A Randomized Controlled Trial to Assess the  Impact of Clinical Pharmacy Interventions on Treatment Outcomes, Health Related Quality of Life and Medication Adherence Among Hepatitis C Patients

Figures & data

Figure 1 Flow diagram showing patient recruitment and follow-up.

Abbreviation: EVR, end-of-treatment virological response; SVR, sustained virological response.

Table 1 Baseline Demographic and Clinical Characteristics of Study Population

		All Patients (n=931)	UC Group (n=466)	PC Group (n=465)
Age, years	Mean ± SD	42.35±1.9	42.85±1.7	41.84±1.7
	<40	439 (47.15%)	213 (45.7%)	226 (48.6%)
	41–60	439 (47.15%)	225 (48.3%)	214 (46.0%)
	>60	53 (5.7%)	28 (6.0%)	25 (5.4%)
Sex	Males	418 (44.9%)	215 (46.1%)	203 (43.7%)
	Females	513 (55.1%)	251 (53.9%)	262 (56.3%)
Residence	Urban	671 (72.1%)	329 (70.6%)	342 (73.6%)
	Rural	260 (27.9%)	137 (29.4%)	123 (26.4%)
Liver-health status	Cirrhotic	109 (11.7%)	47 (10.1%)	62 (13.3%)
	Noncirrhotic	822 (88.3%)	419 (89.9%)	403 (86.7%)
Diagnosis	HCV/CHC	905 (97.2%)	458 (98.3%)	447 (96.1%)
	HCV + comorbidities	26 (2.8%)	8 (1.7%)	18 (3.8%)
Genotype	Untypeable/mixed	8 (0.8%)	2 (0.4%)	6 (1.3%)
	1/1a	9 (1.0%)	4 (0.9%)	5 (1.1%)
	1b	4 (0.4%)	3 (0.6%)	1 (0.2%)
	3a	899 (96.6%)	451 (96.8%)	448 (96.3%)
	3b	11 (1.2%)	6 (1.3%)	5 (1.1%)
Treatment history	Naïve	920 (98.8%)	459 (98.5%)	461 (99.1%)
	Previously treated	11 (1.2%)	7 (1.5%)	4 (0.9%)
Viral load (baseline)	Very low viremia	24 (2.6%)	13 (2.8%)	11 (2.4%)
	Low viremia	22 (2.4%)	13 (2.8%)	9 (1.9%)
	Moderate	287 (30.8%)	139 (29.8%)	148 (31.8%)
	High viremia	275 (29.5%)	139 (29.8%)	136 (29.2%)
	Positive	323 (34.7%)	162 (34.8%)	161 (34.6%)
Treatment choices	Sof/Rv	608 (65.3%)	307 (65.9)	301 (64.7)
	Sof/Dac/Rv	201 (21.5%)	98 (21.0)	103 (22.2)
	Sof/Dac	122 (13.1%)	61 (13.1)	61 (13.1)

Abbreviations: HCV, hepatitis C virus; CHC, chronic hepatitis C; Sof, sofosbuvir; Rv, ribavirin; Dac, daclatasvir; UC, usual care; PC, pharmaceutical care.

Table 2 Comparison of Outcome Parameters (Adherence and Clinical Outcomes) Among Groups

Outcomes	Subcategories	All Patients (n=931) n(%)	UC Group (n=466) n(%)	PC Group (n=465) n(%)	p-value (UC vs PC)
ETR	ETR (NA)	97 (10.4%)	57 (12.2%)	40 (8.6%)
	Failed at ETR	16 (1.7%)	9 (1.9%)	7 (1.5%)
	ETR achieved	818 (87.9%)	400 (85.8%)	418 (89.9%)	0.163
SVR12	Did not have SVR	192 (20.6%)	134 (28.8%)	58 (12.5%)
	Failed	16 (1.7%)	9 (1.9%)	7 (1.5%)
	SVR achieved	723 (77.7%)	323 (69.3%)	400 (86.0%)	0
Adherence (pharmacy refills)	≤60%	115 (12.4%)	68 (14.6%)	17 (3.7%)	0
	61%–79%	41 (4.4%)	35 (7.5%)	36 (7.7%)
	≥80%	775 (83.2%)	363 (77.9%)	412 (88.6%)	0

Notes: p<0.05 considered significant.

Abbreviations: HCV, hepatitis C virus; CHC, chronic hepatitis C; ETR, end-of-treatment response; NA, not available; SVR12, sustained virological response at 12 weeks after end of treatment; UC, usual care; PC, pharmaceutical care.

Figure 2 Comparison of adverse drug events observed between groups (UC vs PC).

Abbreviations: UC, usual care; PC, pharmaceutical care.

Table 3 Drug–drug Interactions Between HCV DAAs and Concomitant Drugs

Notes: Colour legend adopted from EASL 2018 recommendation) .¹⁹ No clinically significant interaction expected. Potential interaction; may require a dosage adjustment, altered timing of administration or monitoring. These drugs should not be coadministered.

Abbreviations: PC, pharmaceutical care; UC, usual care; DAA, direct-acting antiviral; HCV, hepatitis C virus; Sof, sofosbuvir; Dac, daclatasvir; Rv, ribavirin, CV; cardiovascular; PPI, proton-pump inhibitor; BC, Bcomplex; TF, thyroid function.

Table 4 Summary of EQ5D-3L Data for Health Related Quality of Life Domains

Dimensions	All Patients (Reporting Problems)		Patients Reporting Problems in UC Level 2 (n=466)			Patients Reporting Problems in PC Level 2 (n=465)			χ^2 (p-value), UC vs PC
	Baseline, n (%)	Final, n (%)	Baseline, n (%)	Final, n (%)	χ^2 (p-value)^^	Baseline, n(%)	Final, n(%)	χ^2 (p-value)^^
Mobility	486 (52.2)	101 (10.8)*	240 (51.5)	55 (11.8)	20.3 (0)*	246 (52.9)	46 (9.9)	4.3 (0.38)	0.88 (0.35)
Self-care	240 (25.8)	67 (7.2)*	113 (24.2)	21 (4.5)	38.5 (0)*	127 (27.3)	24 (5.2)	12.3 (0)*	0.22 (0.64)
Usual activities	146 (15.7)	46 (4.9)*	72 (15.5)	21 (4.5)	0.023 (0.88)	74 (15.9)	25 (5.4)	2.9 (0.09)*	0.38 (0.54)
Pain/discomfort	438 (47.0)	3 (0.3)*	217 (46.6)	3 (0.6)	3.5 (0.06)	221 (47.5)	2 (0.4)	2.4 (0)*	3.00 (0.08)
Anxiety/depression	672 (72.2)	213 (22.9)*	343 (73.4)	104 (22.3)	8.4 (0.004)*	329 (70.8)	109 (23.5)	11.2 (0.001)*	0.17 (0.68)
EQ5D VAS
(Mean ± SD)	55.7±6.9	71.8±8.5	56.1±7.0	71.8±8.4	0*	55.2±6.8	71.9±8.7	0*	0*, ^a

Notes: p<0.05 considered significant. ^at-test, *significant value. ^McNemar χ² showed significant change over time. HRQoL was analyzed considering two levels of each domain (dichotomized), ie, patients with problems and patients with no problem, wherein the two levels were used to mark the changes before treatment and after treatment, as published elsewhere.⁴⁹

Abbreviations: EQ, EuroQol; UC, usual care; PC, pharmaceutical care.

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