Abstract

Background and Objectives. The objective was to study the adverse drug reaction (ADR) profile in HIV patients receiving first-line antiretroviral therapy. Methods. This was a prospective, observational study that included 171 HIV patients with a follow-up at six months. Demographic details, medical history, details of HIV infection including most recent CD4 count, details of antiretroviral therapy, and other concomitant medication were recorded. Adverse drug reactions were elicited by reviewing patient records and also by interviewing the patient/attendants directly. Results. 171 patients completed the study out of which 88 (51.5%) were males and 83 (48.5%) were females. The study subjects included HIV-positive, treatment naïve patients who were started on treatment regimens recommended by the NACO guidelines. The ADRs observed were a fall in haemoglobin or absolute anaemia in response to zidovudine, nonspecific symptoms like headache, and a nonspecific feeling of being unwell in response to tenofovir, stavudine, and efavirenz; dyslipidaemia, pancreatitis, peripheral neuropathy, and lactic acidosis in response to stavudine; generalised rash in response to nevirapine and one case of nephrotoxicity to efavirenz. Majority of the ADRs satisfied the 'probable' category (60.1%), and the rest were "possible". ADRs to zidovudine and nevirapine superseded all others. Interpretation and Conclusion. Gastrointestinal effects were the most commonly observed group of ADRs, with nausea being the most common ADR, the others being gastritis and diarrhoea. The other ADRs included rash, hepatotoxicity, blood dyscrasias like anaemia, neutropenia, and thrombocytopenia, and fatigue. Few cases of lactic acidosis, peripheral neuropathy, headache, lipoatrophy, and pancreatitis were reported.

Original languageEnglish
Article number8095609
JournalInterdisciplinary Perspectives on Infectious Diseases
Volume2018
DOIs
Publication statusPublished - 01-01-2018

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Drug-Related Side Effects and Adverse Reactions
efavirenz
Pharmaceutical Preparations
Stavudine
Nevirapine
Lactic Acidosis
Tenofovir
Zidovudine
HIV
Peripheral Nervous System Diseases
Exanthema
Pancreatitis
Headache
Anemia
Therapeutics
Gastritis
CD4 Lymphocyte Count
Dyslipidemias
Neutropenia
Thrombocytopenia

All Science Journal Classification (ASJC) codes

  • Parasitology
  • Microbiology
  • Microbiology (medical)
  • Infectious Diseases
  • Virology

Cite this

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title = "Evaluation of Adverse Drug Reaction Profile of Drugs Used as First-Line Antiretroviral Therapy",
abstract = "Background and Objectives. The objective was to study the adverse drug reaction (ADR) profile in HIV patients receiving first-line antiretroviral therapy. Methods. This was a prospective, observational study that included 171 HIV patients with a follow-up at six months. Demographic details, medical history, details of HIV infection including most recent CD4 count, details of antiretroviral therapy, and other concomitant medication were recorded. Adverse drug reactions were elicited by reviewing patient records and also by interviewing the patient/attendants directly. Results. 171 patients completed the study out of which 88 (51.5{\%}) were males and 83 (48.5{\%}) were females. The study subjects included HIV-positive, treatment na{\"i}ve patients who were started on treatment regimens recommended by the NACO guidelines. The ADRs observed were a fall in haemoglobin or absolute anaemia in response to zidovudine, nonspecific symptoms like headache, and a nonspecific feeling of being unwell in response to tenofovir, stavudine, and efavirenz; dyslipidaemia, pancreatitis, peripheral neuropathy, and lactic acidosis in response to stavudine; generalised rash in response to nevirapine and one case of nephrotoxicity to efavirenz. Majority of the ADRs satisfied the 'probable' category (60.1{\%}), and the rest were {"}possible{"}. ADRs to zidovudine and nevirapine superseded all others. Interpretation and Conclusion. Gastrointestinal effects were the most commonly observed group of ADRs, with nausea being the most common ADR, the others being gastritis and diarrhoea. The other ADRs included rash, hepatotoxicity, blood dyscrasias like anaemia, neutropenia, and thrombocytopenia, and fatigue. Few cases of lactic acidosis, peripheral neuropathy, headache, lipoatrophy, and pancreatitis were reported.",
author = "Chowta, {Mukta N.} and Priyanka Kamath and Ramapuram, {John T.} and Shenoy, {K. Ashok} and Sanjay Hadigal",
year = "2018",
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doi = "10.1155/2018/8095609",
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T1 - Evaluation of Adverse Drug Reaction Profile of Drugs Used as First-Line Antiretroviral Therapy

AU - Chowta, Mukta N.

AU - Kamath, Priyanka

AU - Ramapuram, John T.

AU - Shenoy, K. Ashok

AU - Hadigal, Sanjay

PY - 2018/1/1

Y1 - 2018/1/1

N2 - Background and Objectives. The objective was to study the adverse drug reaction (ADR) profile in HIV patients receiving first-line antiretroviral therapy. Methods. This was a prospective, observational study that included 171 HIV patients with a follow-up at six months. Demographic details, medical history, details of HIV infection including most recent CD4 count, details of antiretroviral therapy, and other concomitant medication were recorded. Adverse drug reactions were elicited by reviewing patient records and also by interviewing the patient/attendants directly. Results. 171 patients completed the study out of which 88 (51.5%) were males and 83 (48.5%) were females. The study subjects included HIV-positive, treatment naïve patients who were started on treatment regimens recommended by the NACO guidelines. The ADRs observed were a fall in haemoglobin or absolute anaemia in response to zidovudine, nonspecific symptoms like headache, and a nonspecific feeling of being unwell in response to tenofovir, stavudine, and efavirenz; dyslipidaemia, pancreatitis, peripheral neuropathy, and lactic acidosis in response to stavudine; generalised rash in response to nevirapine and one case of nephrotoxicity to efavirenz. Majority of the ADRs satisfied the 'probable' category (60.1%), and the rest were "possible". ADRs to zidovudine and nevirapine superseded all others. Interpretation and Conclusion. Gastrointestinal effects were the most commonly observed group of ADRs, with nausea being the most common ADR, the others being gastritis and diarrhoea. The other ADRs included rash, hepatotoxicity, blood dyscrasias like anaemia, neutropenia, and thrombocytopenia, and fatigue. Few cases of lactic acidosis, peripheral neuropathy, headache, lipoatrophy, and pancreatitis were reported.

AB - Background and Objectives. The objective was to study the adverse drug reaction (ADR) profile in HIV patients receiving first-line antiretroviral therapy. Methods. This was a prospective, observational study that included 171 HIV patients with a follow-up at six months. Demographic details, medical history, details of HIV infection including most recent CD4 count, details of antiretroviral therapy, and other concomitant medication were recorded. Adverse drug reactions were elicited by reviewing patient records and also by interviewing the patient/attendants directly. Results. 171 patients completed the study out of which 88 (51.5%) were males and 83 (48.5%) were females. The study subjects included HIV-positive, treatment naïve patients who were started on treatment regimens recommended by the NACO guidelines. The ADRs observed were a fall in haemoglobin or absolute anaemia in response to zidovudine, nonspecific symptoms like headache, and a nonspecific feeling of being unwell in response to tenofovir, stavudine, and efavirenz; dyslipidaemia, pancreatitis, peripheral neuropathy, and lactic acidosis in response to stavudine; generalised rash in response to nevirapine and one case of nephrotoxicity to efavirenz. Majority of the ADRs satisfied the 'probable' category (60.1%), and the rest were "possible". ADRs to zidovudine and nevirapine superseded all others. Interpretation and Conclusion. Gastrointestinal effects were the most commonly observed group of ADRs, with nausea being the most common ADR, the others being gastritis and diarrhoea. The other ADRs included rash, hepatotoxicity, blood dyscrasias like anaemia, neutropenia, and thrombocytopenia, and fatigue. Few cases of lactic acidosis, peripheral neuropathy, headache, lipoatrophy, and pancreatitis were reported.

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