
	Naive_C				0		0		0		0
	Exper_NC				0		0		0		0
	Exper_C				0	100.0	1		NE	100.0	1
	HIV coinfected				0		0		0		0
GT3	Naive_NC				0		0		0	100.0	1
	Naive_C				0		0		0		0
	Exper_NC				0		0		0		0
	Exper_C				0		0	0.0	2		0
	HIV coinfected				0		0		0		0
GT4	Naive_NC	97.3	40	100.0	5		0	85.7	7	100.0	1
	Naive_C	97.3	40	66.7	3	100.0	1	100.0	8	100.0	2
	Exper_NC	94	127	100.0	3	100.0	1	94.1	17	100.0	5
	Exper_C	94	127	100.0	1	100.0	2	88.9	36	100.0	11
	HIV coinfected				0	100.0	1		0	100.0	2
GT5/6/7	Naive_NC								0		0
	Naive_C								0		0
	Exper_NC								0		0
	Exper_C							100.0	1		0
	HIV coinfected								0		0

: GT: genotype; Exper: experienced; Naive_NC: treatment naive and non cirrhosis; Exper_NC: treatment experienced and non cirrhosis; Exper_C: treatment experienced and cirrhosis; NE = No patients with available outcome data; Pooled risk/efficacy of network meta analysis was calculated combined with GT1 and GT4; HCV-TARGET: data obtained as of 18 June, 2015; HEPATHER: data obtained as of 2 June, 2015; HEPAVIH: data obtained as of 23 June, 2015.

Information on safety, efficacy and acceptability
Regimen: Ledipasvir + Sofosbuvir; LDV + SOF

Acceptability

Factor	Comment
Treatment duration	12 or 24 weeks
Injections needed	No
Number of doses/day	Harvoni:1, RBV:2
Number of pills/dose (morning-noon-evening)	Harvoni:1-0-0, RBV:2/3-0-3

Safety

		Pooled risk						HCV-TARGET		HEPATHER / HEPAVIH
		GT 1 or 4		GT 2		GT 3		without RBV	with RBV	without RBV		with RBV
		Naive	Exper	Naive	Exper	Naive	Exper	without RBV	with RBV	NC	Cirrhosis	NC	Cirrhosis
All patients	Number	1122	495					1528	222	1	1	0	0
	Discontinuation rate (%)	0.2	0.0					0.8	0.0	0	0
	Number	1122	495					1528	222	1	1	0	0
	Serious Adverse Event (%)	2.2	2.9					2.5	2.3	0	0
HIV co-infected patients	Number							53	8	14	7	0	3
	Discontinuation rate (%)							1.9	0.0	0	0		0
	Serious Adverse Event (%)							0.0	0.0

Efficacy (SVR-12 %)

		Pooled efficacy		HCV-TARGET				HEPATHER / HEPAVIH
		with RBV		without RBV		with RBV		without RBV		with RBV
		SVR (%)	Evaluated number	SVR-12 (%)	Evaluated number	SVR-12 (%)	Evaluated number	SVR-4 (%)	Evaluated number	SVR-4 (%)	Evaluated number
GT1	Naive_NC	97.7	1028	91.1	79		NE		NE		0
	Naive_C	97.7	1028	78.8	33	100.0	1		NE		0
	Exper_NC	97.9	412	94.1	34	100.0	4		0		0
	Exper_C	97.9	412	100.0	9	100.0	1		0		0
	HIV coinfected			83.3	6		NE		0	0.0	1
GT1a	Naive_NC			89.1	46		NE		0		0
	Naive_C			84.6	26	100.0	1		NE		0
	Exper_NC			94.7	19	100.0	4		0		0
	Exper_C			100.0	5		NE		0		0
	HIV coinfected								0	0.0	1
GT1b	Naive_NC			91.7	24		NE		NE		0
	Naive_C			40.0	5		NE		0		0
	Exper_NC			91.7	12		NE		0		0
	Exper_C			100.0	4	100.0	1		0		0
	HIV coinfected								0		0
GT2	Naive_NC				0		0		0		0
	Naive_C				0		0		0		0
	Exper_NC				0		0		0		0
	Exper_C				0		0		0		0
	HIV coinfected				0		0		0		0
GT3	Naive_NC				NE		NE		0		0
	Naive_C				NE		NE		0		0
	Exper_NC				0		NE		0		0
	Exper_C				0		NE		0		0
	HIV coinfected				0		0		0		0
GT4	Naive_NC	76.5	641		NE		NE		0		0
	Naive_C	76.5	641		NE		0		0		0
	Exper_NC	59.4	650		NE		NE		0		0
	Exper_C	59.4	650		NE		0		0		0
	HIV coinfected				0		0		0		0
GT5/6/7	Naive_NC								0		0
	Naive_C								0		0
	Exper_NC								0		0
	Exper_C								0		0
	HIV coinfected								0		0

: GT: genotype; Exper: experienced; Naive_NC: treatment naive and non cirrhosis; Exper_NC: treatment experienced and non cirrhosis; Exper_C: treatment experienced and cirrhosis; NE = No patients with available outcome data; Pooled risk/efficacy of network meta analysis was calculated combined with GT1 and GT4; HCV-TARGET: data obtained as of 18 June, 2015; HEPATHER: data obtained as of 2 June, 2015; HEPAVIH: data obtained as of 23 June, 2015.

Information on safety, efficacy and acceptability
Regimen: Daclatasvir + Sofosbuvir; DCV + SOF

Acceptability

Factor	Comment
Treatment duration	12 weeks or 24 weeks
Injections needed	No
Number of doses/day	SOF:1, DCV:1, RBV:2
Number of pills/dose (morning-noon-evening)	SOF:1-0-0, DCV:1-0-0, RBV:2/3-0-3

Safety

		Pooled risk						HCV-TARGET		HEPATHER / HEPAVIH
		GT 1 or 4		GT 2		GT 3		without RBV	with RBV	without RBV		with RBV
		Naive	Exper	Naive	Exper	Naive	Exper	without RBV	with RBV	NC	Cirrhosis	NC	Cirrhosis
All patients	Number	212	93	NE	NE	101/14^*	51	29	33	234	580	67	203
	Discontinuation rate (%)	0.1	0.0	NE	NE	0.0/0.0^*	0	6.9	12.1	0.43	4.66	20.9	15.76
	Number	183	93	NE	NE	152	152	29	33	234	580	67	203
	Serious Adverse Event (%)	0.9	3.2	NE	NE	0.01	0.01	13.8	18.2	3.42	9.31	5.97	13.3
HIV co-infected patients	Number							0	0	32	80	3	13
	Discontinuation rate (%)									3	4	33	0
	Serious Adverse Event (%)

Efficacy (SVR-12 %)

		Pooled efficacy		HCV-TARGET				HEPATHER / HEPAVIH
		with RBV		without RBV		with RBV		without RBV		with RBV
		SVR (%)	Evaluated number	SVR-12 (%)	Evaluated number	SVR-12 (%)	Evaluated number	SVR-4 (%)	Evaluated number	SVR-4 (%)	Evaluated number
GT1	Naive_NC	98.4	195		0		0	100.0	26	100.0	3
	Naive_C	98.4	195		NE		1	86.0	50	100.0	6
	Exper_NC	98.1	87		NE	100.0	1	97.3	110	97.3	37
	Exper_C	98.1	87		NE	33.3	3	94.2	308	95.2	105
	HIV coinfected				0		0	94.0	36	71.0	7
GT1a	Naive_NC				0		0	100.0	7	100.0	2
	Naive_C				0		NE	95.2	21	100.0	2
	Exper_NC				NE		NE	98.0	50	100.0	25
	Exper_C				0		NE	94.6	149	94.7	57
	HIV coinfected				0		0	92.0	25	60.0	5
GT1b	Naive_NC				0		0	100.0	17	100.0	1
	Naive_C				NE		1	78.6	28	100.0	4
	Exper_NC				0	100.0	1	96.1	51	91.7	12
	Exper_C				NE	33.3	3	93.6	141	95.5	44
	HIV coinfected				0		0	100.0	7	100.0	2
GT2	Naive_NC	100/100^*	11/8^*		0		0		NE		0
	Naive_C	100/100^*	11/8^*		0		0		NE		0
	Exper_NC	100/80.0^*	2/5^*		0		0	0.0	1		0
	Exper_C	100/80.0^*	2/5^*		0	100.0	1	66.7	3	100.0	2
	HIV coinfected				0		0		0		0
GT3	Naive_NC	90.1/100^*	101/14^*		NE		0	100.0	2	100.0	1
	Naive_C	90.1/100^*	101/14^*		0		1	83.3	6	75.0	4
	Exper_NC	87.7/91.5^**	55/67^**		NE		0	88.9	9	100.0	3
	Exper_C	87.7/91.5^**	55/67^**		0	100.0	1	73.7	38	89.5	19
	HIV coinfected				0		0	100.0	4	100.0	3
GT4	Naive_NC	98.4	195		NE		0	100.0	2	100.0	1
	Naive_C	98.4	195		0		0	100.0	4	100.0	1
	Exper_NC	98.1	87		0		NE	87.5	8	100.0	4
	Exper_C	98.1	87		0		0	90.3	31	100.0	16
	HIV coinfected				0		0	90.0	10		0
GT5/6/7	Naive_NC								NE		0
	Naive_C								NE		0
	Exper_NC							100.0	2		0
	Exper_C							100.0	8	100.0	1
	HIV coinfected								0		0

: GT: genotype; Exper: experienced; Naive_NC: treatment naive and non cirrhosis; Exper_NC: treatment experienced and non cirrhosis; Exper_C: treatment experienced and cirrhosis; NE = No patients with available outcome data;
*: Data for: treatment duration 12 weeks/ 24 weeks;
**: Data for: without rivabirin/ with ribavirin; Pooled risk/efficacy of network meta analysis was calculated combined with GT1 and GT4; HCV-TARGET: data obtained as of 18 June, 2015; HEPATHER: data obtained as of 2 June, 2015; HEPAVIH: data obtained as of 23 June, 2015.

Information on safety, efficacy and acceptability
Regimen: Daclatasvir + Asunaprevir; DCV + ASV

Acceptability

Factor	Comment
Treatment duration	24 weeks
Injections needed	No
Number of doses/day	DCV:1, ASV:2
Number of pills/dose (morning-noon-evening)	DCV:1-0-0, ASV:1-0-1

Safety

		Pooled risk						HCV-TARGET		HEPATHER / HEPAVIH
		GT 1 or 4		GT 2		GT 3		without RBV	with RBV	without RBV		with RBV
		Naive	Exper	Naive	Exper	Naive	Exper	without RBV	with RBV	NC	Cirrhosis	NC	Cirrhosis
All patients	Number	265	233							0	2
	Discontinuation rate (%)	5	4.66								0
	Number	265	233							0	2
	Serious Adverse Event (%)	8	5.45								100
HIV co-infected patients	Number
	Discontinuation rate (%)
	Serious Adverse Event (%)

Efficacy (SVR-12 %)

		Pooled efficacy		HCV-TARGET				HEPATHER / HEPAVIH
		with RBV		without RBV		with RBV		without RBV		with RBV
		SVR (%)	Evaluated number	SVR-12 (%)	Evaluated number	SVR-12 (%)	Evaluated number	SVR-4 (%)	Evaluated number	SVR-4 (%)	Evaluated number
GT1	Naive_NC	83.1	265						0
	Naive_C	83.1	265						0
	Exper_NC	62.9	233						0
	Exper_C	62.9	233					100.0	2
	HIV coinfected								0
GT1a	Naive_NC								0
	Naive_C								0
	Exper_NC								0
	Exper_C								0
	HIV coinfected								0
GT1b	Naive_NC								0
	Naive_C								0
	Exper_NC								0
	Exper_C							100.0	2
	HIV coinfected								0
GT2	Naive_NC								0
	Naive_C								0
	Exper_NC								0
	Exper_C								0
	HIV coinfected								0
GT3	Naive_NC								0
	Naive_C								0
	Exper_NC								0
	Exper_C								0
	HIV coinfected								0
GT4	Naive_NC	83.1	265						0
	Naive_C	83.1	265						0
	Exper_NC	62.9	233						0
	Exper_C	62.9	233						0
	HIV coinfected								0
GT5/6/7	Naive_NC								0
	Naive_C								0
	Exper_NC								0
	Exper_C								0
	HIV coinfected								0

: GT: genotype; Exper: experienced; Naive_NC: treatment naive and non cirrhosis; Exper_NC: treatment experienced and non cirrhosis; Exper_C: treatment experienced and cirrhosis; NE = No patients with available outcome data; Pooled risk/efficacy of network meta analysis was calculated combined with GT1 and GT4; HEPATHER: data obtained as of 2 June, 2015; HEPAVIH: data obtained as of 23 June, 2015.

Information on safety, efficacy and acceptability
Regimen: Ombitasvir + Paritaprevir/Ritonavir (+ Dasabuvir); OMB + PAR/r (+ DAS)

Acceptability

Factor	Comment
Treatment duration	12 or 24 weeks
Injections needed	No
Number of doses/day	Viekira Pak: 2, RBV:2
Number of pills/dose (morning-noon-evening)	Viekira Pak: 3-0-1, RBV:2/3-0-3

Safety

		Pooled risk						HCV-TARGET		HEPATHER / HEPAVIH
		GT 1 or 4		GT 2		GT 3		without RBV	with RBV	without RBV		with RBV
		Naive	Exper	Naive	Exper	Naive	Exper	without RBV	with RBV	NC	Cirrhosis	NC	Cirrhosis
All patients	Number	1619	912					28	101	0	0	0	0
	Discontinuation rate (%)	0.4	1.0					0.0	2.0
	Number	1619	912					28	101	0	0	0	0
	Serious Adverse Event (%)	2.2	2.7					0(?)	3.0
HIV co-infected patients	Number							0	2
	Discontinuation rate (%)								0.0
	Serious Adverse Event (%)								0.0

Efficacy (SVR-12 %)

		Pooled efficacy		HCV-TARGET				HEPATHER / HEPAVIH
		with RBV		without RBV		with RBV		without RBV		with RBV
		SVR (%)	Evaluated number	SVR-12 (%)	Evaluated number	SVR-12 (%)	Evaluated number	SVR-4 (%)	Evaluated number	SVR-4 (%)	Evaluated number
GT1	Naive_NC	97.0	1399		NE		NE		0		0
	Naive_C	97.0	1399		NE		NE		0		0
	Exper_NC	97.3	745		NE		NE		0		0
	Exper_C	97.3	745		NE		NE		0		0
	HIV coinfected				0		NE		0		0
GT1a	Naive_NC				NE		NE		0		0
	Naive_C				0		NE		0		0
	Exper_NC				NE		NE		0		0
	Exper_C				NE		NE		0		0
	HIV coinfected								0		0
GT1b	Naive_NC				NE		NE		0		0
	Naive_C				NE		NE		0		0
	Exper_NC				NE		NE		0		0
	Exper_C				NE		NE		0		0
	HIV coinfected								0		0
GT2	Naive_NC				0		NE		0		0
	Naive_C				0		0		0		0
	Exper_NC				0		0		0		0
	Exper_C				0		0		0		0
	HIV coinfected				0		0		0		0
GT3	Naive_NC				0		0		0		0
	Naive_C				0		0		0		0
	Exper_NC				0		0		0		0
	Exper_C				0		0		0		0
	HIV coinfected				0		0		0		0
GT4	Naive_NC	97.0	1399		0		NE		0		0
	Naive_C	97.0	1399		0		0		0		0
	Exper_NC	97.3	745		0		0		0		0
	Exper_C	97.3	745		0		0		0		0
	HIV coinfected				0		0		0		0
GT5/6/7	Naive_NC								0		0
	Naive_C								0		0
	Exper_NC								0		0
	Exper_C								0		0
	HIV coinfected								0		0

: GT: genotype; Exper: experienced; Naive_NC: treatment naive and non cirrhosis; Exper_NC: treatment experienced and non cirrhosis; Exper_C: treatment experienced and cirrhosis; NE = No patients with available outcome data; Pooled risk/efficacy of network meta analysis was calculated combined with GT1 and GT4; HCV-TARGET: data obtained as of 18 June, 2015; HEPATHER: data obtained as of 2 June, 2015; HEPAVIH: data obtained as of 23 June, 2015.

Information on availability as of 25th June, 2015

Availability

DAA	SMV	SOF (Sovaldi)	SOF+LDV (Harvoni)	DCV	DCV+ASV	OMB+PAR/r+DAS (Viekira Pak)
Number of countries with regulatory approval	55	? (7 in the developing world)	? (1 in the developing world)		1?	48
*Countries in MIC*	10					4
*Countries in LIC*	0					0
Number of countries with submit	26	? (12 in the developing world)	? (39 in the developing world)			25
Number of countries with generic agreements		91	91	90		None?
Price in HIC
Price in MIC
Price in LIC
Drug-drug interaction (medicine which should not be co-administered; Reference from EASL Guideline 2015)	Efavirenz, Etravirine, Nevirapine, Atazanavir, Darunavir, Fosamprenavir, Lopinavir, Saquinavir, Elvitegravir/cobicistat (HIV antiretorovirals) Cyclosporine (immunosuppressants)	Aminodarone (antiarrythmics)	Aminodarone (antiarrythmics) Rosubastatin (lipid lowering drugs)	Aminodarone (antiarrythmics)	Verapamil (antiarrythmics) Diltiazem (hypertension and heart failure agents), Efavirenz, Etravirine, Nevirapine, Lopinavir, Ritonavir, Atazanavir, Darunavir, Fosamprenavir, Lopinavir, Saquinavir, Nelfinavir, Indinavir (HIV antiretorovirals), Cyclosporin (immunosuppressants) [Rerefence from drug information in Japan]	Aminodarone (antiarrythmics), Aliskiren (hypertension and heart failure agents), Quetiapine (anti-psychotics), Atorvastatin, Gemfibrozil, Lovastatin, Simvastatin (lipid lowering drugs), Efavirenz, Etravirine, Nevirapine, Lopinavir, Saquinavir, Elvitegravir/cobicistat (HIV antiretorovirals), Everolimus (immunosuppressants)

: HIC: high income country; MIC: middle income country; LIC: low income count

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Guidelines for the Screening Care and Treatment of Persons with Chronic Hepatitis C Infection: Updated Version. Geneva: World Health Organization; 2016 Apr. Appendix 7, Data from observational cohorts.
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Data from observational cohorts - Guidelines for the Screening Care and Treatmen...
Data from observational cohorts - Guidelines for the Screening Care and Treatment of Persons with Chronic Hepatitis C Infection
RECOMMENDATIONS ON CARE OF PEOPLE INFECTED WITH HCV - Guidelines for the Screeni...
RECOMMENDATIONS ON CARE OF PEOPLE INFECTED WITH HCV - Guidelines for the Screening Care and Treatment of Persons with Chronic Hepatitis C Infection
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Guidelines for the Screening Care and Treatment of Persons with Chronic Hepatitis C Infection: Updated Version.

Appendix 7Data from observational cohorts

Acknowledgements

Information on safety, efficacy and acceptabilityRegimen: Telaprevir + PEG-Interferon + Ribavirin; TVR + PR

Acceptability

Safety

Efficacy (SVR-12 %)

Information on safety, efficacy and acceptabilityRegimen: Boceprevir + PEG-Interferon + Ribavirin; BOC + PR

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Information on safety, efficacy and acceptabilityRegimen: Simeprevir + PEG-Interferon + Ribavirin; SMV + PR

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Efficacy (SVR-12 %)

Information on safety, efficacy and acceptabilityRegimen: Sofosbuvir + PEG-Interferon + Ribavirin; SOF + PR

Acceptability

Safety

Efficacy (SVR-12 %)

Information on safety, efficacy and acceptabilityRegimen: Sofosbuvir + Ribavirin; SOF + RBV

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Efficacy (SVR-12 %)

Information on safety, efficacy and acceptabilityRegimen: Simeprevir + Sofosbuvir; SMV + SOF

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Information on safety, efficacy and acceptabilityRegimen: Ledipasvir + Sofosbuvir; LDV + SOF

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Efficacy (SVR-12 %)

Information on safety, efficacy and acceptabilityRegimen: Daclatasvir + Sofosbuvir; DCV + SOF

Acceptability

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Efficacy (SVR-12 %)

Information on safety, efficacy and acceptabilityRegimen: Daclatasvir + Asunaprevir; DCV + ASV

Acceptability

Safety

Efficacy (SVR-12 %)

Information on safety, efficacy and acceptabilityRegimen: Ombitasvir + Paritaprevir/Ritonavir (+ Dasabuvir); OMB + PAR/r (+ DAS)

Acceptability

Safety

Efficacy (SVR-12 %)

Information on availability as of 25th June, 2015

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