Adverse Drug Reactions to Antiretroviral Therapy in HIV-Infected Patients at the Largest Public Hospital in Nicaragua

Lorio, Marco A.; Colasanti, Jonathan; Moreira, S; Gutiérrez, Gamaliel; Quant, Carlos

doi:10.1177/2325957414535978

Cited by 7 publications

(11 citation statements)

References 22 publications

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“…The surveillance data that was used did not have grading of the severity of ADRs. Some studies have graded the ADRs using the World Health Organization grading or the Hartwig scale to determine the level of severity to patients’ morbidity [10,19,31,32]. Not all the data in the database were used as some patients were registered into the surveillance system study long after they had already initiated on ART.…”

Section: Discussionmentioning

confidence: 99%

An assessment of adverse drug reactions among HIV positive patients receiving antiretroviral treatment in South Africa

2015

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BackgroundAntiretroviral treatment (ART) has been effective in reducing HIV/AIDS related morbidity and mortality. However, the use and uptake of ART has resulted in adverse reactions, due mainly to the medicine’s toxicity and interactions with other medicines. The timing of adverse drug reactions (ADRs) among these patients is a critical public health issue for antiretroviral (ARV) treatment adherence and retention. Reliable monitoring of HIV patients on ART is through a structured pharmacovigilance surveillance system. However, recurrent nature of these data pose challenges in their analyses. This study aimed at modelling the timing of ADR events in HIV patients on ART using correlated time-to-event models.MethodsThe data concern 590 HIV patients registered onto the Medunsa National ARV Pharmacovigilance Surveillance System within 6 months of ART initiation between February 2007 and July 2011. Recurrent times of ADRs and baseline characteristics: patient gender, and age, ART regimen, clinic and initiation period were extracted from the data. The recurrent ADR events data were modelled using both shared frailty and marginal models on the five patients’ characteristics as covariates.ResultsOut of 590 patients, 67% were female, 68% started on regimen: Stavudine, Lamivudine and Efavirenz; 37% had experienced at least one ADR and 67% started ART in 2009–2011. Age (p-value = 0.0210), clinic (p-value < 0.0001) and period of ART initiation (p-value = 0.0002) were significantly associated with timing of first ADR. There was a significantly higher rates of ADR recurrences in patients aged 38–44 years [HR = 2.45; 95% CI = (1.47; 4.10)] vs. 30 years and less, patients taking regimen: Zidovudine, Lamivudine and Nevarapine) vs. regimen: Stavudine, Lamivudine and Efavirenz [HR = 2.09; 95% CI = (1.35; 3.22)], while the rate was lower among those who started ART in 2009–2011 vs. those who initiated in 2007–2008 [HR = 0.55; 95% CI = (0.40; 0.76)].ConclusionMore realistic time-to-event models for recurrent events data have been used to analyse timing of ADR events in HIV patients taking ARV treatment. Age, antiretroviral regimen type and period of initiation of ART were associated with the timing of HIV/AIDS drug related adverse reactions regardless of the analysis model used. This study has public health policy implications in addressing the added morbidity among HIV patients taking ARV treatment in the context of universal scaling up of ARV treatment.

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Section: Discussionmentioning

confidence: 99%

An assessment of adverse drug reactions among HIV positive patients receiving antiretroviral treatment in South Africa

2015

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“…Nevertheless, considering the continuum of HIV care in Nicaragua, only 11.5% of people living with HIV are estimated to have suppressed viral load and this is strongly associated with a high ART abandonment rate (estimated over 30%) [ 13 ]. Approximately a third of all persons under ART receive their drugs through a single national referral center: Hospital Dr. Roberto Calderón Gutiérrez in Managua [ 15 ]. This center started ART administration in 2003 with the support of the Global Fund to Fight AIDS, Tuberculosis and Malaria, and functioned as reference center until 2007, when ART administration was decentralized.…”

Section: Introductionmentioning

confidence: 99%

“…On average, the hospital enrolls 250 new patients per year [ 16 ]. Most people starting on first line ART receive regimens composed by two NRTI and one NNRTI, mainly zidovudine (AZT) + (lamivudine) 3TC + efavirenz (EFV), and tenofovir (TDF) + emtricitabine (FTC) + EFV [ 15 , 17 – 19 ]. Protease inhibitors (mainly boosted lopinavir, LPV/r) are used as second line regimens.…”

Section: Introductionmentioning

confidence: 99%

HIV Drug Resistance in Antiretroviral Treatment-Naïve Individuals in the Largest Public Hospital in Nicaragua, 2011-2015

Ávila‐Ríos¹,

García-Morales²,

Matías-Florentino³

et al. 2016

PLoS ONE

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BackgroundIncreasing HIV pre-treatment drug resistance (PDR) levels have been observed in regions with increasing antiretroviral treatment (ART) coverage. However, data is lacking for several low/middle-income countries. We present the first PDR survey in Nicaragua since ART introduction in the country in 2003.MethodsHIV-infected, ART-naïve Nicaraguan individuals were enrolled at Roberto Calderón Hospital, the largest national HIV referral center, from 2011 to 2015. HIV pol sequences were obtained at a WHO-accredited laboratory in Mexico by Sanger and next generation sequencing (NGS). PDR was assessed using the WHO surveillance drug resistance mutation (SDRM) list and the Stanford HIVdb tool.Results283 individuals were enrolled in the study. The overall PDR prevalence based on the list of SDRMs was 13.4%. Using the Stanford HIVdb tool, overall PDR reached 19.4%; with both nucleoside and non-nucleoside reverse transcriptase inhibitor (NRTI and NNRTI) PDR levels independently reaching moderate levels (6.7% and 11.3% respectively). Protease inhibitor PDR was low (2.8%). Using NGS with 2% threshold to detect SDRMs, PDR increased to 25.3%. K103N and M41L were the most frequent SDRMs and were present mostly in proportions >20% in each individual. A significant temporal increase in NNRTI PDR was observed (p = 0.0422), with no apparent trends for other drug classes. Importantly, PDR to zidovudine + lamivudine + efavirenz and tenofovir + emtricitabine + efavirenz, the most widely used first-line regimens in Nicaragua, reached 14.6% and 10.4% respectively in 2015. Of note, a higher proportion of females was observed among individuals with PDR compared to individuals without PDR (OR 14.2; 95% CI: 7.1–28.4; p<0.0001).ConclusionsOverall PDR in the Nicaraguan cohort was high (19.4%), with a clear increasing temporal trend in NNRTI PDR. Current HIVDR to the most frequently used first-line ART regimens in Nicaragua reached levels >10%. These observations are worrisome and need to be evidenced to strengthen the national HIV program. Also, our observations warrant further nationally representative HIVDR surveillance studies and encourage other countries to perform national surveys. Cost-effectiveness studies are suggested to analyze the feasibility of implementation of baseline HIV genotyping as well as to review the choice of first-line ART regimens in Nicaragua.

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“…The most common adverse effects based on organ system classification reported by the study participants in this study were CNS and PNS (62%), metabolic disorder (16.4%), gastrointestinal (8.6%), skin (9%), and others (4%). A similar study by Lorio et al also reported that central nervous system (45%), gastrointestinal (27%), and dermatologic (18%) were the major adverse effects in HIV patients [27]. This might be due to ART regimen.…”

Section: Discussionmentioning

confidence: 87%

Coping Strategies for Adverse Effects of Antiretroviral Therapy among Adult HIV Patients Attending University of Gondar Referral Hospital, Gondar, Northwest Ethiopia: A Cross-Sectional Study

Gelaw

Adugna

Tsegaye

et al. 2018

AIDS Research and Treatment

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Background Adverse effects from antiretroviral therapy (ART) have an impact on quality of life and medication adherence. There is no clear understanding of how people manage the adverse effects of ART. The individual taking medications which cause serious adverse effects may choose to stop or reduce the medications to relieve the adverse effects. Hence, this study was aimed at assessing coping strategies for adverse effects of ART among adult human immunodeficiency virus (HIV) patients. Methods A cross-sectional study was conducted at HIV clinic of University of Gondar Referral Hospital (UoGRH). A total of 394 study participants were recruited by systematic random sampling. Data were collected through interviewing patients. Data were entered to Epi-Info 3.5.4 and analyzed using SPSS-20.0. Descriptive statistics were used to summarize patient's sociodemographic data and the adverse effects of their ART regimen. Binary and multivariate logistic regressions were used to investigate the potential predictors of nonadherence coping strategies. Results The majorities of study participants were females (66%) and aged between 35 and 44 years (38.1%). The major adverse effects reported by the participants were headache (48.2%) followed by fatigability (18%) and loss of appetite (17.5%). Coping strategies used by HIV patients for adverse effect of ART were positive emotion coping strategy (91.1%), social support seeking (76.6%), taking other medications (76.6%), information seeking (48.7%), and nonadherence (35.5%). Younger age (AOR = 29.54, 95% CI = 2.49–35.25, p = 0.007), low level of education (AOR = 5.70, 95% CI = 2.16-15.05, p < 0.001), and living far from the health institution (AOR = 2.68, 95% CI = 1.29–5.57, p = 0.008) were associated with nonadherence coping strategy to relieve the adverse effects of ART. Conclusion The present study revealed that positive emotion coping was the most commonly used strategy. Age, level of education, and distance from health institution were the predictors of nonadherence coping strategy.

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Adverse Drug Reactions to Antiretroviral Therapy in HIV-Infected Patients at the Largest Public Hospital in Nicaragua

Abstract: Adverse drug reactions most frequently affected the central nervous system. No ADR was life threatening. The frequency of ADRs in this Nicaraguan patient population was less than that reported from other studies in resource-limited settings.

Cited by 7 publications

References 22 publications

An assessment of adverse drug reactions among HIV positive patients receiving antiretroviral treatment in South Africa

An assessment of adverse drug reactions among HIV positive patients receiving antiretroviral treatment in South Africa

HIV Drug Resistance in Antiretroviral Treatment-Naïve Individuals in the Largest Public Hospital in Nicaragua, 2011-2015

Coping Strategies for Adverse Effects of Antiretroviral Therapy among Adult HIV Patients Attending University of Gondar Referral Hospital, Gondar, Northwest Ethiopia: A Cross-Sectional Study

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