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

doi:10.4254/wjh.v8.i6.331

Advanced Search

BPG is committed to discovery and dissemination of knowledge

Home / Archive / Volume 8, Issue 6

This Article

Academic Content and Language Evaluation of This Article

CrossCheck and Google Search of This Article

Academic Rules and Norms of This Article

Citation of this article

Corresponding Author of This Article

Research Domain of This Article

Article-Type of This Article

Open-Access Policy of This Article

Times Cited Counts in Google of This Article

Number of Hits and Downloads for This Article

Total Article Views (9375)

All Articles published online

The chart showing PDF series, WORD series, HTML series, Figures (1-3) series, Tables (1-5) series.

Item

Count

PDF

405

WORD

335

HTML

3128

Figures (1-3)

291

Tables (1-5)

294

Sum=4453

Featured Article

The chart showing Browse series, Download series.

Item

Count

Browse

485

Download

1056

Sum=1541

Publishing Process of This Article

Item

Count

Browse

1143

Download

2238

Sum=3381

Feb 28, 2016 (publication date) through Feb 24, 2025

Times Cited of This Article

Times Cited (4)

Journal Information of This Article

Publication Name

World Journal of Hepatology

ISSN

1948-5182

Publisher of This Article

Baishideng Publishing Group Inc, 7041 Koll Center Parkway, Suite 160, Pleasanton, CA 94566, USA

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.

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.

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.

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.

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.

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