scholarly journals Dolutegravir (DTG) Based Fixed Dose Combination (FDC) of Tenofovir/Lamivudine/Dolutegravir (TLD) and Viral Load Suppression in Children in Port Harcourt, Nigeria

Author(s):  
Nsirimobu Ichendu Paul ◽  
Rosemary Ogochukwu Ugwu

Background: Currently, dolutegravir (DTG) based fixed dose combinations (FDC) of tenofovir/ lamivudine/dolutegravir (TLD) and Abacavir/lamivudine/dolutegravir (ABC/3TC/DTG) is now recommended by the World Health Organisation (WHO) as the preferred first-and second line antiretroviral drug necessitating transition of eligible children to TLD. Objective: The objective of this study is to compare the HIV viral suppression rate at baseline and after 6 months of transition to TLD and to determine adverse drug reaction associated with the use of TLD if any. Methods: This was a prospective cross-sectional study carried out among stable children who were on treatment and follow up for HIV disease at the Paediatric HIV clinic of the University of Port Harcourt Teaching Hospital (UPTH). All Children who were eligible for transition to TLD, whose care givers/parents gave a verbal consent and who gave consent or accent were recruited for the study. Information obtained included the sociodemographic characteristics, weight and height, ART regimen at initiation of treatment and when it was commenced, the baseline viral load and viral load 6 months after transition and any adverse drug reaction. Obtained data were analysed. Comparison of categorical variables was done using chi square and Fischer’s exact test while A p-value of < 0.05 was set as statistically significant. Results: A total 106 children aged 9 to 18 years with a mean age of 13.4±2.3 years were recruited for the study. Sixty (56.6%) were males, while 59 (55.5%) were from the lower socioeconomic class. The mean weight was 44.4±11.1 kg while the mean height was 151.3 ± 15.2 cm. At baseline, 48 (45.3%) were virally suppressed (viral load < 1000 copies/ml), however after 6 months, 97 (91.5%) became virally suppressed, the difference in viral suppression rate was statistically significant (X2 =53.77, p= 0.0001).  Twenty-five (23.6%) had undetectable viral load (<20 copies/ml) at baseline while 61(57.5%) had undetectable viral load after transition. All those who were virally suppressed at baseline remained so 6 months after transition. Also, 80.6% (29/36) of those with treatment failure became virally suppressed. Only one child developed severe erythematous skin rashes. There was no statistically significant relationship between viral suppression and age, sex and social class (P >0.05). Conclusion: This study has shown that DTG-based FDC is efficacious in the treatment of eligible children and adolescents with HIV/AIDS with significant viral load suppression in all age groups, gender and social class. Adverse drug reaction with the use of DTG-based ART is low. Transition to TLD is therefore advocated in eligible patients.

2018 ◽  
Vol 6 ◽  
pp. 205031211881691 ◽  
Author(s):  
Shashi N Kapadia ◽  
Robert R Grant ◽  
Susan B German ◽  
Baljinder Singh ◽  
Amy L Davidow ◽  
...  

Background: Single-tablet regimens are preferred prescription choices for HIV treatment, but there are limited outcomes data comparing single-tablet regimens to multiple-tablet regimens. Methods: We retrospectively assessed treatment-naïve patients at a single urban HIV clinic in the United States for viral load suppression at 6 and 12 months after initiating either single-tablet or multiple-tablet regimens. Multivariate regression was performed to obtain relative risks and adjust for potential confounders. Results: Of 218 patients, 47% were on single-tablet regimens and 53% on multiple-tablet regimens; 77% of single-tablet regimen patients had undetectable viral load at 6 months compared to 61% of multiple-tablet regimen patients (p = 0.012). At 12 months, 82% on single-tablet regimens and 66% on multiple-tablet regimens (p = 0.019) had undetectable viral load. Relative risk of any detectable viral load was 1.6 (95% confidence interval: 1.1–2.5) for patients on multiple-tablet regimens compared to single-tablet regimens at 6 months, and 2.2 (95% confidence interval: 1.2–4.0) at 12 months. Conclusion: Single-tablet regimens may provide better virologic control than multiple-tablet regimens in urban HIV-infected persons.


2017 ◽  
Vol 4 (suppl_1) ◽  
pp. S430-S431
Author(s):  
Jonathan Chang ◽  
Sulggi Lee ◽  
Peter Hunt ◽  
Deanna Kroetz ◽  
Mark Siedner

Abstract Background Single-nucleotide polymorphisms (SNPs) in CYP2B6 have previously been associated with a 10-fold range in trough plasma efavirenz concentrations, but associations between these SNPs and efavirenz (EFV)-mediated viral suppression and tolerability remain unclear. Methods We evaluated three SNPs in CYP2B6 (rs3745274, rs28399499, and rs4803419, Illumina OmniExpress) among HIV-infected Ugandans observed in a cohort study every 3–4 months from 2005–2015. Genotypes from these SNPs were used to group participants into previously described pharmacokinetic strata: extensive (EXT), intermediate (INT), and slow metabolizers (Figure 1). The primary outcomes were viral suppression, defined by an undetectable viral load in the first measurement a minimum of three months after ART initiation, and incident depression in the first two years, defined by a mean score &gt;1.75 on the Hopkins Symptom Checklist. We fitted standard and generalized estimating equations (GEE) logistic regression models for viral suppression and depression, respectively. Models were adjusted for clinical and demographic covariates that reached a significance of P &lt; 0.25 in unadjusted models. Results Among 103 participants with genotyping, there were no differences in pre-ART viral load or depression by metabolism strata (P &gt; 0.5). Minor allele frequencies for rs3745274, rs28399499, and rs4803419 were 33%, 7%, and 4%, respectively. Approximately 79%, 78%, and 94% of participants were suppressed at their first viral load measurement in the extensive, intermediate, and slow metabolizer strata, respectively (Figure 2; P = 0.35). In adjusted models, metabolism strata were not associated with viral suppression (AORINT 0.81, 95% CI 0.26–2.56; AORSLOW 3.92, 95% CI 0.39–39.40) or with depression (AORINT 1.95, 95% CI 0.75–5.09; AORSLOW 0.72, 95% CI 0.17–3.02; Table). Conclusion We did not identify an association between efavirenz-metabolizing polymorphisms and viral suppression or depression in a cohort of HIV-infected individuals initiating ART in southwestern Uganda. Future work should reassess these relationships with larger samples and longer-term outcomes and explore additional polymorphisms that may be associated with efavirenz metabolism in this population. Disclosures P. Hunt, Merck: Consultant, Consulting fee; Gilead: Consultant, Consulting fee; Viiv: Consultant, Consulting fee


2019 ◽  
Vol 30 (8) ◽  
pp. 748-755 ◽  
Author(s):  
Geoffrey J Barrow ◽  
Margaret L Brandeau

To achieve the goal of HIV viral suppression, provision of medication alone is not sufficient. Concomitant frameworks to evaluate HIV care delivery programmes are needed. This study examined the care continuum at a hospital-based HIV clinic in Kingston, Jamaica using a modified HIV continuum of care, with an increased focus on viral load indicators (viral load samples taken, results returned and viral suppression). A statistical analysis of patient flow through the care continuum to identify gaps in programme delivery was performed. Key programmatic areas for process improvement and the utility of this approach for viral load suppression interpretation were identified. Between 2010 and 2015, more than 1600 patients had been registered for care and more than 1000 had accessed antiretroviral therapy at this location. Consistent trends in programme performance were seen from 2010 to 2012. Although declines in the proportion of viral load samples taken and results returned occurred because of laboratory failures in 2013, the trend of increasing numbers and proportions of virally suppressed patients continued. Statistical analysis indicated that improvements in laboratory quality (fraction of viral load samples returned with accurate test results) could increase viral load suppression among patients at the clinic by up to 17%. Refining care delivery processes can significantly improve HIV viral load suppression rates. Expanding monitoring frameworks to include all of the essential processes that affect final outcome indicators can provide valuable insight into trends of outcome indicators and programme performance.


2021 ◽  
Vol 18 (1) ◽  
Author(s):  
Pascal O. Bessong ◽  
Nontokozo D. Matume ◽  
Denis M. Tebit

Abstract Background South Africa, with one of the highest HIV prevalences in the world, introduced the universal test and treat (UTT) programme in September 2016. Barriers to sustained viral suppression may include drug resistance in the pre-treated population, non-adherence, acquired resistance; pharmacokinetics and pharmacodynamics, and concurrent use of alternative treatments. Objective The purpose of this review is to highlight potential challenges to achieving sustained viral load suppression in South Africa (SA), a major expectation of the UTT initiative. Methodology Through the PRISMA approach, published articles from South Africa on transmitted drug resistance; adherence to ARV; host genetic factors in drug pharmacokinetics and pharmacodynamics, and interactions between ARV and herbal medicine were searched and reviewed. Results The level of drug resistance in the pre-treated population in South Africa has increased over the years, although it is heterogeneous across and within Provinces. At least one study has documented a pre-treated population with moderate (> 5%) or high (> 15%) levels of drug resistance in eight of the nine Provinces. The concurrent use of ARV and medicinal herbal preparation is fairly common in SA, and may be impacting negatively on adherence to ARV. Only few studies have investigated the association between the genetically diverse South African population and pharmacokinetics and pharmacodynamics of ARVs. Conclusion The increasing levels of drug resistant viruses in the pre-treated population poses a threat to viral load suppression and the sustainability of first line regimens. Drug resistance surveillance systems to track the emergence of resistant viruses, study the burden of prior exposure to ARV and the parallel use of alternative medicines, with the goal of minimizing resistance development and virologic failure are proposed for all the Provinces of South Africa. Optimal management of the different drivers of drug resistance in the pre-treated population, non-adherence, and acquired drug resistance will be beneficial in ensuring sustained viral suppression in at least 90% of those on treatment, a key component of the 90-90-90 strategy.


Author(s):  
BALA SUBRAMANIAM ◽  
MEGHA SHAH ◽  
CHETNA DESAI ◽  
JIGAR PANCHAL ◽  
SAMIDH SHAH

Objectives: Drug-induced liver injury (DILI) is a frequent cause of liver injury and acute liver failure .We aimed to analyze the cases of DILI reported over a period of 8 years to the adverse drug reaction (ADR) monitoring center (AMC) at our institution. Methods: This observational retrospective study was conducted at the ADR monitoring center of a tertiary care hospital. Cases reported to the AMC, Pharmacovigilance Programme of India during the year 2011–2018 were analyzed as per the criteria used to analyze the ADRs. Results: A total of 5448 ADRs were reported during the study period, of which 105 (2%) were suspected to be DILI. The mean age of the patients with DILI was 39.26 years. Men (66.66%) were more commonly affected than women (33.34%). The most common drug groups causing DILI were antiretroviral (ART) (42.85%) and antitubercular (ATT) (40%). Most common single drug responsible for DILI was isoniazid (44.44%) followed by atazanavir (28%) and pyrazinamide (22.22%). Increase in serum bilirubin was the most common DILI (64.75%). About 79% of cases had a possible causality and 21% of cases had probable causal association with the suspected drugs. Majority of the ADRs (83%) were not preventable and mild in severity (21%). All ADR forms were complete in accordance with National Coordinating Center scale. Conclusion: DILI is commonly observed in patients taking ART and ATT drugs for more than a month. Regular monitoring and assessment in these patients may help in preventing DILI and manage these ADRs.


Author(s):  
Srikanth M S ◽  
Adepu R

Objective: A prospective interventional study was conducted to evaluate the impact of educational intervention on knowledge, attitude, and practices (KAP)(of rural community pharmacists toward adverse drug reaction (ADR) reporting.Methods: A validated KAP questionnaire was administered on the enrolled community pharmacists in the study. SPSS software package version-19 was used to calculate the influence of educational intervention on KAP scores of the participants. Pre-training KAP scores were compared with the post-training KAP scores.Results: About 49 community pharmacists have participated in the study, 95.91% (n=47) were males, and 4.08% (n=2) were females. The mean±SD age of the participants was 40.93±7.84 years. The mean ± SD score in the knowledge component was significantly increased from 4.87±2.015 to 7.09 ± 0.68 (n=49, p<0.05). After the educational intervention, 77.55% (n=38) of participants could correctly define the ADRs, and 73.46% (n=36) of participants were aware of the consequence of ADRs. About 57.34% of participants disagree with the statement reporting of ADRs incurs the addtional workload with post education intervention. At the end of the study, the participants’ knowledge was significantly increased and participant pharmacists felt responsible toward ADR reporting.Conclusion: Educational interventional program have shown a tremendous change in knowledge and awareness of the respondents towards adverse drug reaction monitoring and reporting. It is well understood that there is a need for promoting the pharmacovigilance activities among community pharmacists.


Pharmacy ◽  
2020 ◽  
Vol 8 (4) ◽  
pp. 222
Author(s):  
Md. Ashraful Islam ◽  
Aseel Fuad Al-Karasneh ◽  
Atta Abbas Naqvi ◽  
Dhfer Mahdi AlShayban ◽  
Fatimah Al-Hayek ◽  
...  

This study aimed to assess public knowledge about medicine information, safety, and adverse drug reaction reporting (ADR) in Dammam, Saudi Arabia. A cross sectional study was conducted using purposive stratified sampling in different settings of Dammam city for three months (January–March 2020). The target population was identified as consumers who had used the medicines in the last 3 months. The questionnaire was adopted from the literature and was validated. Content and face validities were established, and reliability was assessed. The study was approved by the concerned ethics committee. A total of 915 participants returned completed questionnaires. A total of 54.4% participants aged between 18 and 30 years, 65.8% were females and 53.1% had obtained bachelor level education. The mean score for knowledge of medicines (K1) was 5.46 ± 1.07. The mean score for knowledge regarding medication safety (K2) was 5.94 ± 1.73. The mean score for tendency to report a suspected ADR (T1) was 3.43 ± 1.57. Gender was a determinant of knowledge regarding medication safety (K2) (p < 0.01) and ADR reporting tendency (T1) (p < 0.01). The marital status of patients was a determinant for both knowledge of medicines (K1) (p < 0.01) and, knowledge regarding medication safety (K2) (p < 0.01). The results of this study highlighted that although the scores for knowledge of medicines, and tendency to report ADR were better, the score for knowledge regarding medication safety was unsatisfactory.


Author(s):  
Nagaraju Kancherla ◽  
G. Chitti Babu ◽  
Hukum Singh ◽  
Mayank Khandelwal ◽  
Nitika Sharma ◽  
...  

Background: Neuropathic pain has a significant negative impact on the patients’ quality of life. Now a day’s anticonvulsants and antidepressants drugs are often used as first-line drugs for the treatment of neuropathic pain. The present study aims to evaluate the safety and efficacy of gabapentin, amitriptyline, and pregabalin in patients of severe neuropathic pain not controlled by simple analgesics.Methods: A total of 360 patients diagnosed with cases of chronic lumbar radiculopathy based on symptoms, clinical examination, X-ray, and magnetic resonance imagining (MRI) scan of the lumbosacral spine, were randomized into three groups. Group A patients received pregabalin 75 mg, Group B patients received gabapentin 300 mg, and Group C patients received amitriptyline 10 mg, respectively. Pain intensity was measured at the baseline, after 1 month and after 2 months with the Numeric pain rating scale (NPRS). Adverse drug reaction reported by the patient or observed by the clinician during the study was reported using the adverse drug reaction (ADR) reporting form.Results: At baseline, the mean±SD of NPRS score in Group A was 8.42±1.48, in Group B and Group C were 8.53±1.94 and 8.33±1.26 respectively with an F-value of 0.843 and p value of 0.584, which was not statistically significant. At 1 month, the mean±SD of NPRS score in Group A was 7.23±1.58, in Group B and Group C were 7.43±2.03 and 7.99±2.10 respectively with F-value of 1.58 and p value of 0.085 which was not statistically significant. At 2 months, the mean±SD of NPRS score in Group A was 4.38±2.72, in Group B and Group C were 4.74±2.86 and 6.32±2.31 respectively with F-value of 5.53 and p value of 0.002 which was statistically significant.Conclusions: Pregabalin has the advantages in terms of the NPRS score over gabapentin and amitriptyline. Gabapentin has fewer reported adverse effects and hence better patient compliance on long term use. Amitriptyline is more cost effective than pregabalin which is an important factor to keep in mind while treating patients.


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