Abstract

Background: Adverse drug reactions (ADRs) to antiretrovirals have been a matter of concern as they can affect patient compliance and treatment outcome. Hence, it is important to detect them early and institute appropriate treatment. Aims and Objective: To assess the prevalence, distribution, causality, severity, predictability and preventability of ADRs to antiretrovirals and to identify risk factors for their development in a tertiary care hospital in South India. Materials and Methods: This was a descriptive observational study. Data were collected from the case records of adult, treatment naïve HIV-positive patients, newly initiated on antiretroviral drugs, January 2012 onward and closure of data set was on 31st December 2014. Results: A total of 238 cases met the inclusion criteria. Overall, 56 ADRs were noted. ADRs were observed in 39 males and 17 females. They were common in the age group 51-60 years. Anemia was the most common ADR followed by rash and hyperpigmentation. Most of the ADRs observed were of mild severity, requiring neither change in regimen nor any specific treatment. Zidovudine caused the highest number of ADRs, followed by nevirapine and stavudine. Most ADRs occurred within 6 months of starting antiretroviral therapy (ART). Causality relationship between drug and ADR was graded as “possible” according to WHO causality assessment scale. No statistically significant correlation of age, gender, weight, hemoglobin, CD4 count and the presence of opportunistic infections to the development of ADRs were noted. Conclusion: Regular monitoring, an early detection of ADRs to antiretrovirals and their treatment is essential to optimize ART.

Original languageEnglish
Pages (from-to)488-493
Number of pages6
JournalNational Journal of Physiology, Pharmacy and Pharmacology
Volume6
Issue number5
DOIs
Publication statusPublished - 2016

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Tertiary Healthcare
Drug-Related Side Effects and Adverse Reactions
Tertiary Care Centers
HIV
Causality
Therapeutics
Stavudine
Nevirapine
Hyperpigmentation
Zidovudine
Opportunistic Infections
CD4 Lymphocyte Count
Patient Compliance
Exanthema
Pharmaceutical Preparations
Observational Studies
Anemia
India
Hemoglobins
Age Groups

All Science Journal Classification (ASJC) codes

  • Physiology
  • Pharmacology, Toxicology and Pharmaceutics(all)

Cite this

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title = "Evaluation of adverse drug reaction profile of antiretrovirals in HIV-positive patients in a tertiary care hospital",
abstract = "Background: Adverse drug reactions (ADRs) to antiretrovirals have been a matter of concern as they can affect patient compliance and treatment outcome. Hence, it is important to detect them early and institute appropriate treatment. Aims and Objective: To assess the prevalence, distribution, causality, severity, predictability and preventability of ADRs to antiretrovirals and to identify risk factors for their development in a tertiary care hospital in South India. Materials and Methods: This was a descriptive observational study. Data were collected from the case records of adult, treatment na{\"i}ve HIV-positive patients, newly initiated on antiretroviral drugs, January 2012 onward and closure of data set was on 31st December 2014. Results: A total of 238 cases met the inclusion criteria. Overall, 56 ADRs were noted. ADRs were observed in 39 males and 17 females. They were common in the age group 51-60 years. Anemia was the most common ADR followed by rash and hyperpigmentation. Most of the ADRs observed were of mild severity, requiring neither change in regimen nor any specific treatment. Zidovudine caused the highest number of ADRs, followed by nevirapine and stavudine. Most ADRs occurred within 6 months of starting antiretroviral therapy (ART). Causality relationship between drug and ADR was graded as “possible” according to WHO causality assessment scale. No statistically significant correlation of age, gender, weight, hemoglobin, CD4 count and the presence of opportunistic infections to the development of ADRs were noted. Conclusion: Regular monitoring, an early detection of ADRs to antiretrovirals and their treatment is essential to optimize ART.",
author = "Chaithanya Malalur and Smita Shenoy and Muralidhar Varma and Asha Kamath and Hasitha Manohar and Kavitha Saravu",
year = "2016",
doi = "10.5455/njppp.2016.6.0514520072016",
language = "English",
volume = "6",
pages = "488--493",
journal = "National Journal of Physiology, Pharmacy and Pharmacology",
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publisher = "Mrs Dipika Charan for MedScience Publishers",
number = "5",

}

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T1 - Evaluation of adverse drug reaction profile of antiretrovirals in HIV-positive patients in a tertiary care hospital

AU - Malalur, Chaithanya

AU - Shenoy, Smita

AU - Varma, Muralidhar

AU - Kamath, Asha

AU - Manohar, Hasitha

AU - Saravu, Kavitha

PY - 2016

Y1 - 2016

N2 - Background: Adverse drug reactions (ADRs) to antiretrovirals have been a matter of concern as they can affect patient compliance and treatment outcome. Hence, it is important to detect them early and institute appropriate treatment. Aims and Objective: To assess the prevalence, distribution, causality, severity, predictability and preventability of ADRs to antiretrovirals and to identify risk factors for their development in a tertiary care hospital in South India. Materials and Methods: This was a descriptive observational study. Data were collected from the case records of adult, treatment naïve HIV-positive patients, newly initiated on antiretroviral drugs, January 2012 onward and closure of data set was on 31st December 2014. Results: A total of 238 cases met the inclusion criteria. Overall, 56 ADRs were noted. ADRs were observed in 39 males and 17 females. They were common in the age group 51-60 years. Anemia was the most common ADR followed by rash and hyperpigmentation. Most of the ADRs observed were of mild severity, requiring neither change in regimen nor any specific treatment. Zidovudine caused the highest number of ADRs, followed by nevirapine and stavudine. Most ADRs occurred within 6 months of starting antiretroviral therapy (ART). Causality relationship between drug and ADR was graded as “possible” according to WHO causality assessment scale. No statistically significant correlation of age, gender, weight, hemoglobin, CD4 count and the presence of opportunistic infections to the development of ADRs were noted. Conclusion: Regular monitoring, an early detection of ADRs to antiretrovirals and their treatment is essential to optimize ART.

AB - Background: Adverse drug reactions (ADRs) to antiretrovirals have been a matter of concern as they can affect patient compliance and treatment outcome. Hence, it is important to detect them early and institute appropriate treatment. Aims and Objective: To assess the prevalence, distribution, causality, severity, predictability and preventability of ADRs to antiretrovirals and to identify risk factors for their development in a tertiary care hospital in South India. Materials and Methods: This was a descriptive observational study. Data were collected from the case records of adult, treatment naïve HIV-positive patients, newly initiated on antiretroviral drugs, January 2012 onward and closure of data set was on 31st December 2014. Results: A total of 238 cases met the inclusion criteria. Overall, 56 ADRs were noted. ADRs were observed in 39 males and 17 females. They were common in the age group 51-60 years. Anemia was the most common ADR followed by rash and hyperpigmentation. Most of the ADRs observed were of mild severity, requiring neither change in regimen nor any specific treatment. Zidovudine caused the highest number of ADRs, followed by nevirapine and stavudine. Most ADRs occurred within 6 months of starting antiretroviral therapy (ART). Causality relationship between drug and ADR was graded as “possible” according to WHO causality assessment scale. No statistically significant correlation of age, gender, weight, hemoglobin, CD4 count and the presence of opportunistic infections to the development of ADRs were noted. Conclusion: Regular monitoring, an early detection of ADRs to antiretrovirals and their treatment is essential to optimize ART.

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U2 - 10.5455/njppp.2016.6.0514520072016

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EP - 493

JO - National Journal of Physiology, Pharmacy and Pharmacology

JF - National Journal of Physiology, Pharmacy and Pharmacology

SN - 2320-4672

IS - 5

ER -