Intensive Treatment With Ivermectin and Iota-Carrageenan as Pre-exposure Prophylaxis for COVID-19 in Health Care Workers From Tucuman, Argentina.
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ABSTRACT:
SUBMITTER: Chahla RE
PROVIDER: S-EPMC8415509 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundIvermectin is a drug that has been shown to be active against coronavirus disease 19 (COVID-19) in previous studies. Healthcare personnel are highly exposed to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Therefore, we decided to offer them ivermectin as a pre-exposure prophylaxis (PrEP) method.PurposePrimary outcome was to measure the number of healthcare workers with symptomatic SARS-CoV-2 infection and a positive reverse transcription polymerase chain reaction (RT-PCR) COVID-19 test in the ivermectin group and in the control group. Secondary outcome was to measure the number of sick healthcare workers with a positive RT-PCR COVID-19 test whose condition deteriorated and required hospitalization and/or an Intensive Care Unit (ICU), or who died, in the ivermectin group and in the control group.Material and methodsThis observational and retrospective cohort study was carried out in two medical centers, Centro Medico Bournigal (CMBO) in Puerto Plata and Centro Medico Punta Cana (CMPC) in Punta Cana, Dominican Republic. The study began on June 29, 2020, and ended on July 26, 2020. A Statistical Package for Social Sciences (SPSS) Propensity Score Matching procedure was applied in a 1:1 ratio to homogeneously evaluate 271 healthcare personnel that adhered to a PrEP program with ivermectin at a weekly oral (PO) dose of 0.2 mg/kg, and 271 healthcare personnel who did not adhere to the program were assigned as a control group.ResultsIn 28 days of follow-up, significant protection of ivermectin preventing the infection from SARS-CoV-2 was observed: 1.8% compared to those who did not take it (6.6%; p-value = 0.006), with a risk reduction of 74% (HR 0.26, 95% CI [0.10,0.71]). Conclusions: These results suggest that compassionate use of weekly ivermectin could be an option as a preventive method in healthcare workers and as an adjunct to immunizations, while further well-designed randomized controlled trials are developed to facilitate scientific consensus.
| S-EPMC8405705 | biostudies-literature
Project description:Purpose: In Argentina, transgender women face a disproportionately high prevalence of HIV infection (34%). Although not currently approved in Argentina, pre-exposure prophylaxis (PrEP) may offer a potential effective HIV prevention tool for this population. In this study, we assessed the willingness to use PrEP among transgender women in Argentina. Methods: Data were drawn from a nationwide cross-sectional survey conducted among transgender women in 2013. Using multivariable logistic regression, we assessed the prevalence of and factors associated with willingness to use PrEP among transgender women with negative or unknown HIV status. Results: This study included 337 transgender women (278 HIV negative and 59 with unknown HIV status), most of whom had a history of sex work involvement (81.8%). Overall, 301 (89.3%) expressed willingness to use PrEP. In a multivariable analysis, having casual sexual partners was positively associated with willingness to use PrEP (adjusted odds ratio [AOR]=4.26, 95% confidence interval [CI] 1.73-10.51), while discrimination by healthcare workers was negatively associated (AOR=0.33, 95% CI 0.12-0.88). Conclusion: We found high levels of willingness to use PrEP among transgender women in Argentina, suggesting that there is high perception of HIV risk in this population. However, discrimination by healthcare workers was a strong negative correlate of willingness to use PrEP, suggesting that multilevel interventions that address gender-based stigma in healthcare settings will be critical for the success of PrEP as an HIV prevention strategy in this population.
| S-EPMC5367484 | biostudies-other
Project description: Not available
| S-EPMC7717339 | biostudies-literature
Project description:There are too many new HIV infections globally with 1.8 million persons infected in 2016 alone. Pre-exposure prophylaxis (PrEP) holds potential to decrease new infections and is synergistic with efforts currently in place to achieve an end to the AIDS epidemic in Sub-Saharan African, but uptake is limited. Given its novelty, assessing the beliefs and attitudes of healthcare professionals and members of the community towards HIV transmission and PrEP will be helpful to inform implementation efforts. Study was a random survey of 201 community members and 51 healthcare providers, carried out at multiple community sites in Huye district, Southern Province, Rwanda and at Kigali University Teaching Hospital (KUTH). The study findings are that there are still misconceptions about HIV in the community with some respondents believing that HIV is due to punishment from God (5.4%), poverty (3.0%), smoking cigarettes (1.0%), drinking alcohol (2.0%), punishment from ancestors (1.0%) and witchcraft (1.5%), and that its transmission is by mosquito bites (10.9%), sharing food or drinks with a HIV infected person (6.5%) or as a result of carelessness (47.8%). More than 50% of respondents from both groups had insufficient knowledge regarding PrEP, but expressed some interest in PrEP (82.6% of the respondents from the community and 86.5% of the health workers). However, some healthcare workers felt that promotion of safe sex practices (74.5%), HIV testing and treating HIV infected patients (60.8%) would work better than PrEP to decrease new HIV infections. Barriers to PrEP implementation included perceived stigma, delayed access to prevention services at the health facilities while personal-level concerns included lack of family support, reluctance to take a medication daily and fear of being perceived as having HIV. This study showed that health care workers and community members are willing to utilize PrEP in Rwanda, but many challenges exist including limited knowledge about PrEP, stigma, provider and system level service delivery barriers at health facilities among others. More studies are needed to assess ways of addressing and /or eliminating these barriers.
| S-EPMC6261021 | biostudies-literature
Project description:ObjectivesAcceptability of pre-exposure prophylaxis (PrEP) and willingness to participate in a clinical trial for both safety and efficacy of PrEP were investigated among female sex workers (FSWs) in Guangxi, China.MethodsA cross-sectional study was performed in three cities in Guangxi. Structured, self-administered questionnaires were used to assess the acceptability of PrEP and the willingness to participate in a clinical trial. Multivariable logistic regression models were fitted to identify predictors.ResultsAmong 405 participants, 15.1% had heard of PrEP. If PrEP was deemed to be effective, safe and provided for free, 85.9% reported that they would accept it, and 54.3% of those who accepted PrEP said that they would participate in a clinical trial. The increased acceptability of PrEP was associated with working in male dominated venues, higher income, a poor family relationship, better HIV/AIDS knowledge, not realizing HIV risk from unfamiliar clients, not being forced to use condoms by the gatekeepers, consistent use of condoms, and use of drugs to prevent STD infection. The increased willingness to participate in a clinical trial was associated with a poor family relationship, better HIV/AIDS knowledge, not realizing HIV risk from unfamiliar clients, a willingness to adhere to daily PreP use, and not being concerned about discrimination by others. The main reason for rejecting PrEP or participating in a clinical trial was the concern about the side effects of PrEP.ConclusionsAcceptability of PrEP among Guangxi FSWs is relatively high, indicating that PrEP intervention programs may be feasible for Chinese FSWs. Given the fact that most of the participants had never heard of PrEP before, and that family, gatekeepers, and social discrimination could significantly affect its acceptability, a comprehensive mix of multiple interventions is necessary for the successful implementation of a PrEP program among this population in Guangxi.
| S-EPMC3899205 | biostudies-literature
Project description:Little is known about the potential population-level impact of HIV pre-exposure prophylaxis (PrEP) use among cisgender male sex workers (MSWs), a high-risk subset of cisgender men who have sex with men (MSM). Using an agent-based model, we simulated HIV transmission among cisgender MSM in Rhode Island to determine the impacts of PrEP implementation where cisgender MSWs were equally ("standard expansion") or five times as likely ("focused expansion") to initiate PrEP compared to other cisgender MSM. Without PrEP, the model predicted 920 new HIV infections over a decade, or an average incidence of 0.39 per 100 person-years. In a focused expansion scenario where 15% of at-risk cisgender MSM used PrEP, the total number of new HIV infections was reduced by 58.1% at a cost of $57,180 per quality-adjusted life-year (QALY) gained. Focused expansion of PrEP use among cisgender MSWs may be an efficient and cost-effective strategy for reducing HIV incidence in the broader population of cisgender MSM.
| S-EPMC7101419 | biostudies-literature
Project description:BACKGROUND:Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a rapidly emerging virus causing the ongoing Covid-19 pandemic with no known effective prophylaxis. We investigated whether hydroxychloroquine could prevent SARS CoV-2 in healthcare workers at high-risk of exposure. METHODS:We conducted a randomized, double-blind, placebo-controlled clinical trial of healthcare workers with ongoing exposure to persons with Covid-19, including those working in emergency departments, intensive care units, Covid-19 hospital wards, and first responders. Participants across the United States and in the Canadian province of Manitoba were randomized to hydroxychloroquine 400mg once weekly or twice weekly for 12 weeks. The primary endpoint was confirmed or probable Covid-19-compatible illness. We measured hydroxychloroquine whole blood concentrations. RESULTS:We enrolled 1483 healthcare workers, of which 79% reported performing aerosol-generating procedures. The incidence of Covid-19 (laboratory-confirmed or symptomatic compatible illness) was 0.27 events per person-year with once-weekly and 0.28 events per person-year with twice-weekly hydroxychloroquine compared with 0.38 events per person-year with placebo. For once weekly hydroxychloroquine prophylaxis, the hazard ratio was 0.72 (95%CI 0.44 to 1.16; P=0.18) and for twice weekly was 0.74 (95%CI 0.46 to 1.19; P=0.22) as compared with placebo. Median hydroxychloroquine concentrations in whole blood were 98 ng/mL (IQR, 82-120) with once-weekly and 200 ng/mL (IQR, 159-258) with twice-weekly dosing. Hydroxychloroquine concentrations did not differ between participants who developed Covid-19 (154 ng/mL) versus participants without Covid-19 (133 ng/mL; P=0.08). CONCLUSIONS:Pre-exposure prophylaxis with hydroxychloroquine once or twice weekly did not significantly reduce laboratory-confirmed Covid-19 or Covid-19-compatible illness among healthcare workers.
| S-EPMC7523161 | biostudies-literature
Project description:Carrageenan has been widely used as food additive for decades and therefore, an extended oral data set is available in the public domain. Less data are available for other routes of administration, especially intranasal administration. The current publication describes the non-clinical safety and toxicity of native (non-degraded) iota-carrageenan when applied intranasally or via inhalation. Intranasally applied iota-carrageenan is a topically applied, locally acting compound with no need of systemic bioavailability for the drug's action. Animal experiments included repeated dose local tolerance and toxicity studies with intranasally applied 0.12% iota-carrageenan for 7 or 28 days in New Zealand White rabbits and nebulized 0.12% iota-carrageenan administered to F344 rats for 7 days. Permeation studies revealed no penetration of iota-carrageenan across nasal mucosa, demonstrating that iota-carrageenan does not reach the blood stream. Consistent with this, no relevant toxic or secondary pharmacological effects due to systemic exposure were observed in the rabbit or rat repeated dose toxicity studies. Data do not provide any evidence for local intolerance or toxicity, when carrageenan is applied intranasally or by inhalation. No signs for immunogenicity or immunotoxicity have been observed in the in vivo studies. This is substantiated by in vitro assays showing no stimulation of a panel of pro-inflammatory cytokines by iota-carrageenan. In conclusion, 0.12% iota-carrageenan is safe for clinical use via intranasal application.
| S-EPMC4395440 | biostudies-literature
Project description:Rectal pre-exposure prophylaxis (PrEP) will be a critical component of HIV prevention products due to the prevalence of unprotected receptive anal intercourse among men who have sex with men and heterosexual couples. Given the biological considerations of this compartment and the complexity of HIV infection, design of a successful rectal microbicide product faces a number of challenges. Important information is being compiled to begin to address deficits in knowledge toward design of rectal PrEP products for men and women. Aspects of formulation development and preclinical and clinical evaluation of rectal products studied to date are summarized in this review. This article is based on a presentation at the "Product Development Workshop 2013: HIV and Multipurpose Prevention Technologies," held in Arlington, Virginia on February 21-22, 2013. It forms part of a special supplement to Antiviral Research.
| S-EPMC3896093 | biostudies-literature
Project description:Pre-exposure prophylaxis (PrEP) has emerged as a promising strategy for preventing the transmission of HIV. Although only one formulation is currently approved for PrEP, research into both new compounds and new delivery systems for PrEP regimens offer intriguing challenges from the perspective of pharmacokinetic and pharmacodynamic modeling. This review aims to provide an overview the current modeling landscape for HIV PrEP, focused on PK/PD and QSP models relating to antiretroviral agents. Both current PrEP treatments and new compounds that show promise as PrEP agents are highlighted, as well as models of uncommon administration routes, predictions based on models of mechanism of action and viral dynamics, and issues related to adherence to therapy. The spread of human immunodeficiency virus (HIV) remains one of the foremost global health concerns. In the absence of a vaccine, other prophylactic strategies have been developed to prevent HIV transmission. One approach, known as pre-exposure prophylaxis (PrEP), allows HIV-negative individuals who are at high risk of exposure to the virus, be it through an HIV-positive sexual partner or through the shared use of drug injection equipment, to substantially reduce the risk of developing an HIV infection. PrEP is a relatively recent approach to combating the HIV epidemic, with the only currently approved treatment being Truvada, a daily oral antiretroviral (ARV) therapy initially indicated in the treatment of active HIV-1 infections, but approved for HIV PrEP in 2012. Although PrEP therapy has consistently demonstrated high efficacy in preventing HIV infection, this efficacy is dependent on patient adherence to the prescribed treatment regimen. This can present a significant problem in low- and middle-income countries, which may lack the infrastructure to provide sufficient access to PrEP medication to maintain daily dosing regimens. Furthermore, while the conventional approach has generally been to advocate for continuous administration akin to regimens used for viral suppression in infected patients, there has been some discussion of whether a better treatment paradigm might be to push for PrEP therapy primarily during those known periods of heightened exposure risk, while relying on post-exposure prophylaxis regimens to prevent infection after unanticipated exposures during low-risk periods. These considerations have led to a push for the development of long-duration and on-demand PrEP formulations, including subdermal and subcutaneous implants, slow-release intramuscular depot injections, vaginal and rectal antimicrobial gels, and intravaginal rings and dissolving films. PrEP therapy is a quickly evolving field, with a variety of antiretroviral compounds and formulations under investigation. This review aims to report on notable drugs and formulations from a pharmacokinetic/pharmacodynamic (PK/PD) modeling perspective. Given the nature of PrEP as a preventive therapy designed for long-term use, clinical trials for PrEP therapies can last for months or even years, particularly in the case of long-duration formulations. Furthermore, in contrast to antiretroviral trials in infected patients, pharmacodynamic endpoints in PrEP therapies are difficult to quantify, as the primary endpoint for efficacy is generally the rate of seroconversion. Computational modeling approaches offer flexible and powerful tools to provide insight into drug behavior in clinical settings, and can ultimately reduce the time, expense, and patient burden incurred in the development of PrEP therapies.
| S-EPMC7005100 | biostudies-literature