Evaluating the effects of combination antiretroviral therapy regimens and the development of adverse drug reactions in Indian human immunodeficiency virus positive patients

Rajesh, Radhakrishnan; Vidyasagar, Sudha; Varma, Muralidhar; Guddattu, Vasudeva; Patel, Naren; Varghese, Manju; Pulagam, Poornima

doi:10.4103/2278-0521.134865

Cited by 3 publications

(1 citation statement)

References 1 publication

Supporting

Mentioning

Contrasting

Order By: Relevance

“…[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. [161819] In this study, ADRs were most commonly found in the age group of 38–48 years followed by 27–37 years.…”

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

View full text Add to dashboard Cite

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.

show abstract

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

View full text Add to dashboard Cite

show abstract

Adverse Drug Reactions in Children Living with HIV/AIDS Receiving First Line ART

R¹

2017

jmscr

View full text Add to dashboard Cite

Pharmacovigilance Study of Antiretroviral Drugs in Tertiary Care Hospital - A Prospective Study

Dharmadhikari¹

2018

jmscr

View full text Add to dashboard Cite

Background: Anti-retroviral therapy present today has reduced morbidity and prolong life span of patients. Globally physicians are faced everyday with problems of adverse drug reactions (ADRs). World health organization focus on studies reporting adverse reactions for safety of patients. Such studies leads to revision of ART guidelines. Aim: To carry out Pharmacovigilance study of antiretroviral drugs in our tertiary care hospital. Objectives: To detect, assess and classify ADRs in patients receiving Highly Active Antiretroviral Therapy (HAART). Material and Methods: This was a prospective, observational study carried out at Government medical college and tertiary care hospital Latur, Maharashtra. Both old and newly diagnosed patients of either sex and all age group receiving HAART were included in this study. Data was collected in suspected adverse drug reaction reporting form by using patient's record and analysis was done. Results: A total 157 patients presented with 223 ADRs during this study. Among them 106 were female and 51 were male. Females in the age group 20-40 years were most commonly affected. Common ADRs observed included anemia, dizziness, giddiness, skin rash. Most of ADRs were Type A, probable, non serious, moderate in severity, probably preventable. Conclusion: This pharmacovigilance study of antiretroviral drugs concludes that the risk factors for development of ADRs were female gender, age group 20-40 years, people in rural area, labor by occupation taking ZLN and TLE regimens. So there is need of continuous monitoring of ADRs.

show abstract

Evaluating the effects of combination antiretroviral therapy regimens and the development of adverse drug reactions in Indian human immunodeficiency virus positive patients

Cited by 3 publications

References 1 publication

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

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

Adverse Drug Reactions in Children Living with HIV/AIDS Receiving First Line ART

Pharmacovigilance Study of Antiretroviral Drugs in Tertiary Care Hospital - A Prospective Study

Contact Info

Product

Resources

About