scholarly journals Incidence of neuropsychiatric side effects of efavirenz in HIV-positive treatment-naïve patients in public-sector clinics in the Eastern Cape

2016 ◽  
Vol 17 (1) ◽  
Author(s):  
Razia Gaida ◽  
Ilse Truter ◽  
Christoffel Grobler
Keyword(s):  
Public Sector ◽  
Side Effects ◽  
Third Party ◽  
Hiv Positive ◽  
Eastern Cape ◽  
True Incidence ◽  
Treatment Naïve ◽  
Positive Treatment ◽  
Neuropsychiatric Side Effects

Background: It is acknowledged that almost half of patients initiated on efavirenz will experience at least one neuropsychiatric side effect.Objectives: The aim was to determine the incidence and severity of neuropsychiatric side effects associated with efavirenz use in five public-sector primary healthcare clinics in the Eastern Cape.Method: The study was a prospective drug utilisation study. A total of 126 medical records were reviewed to obtain the required information. After baseline assessment, follow-up reviews were conducted at 4 weeks, 12 weeks and 24 weeks from 2014 to 2015.Results: The participant group was 74.60% female (n = 94), and the average age was 37.57±10.60 years. There were no neuropsychiatric side effects recorded for any patient. After the full follow-up period, there were a total of 49 non-adherent patients and one patient had demised. A non-adherent patient was defined as a patient who did not return to the clinic for follow-up assessment and medication refills 30 days or more after the appointed date. Some patients (n = 11) had sent a third party to the clinic to collect their antiretroviral therapy (ART). The clinic pharmacy would at times dispense a two-month supply of medication resulting in the patient presenting only every two months.Conclusion: Further pharmacovigilance studies need to be conducted to determine the true incidence of these side effects. Healthcare staff must be encouraged to keep complete records to ensure meaningful patient assessments. Patients being initiated on ART need to personally attend the clinic monthly for at least the first 6 months of treatment. Clinic staff should receive regular training concerning ART, including changes made to guidelines as well as reminders of side effects experienced.Keywords: neuropsychiatric; side effects; efavirenz; HIV-positive patients

scholarly journals Pharmacokinetics of maraviroc administered at 150 mg once daily in association with lopinavir/ritonavir in HIV-positive treatment-naive patients

2013 ◽  
Vol 68 (7) ◽  
pp. 1686-1688 ◽  
Author(s):  
A. Calcagno ◽  
S. Nozza ◽  
D. G. de Requena ◽  
A. Galli ◽  
A. D'Avolio ◽  
...  
Keyword(s):  
Hiv Positive ◽  
Once Daily ◽  
Treatment Naïve ◽  
Positive Treatment

scholarly journals Ocrelizumab initiation in patients with MS

2020 ◽  
Vol 7 (4) ◽  
pp. e719 ◽  
Author(s):  
Erik Ellwardt ◽  
Leoni Rolfes ◽  
Julia Klein ◽  
Katrin Pape ◽  
Tobias Ruck ◽  
...  
Keyword(s):  
Side Effects ◽  
Disease Course ◽  
Relapsing Remitting ◽  
Immune Therapies ◽  
Treatment Naïve ◽  
Previously Treated Patients ◽  
Pretreated Patients ◽  
Previously Treated ◽  
Class Iv

ObjectiveTo provide first real-world experience on patients with MS treated with the B cell–depleting antibody ocrelizumab.MethodsWe retrospectively collected data of patients who had received at least 1 treatment cycle (2 infusions) of ocrelizumab at 3 large neurology centers. Patients' characteristics including premedication, clinical disease course, and documented side effects were analyzed.ResultsWe could identify 210 patients (125 women, mean age ± SD, 42.1 ± 11.4 years) who had received ocrelizumab with a mean disease duration of 7.3 years and a median Expanded Disability Status Scale score of 3.75 (interquartile range 2.5–5.5; range 0–8). Twenty-six percent of these patients had a primary progressive MS (PPMS), whereas 74% had a relapsing-remitting (RRMS) or active secondary progressive (aSPMS) disease course. Twenty-four percent of all patients were treatment naive, whereas 76% had received immune therapies before. After ocrelizumab initiation (median follow-up was 200 days, range 30–1,674 days), 13% of patients with RRMS/aSPMS experienced a relapse (accounting for an annualized relapse rate of 0.17, 95% CI 0.10–0.24), and 5% of all patients with MS experienced a 12-week confirmed disability progression. Treatment was generally well tolerated, albeit only short-term side effects were recorded, including direct infusion-related reactions and mild infections.ConclusionsWe provide class IV evidence that treatment with ocrelizumab can stabilize naive and pretreated patients, indicating that ocrelizumab is an option following potent MS drugs such as natalizumab and fingolimod. Further studies are warranted to confirm these findings and to reveal safety concerns in the longer-term follow-up.Classification of evidenceThis study provides Class IV evidence that for patients with MS, ocrelizumab can stabilize both treatment-naive and previously treated patients.

Combination of Transplantation of Haploidentical Human Mesenchymal Stem Cells and Rituximab Therapy in a Patient with Extensive Therapy-Refractory Chronic Graft Versus Host Disease.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 5290-5290
Author(s):  
L. Mueller ◽  
M. Christopeit ◽  
J. Luetzkendorf ◽  
K. Reichelt ◽  
E. Schlesinger ◽  
...  
Keyword(s):  
Side Effects ◽  
Graft Versus Host Disease ◽  
Liver Enzymes ◽  
Lymphoproliferative Disease ◽  
Third Party ◽  
Treatment Schedule ◽  
Host Disease ◽  
Graft Versus Host

Abstract Background Novel treatment options with reduced side effects against therapy refractory chronic Graft versus Host Disease are urgently warranted. Human marrow stromal cells (hMSC) posses an immunosuppressive potential and have been successfully applied in acute GvHD. The monoclonal anti-CD20 antibody (rituximab) comprises immunosuppression through reduction of B-lymphocytes. Here, we report a patient with refractory cGvHD in whom conventional immunosuppression could be terminated after treatment with rituximab and haploidentical hMSC. Patient and methods A 48-year old Caucasian female received an allogeneic DRB1/DQB1/Cw mismatched unrelated transplant for AML in 2. CR. GvHD grade 2 – 3 was recorded day +11. Treatment of repeated exacerbation of GvHD over the course of 5 ½ years included ciclosporin (CsA), mycophenolat mofetil, tacrolimus, steroids. Treatment-associated complications included pneumonia requiring mechanical ventilation, deep venous thrombosis with pulmonary embolism, cerebral toxoplasmosis, renal failure, AV-reentry tachycardia, encephalopathy and CMV reactivation. Increasing sicca symptoms with deterioration of visual capacity, generalized sclerodermic skin changes and recurrent elevation of cholestasis-markers were noted 66 months after HSCT. A chronic extensive GvHD affecting skin and liver was diagnosed clinically. 67 and 68 months after HSCT EBV-reactivation was noted repeatedly and rituximab was given two times at a 4 week interval to prevent post-transplant lymphoproliferative disease. Analysis of serum liver enzymes, immunphenotyping of leukocytes and regulatory T-cells were performed weekly. Results After rituximab-treatment a stable clinical condition with persisting CR and 100% donor chimerism was noted allowing reduction of CsA to 50 mg p.o. daily. Subsequently, an experimental treatment for refractory cGvHD with third party hMSC was performed after obtaining informed consent and approval by the institutional ethics review board. 100ml sodium-citrate bone marrow aspirate were obtained from the healthy haploidentical son of the patient. hMSC were expanded over 2 passages under GMP conditions. 72 months after HSCT, 1,4 × 106 hMSC/kg were transplanted without complications. In the light of subjective improvement, CsA was stopped 3 days after hMSC transplantation. At present within a short follow up of 3 weeks, the patient remains off immunosuppression with stable sicca syndrome and skin alterations, without detectable infection or signs of deterioration of suspected liver GvHD. No adverse events were recorded. Among other evaluable data, an improvement of liver enzymes and a decrease in lymphocytosis have been observed. Further follow-up will be presented at the meeting. Conclusion The patient presented experienced refractory GvHD and respective treatment accompanied by life threatening adverse effects. The stabilization of GvHD upon rituximab-treatment supports recent reports on a reduction of GvHD incidence in rituximab-treated patients after allogeneic HSCT. Our data prove that the transplantation of hMSC in patients with cGvHD is safe without relevant side effects. Further investigation regarding the dose, treatment schedule and probable in-vitro priming of hMSC are needed and encouraged by our observation.

scholarly journals Dolutegravir induced sub-acute hepatic failure in HIV positive treatment naïve man in Botswana

2019 ◽  
Vol 6 (4) ◽  
pp. 5
Author(s):  
Godfrey Mutashambara Rwegerera ◽  
Munashe Rimbi ◽  
Vimbai Mudhina ◽  
Marang Tiny Simone ◽  
Moranodi Sefo ◽  
...  
Keyword(s):  
Hepatic Failure ◽  
Hepatic Injury ◽  
Acute Hepatic Failure ◽  
Hiv Positive ◽  
Close Monitoring ◽  
Naive Patient ◽  
Treatment Naïve ◽  
Positive Treatment

Dolutegravir associated hepatic failure has rarely been reported. Hepatic failure can occur either acutely or after few weeks as it happened in our patient. We report a case of 61 years old HIV-positive treatment naïve patient who started experiencing features of hepatic injury one month after starting Dolutegravir-based regimen. Patient presented late with overt hepatic failure. We emphasize the importance of close monitoring both at initiation and long-term so as identify patients with early hepatic injury and limit fatal outcomes which are potentially avoidable.

scholarly journals Cognıtıve Assessment of Young Adults Before and After Inıtıatıon of Combınatıon Antıretrovıral Therapy

2021 ◽  
Author(s):  
Özlem Gül ◽  
Alper Gündüz ◽  
Dilek Yıldız Sevgi ◽  
Nuray Uzun ◽  
İlyas Dökmetaş
Keyword(s):  
Antiretroviral Therapy ◽  
Cognitive Functions ◽  
Cognitive Assessment ◽  
Hiv Positive ◽  
Combination Antiretroviral Therapy ◽  
Factors Affecting ◽  
Before And After ◽  
Treatment Naïve ◽  
Positive Treatment ◽  
Moca Score

Abstract Background: This study aimed to evaluate cognitive functions and the factors affecting them in naive HIV-positive patients by Montreal Cognitive Assessment (MoCA) test before and after the initiation of combination antiretroviral therapy. Method: HIV-positive, treatment-naive patients monitored between January-June 2017 were included in the study. MoCA test was performed at the beginning and the 6th month of the treatment.Findings: Forty male patients were included in the study. The mean age was calculated as 29.1±4.0. When the factors affecting the MoCA score were examined, there was a significant relationship between the education level and the MoCA score. Smoking ,alcohol and substance did not have a meaningful impact on baseline MoCA values. A significant correlation was found between CD4 count and HIV RNA level and attention function. There was a significant increase in the total MoCA score and the MoCA subgroup scores at the end of the 6th month of the treatmentConclusion: MoCA test is one of the practical tests that can be applied in a short time period and it was found useful in evaluating the changes in the cognitive functions of HIV positive patients during antiretroviral treatment.

scholarly journals Renal Function among HIV Infected Patients on Combination Antiretroviral Therapy: ALongitudinal Cohort Study

2021 ◽  
Author(s):  
Bijaya Kumar Behera ◽  
Sritam Acharya ◽  
Sukanta Kumar Jena ◽  
Keshaba Chandra Budula
Keyword(s):  
Renal Function ◽  
T Cell ◽  
Cell Count ◽  
Cd4 T Cell ◽  
Hiv Positive ◽  
P Value ◽  
Treatment Naïve ◽  
Positive Treatment ◽  
The Mean ◽  
Cd4 T Cell Count

Introduction: A large number of Human Immunodeficiency Virus (HIV) infected patients are taking combination Antiretroviral Therapy (cART) worldwide as it has led to dramatic improvements in them with a decreased viral load as well as an increase in Cluster of Differentiation (CD4+) T cell count. Though the incidence of HIV associated Chronic Kidney Disease (CKD) has decreased with the use of effective cART, the prevalence of End Stage Renal Disease (ESRD) in HIV positive patients has increased due to the risen longevity owing to them. Aim: To study the renal function abnormalities in HIV infected patients and to compare the change in renal function of treatment naïve patients with patients on triple drug regimen (cART). Materials and Methods: This prospective longitudinal cohort study was conducted on 54 Enzyme Linked Immunosorbent Assay (ELISA) positive HIV patients belonging to the age group of 18-70 years of both the genders over a period of two years from August 2017 to September 2019 in MKCG Medical College and Hospital, Berhampur, Odisha, India. Forty nine HIV infected patients naive to cART and five patients on cART for a minimum period of three months were included in this study. All patients were treated with triple therapy regimens of either ZLN (Zidovudine 300 mg+Lamivudine 150 mg+Nevirapine 200 mg) or TLE (Tenofovir 300 mg+Lamivudine 150+Efavirenz 600 mg) daily; in a single dose at bed time. Renal function parameters like serum urea, serum creatinine, Creatinine Clearance (CrCl), estimated Glomerular Filtration Rate (eGFR) and CD4+ T cell count of treatment naive patients were compared with the same patients on cART after six months duration. GFR was calculated by Modification of Diet in Renal Disease (MDRD) equation. Results were analysed using the Statistical Package for the Social Sciences (SPSS) software for Windows Version 17.0. Results: Out of 54 patients, 53.7% (n=29) were males and 46.3% (n=25) were females. The mean CrCl of HIV positive patients on cART (79.09±25.705 mL/min) was higher than treatment naive (69.65±25.506 mL/min) patients and was highly significant (p-value=0.003). The mean eGFR of HIV positive patients on cART (102.711±26.9424 mL/min/1.73 m2) was higher than treatment naïve (90.189±28.2575 mL/min/1.73 m2) patients and was highly significant (p-value=0.003). The mean serum urea of HIV positive patients on cART (25.78± 4.721 mg/dL) was lower than HIV positive treatment naïve (26.19±4.742 mg/dL) patients but was non-significant (p-value=0.640). The mean serum creatinine of HIV positive patients on cART (0.815±0.1393 mg/dL) was lower than HIV positive treatment naïve patients (0.906±0.1687 mg/dL) and was also highly significant (p-value=0.003). The mean CD4+ T cell count of HIV positive patients on cART (401.63±225.816 cells/μL) was higher than HIV positive treatment naïve (287.13±198.263 cells/μL) patients and was very highly significant (p=0.001). Conclusion: Renal impairment (CrCl <60 mL/min) and eGFR (<60 mL/min/1.73 m2) were higher in HIV positive treatment naive patients than those on cART. Radiological parameters like size of the kidney and cortical echogenicity became normal after six months on cART.

scholarly journals Immune activation is associated with decreased thymic function in asymptomatic, untreated HIV-infected individuals

2016 ◽  
Vol 17 (1) ◽  
Author(s):  
Thandiwe Manjati ◽  
Bongani Nkambule ◽  
Hayley Ipp
Keyword(s):  
Viral Load ◽  
Immune Activation ◽  
Hiv Positive ◽  
Thymic Function ◽  
Cd4 Counts ◽  
Inflammatory Damage ◽  
Combined Antiretroviral Therapy ◽  
Treatment Naïve ◽  
Positive Treatment ◽  
Immunological Reconstitution

Background: Reduced thymic function causes poor immunological reconstitution in human immunodeficiency virus (HIV)-positive patients on combined antiretroviral therapy (cART).The association between immune activation and thymic function in asymptomatic HIV positive treatment-naive individuals has thus far not been investigated.Aims and objectives: To optimise a five-colour flow cytometric assay for measurement of thymic function by measuring recent thymic emigrants (RTEs) in treatment-naive HIV-infected patients and healthy controls and correlate results with levels of immune activation, CD4 counts and viral load.Methods: Blood obtained from 53 consenting HIV-positive individuals and 32 controls recruited from HIV prevention and testing clinic in Cape Town, South Africa. RTEs were measured (CD3+/CD4+/CD45RA+/CD31+/CD62L+) and levels were correlated with CD4 counts of HIV-infected individuals, log viral load and levels of immune activation (CD8+/CD38+ T-cells).Results: HIV-infected individuals had reduced frequencies of RTEs when compared to controls (p = 0.0035). Levels of immune activation were inversely correlated with thymic function(p = 0.0403), and the thymic function in HIV-infected individuals showed no significant correlation with CD4 counts (p = 0.31559) and viral load (p = 0.20628).Conclusions: There was impaired thymic function in HIV-infected individuals, which was associated with increased levels of immune activation. The thymic dysfunction was not associated with CD4 counts and viral load. Immune activation may result in inflammatory damage to the thymus and subsequent thymic dysfunction, and CD4 counts and viral load may not necessarily reflect thymic dysfunction in HIV.

scholarly journals Early post-partum viremia predicts long-term non-suppression of viral load in HIV-positive women on ART in Malawi: Implications for the elimination of infant transmission

PLoS ONE ◽  
2021 ◽  
Vol 16 (3) ◽  
pp. e0248559
Author(s):  
Megan Landes ◽  
Monique van Lettow ◽  
Joep J. van Oosterhout ◽  
Erik Schouten ◽  
Andrew Auld ◽  
...  
Keyword(s):  
Viral Load ◽  
Limit Of Detection ◽  
Post Partum ◽  
Multivariable Analysis ◽  
Sub Saharan Africa ◽  
Hiv Positive ◽  
True Incidence ◽  
Adherence Support

Background Long-term viral load (VL) suppression among HIV-positive, reproductive-aged women on ART is key to eliminating mother-to-child transmission (MTCT) but few data exist from sub-Saharan Africa. We report trends in post-partum VL in Malawian women on ART and factors associated with detectable VL up to 24 months post-partum. Methods 1–6 months post-partum mothers, screened HIV-positive at outpatient clinics in Malawi, were enrolled (2014–2016) with their infants. At enrollment, 12- and 24-months post-partum socio-demographic and PMTCT indicators were collected. Venous samples were collected for determination of maternal VL (limit of detection 40 copies/ml). Results were returned to clinics for routine management. Results 596/1281 (46.5%) women were retained in the study to 24 months. Those retained were older (p<0.01), had higher parity (p = 0.03) and more likely to have undetectable VL at enrollment than those lost to follow-up (80.0% vs 70.2%, p<0.01). Of 590 women on ART (median 30.1 months; inter-quartile range 26.8–61.3), 442 (74.9%) with complete VL data at 3 visits were included in further analysis. Prevalence of detectable VL at 12 and 24 months was higher among women with detectable VL at enrollment than among those with undetectable VL (74 detectable VL results/66 women vs. 19/359; p<0.001). In multivariable analysis (adjusted for age, parity, education, partner disclosure, timing of ART start and self-reported adherence), detectable VL at 24 months was 9 times more likely among women with 1 prior detectable VL (aOR 9.0; 95%CI 3.5–23.0, p<0.001) and 226 times more likely for women with 2 prior detectable VLs (aOR 226.4; 95%CI 73.0–701.8, p<0.001). Conclusions Detectable virus early post-partum strongly increases risk of ongoing post-partum viremia. Due to high loss to follow-up, the true incidence of detectable VL over time is probably underestimated. These findings have implications for MTCT, as well as for the mothers, and call for intensified VL monitoring and targeted adherence support for women during pregnancy and post-partum.

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