Efficacy of direct-acting antiviral therapy for hepatitis C viral infection. Real-life experience in Bahrain

Figures & data

Table 1 Baseline (pre-treatment) patients’ characteristics (n=167)

Variable	Unit or category	Result
Age	Years <40 years ≥40 years	50.9±12.4 34 (20.4) 133 (79.6)
Sex	Male:Female	91 (54.5):76 (45.5)
Cirrhosis		63 (37.7)
Diabetes mellitus		55 (32.9)
Hypertension		41 (24.6)
Liver transplant		21 (12.6)
ESRD		8 (4.8)
Renal transplant		3 (1.8)
Hyperlipidemia		31 (18.6)
Hypothyroidism		14 (8.4)
Sickle-cell disease		14 (8.4)
Viral load	(IU/mL) Log10 viral load <400,000 ≥40,000	1.35E+6±1.9E+6 5.81±0.66 6.52 (31.1) 115 (68.9)
HCV genotype	G1 G2-3 G4	122 (73.1) 22 (13.1) 23 (13.8)
WBCs	(x109/L)	5.81±2.16
Hemoglobin	(gm/dL)	12.78±2.10
Platelets	(x109/L)	191.83±95.49
INR		1.29±2.10
PTT	Second	26.10±3.68
Serum creatinine	(µmol/L)	88.05±140.73
Serum albumin	(gm/L)	38.79±5.85
Total bilirubin	(µmol/L)	18.73±17.86
ALT	(IU/L)	61.00±40.35
ALP	(IU/L)	102.66±44.47
γGT	(IU/L)	97.69±89.27

Note: Data expressed as mean±SD or number (%) as appropriate.

Abbreviations: ALP, alkaline phosphatase; ALT, alanine aminotransferase; ESRD, end-stage renal disease; HCV, hepatitis C virus; INR, international normalization ratio; γGT, gamma-glutamyl-transferase; PTT, partial thromboplastin time.

Table 2 Types, duration, and combinations of treatment regimes

Type	OPR-based SOF-based	66 (39.5) 101 (60.5)
Duration	12 weeks 24 weeks	148 (88.6) 19 (11.4)
Combination	Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + Ribavirin Ombitasvir/Paritaprevir/Ritonavir + Ribavirin Sofosbuvir + Daclatasvir Sofosbuvir + Daclatasvir + Ribavirin Sofosbuvir + Pegylated Interferon + Ribavirin Sofosbuvir + Ledipasvir + Ribavirin Sofosbuvir + Ledipasvir Sofosbuvir + Simeprevir + Ribavirin Sofosbuvir + Ribavirin	27 (16.2) 28 (16.8) 11 (6.6) 5 (3.0) 26 (15.6) 1 (0.6) 50 (29.9) 15 (9.0) 1 (0.6) 3 (1.8)
Ribavirin included?	Yes With SOF-based regimens With OPR-based regimens No	120 (71.9) 81 (67.5) 39 (32.5) 47 (28.1)

Note: Data expressed as n (%).

Abbreviations: SOF; sofosbuvir. OPR; Ombitasvir/Paritaprevir/Ritonavir.

Table 3 Baseline characteristics of 11 patients with failure to achieve SVR12

Characteristics	Patient 1	Patient 2	Patient 3	Patient 4	Patient 5	Patient 6	Patient 7	Patient 8	Patient 9	Patient 10	Patient 11
Age (years)	53	61	68	61	37	52	32	52	34	47	79
Sex	M	F	F	M	M	M	M	M	F	M	F
Cirrhosis	Yes	Yes	Yes	Yes	Yes	Yes	No	Yes	Yes	Yes	Yes
DM	Yes	No	No	Yes	No	No	No	No	Yes	Yes	No
Hypertension	Yes	No	No	Yes	No	No	No	No	No	No	No
Liver Tx.	No	No	No	No	No	No	No	No	No	No	No
Renal Tx.	No	No	No	No	No	No	No	No	Yes	No	No
ESRD	No	No	No	No	No	No	No	No	No	No	No
Hypothyroidism	No	No	No	No	No	No	No	No	No	No	No
Hyperlipidemia	No	No	No	Yes	No	No	No	No	Yes	No	Yes
SCD	No	No	No	No	No	No	No	No	No	No	Yes
Genotype	3	1b	4	1a	4	1b	1a	1a	1b	1a	1b
Log10 viral load	6.17	5.47	6.05	5.56	6.66	5.61	6.1	5.25	5.40	4.17	5.84
Regimen type	SOF-B^A	SOF-B^B	OPR-B^C	OPR-B^D	SOF-B^E	SOF-B^E	OPR-B^F	SOF-B^E	SOF-B^E	OPR-B^F	OPR-B^F
RBV used	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes	No	Yes
Fail OR Stop	Stop	Stop	Fail	Stop	Fail	Stop	Fail	Stop	Stop	Fail	Stop
Therapy period	24	24	24	24	12	12	12	12	12	12	12

Note: The following treatments were given: ^ASofosbuvir + daclatasvir + ribavirin for 24 weeks. ^BSofosbuvir/Ledipasvir + Ribavirin for 24 weeks. ^COPR + Ribavirin for 24 weeks. ^DOPR + Dasabuvir + Ribavirin for 24 weeks. ^ESofosbuvir/Ledipasvir + Ribavirin for 12 weeks. ^FOPR + Dasabuvir + Ribavirin for 12 weeks.

Abbreviations: DM, diabetes mellitus; M, male; F, female; SCD, Sickle cell disease; ESRD, end-stage renal disease; RBV, ribavirin; SOF-B, sofosbuvir-based; OPR-B, Ombitasvir/Paritaprevir/Ritonavir based; Tx, transplantation; Stop, patient stopped therapy; Fail, patient failed to achieve SVR12.

Table 4 Comparison between patients according to response to therapy

Variable	SVR (n=156)	No SVR (n=11)	P-value
Age	50.81±12.31	52.36±14.56	0.882
Age ≥40 years	125 (80.1)	8 (72.6)	0.556
Male gender	84 (53.8)	7 (63.6)	0.529
Cirrhosis	53 (34.0)	10 (90.9)	<0.001
Diabetes mellitus	52 (33.3)	3 (27.3)	0.679
Hypertension	39 (25.0)	2 (18.2)	0.612
Liver transplant	21 (13.5)	0 (0.0)	0.193
End-stage renal disease	8 (5.1)	0 (0.0)	0.441
Renal transplant	2 (1.3)	1 (9.1)	0.661
Hyperlipidemia	29 (18.7)	2 (18.2)	0.965
Hypothyroidism	14 (9.0)	0 (0.0)	0.299
Sickle-cell disease	13 (8.3)	1 (9.1)	0.930
Regimen (SOF-Base)	95 (60.1)	6 (54.5)	0.677
Duration of therapy 12-weeks	141 (90.4)	7 (63.6)	0.007
Presence of Ribavirin	110 (70.5)	10 (90.9)	0.148
Log10 viral load	5.82±0.60	5.66±0.64	0.375
Viral load	109 (69.9)	6 (54.5)	0.520
Genotype 1 and 4 Genotype 4 Genotype 1	136 (87.2) 21 (13.5) 115 (73.7)	9 (81.8) 2 (18.2) 7 (63.6)	0.611 0.661 0.466
WBC (x10^Citation9/L)	5.76±2.15	6.49±2.31	0.281
Hemoglobin (gm/dL)	12.77±2.10	12.90±2.13	0.950
Platelets (x10^Citation9/L)	191.38±89.50	198.09±164.45	0.324
PT (Second)	13.31±1.84	13.61±1.66	0.399
PTT (Second)	26.06±3.75	26.77±2.58	0.437
INR	1.30±2.18	1.16±0.15	0.399
Serum creatinine (µmol/L)	89.63±145.42	65.64±19.62	0.834
Serum albumin (g/L)	38.85±5.92	38.00±4.94	0.468
Total bilirubin (µmol/L)	18.93±18.38	16.00±6.84	0.727
ALT (IU/L)	80.19±39.98	72.45±45.79	0.391
ALP (IU/L)	103.03±45.40	97.45±29.10	0.900
γGT (IU/L)	94.94±88.09	136.73±100.96	0.125

Note: Data expressed as mean±SD or n (% of SVR group) as appropriate.

Abbreviations: ALP, alkaline phosphatase; ALT, alanine aminotransferase; INR, international normalization ratio; γGT, gamma-glutamyl-transferase; PTT, partial thromboplastin time; SVR; SOF, sofosbuvir sustained virologic response; WBCs, white blood cells.

Figure 1 Sustained virologic response (SVR) rate based on different baseline patient demographic data and comorbidities.

Abbreviations:  DM; diabetes mellitus. ESRD; end-stage renal disease. HTN; hypertension. RTx; renal transplant. SCD; sickle-cell disease. P-values are >0.05 in all by Chi-Square.

Figure 2 Sustained virologic response (SVR) rate based on viral, hepatic, and regimen parameters. SOF; sofosbuvir.

Abbreviations: OPR; Ombitasvir/Paritaprevir/Ritonavir. LTx; liver transplantation. 400 K; 400,000 IU/L. GT; genotype. RIBA; ribavirin. P-value by Chi-Square test.

Table 5 Results of the multivariate logistic regression analysis for the independent predictors of sustained virologic response

Variable	Odd ratio	P-value	95% Confidence interval
			Minimum	Maximum
Presence of cirrhosis	16.091	0.010	1.963	131.905
Duration of therapy (12 weeks)	2.379	0.127	0.731	12.280

Figure 3 Percentage Sustained virologic response (SVR) and non-sustained virologic response (No SVR) in patients who received the SOF-based (n=101) and OPR-Bree (n=66) regimens. P=0.754 by Fisher’s exact test. SOF= sofosbuvir.

Table 6 The impact of treatment on the laboratory results

Variable	Pre-treatment	Post-treatment	P-value
WBC (x10^Citation9/L)	5.81±2.16	6.07±2.38	0.025
Hemoglobin (gm/dL)	12.78±2.10	12.82±2.26	0.671
Platelets (x10^Citation9/L)	191.83±95.49	215.70±99.09	<0.001
INR	1.29±2.10	1.12±0.17	0.320
PTT (second)	26.10±3.68	26.07±4.02	0.981
Serum creatinine (µmol/L)	88.05±140.73	90.40±133.79	0.625
Serum albumin (g/L)	38.79±5.85	41.15±5.35	<0.001
Total bilirubin (µmol/L)	18.73±17.86	15.24±13.68	0.003
ALT (IU/L)	61.00±40.35	27.42±22.72	<0.001
ALP (IU/L)	102.66±44.47	93.03±71.87	0.061
γGT (IU/L)	97.69±89.27	47.06±55.88	<0.010

Note: Data expressed as mean±SD or n (%) as appropriate.

Abbreviations: ALP, alkaline phosphatase; ALT, alanine aminotransferase; INR, international normalization ratio; WBCs, white blood cells.

Arase Y, Ikeda K, Suzuki F, et al. Long-term outcome after interferon therapy in elderly patients with chronic hepatitis C. Intervirology. 2007;50:16–23. doi:10.1159/00009630817164553

 PubMed Web of Science ®Google Scholar