Adverse drug reactions to antiretroviral therapy in aids patients at a tertiary care hospital in India: A prospective observational study

Nagpal, Manish; Tayal, Vandana; Kumar, Suresh; Gupta, Usha

doi:10.4103/0019-5359.99597

Cited by 31 publications

(29 citation statements)

References 12 publications

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“…Our findings indicated a high proportion of patients (89.8%) reported at least one adverse drug reactions because of antiretroviral therapy since they began ART. This finding is closely consistent with works of other studies that showed a high proportion of patients on ART reported at least one ADR to be as high as 86%-94% of the patients [8,11,14,19]. Almost, all these studies used a similar study design.…”

Section: Discussionsupporting

confidence: 91%

“…In agreement with previous studies, gastrointestinal complaints were the reactions most commonly encountered [4,8,11]. In a Brazilian study of 406 patients, the most frequently reported adverse drug reaction was nausea where the occurrence was as high as 51.2% [8].…”

Section: Discussionsupporting

confidence: 89%

“…reported that 86% of patients had at least one ADR, of which, the most common observed was peripheral neuropathy [14]. A prospective observational study by Nagpal et al reported that about 90% of patients experienced ADR [11]. In this study, non-compliance due to ADRs was observed in 28.9% of patients.…”

Section: Introductionmentioning

confidence: 54%

“…Not only this, studies also showed that ADRs could be a source for new co-morbidities and hospital admission [9,10]. ADRs due to antiretrovirals can range from mild gastrointestinal disturbance [11] to serious adverse effects including hematological disorders [10], hepatotoxicity [12,13] and lactic acidosis [12]. A study done in Brazil among patients initiating ART in the first six month of therapy showed that at least one adverse reaction was reported by 92.2% of the participants while 56.2% reported four or more different reactions [8].…”

Section: Introductionmentioning

confidence: 99%

“…However, ADRs are considered the most limiting factor that compromises patient compliance and adherence. A number of authors reported ADRs as reasons for non-adherence [4,11,15-17]. Moreover, meta-analysis and review studies reported that non-adherence to treatment is one of the factors that leads to treatment failure and poor prognosis [12,18].…”

Section: Introductionmentioning

confidence: 99%

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Self-reported adverse drug reactions and their influence on highly active antiretroviral therapy in HIV infected patients: a cross sectional study

Tadesse

Mekonnen

Tesfaye

et al. 2014

BMC Pharmacol Toxicol

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BackgroundPatients on antiretroviral therapy have higher risk of developing adverse drug reactions (ADRs). The impact of ADRs on treatment adherence, treatment outcomes and future treatment options is quiet considerable. Thus, the purpose of this study was to describe the common self-reported ADRs and their impact on antiretroviral treatment.MethodsCross-sectional study was conducted at antiretroviral therapy (ART) clinic of Gondar University Hospital. Semi-structured interview questionnaire was used to extract self-reported ADRs, socio-demographic, and psycho-social variables. Variables related to antiretroviral medication, laboratory values and treatment changes were obtained from medical charts. Chi-square and odds ratio with 95% confidence interval were used to determine the associations of dependent variables.ResultA total of 384 participants were enrolled. At least one adverse drug reaction was reported by 345 (89.8%) study participants and the mean number of ADRs reported was 3.7 (±0.2). The most frequently reported ADRs were nausea (56.5%) and headache (54.9%). About 114 (31.0%) participants considered antiretroviral therapy to be unsuccessful if ADRs occurred and only 10 (2.6%) decided to skip doses as ADRs were encountered. Based on chart review, treatment was changed for 78 (20.3%) patients and from which 79% were due to documented ADRs (p = 0.00). Among them, CNS symptoms (27.4%) and anemia (16.1%) were responsible for the majority of changes. Around four percent of patients were non-adherent to ART. Non-adhered participants and those on treatment changes were not statistically associated with self-reported ADRs. Only unemployment status (AOR = 1.76 (1.15 - 2.70), p = 0.01) and ADR duration of less than one month (AOR = 1.95 (1.28-2.98), p = 0.001) were significantly associated with self-reported adverse effects of three or more in the multivariate analysis.ConclusionSelf-reported ADRs to antiretroviral therapy are quite common. More of the reactions were of short lasting and their impact on adherence and treatment change were less likely. However, documented ADRs were the most prevalent reasons for ART switch. Moreover, the level of unemployment was a strong predictor of self-reported ADRs.

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Section: Discussionsupporting

confidence: 91%

Section: Discussionsupporting

confidence: 89%

Section: Introductionmentioning

confidence: 54%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Self-reported adverse drug reactions and their influence on highly active antiretroviral therapy in HIV infected patients: a cross sectional study

Tadesse

Mekonnen

Tesfaye

et al. 2014

BMC Pharmacol Toxicol

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Prevalence of ABCC3‐1767G/A polymorphism among patients with antiretroviral‐associated hepatotoxicity

Singh

Lata

Choudhari

et al. 2020

Molec Gen & Gen Med

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Background Plasma concentrations of antiretrovirals (ARVs) regimens have considerably varied in individuals of human immunodeficiency virus (HIV) because of variations in the expression of drug‐metabolizing and transporter genes. Transporter genes play an important role in the disposition of drugs. Polymorphism in transporter gene (ABCC3) affects the MRP3 expression and varies the treatment outcome. Method We examined the polymorphism of ABCC3‐1767G/A gene in a total of 165 HIV patients (out of 165 HIV patients, 34 were with and 131 were without hepatotoxicity) and 156 healthy individuals using the polymerase chain reaction–restriction fragment length polymorphism method. Results In univariate analysis, we found a decreased prevalence of ABCC3 1767GA, 1767GA+AA genotypes, and 1767A allele in patients with hepatotoxicity as compared to patients without hepatotoxicity (23.5% vs. 28.2% and 23.5% vs. 30.53%; 11.76% vs. 16.41%), while a higher prevalence of 1767AA genotype was observed in HIV patients in comparison with healthy controls (2.3% vs. 1.3%, odds ratio [OR] = 1.71, 95% confidence interval [CI]: 0.23–15.03, p = .89). The frequency of ABCC3‐1767AA genotype was dispersed higher in individuals with early and advanced HIV disease stage in comparison with healthy controls (5.3% vs. 1.3%, OR = 4.73, p = .70; 8.9% vs. 1.3%, OR = 1.89, p = .91). A higher occurrence of ABCC3‐1767AA genotype was found in tobacco using HIV patients without hepatotoxicity compared with nonusers (4.7% vs. 1.1%, OR = 4.28, p = .52). The distribution of ABCC3‐1767GA genotype was higher in nevirapine receiving HIV patients irrespective of their hepatotoxicity status as compared to nonusers (30.4% vs. 9.1%, OR = 3.34, p = .22; 29.4% vs. 16.7%, OR = 1.69, p = .77). In multivariate analysis, HIV patients receiving nevirapine and with hepatotoxicity was found to have a significant risk for severity of hepatotoxicity (OR = 4.56, 95% CI: 1.60–12.99, p = .004). Conclusion ABCC3 1767G/A polymorphism was not significantly associated with susceptibility to ARV‐associated hepatotoxicity, although ABCC3 1767AA genotype designated a risk for acquisition of hepatotoxicity and advancement of the disease. Nevirapine usage emerged as an independent risk factor for hepatotoxicity severity.

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ABCG2 polymorphisms and susceptibility to ARV‐associated hepatotoxicity

Singh,

Dhotre,

Shyamveer

et al. 2024

Molec Gen & Gen Med

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BackgroundThe ABCG2 421C/A polymorphism contributes significantly to the distribution and absorption of antiretroviral (ARV) regimens and is associated with the undesirable side effects of efavirenz.MethodsTo investigate this, we examined ABCG2 34G/A (rs2231137) and 421C/A (rs2231142) genetic variations in 149 HIV‐infected patients (116 without hepatotoxicity, 33 with ARV‐induced hepatotoxicity) and 151 healthy controls through the PCR‐restriction fragment length polymorphism (PCR‐RFLP) technique.Results and DiscussionThe ABCG2 34GA genotype and 34A allele indicated a risk for antiretroviral therapy‐associated hepatotoxicity development (p = 0.09, OR = 1.58, 95% CI: 0.93–2.69; p = 0.06, OR = 1.50, 95% CI: 0.98–2.30). The haplotype GA was associated with hepatotoxicity (p = 0.042, OR = 2.37, 95% CI: 1.04–5.43; p = 0.042, OR = 2.49, 95% CI: 1.04–5.96). Moreover, when comparing HIV patients with hepatotoxicity to healthy controls, the haplotype GA had an association with an elevated risk for the development of hepatotoxicity (p = 0.041, OR = 1.73, 95% CI: 1.02–2.93). Additionally, the association of the ABCG2 34GA genotype with the progression of HIV (p = 0.02, OR = 1.97, 95% CI: 1.07–3.63) indicated a risk for advanced HIV infection. Furthermore, the ABCG2 421AA genotype was linked to tobacco users and featured as a risk factor for the progression of HIV disease (p = 0.03, OR = 11.07, 95% CI: 1.09–270.89).ConclusionThe haplotype GA may enhance the risk of hepatotoxicity development and its severity. Individuals with the ABCG2 34A allele may also be at risk for the development of hepatotoxicity. Additionally, individuals with an advanced stage of HIV and the ABCG2 34GA genotype may be at risk for disease progression.

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Adverse drug reactions to antiretroviral therapy in aids patients at a tertiary care hospital in India: A prospective observational study

Abstract: Myriad ADRs are associated with ART which leads to poor patient compliance. With the increasing access to ART in India, it is prudent that antiretroviral drugs are used judicially with regular monitoring of ADRs.

Cited by 31 publications

References 12 publications

Self-reported adverse drug reactions and their influence on highly active antiretroviral therapy in HIV infected patients: a cross sectional study

Self-reported adverse drug reactions and their influence on highly active antiretroviral therapy in HIV infected patients: a cross sectional study

Prevalence of ABCC3‐1767G/A polymorphism among patients with antiretroviral‐associated hepatotoxicity

ABCG2 polymorphisms and susceptibility to ARV‐associated hepatotoxicity

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