Boceprevir plus peginterferon/ribavirin for treatment of chronic hepatitis C in Russia

doi:10.4254/wjh.v8.i6.331

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World Journal of Hepatology

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1948-5182

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Randomized Controlled Trial

World J Hepatol. Feb 28, 2016; 8(6): 331-339
Published online Feb 28, 2016. doi: 10.4254/wjh.v8.i6.331

Table 1 Patient demographics n (%)

	Boceprevir plus PR (n = 159)	PR (n = 78)
Sex
Male	94 (59.1)	45 (57.7)
Female	65 (40.9)	33 (42.3)
Age (yr), mean (SD)	38.6 (9.8)	38.1 (10.0)
Race
White	158 (99.4)	77 (98.7)
Asian	1 (0.6)	1 (1.3)
Ethnicity
Not Hispanic or Latino	159 (100)	78 (100)
Weight (kg), mean (SD)	78.1 (16.6)	78.5 (16.8)
BMI (kg/m²), mean (SD)	25.9 (4.2)	26.0 (4.4)
Previous treatment
Naive	97 (61.0)	48 (61.5)
Experienced	62 (39.0)	30 (38.5)
IL28B genotype
CC allele	22 (13.8)	11 (14.1)
Non-CC allele	137 (86.2)	67 (85.9)
HCV genotype
GT1a	4 (2.5)	0 (0)
GT1b	155 (97.5)	78 (100)
Baseline HCV RNA
≤ 800000 IU/mL	89 (56.0)	53 (67.9)
> 800000 IU/mL	70 (44.0)	25 (32.1)
Hemoglobin (g/dL), mean (SD)	15.0 (1.5)	14.9 (1.5)
Liver histology
Cirrhosis	7 (4.4)	2 (2.6)
No cirrhosis	152 (95.6)	76 (97.4)

GT: Genotype; HCV: Hepatitis C virus; PR: Peginterferon/ribavirin; SD: Standard deviation; BMI: Body mass index; IL28B: Interleukin-28B.

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Table 2 Sustained virologic response by previous treatment, interleukin-28B genotype, and on-treatment virologic response n (%)

	Boceprevir plus PR (n = 159)	PR (n = 78)
Treatment naive	76/97 (78.4)	27/48 (56.3)
Treatment experienced	43/62 (69.4)	9/30 (30.0)
Null responder	8/17 (47.1)	1/6 (16.7)
Partial responder	5/8 (62.5)	1/4 (25.0)
Relapser	30/37 (81.1)	7/20 (35.0)
Treatment naive
IL28B CC genotype	19/20 (95.0)	11/11 (100.0)
IL28B non-CC genotype	57/77 (74.0)	16/37 (43.2)
Treatment experienced
IL28B CC genotype	2/2 (100.0)	0/0
IL28B non-CC genotype	41/60 (68.3)	9/30 (30.0)
SVR according to baseline HCV RNA
All patients
≤ 800000 IU/mL	71/89 (79.8)	25/53 (47.2)
> 800000 IU/mL	48/70 (68.8)	11/25 (44.0)
Treatment naive
≤ 800000 IU/mL	45/52 (86.5)	16/27 (59.3)
> 800000 IU/mL	31/45 (68.9)	11/21 (52.4)
Treatment experienced
≤ 800000 IU/mL	26/37 (70.3)	9/26 (34.6)
> 800000 IU/mL	17/25 (68.0)	0/4 (0)
SVR according to TW4 response
TW4 < 1 log drop	20/43 (46.5)	0/22 (0)
TW4 ≥ 1 log drop	75/90 (83.3)	26/45 (57.8)
TW4 undetectable	23/23 (100)	10/10 (100)
Missing	1/3	0/1
SVR according to TW8 response
TW8 undetectable	115/139 (82.7)	29/33 (87.9)
TW8 detectable	4/16 (25)	7/44 (15.9)
Missing	0/4	0/1
SVR according to presence of anemia
Yes	47/66 (71.2)	6/11 (54.5)
No	72/93 (77.4)	30/67 (44.8)
SVR according to EPO use
Yes	10/15 (66.7)	3/3 (100)
No	109/144 (75.7)	33/75 (44)
SVR according to ribavirin dose reduction
Yes	46/67 (68.7)	12/17 (70.6)
No	73/92 (79.4)	24/61 (39.3)

SVR is defined as the virologic response at follow-up week 24. If a patient had missing data at and after the follow-up week 24 window and had undetectable HCV RNA at follow-up week 12, the patient was considered a sustained virologic responder. EPO: Erythropoietin; HCV: Hepatitis C virus; SVR: Sustained virologic response; TW: Treatment week; PR: Peginterferon/ribavirin; IL28B: Interleukin-28B.

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Table 3 Sustained virologic response at follow-up week 24 in the crossover group n (%)

	SVR
Total	19/27 (70.4)
TN TW12 failure (< 2 log decline HCV RNA)	8/11 (72.7)
TE TW12 failure (detectable HCV RNA)	11/16 (68.8)
TN TW24 failure (detectable HCV RNA)	0/0

HCV: Hepatitis C virus; SVR: Sustained virologic response; TE: Treatment-experienced; TN: Treatment-naive; TW: Treatment week.

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Table 4 Adverse events (≥ 20% in any treatment arm) n (%)

	Boceprevir plus PR (n = 159)	PR (n = 78)
Any AE	155 (97.5)	71 (91.0)
Neutropenia	84 (52.8)	31 (41.0)
Pyrexia	77 (48.4)	36 (46.2)
Anemia	75 (47.2)	19 (24.4)
Leukopenia	62 (39.0)	25 (32.1)
Dysgeusia	59 (37.1)	3 (3.8)
Asthenia	44 (27.7)	23 (29.5)
Headache	43 (27.0)	25 (32.1)
Influenza-like illness	39 (24.5)	14 (17.9)
Nausea	39 (24.5)	9 (11.5)
Anemia
8.5-10 g/dL	56 (35.2)	9 (11.5)
< 8.5 g/dL	10 (6.3)	2 (2.6)
Ribavirin dose reduction	65 (40.9)	14 (17.9)
EPO use	15 (9.4)	3 (3.8)
Serious AE	17 (10.7)	9 (11.5)
Discontinued because of an AE	7 (4.4)	2 (2.6)
Dose modification due to an AE	89 (56.0)	26 (33.3)

AE: Adverse event; EPO: Erythropoietin; PR: Peginterferon/ribavirin.

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Table 5 Comparison of virologic response rates between Russian patients and western patients receiving boceprevir-based triple therapy in the serine protease inhibitor therapy 2 and retreatment with hepatitis C virus serine protease inhibitor boceprevir and pegIntron/rebetol 2 studies n (%)

	Russian patients		SPRINT-2		RESPOND-2
	RGT of BOC	PR	RGT of BOC	PR	RGT of BOC	PR
TN
EOT	89/97 (91.8)	33/48 (68.8)	277/366 (76)	191/363 (53)	-	-
SVR	76/97 (78.4)	27/48 (56.3)	242/366 (66)	137/363 (38)	-	-
Relapse	13/89 (14.6)	6/33 (18.2)	24/265 (9)	39/176 (22)	-	-
TE
EOT	50/62 (80.6)	13/30 (43.3)	-	-	114/162 (70.4)	25/80 (31)
SVR	43/62 (69.4)	9/30 (30)	-	-	107/161 (66)	17/80 (21)
Relapse	7/48 (14.6)	3/12 (25.0)	-	-	14/121 (12)	8/25 (32)

BOC: Boceprevir; EOT: End of treatment response; PR: Peginterferon/ribavirin; RESPOND-2: Retreatment with hepatitis C virus serine protease inhibitor boceprevir and pegIntron/rebetol 2 study; RGT: Response-guided therapy; SPRINT-2: Serine protease inhibitor therapy 2 study; SVR: Sustained virologic response; TE: Treatment experienced; TN: Treatment naive.

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Citation: Isakov V, Nikitin I, Chulanov V, Ogurtsov P, Lukyanova E, Long J, Wahl J, Helmond FA, The P08160 Trial Investigators. Boceprevir plus peginterferon/ribavirin for treatment of chronic hepatitis C in Russia. World J Hepatol 2016; 8(6): 331-339
URL: https://www.wjgnet.com/1948-5182/full/v8/i6/331.htm
DOI: https://dx.doi.org/10.4254/wjh.v8.i6.331