Pharmacology
INTRODUCTION
+XPDQLPPXQRGHÀFLHQF\YLUXV+,9LQIHFWHGSDWLHQWV require a combination of three to four antiretroviral drugs, WHUPHG KLJKO\ DFWLYH DQWLUHWURYLUDO WKHUDS\ +$$57 $GKHUHQFHWR+$$57LVLQFUHDVLQJO\UHFRJQL]HGDVWKH NH\IDFWRUWRSUHYHQWWUHDWPHQWIDLOXUHLQPRVWSHRSOHZLWK +,9LQIHFWLRQ7KHUHLVDVLJQLÀFDQWDVVRFLDWLRQEHWZHHQ medication adherence and virological suppression in the WUHDWPHQWRI +,9LQIHFWLRQ>@ India stands at the third SRVLWLRQLQKDYLQJWKHKLJKHVWEXUGHQRI +,9DFTXLUHG
Association between Medication Adherence Outcomes and
Adverse Drug Reactions to Highly Active Antiretroviral Therapy in
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Rajesh R, Sudha V
1,
Varma DM
1
, Sonika S
Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal, Karnataka, 1Department of Medicine, Kasturba Medical College, Manipal University, Manipal, Karnataka, India
Address for correspondence: Dr. Radhakrishnan Rajesh, E-mail: [email protected]
Access this article online
Quick Response Code:
Website: www.jyoungpharm.in
DOI:
10.4103/0975-1483.104369
ABSTRACT
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Key words:$GYHUVHGUXJUHDFWLRQKLJKO\DFWLYHDQWLUHWURYLUDOWKHUDS\KXPDQLPPXQRGH¿FLHQF\YLUXV
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MATERIALS AND METHODS
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LQIRUPHGFRQVHQWZDVWDNHQIURPWKHSDWLHQWV7KH$,'6 &OLQLFDO7UDLO*URXS$&7*DGKHUHQFHTXHVWLRQQDLUH>@ZDV used for medication adherence assessment. Demographic details, information on sociodemographic factors, SV\FKRORJLFDO IDFWRUV GLVFORVXUH RI VWDWXV VRFLDO KDELWV WLPHRI GLDJQRVLVRI +,9KHDOWKFDUHV\VWHPDQGKHDOWK FDUHSURIHVVLRQDOUHODWHGIDFWRUV+$$57UHODWHGIDFWRUV NQRZOHGJH DQG EHOLHI UHODWHG WR +$$57 DQG UHDVRQV IRU ODFN RI DGKHUHQFH>@ ZHUH GRFXPHQWHG LQ DGKHUHQFH DVVHVVPHQW$JUHHGSDWLHQWVIRUDGKHUHQFHDVVHVVPHQWZHUH LQWHUYLHZHGDQGDVNHGWRUHFDOODQGUHSRUWWKHQXPEHURI missed antiretroviral doses in the last one month (each PLVVHGPHGLFDWLRQUHJDUGHGDVRQHGRVH7KHSHUFHQWDJH RI DGKHUHQFHIURPVHOIUHSRUWZDVFDOFXODWHGE\XVLQJWKH IROORZLQJIRUPXOD>@
Percentage of adherence
No. of doses the patient should hav
= ee taken No. of doses missed
No. of doses the patient shoul
−
d
d have taken
100
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Statistical analysis
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RESULTS
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Table 1: Demographic characteristic of patients on highly active antiretroviral therapy
Characteristic Total number of patients on HAART
n = 105 (%)
Gender
Male 68 (64.8)
Female 37 (35.2)
Age group (years)
18–28 8 (7.6)
29–38 23 (21.9)
39–48 47 (44.8)
49–58 19 (18.1)
59–68 8 (7.6)
BMI(kg/m2)
18.4 37 (35.2)
18.5–24.5 53 (50.4)
6 (5.8)
9 (8.6)
Marital status
Single 6 (5.7)
Married 86 (81.9)
Widowed 8 (7.6)
Separated 5 (4.8)
Occupation
Employed 37 (35.2)
Unemployed 68 (64.8)
Alcoholic
Yes 31 (29.5)
No 74 (70.5)
Smoker
Yes 27 (25.7)
No 78 (74.3)
Complementary treatment
Yes 9 (8.6)
No 96 (91.4)
Status of HAART
HAART naïve 31 (29.5)
HAART experienced 66 (62.9)
HAART defaulter 8 (7.6)
Adherence assessment status
Interviewed and assessed 50 (47.6) Refused to be Interviewed 23 (21.9)
Non-eligible 32 (30.5)
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Table 2: Sociodemographic and psychological factors for adherence
Sociodemographic factors for adherence
n =50 (%) Percentage of adherence P-value
<80% 80-95% >95%
n=23 n=14 n=13
Gender
Male 39 (78) 20 (87) 12 (85.7) 7 (53.8) 0.05
Female 11 (22) 3 (13) 2 (14.3) 6 (46.2)
Age group (years)
18–28 3 (6) 1 (4.3) 1 (7.1) 1 (7.7) 0.147
29–38 13 (26) 7 (30.5) 2 (14.3) 4 (30.8)
39–48 23 (46) 12 (52.2) 5 (35.7) 6 (46.2)
49–58 10 (20) 2 (8.7) 6 (42.9) 2 (15.3)
59–68 1 (2) 1 (4.3)
Marital status
Single 4 (8) 2 (8.7) 1 (7.1) 1 (7.7) 0.048
Married 37 (74) 16 (69.6) 10 (71.5) 11 (84.6)
Widowed 4 (8) 2 (8.7) 1 (7.1) 1 (7.7)
Separated/divorced 5 (10) 3 (13) 2 (14.3)
Level of education
Primary school 4 (8) 2 (8.7) 1 (7.1) 1 (7.7) 0.362
Secondary school 37 (74) 18 (78.3) 8 (57.1) 11 (84.6)
College level Illiterate 9 (18) 3 (13) 5 (35.7) 1 (7.7)
Occupation
Employed 21 (42) 12 (52.2) 6 (42.9) 3 (23.1) 0.235
Unemployed 29 (58) 11 (47.8) 8 (57.1) 10 (76.9)
Income in per month (INR)
<5000a 13 (26) 6 (26.1) 3 (21.4) 4 (30.8) 0.180
5000-10,000b 19 (38) 9 (39.1) 4 (28.6) 6 (46.2)
10,000–20,000c 15 (30) 8 (34.8) 4 (28.6) 3 (23.0)
>200,000d 3 (6) 3 (21.4)
Psychological factors for adherence Disclosed to spouse
Yes 33 (66) 8 (34.8) 13 (92.8) 12 (92.3) 0.040
No 17 (34) 15 (65.2) 1 (7.2) 1 (7.7)
Help from family members in taking medicines regularly
Yes 43 (86) 21 (91.3) 12 (85.7) 10 (76.9) 0.049
No 7 (14) 2 (8.7) 2 (14.3) 3 (23.1)
Moral support from family
Yes 40 (80) 17 (74) 11 (78.5) 12 (92.3) 0.032
No 10 (20) 6 (26) 3 (21.5) 1 (7.7)
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Table 3: Health care and social factors for adherence
Health care- system and health care team-related factors
Number of patients n
= 50 (%)
Percentage of adherence P-value <80% 80-95% >95%
n = 23 n = 14 n = 13 Knowledge about importance of taking medicines needed?
Yes 49 (98) 22 (95.7) 14 (100) 13 (100) 0.549
No 1 (2) 1 (4.3)
How often do you follow instructions provided by the clinician?
Never 8 (16) 8 (34.8) 0.001
Sometime 12 (24) 11 (47.8) 1 (7.1)
Most of the time 15 (30) 4 (17.4) 8 (57.1) 3 (23.1)
All the time 15 (30) 0 5 (35.8) 10 (76.9)
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Yes 30 (60) 16 (69.6) 7 (50) 7 (53.8) 0.435
No 20 (40) 7 (30.4) 7 (50) 6 (46.2)
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Yes 25 (50) 13 (56.5) 6 (42.9) 6 (46.2) 0.686
No 25 (50) 10 (43.5) 8 (57.1) 7 (53.8)
Discomfort
Yes 14 (28) 7 (30.4) 4 (28.6) 3 (23.1) 0.893
No 36 (72) 16 (69.6) 10 (71.4) 10 (76.9)
Lack of time
Yes 7 (14) 3 (13) 3 (21.4) 1 (7.7) 0.580
No 43 (86) 20 (87) 11 (78.6) 12 (92.3)
Distance to center
Yes 2 (4) 1 (4.3) 1 (7.1) 13 (100) 0.635
No 48 (96) 22 (95.7) 13 (92.9)
Social factors for adherence Alcohol
Regular 6 (12) 5 (21.7) 1 (7.1) 1 (7.7) 0.027
Occasional 4 (8) 3 (13.1) 4 (28.6) 1 (7.7)
Rare 1 (2) 1 (4.3) 9 (64.3) 11 (84.6)
Reformed 8 (16) 3 (13.1)
Never 31 (62) 11 (47.8)
Smoking
Regular 10 (20) 7 (30.5) 2 (14.3) 1 (7.7) 0.391
Occasional 1 (2) 1 (4.3) 3 (21.4) 1 (7.7)
Rare 1 (2) 1 (4.3) 9 (64.3) 11 (84.6)
Reformed 5 (10) 1 (4.3)
Never 33 (66) 13 (56.6)
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reported
Highly active antiretroviral therapy-related factors Number of patients n = 50 (%) Percentage of adherence P-value <80% 80-95% >95%
n = 23 n = 14 n = 13 $57LGHQWL¿FDWLRQ
By brand name 29 (58) 13 (56.5) 10 (71.4) 6 (46.2) 0.293
By medication wrapper 16 (32) 7 (30.4) 3 (21.5) 6 (46.2)
By color, shape, size 2 (4) – 1 (7.1) 1 (7.6)
Cannot identify 3 (6) 3 (13) – –
Frequency
Once/day 15 (30) 7 (30.4) 1 (7.1) 7 (53.8) 0.031
Twice/day 35 (70) 16 (69.6) 13 (92.9) 6 (46.2)
No. of pills/day
One 12 (24) 6 (26.1) 1 (7.1) 5 (38.5) 0.147
Two 22 (44) 11 (47.8) 5 (35.7) 6 (46.1)
Three 16 (32) 6 (26.1) 8 (57.2) 2 (15.4)
Duration of ART
6 months 21 (42) 7 (30.4) 5 (35.7) 9 (69.2) 0.06
More than a year 29 (58) 16 (69.6) 9 (64.3) 4 (30.8)
Reason of taking ART
To prevent progression of HIV 45 (90) 21 (91.4) 14 (100) 10 (76.9) 0.080
To increase CD4 count 1 (2) 1 (4.3) – –
Both 3 (6) – – 3 (23.1)
Don’t know 1 (2) 1 (4.3) – –
Attitude of treatment to ART
Very well 13 (26) 5 (21.7) 2 (14.2) 6 (46.2) 0.373
Okay 18 (36) 8 (34.8) 6 (42.9) 4 (30.8)
Not well 19 (38) 10 (43.5) 6 (42.9) 3 (23.0)
Frequency of skipping medication
Yes, very often 17 (34) 16 1 – 0.487
Sometimes 18 (36) 7 9 2
No 15 (30) – 4 11
Behavior of skipping
Skip regularly 31 (62) 21 (91.3) 9 (64.3) 1 (7.7) 0.487
Take when remember 3 (6) 2 (8.7) 1 (7.1) –
Skip if it’s time for the next dose 1 (2) – – 1 (7.7)
Double the dose 15 (30) – 4 (28.6) 11 (84.6)
ART affordable?
Yes 30 (60) 13 (56.5) 10 (71.4) 7 (53.8) 0.582
No 20 (40) 10 (43.5) 4 (28.6) 6 (46.2)
Knowledge and belief related to ART Medications to be taken for whole life?
Yes 49 (98) 22 (95.7) 14 (100) 13 (100) 0.549
No – – – –
Don’t know 1 (2) 1 (4.3) – –
Time of medication will affect the effectiveness of treatment?
Yes 33 (66) 8 (34.8) 12 (85.7) 13 (100) 0.001
No 3 (6) 3 (13) – –
Don’t know 14 (28) 12 (52.2) 2 (14.3) –
Do you think special instructions are necessary to be followed?
Yes 34 (68) 9 (39.1) 12 (85.7) 13 (100) 0.001
No 3 (6) 3 (13) – –
Don’t know 13 (26) 11 (47.8) 2 (14.3) –
Once after getting better Can you stop drugs?
Yes 29 (58) 5 (21.7) 11 (78.6) 13 (100) 0.001
No 6 (12) 4 (17.4) 2 (14.3) –
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DISCUSSION
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0RVW RI RXU SDWLHQWV ZHUH ZHOO HGXFDWHG EXW XQDEOH WR H[SUHVV WKHLU V\PSWRPV RI DGYHUVH GUXJ HIIHFWV WR clinicians due to fear and their personal beliefs regarding LQWHQWLRQDO QRQDGKHUHQFH 7KLV ILQGLQJ LV FRQVLVWHQW ZLWKYDULRXVVWXGLHV>@0RVWRI RXUSDWLHQWVZHUHQRQ
alcoholics (P LHP DQG QRQVPRNHUV
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gaining overall moral support (P LHPIURP
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Highly active antiretroviral therapy-related factors Number of patients n = 50 (%) Percentage of adherence P-value
<80% 80-95% >95%
n = 23 n = 14 n = 13
Don’t know 15 (30) 14 (60.9) 1 (7.1) –
Do you know ART is life saving?
Yes 44 (88) 17 (73.9) 14 (100) 13 (100) 0.091
No 1 (2) 1 (4.3) – –
Don't know 5 (10) 5 (21.7) – –
Adverse drug reactions
Present 32 (64) 13 (56.5) 12 (85.7) 7 (53.8) <0.001
Absent 18 (36) 10 (43.5) 2 (14.3) 6 (46.2)
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,QRXUVWXG\WKHRFFXUUHQFHRI PRGHUDWHWRVHYHUHUHQDO G\VIXQFWLRQ ZDV KLJKO\ DVVRFLDWHG ZLWK WKH XVH RI WHQRIRYLUFRQWDLQLQJ+$$57UHJLPHQZLWKWKHVLJQV RI SURWHLQXULD IDWLJXH JOXFRVXULD QDXVHD DQG ZHLJKW ORVVZLWKLQ²PRQWKVRI LQLWLDWLRQUHVXOWLQJIRUQRQ DGKHUHQFH7KHUHQDOIXQFWLRQWHVWDQGRWKHUODERUDWRU\ YDOXHV UHWXUQHG WR QRUPDO ZLWKLQ D IHZ PRQWKV DIWHU tenofovir discontinuation.
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adverse drug reactions
Characteristic Total number of patients with adverse drug reactions N = 32 (%)
Gender
Male 27 (84.4)
Female 5 (15.6)
Age group (years)
18–28 2 (6.3)
29–38 8 (25)
39–48 13 (40.6)
49–58 9 (28.1)
BMI (kg/m2)
18.4 13 (40.7)
18.5–24.5 17 (53.1)
1 (3.1)
1 (3.1)
Marital status
Single 3 (9.3)
Married 23 (71.9)
Widowed 2 (6.2)
Separated 4 (12.6)
Occupation
Housewife 4 (12.5)
Agriculturist 12 (37.5)
Employed 11 (34.4)
Selfemployed 4 (12.5)
Student 1 (3.1)
Alcoholic
Regular 4 (12.5)
Occasional 3 (9.4)
Rare 1 (3.1)
Reformed 7 (21.9)
Never 17 (53.1)
Smoker
Regular 8 (25)
Occasional
--Rare 1 (3.1)
Reformed 5 (15.6)
Never 18 (56.3)
Complementary treatment
Yes 4 (12.5)
No 28 (87.5)
HAART status
HAART experienced 30 (93.7)
HAART defaulter 2 (6.3)
CD4 count (cells/μl)
25 (78.1)
>200 7 (21.9)
Occurrence of ADRs
ADRs during hospital stay 10 (31.2) ADRs at the time of admission 12 (37.6) Previous exposure of ADRs 10 (31.2) Polypharmacy
Minor (two to three drugs) 4 (12.5) 0RGHUDWHIRXUWR¿YHGUXJV 12 (37.5) 0DMRUJUHDWHUWKDQ¿YHGUXJV 16 (50) Highly active antiretroviral
therapy implicated in ADRs
Contd....
7DEOH&RQWG
Characteristic Total number of patients with adverse drug reactions N = 32 (%) Zidovudine + lamivudine +
nevirapine
10 (31.5)
Zidovudine + lamivudine + efavirenz
7 (22)
Tenofovir + lamivudine + efavirenz
2 (6.2)
Tenofovir + efavirenz +emtricitabine
2 (6.2)
Nevirapine + stavudine + lamivudine
2 (6.2)
Stavudine + lamivudine + efavirenz
2 (6.2)
Atazanavir + ritonavir + tenofovir
2 (6.2)
Zidovudine + lamivudine 1 (3.1) Stavudine + lamivudine 1 (3.1) Atazanavir + ritonavir +
tenofovir + emtricitabine
1 (3.1)
Atazanavir + tenofovir + emtricitabine
1 (3.1)
Indinavir + abacavir + tenofovir
7DEOH&DXVDOLW\DVVHVVPHQWRIDGYHUVHGUXJ
reactions
Assessment of adverse drug reactions Number of ADRs,
n = 32 (%) Causality of ADRs
WHO probability scale
Certain 6 (18.8)
Probable 16 (50)
Possible 10 (31.2)
Naranjo’s scale
'H¿QLWH 2 (6.2)
Probable 22 (68.8)
Possible 8 (25)
Severity (Hartwig et al.’s scale)
Mild 9 (28.2)
Moderate 23 (71.8)
Severe Nil
Predictability
Predictable 28 (87.5)
Non predictable 4 (12.5)
3UHYHQWDELOLW\0RGL¿HG6FKXPRFNDQG7KRUQWRQ¶VVFDOH
'H¿QLWHO\SUHYHQWDEOH 9 (28.1)
Probably preventable 6 (18.8)
Not preventable 17 (53.1)
Management of ADRs
Drug withdrawn 20 (62.5)
Dose altered Nil
No change 12 (37.5)
Treatment given
6SHFL¿F 13 (40.7)
Symptomatic 11 (34.3)
No change in treatment 8 (25)
Outcome of management of ADRs
Recovered 25 (78.1)
Continuing 5 (15.7)
Unknown 2 (6.2)
Dechallenge
No dechallenge 11 (34.3)
'H¿QLWHLPSURYHPHQW 19 (59.5)
Unknown 2 (6.2)
Rechallenge
No rechallenge 30 (93.8)
No occurrence of symptoms 1 (3.1)
Unknown 1 (3.1)
Adverse drug reactions reported
Anemia Zidovudine 7 (22)
Pancytopenia Zidovudine 6 (18.9)
Leucopenia Zidovudine 1 (3.1)
Renal failure Tenofovir 4 (12.6)
SJS and TEN Nevirapine 3 (9.3)
Sensory neuropathy Stavudine 2 (6.2)
Hepatitis Stavudine 2 (6.2)
Hyperbilirubinemia Atazanavir 1 (3.1)
Maldistribution Atazanavir 1 (3.1)
Insomnia Efavirenz 1 (3.1)
Vomiting Zidovudine 1 (3.1)
IRIS Efavirenz 1 (3.1)
Contd...
7DEOH&RQWG
Assessment of adverse drug reactions Number of ADRs,
n = 32
(%)
Gastritis Efavirenz 1 (3.1)
Fever Zidovudine 1 (3.1)
System organ class codes WHO-ART
Red blood cell disorders (1210) 14 (43.8) Urinary system disorders (1300) 4 (12.5) Skin and appendages disorders (0100) 3 (9.3) Gastrointestinal system disorders (0600) 2 (6.3) Central and peripheral nervous system
disorders (0410)
2 (6.3)
Liver and biliary system disorders (0700) 2 (6.3) White cell and RES disorders (1220) 1 (3.1) Psychiatric disorders (0500) 1 (3.1) Metabolic and nutritional disorders (0800) 1 (3.1) Body as a whole – general disorders (1810) 1 (3.1) Resistance mechanism disorders (1830) 1 (3.1) 6-6 6WHYHQ-RKQVRQV\QGURPH7(1 7R[LFHSLGHUPDOQHFURO\VLV,5,6 ,PPXQHUHFRQVWLWXWLRQLQÀDPPDWRU\V\QGURPH
LQFUHDVHG ULVN RI JUDGHV ² QHSKURWR[LFLW\ ,Q RQH RI WKH IRXU FDVHV RI WHQRIRYLULQGXFHG UHQDO IDLOXUH HYHQ after tenofovir discontinuation, the renal function test ZDV DEQRUPDO DQG GLDO\VLV ZDV SHUIRUPHG 2XU VWXG\ ÀQGLQJVDUHVLPLODUWRDVWXG\>@ZKHUHDVLPLODUW\SHRI QHSKURWR[LFLW\ZLWKWHQRIRYLUXVDJHZDVREVHUYHGLQ+,9 infected patients.
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CONCLUSION
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ACKNOWLEDGMENTS
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REFERENCES
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between medication adherence outcomes and adverse drug reactions to highly
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