viral load monitoring
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2021 ◽  
Vol 11 (2) ◽  
pp. 108-111
Author(s):  
Rakhi M Chandak ◽  
Shivlal M Rawlani ◽  
Pranali S Thakare ◽  
Ramhari S Sathawane ◽  
Ashish B Lanjekar ◽  
...  

Saliva is a valuable tool for early detection, better treatment, and a better prognosis. Early detection of illnesses is sometimes challenging, and it necessitates additional clinical and laboratory tests, which can delay treatment and have a significant impact on prognosis. A large range of chemicals may be found in saliva, providing useful information for clinical diagnostic purposes.The coronavirus disease pandemic (Covid-19) is the world's largest challenge and global health disaster since World War II. Controlling the epidemic in the community and in hospitals requires a quick and precise diagnosis of Covid-19. For Covid-19 diagnostic testing, nasopharyngeal and oropharyngeal swabs are the suggested specimen types.The collection of these specimens necessitates intimate contact between healthcare staff and patients, which increases the risk of viral transmission. As a result, nasopharyngeal or oropharyngeal swabs are not recommended for sequential viral load monitoring. Saliva specimens are simply collected by having the patient spit into a sterile container. Saliva collection is non-invasive and significantly reduces healthcare personnel' exposure to Covid-19. To develop quick chair side assays for the detection of Covid-19, more study is needed to investigate the potential diagnostic of Covid-19 in saliva.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Collins Iwuji ◽  
Meg Osler ◽  
Lusanda Mazibuko ◽  
Natalia Hounsome ◽  
Nothando Ngwenya ◽  
...  

Abstract Background There is poor viral load monitoring (VLM) and inadequate management of virological failure in HIV-positive individuals on antiretroviral therapy in rural KwaZulu-Natal, South Africa. This could be contributing to increasing HIV drug resistance in the setting. This study aims to investigate the clinical and process impediments in VLM within the health system and to evaluate a quality improvement package (QIP) to address the identified gaps. The QIP comprises (i) a designated viral load champion responsible for administrative management and triaging of viral load results (ii) technological enhancement of the routine clinic-based Three Interlinked Electronic Register (TIER.Net) to facilitate daily automatic import of viral load results from the National Health Service Laboratory to TIER.Net (iii) development of a dashboard system to support VLM. Methods/design The study will evaluate the effectiveness of the QIP compared to current care for improving VLM and virological suppression using an effectiveness implementation hybrid type 3 design. This will use a cluster-randomised design with the primary healthcare clinics as the unit of randomisation with ten clinics randomised in a 1:1 ratio to either the intervention or control arm. We will enrol 150 HIV-positive individuals who had been on ART for ≥ 12 months from each of the ten clinics (750 in 5 intervention clinics vs. 750 in 5 control clinics) and follow them up for a period of 12 months. The primary outcome is the proportion of all patients who have a viral load (VL) measurement and are virally suppressed (composite outcome) after 12 months of follow up. Secondary outcomes during follow up include proportion of all patients with at least one documented VL in TIER.Net, proportion with VL ≥ 50 copies/mL, proportion with VL ≥ 1000 copies/mL (virological failure) and subsequent switch to second-line ART. Discussion We aim to provide evidence that a staff-centred quality improvement package, designated viral load monitoring champion, and augmentation of TIER.Net with a dashboard system will improve viral load monitoring and lead to improved virological suppression. Trial registration: This trial is registered on ClinicalTrials.gov on 8 Oct 2021. Identifier: NCT05071573; https://clinicaltrials.gov/ct2/show/NCT05071573?term=NCT05071573&draw=2&rank=1


2021 ◽  
Author(s):  
Minh D. Pham ◽  
Huy V. Nguyen ◽  
David Anderson ◽  
Suzanne Crowe ◽  
Stanley Luchters

Abstract Background Treatment of HIV with antiretroviral therapy (ART) can improve the health of people living with HIV (PLHIV), stop onward transmission of HIV and effectively prevent the spread of the virus. In 2016, we conducted a systematic review to assess the feasibility of treatment monitoring for PLHIV on ART in low and middle-income countries (LMICs), in line with the 90-90-90 treatment target. By 2020, global estimates suggest the 90-90-90 target remains unattainable in many LMICs. This study aims to review the progress and identify needs for public health interventions to improve viral load monitoring and viral suppression for PLHIV in LMICs. Methods A literature search was conducted using an update of the initial search strategy developed for the 2016 review with key search terms relevant to HIV treatment and care, decentralization and viral load monitoring. Electronic databases (Medline and PubMed) were searched to identify relevant literature published in English between Dec 2015 and August 2021. The primary outcome was initial viral load (VL) monitoring (the proportion of PLHIV on ART and eligible for VL monitoring who received a VL test). Secondary outcomes included follow-up VL monitoring (the proportion of PLHIV who received a follow-up VL after an initial elevated VL test), confirmation of treatment failure (the proportion of PLHIV who had two consecutive elevated VL results) and switching treatment regimen rates (the proportion of PLHIV who switched treatment regimen after confirmation of treatment failure). Results The search strategy identified 1984 non-duplicate records, of which 34 studies were included in the review. More than 85% (29/34) of included studies were conducted in 11 sub-Saharan African countries (SSA) using routinely collected program data; two studies were conducted among key populations (KPs) attending research clinics. Sixty per cent (20/34) of these studies were designed to evaluate VL monitoring and/or VL cascade among PLHIV on ART, and most were published in 2019–2021. Marked variations in initial VL monitoring coverage were reported across study settings/countries (range: 12–93% median: 74% IQR: 46-82%) and study populations (adults (range: 25–96%, median: 67% IQR: 50-84%), children, adolescents/young people (range: 2–94%, median: 72% IQR: 47-85%), and pregnant women (range: 32–82%, median: 57% IQR: 43-71%)). Community-based models reported higher VL monitoring (median: 85%, IQR: 82%-88%) compared to decentralised care at primary health facility (median: 64%, IRQ: 48%-82%). Suboptimal uptake of follow-up VL monitoring and low regimen switching rates were observed. Conclusions There was a marked increase in the number of studies of VL monitoring for PLHIV on ART in LMICs over the past five years. Substantial gaps in VL coverage across study settings and study populations were evident, with limited data availability outside of SSA and in KPs. Further research is needed to fill the data gaps. Development and implementation of innovative, community-based interventions are required to improve VL monitoring and address the “failure cascade” in PLHIV on ART who fail to achieve viral suppression.


2021 ◽  
Vol 3 ◽  
Author(s):  
Anne Kaggiah ◽  
Grace Kimemia ◽  
Hellen Moraa ◽  
Peter Muiruri ◽  
John Kinuthia ◽  
...  

Human immunodeficiency virus-serodiscordant couples are an important source of new HIV infections in Africa. When trying to conceive, uninfected partners may be at high risk of infection if the infected partner is not virally suppressed. Multiple strategies targeting safer conception exist, but these services are limited. However, when services are available and used, serodiscordant couples can be protected from HIV transmission, and safe to have children if desired. To successfully introduce, integrate, promote, and optimize the service delivery of safer conception with HIV care, it is crucial to understand how HIV-serodiscordant couples perceive and experience these services. Further, viral load monitoring can be critical to safer conception, but there is limited literature on how it informs the decision of the partners about conception. This qualitative study describes the knowledge, perceptions, and experiences of both safer conception services and viral load monitoring among 26 HIV-serodiscordant couples seeking safer conception care at a referral hospital in Nairobi, Kenya. In-depth interviews of HIV-serodiscordant couples were conducted from April to July 2017, and transcripts were analyzed to identify the themes central to the experience of safer conception services of couples and viral load monitoring. Serodiscordant couples reported success in using some of the safer conception methods and had positive experiences with healthcare providers. However, despite using the services, some were concerned about HIV transmission to the seronegative partner and baby, while others faced challenges when using pre-exposure prophylaxis (PrEP) and vaginal insemination. Overall, their motivation to have children overcame their concern about HIV transmission, and they welcomed discussions on risk reduction. Moreover, supportive clinic staff was identified as key to facilitating trust in safer conception methods. Furthermore, viral load monitoring was identified as integral to safer conception methods, an emerging theme that requires further evaluation, especially where routine viral load monitoring is not performed. In conclusion, healthcare providers offering safer conception services should build trust with couples, and recognize the need for continual couple counseling to encourage the adoption of safer conception services.


2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S534-S535
Author(s):  
Gerald Pierone ◽  
Jennifer S Fusco ◽  
Laurence Brunet ◽  
Cassidy Henegar ◽  
Jean A van Wyk ◽  
...  

Abstract Background The COVID-19 pandemic has disrupted health care services for people living with HIV (PLWH). This study aimed to compare rates of clinical visits, viral load monitoring and antiretroviral therapy (ART) regimen discontinuation among virally suppressed PLWH in the US before and during the COVID pandemic. Methods The study population consisted of ART-experienced PLWH ≥18 years of age and active in care in the OPERA cohort within 2 years prior to 31OCT2020. Virally suppressed PLWH (i.e., viral load < 200 copies/mL) were included if they switched to either dolutegravir/lamivudine or a dolutegravir- or bictegravir-based 3-drug regimen between 01MAY2019 and 30APR2020. The study periods spanned from 01MAY2019 to 28FEB2020 (pre-COVID) and 01MAR2020 to 31OCT2020 (during COVID). Incidence rates of clinical visits, viral load measurements and regimen discontinuation were estimated using univariate Poisson regression for both study periods. In-person visits comprised any scheduled or walk-in outpatient, inpatient, emergency or laboratory visit. Telehealth visits comprised any phone or video encounters. Results The study included 4806 PLWH in the pre-COVID and 4992 in the COVID period. Rates of in-person visits were reduced almost 2-fold during COVID, while telehealth visits increased almost 9-fold, resulting in an overall reduction in any visits rates from 10.07 visits per person-year (95% CI: 9.93, 10.21) pre-COVID to 7.10 (95% CI: 7.01, 7.19) during COVID [Fig 1]. Rates of viral load measurements dropped from 2.99 viral loads per person-year (95% CI: 2.92, 3.07) pre-COVID to 1.97 (95% CI: 1.92, 2.02) during COVID [Fig 2]. Regimen discontinuation rates were also reduced from 14.3 discontinuations per 100 person-years pre-COVID (95% CI: 12.7, 16.1) to 9.6 (95% CI: 8.6, 10.8) during COVID [Fig 3]. In both study periods, virologic failures were detected in < 1% of PLWH with ≥ 1 viral load. Figure 1. Incidence rates for overall, in-person, and telehealth visits during the pre-COVID (open circle) and the COVID (filled circle) study periods Incidence rates for viral load measurements during the pre-COVID (open circle) and the COVID (filled circle) study periods Incidence rates for regimen discontinuation during the pre-COVID (open circle) and the COVID (filled circle) study periods Conclusion The COVID pandemic has led to an important reduction in the frequency and type of clinical follow-up visits and viral load monitoring among virally suppressed PLWH in the US. A reduction in regimen discontinuation rates was also observed, presumably associated to less frequent follow-up. The long-term impact of the pandemic on HIV care remains uncertain. Disclosures Gerald Pierone, MD, Epividian (Board Member) Jennifer S. Fusco, BS, Epividian, inc (Employee) Laurence Brunet, PhD, Epividian, inc (Employee) Cassidy Henegar, PhD, GSK (Shareholder)ViiV Healthcare (Employee) Jean A. van Wyk, MB,ChB, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee) Supriya Sarkar, PhD, GSK (Shareholder)ViiV Healthcare (Employee) Vani Vannappagari, MBBS, MPH, PhD, ViiV Healthcare Limited (Employee) Andrew Zolopa, MD, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee) Michael B. Wohlfeiler, MD, Epividian, inc (Board Member)ViiV Healthcare (Research Grant or Support) Gregory Fusco, MD, MPH, Epividian, inc (Employee)


2021 ◽  
Vol 36 (2) ◽  
Author(s):  
Angela Saraiello ◽  
Federica Ferrentino ◽  
Nunzia Cuomo ◽  
Maria Grimaldi ◽  
Erasmo Falco ◽  
...  

Background and aims. Real-time reverse transcription polymerase chain reaction (RT-PCR) is the gold-standard assay to detect SARS-CoV-2, but it has limitations compared to viral load analysis. Quantitative detection improves surveillance, diagnosis, and prevention. We performed a comparative study of qualitative and quantitative tests for the diagnosis of COVID-19 on respiratory samples from patients screened for SARS-CoV-2 infection, and explored the correlation between viral load compared to the threshold cycle (Ct) value obtained in RT-PCR.Materials and methods. Sixty respiratory samples from patients affected by SARS-CoV-2 were subjected to both the qualitative (Allplex ™ 2019-nCoV Seegene) and the quantitative (Clonit® Quanty COVID-19) assays, and the relationship between viral load and Ct value was assessed by Spearman correlation analysis (ρ). In addition, the viral load of samples collected from a patient with symptomatic cancer was monitored. Results. The results show 100% agreement between the results obtained with quantitative assay and the reference standards, whereas 99.2% agreement was found for the qualitative test. A strong negative Spearman’s correlation between the Ct values of the N genes and RdRP gene was observed from qualitative assay values and viral loads.Conclusions. Quantitative assay has a higher sensitivity than qualitative assay, and viral load testing allows the clinicians to better orient themself in the choice of therapeutic treatment to be adopted. The constantly higher viral load of clinical cases considered, irrespective of the different therapies used, confirms that viral load monitoring could represent a great advantage in clinical practice.


2021 ◽  
Author(s):  
Yue Qiu ◽  
Ling Lu ◽  
Dexiang Gao ◽  
Patrick McGrath ◽  
Chann Han ◽  
...  

Real-time quantitative reverse transcriptase polymerase chain reaction (RT-qPCR) remains the foundation of SARS-CoV-2 testing due to its accessibility, scalability, and superior assay performance. Variability in specimens and methods prevent standardization of RT-qPCR assays and reliable quantitative reporting to assess viral load. We developed an extraction-free RT-qPCR assay for detection of SARS-CoV-2 in saliva and monitored viral load until convalescence in COVID-19 patients. Comparison of 231 matched anterior nares swab and saliva specimens demonstrated that extraction-free testing of saliva has equivalent analytical and clinical assay performance compared to testing of RNA extracts from either anterior nares or saliva specimens. Analysis of specimen pairs revealed higher viral loads in the nasal cavity compared to the oral cavity, although this difference did not impact clinical sensitivity for COVID-19. Extraction-free testing of a combination specimen consisting of both nasal swab and saliva is also demonstrated. Assessment of viral load by RT-qPCR and parallel digital droplet PCR (ddPCR) revealed that cycle threshold (Ct) values less than approximately 30 correlated well with viral load, whereas Ct values greater than 30 correspond to low viral loads <10 copies/uL. Therefore, extraction-free saliva testing maximizes testing efficiency without compromising assay performance and approximates viral loads >10 copies/uL. This technology can facilitate high-throughput laboratory testing for SARS-CoV-2, monitor viral load in individual patients, and assess efficacy of therapies for COVID-19.


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