Efficacy and safety of ledipasvir/sofosbuvir in liver fibrosis patients with hepatitis C virus and human immunodeficiency virus coinfection

doi:10.3877/cma.j.issn.1674-1358.2018.05.013

Abstract

Abstract:

Objective

To investigate the efficacy and safety of redeepavir (LDV)-sofebutavir (SOF) in the treatment of liver fibrosis patients with hepatitis C virus (HCV) and human immunodeficiency virus (HIV) coinfection.

Methods

From March 2014 to June 2015, total of 60 patients with HCV/HIV coinfection were divided into two groups: fibrosis group (30 cases) and non-fibrosis group (30 cases). Patients in fibrosis group and non-fibrosis group were treated with LDV/SOF fixed dose for 400 mg/d and routine anti-HIV treatment for 24 weeks and 12 weeks, respectively. The virological response (SVR12), persistent virus response (SVR24), adverse reaction (ADR) and life health assessment (SF-12) were compared between the two groups, respectively.

Results

During the follow-up period, 8 cases were lost, the missing rate was 13.3%. There was no significant difference in the virological response rates of EOT, SVR12, SVR24 between patients in non-fibrosis group and fibrosis group after treatment (allP> 0.05). Both groups showed several adverse reactions, the incidence of adverse reactions were both 100%, with no significant difference between the two groups (allP> 0.05). There was no significant difference in somatic health score and mental health score between the two groups at 12 and 24 weeks follow-up (allP > 0.05). At the end of the treatment, there was a significant difference in the SF-12 scores of the patients (Z=-2.125,P = 0.028).

Conclusions

LDV/SOF could be used to treat HCV/HIV coinfection with higher SVR. Although the incidence of adverse reactions after treatment was high, it could be alleviated by symptomatic treatment.

Key words: Human immunodeficiency virus, Hepatitis C virus, Coinfection, Ledipasvir, Sofosbuvir, Liver cirrhosis

Lan Bu, Xuan Bai. Efficacy and safety of ledipasvir/sofosbuvir in liver fibrosis patients with hepatitis C virus and human immunodeficiency virus coinfection[J]. Chinese Journal of Experimental and Clinical Infectious Diseases(Electronic Edition), 2018, 12(05): 488-493.

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References 24

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临床资料		无纤维化组(28例)	纤维化组(24例)	统计量	P值
年龄(±s，岁)		53.3 ± 7.6	54.5 ± 6.5	t = 0.706	0.112
性别(例，男/女)		24/4	17/7	χ² = 1.716	0.190
HCV基因型[例(%)]		?	?	χ² = 0.013	0.910
?	1a	5(17.9)	4(16.7)	?	?
?	1b	23(82.1)	20(83.3)	?	?
?	HCV RNA [M(IQR)，log₁₀IU/ml]	6.2(5.8～6.3)	6.1(5.5～6.4)	U = 0.258	0.857
?	HIV RNA < 50拷贝/ml [例(%)]	28(100.0)	24(100.0)	—	—
?	CD4细胞计数[M(IQR)，cells/μl]	647(489～879)	537(465～758)	U = 1.125	?
HIV抗逆转录治疗[例(%)]		?	?	χ² = 6.451	0.092
?	拉替拉韦+恩曲他滨+替诺福韦酯	22(78.6)	15(62.5)	?	?
?	利匹韦林+恩曲他滨+替诺福韦酯	3(10.7)	3(12.5)	?	?
?	依非韦伦+恩曲他滨+替诺福韦酯	0(0.0)	2(8.3)	?	?
?	其他	3(10.7)	4(16.7)	?	?
HCV治疗史[例(%)]		?	?	χ² = 1.520	0.468
?	抗HCV治疗≥ 3个月[例(%)]	5(17.9)	8(33.3)	?	?
?	HCV PI治疗失败[例(%)]	21(75.0)	20(83.3)	?	?
?	HCV PI治疗不耐受而终止治疗[例(%)]	7(25.0)	4(16.7)	?	?

临床资料		无纤维化组(28例)	纤维化组(24例)	统计量	P值
年龄(±s，岁)		53.3 ± 7.6	54.5 ± 6.5	t = 0.706	0.112
性别(例，男/女)		24/4	17/7	χ² = 1.716	0.190
HCV基因型[例(%)]		?	?	χ² = 0.013	0.910
?	1a	5(17.9)	4(16.7)	?	?
?	1b	23(82.1)	20(83.3)	?	?
?	HCV RNA [M(IQR)，log₁₀IU/ml]	6.2(5.8～6.3)	6.1(5.5～6.4)	U = 0.258	0.857
?	HIV RNA < 50拷贝/ml [例(%)]	28(100.0)	24(100.0)	—	—
?	CD4细胞计数[M(IQR)，cells/μl]	647(489～879)	537(465～758)	U = 1.125	?
HIV抗逆转录治疗[例(%)]		?	?	χ² = 6.451	0.092
?	拉替拉韦+恩曲他滨+替诺福韦酯	22(78.6)	15(62.5)	?	?
?	利匹韦林+恩曲他滨+替诺福韦酯	3(10.7)	3(12.5)	?	?
?	依非韦伦+恩曲他滨+替诺福韦酯	0(0.0)	2(8.3)	?	?
?	其他	3(10.7)	4(16.7)	?	?
HCV治疗史[例(%)]		?	?	χ² = 1.520	0.468
?	抗HCV治疗≥ 3个月[例(%)]	5(17.9)	8(33.3)	?	?
?	HCV PI治疗失败[例(%)]	21(75.0)	20(83.3)	?	?
?	HCV PI治疗不耐受而终止治疗[例(%)]	7(25.0)	4(16.7)	?	?

治疗及随访		无纤维化组(28例)	纤维化组(24例)	χ²值	P值
治疗时间		?	?	?	?
?	1周	0(0.0)	0(0.0)	?	?
?	2周	3(10.7)	1(4.2)	0.780	0.615
?	4周	12(42.8)	6(25.0)	1.821	0.177
?	8周	21(75.0)	12(50.0)	3.483	0.062
治疗后随访		?	?	?	?
?	12周	27(96.4)^a	15(54.2)	9.578	0.002
?	16周	27(96.4)	19(75.0)	3.773	0.052
?	20周	27(96.4)	22(91.7)	0.539	0.463
?	24周	27(96.4)^b	23(95.8)^a	0.012	0.911
?	30周	27(96.4)	23(95.8)	0.012	0.911
?	36周	27(96.4)^c	23(95.8)^b	0.012	0.911
?	42周	—	23(95.8)	—	—
?	48周	—	23(95.8)^c	—	—

治疗及随访		无纤维化组(28例)	纤维化组(24例)	χ²值	P值
治疗时间		?	?	?	?
?	1周	0(0.0)	0(0.0)	?	?
?	2周	3(10.7)	1(4.2)	0.780	0.615
?	4周	12(42.8)	6(25.0)	1.821	0.177
?	8周	21(75.0)	12(50.0)	3.483	0.062
治疗后随访		?	?	?	?
?	12周	27(96.4)^a	15(54.2)	9.578	0.002
?	16周	27(96.4)	19(75.0)	3.773	0.052
?	20周	27(96.4)	22(91.7)	0.539	0.463
?	24周	27(96.4)^b	23(95.8)^a	0.012	0.911
?	30周	27(96.4)	23(95.8)	0.012	0.911
?	36周	27(96.4)^c	23(95.8)^b	0.012	0.911
?	42周	—	23(95.8)	—	—
?	48周	—	23(95.8)^c	—	—

治疗结局		无纤维化组(28例)	纤维化组(24例)	χ²值	P值
因不良反应终止治疗者		0(0.0)	1(4.2)	—	—
死亡		0(10.7)	0(0.0)	—	—
出现不良反应者		28(100.0)	24(100.0)	—	—
严重不良反应者^a		5(17.9)	4(16.7)	0.013	1.000
常规不良反应		?	?	?	?
?	疲劳	8(28.6)	13(54.2)	3.516	0.061
?	高血压	15(53.5)	7(29.2)	3.153	0.076
?	头痛	12(42.9)	10(41.6)	0.008	0.931
?	恶心	8(28.6)	4(16.7)	1.032	0.310
?	腹泻	7(25.0)	5(20.8)	0.126	0.722
?	咳嗽	9(32.1)	5(20.8)	0.840	0.359
睡眠障碍		12(42.9)	14(58.3)	1.238	0.266
视线模糊		5(17.8)	6(25.0)	0.395	0.530
关节疼痛		8(28.6)	12(50.0)	2.507	0.113
呼吸困难		10(35.7)	11(45.8)	0.550	0.458
流感样症状		6(21.4)	8(33.3)	0.931	0.335
记忆障碍		11(39.3)	8(33.3)	0.197	0.657

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