Adverse drug events due to Antiretroviral Therapy in a Northern Indian Tertiary Care Institution

Sadiq, Shamiya; Gupta, Sapna; Khajuria, Vijay; Tandon, Vishal R; Mahajan, Annil; Gupta, Monika

doi:10.5455/njppp.2016.6.31012016114

Cited by 7 publications

(10 citation statements)

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“…Similar type of results was found by Anwikar et al [30]where 8.77%, 77%, and 14.02% ADRs were mild, moderate, and severe, respectively. These results are in contrast to Sadiq et al [17] and Kumar et al [20] where the majority of ADRs were mild followed by moderate and severe in nature.…”

Section: Discussioncontrasting

confidence: 92%

“…Our study showed a higher prevalence of ADR in female (52.7%) than male (47.3%). Similar finding was also reported by Sadiq et al [17], with a higher prevalence in female (64%) as compared to male (36%). In contrast, Khan et al [18] reported a higher prevalence of ADRs in male (74.8%) than female (25.2%).…”

Section: Discussionsupporting

confidence: 90%

“…Others ADRs such as fatigue 4%, lipodystrophy 1.4%, myalgia 1.2%, fever 0.9%, and giddiness 0.7% were also reported in our study. Sadiq et al [17] and Reddy et al [23] found similar types of ADRs in their studies.…”

Section: Discussionsupporting

confidence: 57%

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Pharmacovigilance Study of Antiretroviral Therapy in Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome Patients at Antiretroviral Therapy Centre, Jabalpur

Bansal

Daryani

Singh

2018

Asian J Pharm Clin Res

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Objective: The objective of the study was to assess the adverse drug reactions (ADRs) of antiretroviral therapy along with its causality, severity, and preventability.Method: A prospective as well as a retrospective observational study with a sample size of 260, jointly conducted in the Department of Pharmacology and antiretroviral therapy (ART) center of N.S.C.B. Medical College Jabalpur, India, from March 2016 to July 2017. We observed various ADRs to ART in human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS) patients and assessed causality, severity, and preventability of the reported ADRs as per the standard scales.Results: A total of 260 patients were enrolled of which 220 (84.6%) patients developed a total of 425 ADRs. Maximum 51.7% of ADRs were caused by TLE followed by 37% with ZLN regimen. Most common ADRs were dizziness 18.6%, rashes 14.6%, anemia 10.6%, and vomiting 6.6%. Dizziness and rashes are mainly caused by TLE and ZLN regimen, respectively. Management of ADRs with a change in the regimen was applied as an interventional tool in 40% of the patients. Causality assessment as per the WHO-UMC scale showed that 55.5% of ADR were probable and 45.5% were possible. 84.5% of ADR was not preventable, while 15.5% of ADRs were probably preventable. 38% of ADRs were mild, 56% were moderate, and 6% were severe in nature.Conclusion: Antiretrovirals, however, the milestone for the treatment of HIV/AIDS have very high potential for developing ADRs. Hence, active pharmacovigilance is needed for not only safety of the patients but also compliance to the treatment which is necessary for optimal therapeutic outcomes and to improve quality of life.

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Section: Discussioncontrasting

confidence: 92%

Section: Discussionsupporting

confidence: 90%

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Pharmacovigilance Study of Antiretroviral Therapy in Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome Patients at Antiretroviral Therapy Centre, Jabalpur

Bansal

Daryani

Singh

2018

Asian J Pharm Clin Res

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“…In our study, males were more affected than females which is similar to other studies as shown in Table 3. [141516] However, in other studies, females were commonly affected. [17] Possible explanation for this gender difference is because of the incidence of AIDS in male, hormonal effect on drug metabolism, body mass index, and genetic constitution.…”

Section: Discussionmentioning

confidence: 92%

“…While in other studies, as shown in Table 3, the most common regimen responsible for ADRs are ZLN and SLN/E. [141516] The reason for this can be due to drug regimens prescribed for HIV patients. We have seen less number of ADR with other regimen as TLE and ZLN are first-line regimens; if patients do not respond or developed some serious ADRs, then they are prescribed second-line regimens such as atazanavir/ritonavir + lamivudine + efavirenz and abacavir + lamivudine + atazanavir/ritonavir[6] [Table 3].…”

Section: Discussionmentioning

confidence: 99%

A safety analysis of different drug regimens used in human immunodeficiency virus-positive patients

Chauhan

Shah

Desai

et al. 2018

Indian J Sex Transm Dis

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Background:Long-term toxicity of antiretroviral agents is rarely addressed in initial clinical trials. Effective pharmacovigilance is essential for long-term safety of antiretroviral therapy (ART).Materials and Methods:All adverse drug reactions (ADRs) reported due to ART between January 2014 and September 2016 were analyzed as per different drug regimens used. ADRs were also analyzed for system organ classification, seriousness, time relationship of ADRs with drug therapy, causality (as per the World Health Organization-Uppsala Monitoring Centre scale and Naranjo algorithm), and severity (Hartwig and Siegel scale). Comparison was done between (tenofovir + lamivudine + efavirenz [TLE]) and (zidovudine + lamivudine + nevirapine [ZLN]) regimens.Results:During a study period, 2983 patients were on ART. The most common drug regimen prescribed was TLE (1805) followed by ZLN (326). A total of 325 (10.89%) ADRs were reported in which 150 ADRs were reported in TLE regimens (46%) and 130 in ZLN regimens (40%). The mean age of patients with ADRs was 40 ± 12.56 years and men (58.1%) were more affected than women (41.8%). The most common system organ involved in ZLN regimen was blood (50, 39%) and skin (35, 27%), while it was neurological (63, 42%) and renal disorder (27, 18%) in TLE regimen. Most of ADRs were observed after 1 month of therapy (79.5%) and showed possible causal relation with drug therapy (78.15%). Majority of ADRs were mild in nature (86.7%). The serious ADRs were reported more in ZLN (18%) regimen as compared to TLE (9%) (P < 0.05).Conclusion:Both ART regimens are associated with ADRs affecting all body system; however, the frequency and severity of ADR are high with ZLN regimen.

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Pharmacoepidemiological Evaluation of Hiv Pharmacotherapy at District Art Center in South Telangana

AKHILA¹,

DIVYA²,

ADEPU³

et al. 2022

Asian J Pharm Clin Res

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Objective: Objective of the study was to assess the drug utilization pattern of antiretroviral drugs, and medication adherence behavior among human immunodeficiency virus (HIV) patients attending a local ART center, Suryapet, South Telangana. Methods: This was a prospective observational study approved by institutional ethics committee. Demographic, clinical, laboratory, and the treatment details were collected on daily basis for new cases and the data add on was collected for old cases. Medication adherence behavior was assessed through Morisky Medication Adherence Scale-8. Results: During the study period, a total of 505 HIV patients were enrolled. Among them, majority patients were women (61%), in the age group of 31–45 (49.7%). Illiterates (52.6%). Major mode of transmission identified was intimate contact (74%), and majority patients were in Stage I (49%). TLE regimen was prescribed in 69.9% patients and for children the prescribed regimen was ABC, 3TC, EFV (5.1%). About 43% patients were found with medium adherence. Conclusion: This study concludes that the most prescribed regimens were combination of TLE, and majority of the patients were found with medium adherence.

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Adverse drug events due to Antiretroviral Therapy in a Northern Indian Tertiary Care Institution

Cited by 7 publications

References 0 publications

Pharmacovigilance Study of Antiretroviral Therapy in Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome Patients at Antiretroviral Therapy Centre, Jabalpur

Pharmacovigilance Study of Antiretroviral Therapy in Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome Patients at Antiretroviral Therapy Centre, Jabalpur

A safety analysis of different drug regimens used in human immunodeficiency virus-positive patients

Pharmacoepidemiological Evaluation of Hiv Pharmacotherapy at District Art Center in South Telangana

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