scholarly journals A 28-Day Toxicity Study of Tenofovir Alafenamide Hemifumarate by Subcutaneous Infusion in Rats and Dogs

Author(s):  
Doris Zane ◽  
Shane Roller ◽  
Josephine Shelton ◽  
Roshni Singh ◽  
Rachna Jain ◽  
...  

Human immunodeficiency virus (HIV) infection continues to be a serious global human health issue, with ∼38 million people living with HIV worldwide at the end of 2019. HIV preexposure prophylaxis (PrEP) has introduced the use of antiretroviral therapies as another helpful tool for slowing the spread of HIV worldwide.

Author(s):  
Arkaitz Imaz ◽  
Juan M Tiraboschi ◽  
Jordi Niubó ◽  
Javier Martinez-Picado ◽  
Mackenzie L Cottrell ◽  
...  

Abstract Background The pharmacokinetics of bictegravir (BIC) and its association with the decay of human immunodeficiency virus (HIV)–1 RNA in genital fluids and the rectum have not yet been addressed. Methods We conducted a prospective, multicenter study of antiretroviral-naive people living with HIV-1 and initiating BIC/emtricitabine (FTC)/tenofovir alafenamide (TAF). HIV-1 RNA was measured (limit of quantification, 40 copies/mL) in blood plasma (BP), seminal plasma (SP), rectal fluid (RF), and cervicovaginal fluid (CVF) at baseline; Days 3, 7, 14, and 28; and Weeks 12 and 24. Total and protein-unbound BIC concentrations at 24 hours postdose (C24h) were quantified in BP, SP, CVF and rectal tissue (RT) on Day 28 and Week 12 using a validated liquid chromatography-tandem mass spectrometry assay. Results The study population comprised 15 males and 8 females. In SP, RF, and CVF, the baseline HIV-1 RNA was >40 copies/mL in 12/15, 13/15, and 4/8 individuals, respectively, with medians of 3.54 (2.41–3.79), 4.19 (2.98–4.70), and 2.56 (1.61–3.56) log10 copies/mL, respectively. The initial decay slope was significantly lower in SP than in RF and BP. The time to undetectable HIV-1 RNA was significantly shorter in SP and RF than in BP. All women achieved undetectable HIV-1 RNA in CVF at Day 14. The median total BIC concentrations in SP, RT, and CVF were 65.5 (20.1–923) ng/mL, 74.1 (6.0–478.5) ng/g, and 61.6 (14.4–1760.2) ng/mL, respectively, representing 2.7%, 2.6%, and 2.8% of the BP concentration, respectively, while the protein-unbound fractions were 51.1%, 44.6%, and 42.6%, respectively. Conclusions BIC/FTC/TAF led to rapid decay of HIV-1 RNA in genital and rectal fluids. Protein-unbound BIC concentrations in SP, RT, and CVF highly exceeded the half-maximal effective concentration (EC50) value (1.1 ng/mL). Clinical Trials Registration EudraCT 2018-002310-12.


2020 ◽  
Vol 18 (2) ◽  
Author(s):  
Abdullah F ◽  
Hashi AA ◽  
Said AH ◽  
Mat Nor MB

Human Immunodeficiency Virus (HIV) that causes Acquired Immune Deficiency Syndrome (AIDS) is one of the world’s most serious health and nation-state destructions. It creates long-term economic and psychosocial impact on the lives of individuals, families and communities. Since the first reported case of HIV/AIDS in Malaysia in 1986, its prevalence has escalated significantly. As of December 2017, there are over 115,263 reported cases of HIV infections in the country and over 40,000 people died from HIV/AIDS.1 Although many religious people regarded HIV infection as a divine punishment for their sins of sexual promiscuity, Islamic teaching emphasises the prevention of the disease and care for people living with HIV or AIDS. It is imperative to discuss the Islamic perspectives in providing ways to prevent the spread of HIV and support to people living with HIV (PLHIV). This article focuses on epidemiological data; highlight the burden of HIV infection/AIDS in Malaysia and its impact on the society, HIV infection from medical perspective and its preventive measures from Islamic viewpoints. A good teamwork among healthcare providers and religious leaders is compulsory as it may improve the preventive strategies to curb the disease in the country.


2021 ◽  
Vol 11 (2) ◽  
pp. 248
Author(s):  
Marina Nosik ◽  
Vyacheslav Lavrov ◽  
Oxana Svitich

Over the more than thirty-year period of the human immunodeficiency virus type 1 (HIV-1) epidemic, many data have been accumulated indicating that HIV infection predisposes one to the development of mental pathologies. It has been proven that cognitive disorders in HIV-positive individuals are the result of the direct exposure of the virus to central nervous system (CNS) cells. The use of antiretroviral therapy has significantly reduced the number of cases of mental disorders among people infected with HIV. However, the incidence of moderate to mild cognitive impairment at all stages of HIV infection is still quite high. This review describes the most common forms of mental pathology that occur in people living with HIV and presents the current concepts on the possible pathogenetic mechanisms of the influence of human immunodeficiency virus (HIV-1) and its viral proteins on the cells of the CNS and the CNS’s functions. This review also provides the current state of knowledge on the impact of the antiretroviral therapy on the development of mental pathologies in people living with HIV, as well as current knowledge on the interactions between antiretroviral and psychotropic drugs that occur under their simultaneous administration.


2019 ◽  
Author(s):  
Agnes Bwanika Naggirinya

BACKGROUND : Adherence to treatment is critical to obtain successful treatment outcomes. While factors influencing antiretroviral therapy (ART) adherence vary, young adults are less likely to adhere because of psychosocial issues such as stigma, ART-related side effects as well as lack of access to treatment. Call for Life mHealth tool (C4LU), is a mobile phone- based technology that provides text messages or Interactive Voice Response (IVR) functionalities, through a web-interface and offers four modules including pill reminders, clinic visit reminders, health tips and symptom self-reporting support. Within a randomised control trial, we assessed perspectives and experiences of young adults living with human immunodeficiency virus towards the C4LU- system, with the objective to improve ART adherence among young people living with HIV with help of mHealth tool. OBJECTIVE To improve ART adherence among young people living with HIV through use of mHealth tool. METHODS This was an exploratory qualitative design at two study sites nested within an open label randomized controlled trial (RCT) entitled: “Improving outcomes in human immunodeficiency virus (HIV) patients using mobile phone based interactive software support “Call for Life study A total of 600 participants were randomly assigned 1:1 to either Standard of Care (SoC)- face-to-face counsellor adherence support or SoC plus mHealth call for life system (C4LU). C4LU uses Interactive voice response or text messages delivered via mobile phone. The qualitative study explored perspectives and experiences of young adults (18-24 years) towards the mHealth tool “C4LU”. A purposive sample of twenty-one vulnerable youth, seventeen from the intervention and four from the SoC arm were selected. We used semi-structured interviews to facilitate an in-depth exploration of experiences of young adults regarding C4LU-System. Thirteen in-depth interviews and one focus group discussion were conducted. The young adults were from four categories of population of interest that were targeted to be offered specialised care: young adults on PMTCT, switching to / or on second line ART, positive partners in a discordant relationship and initiating 1st line ART. Data was managed using Nvivo version 11 and analysed thematically. RESULTS C4LU-mHealth tool was perceived as an acceptable intervention for young adults. While on the system, participants reported: improvement in medication adherence, strengthened doctor /clinician -patient relationships, increased health knowledge through educative health tips. Appointment reminders and symptom reporting were singled out as beneficial because the system would address and manage the problems of forgetfulness, and stigma related issues. CONCLUSIONS The system was described as an acceptable and feasible strategy to improve ART adherence and retention among young adults in resource limited settings CLINICALTRIAL Trial Registration: ClinicalTrials.gov NCT 02953080


2019 ◽  
Vol 71 (2) ◽  
pp. 353-362 ◽  
Author(s):  
Beatriz López-Centeno ◽  
Carlos Badenes-Olmedo ◽  
Ángel Mataix-Sanjuan ◽  
Katie McAllister ◽  
José M Bellón ◽  
...  

Abstract Background Drug–drug interactions (DDIs) that involve antiretrovirals (ARVs) tend to cause harm if unrecognized, especially in the context of comorbidity and polypharmacy. Methods A linkage was established between the drug dispensing registry of Madrid and the Liverpool human immunodeficiency virus (HIV) DDI database (January 2017–June 2017). Polypharmacy was defined as the use of ≥5 non-HIV medications, and DDIs were classified by a traffic-light ranking for severity. Results A total of 22 945 people living with HIV (PLWH) and 6 613 506 individuals without HIV had received medications. ARV regimens were predominantly based on integrase inhibitors (51.96%). Polypharmacy was higher in PLWH (32.94%) than individuals without HIV (22.16%; P < .001); this difference was consistently observed across all age strata except for individuals ≥75 years. Polypharmacy was more common in women than men in both PLWH and individuals without HIV. The prevalence of contraindicated combinations involving ARVs was 3.18%. Comedications containing corticosteroids, quetiapine, or antithrombotic agents were associated with the highest risk for red-flag DDI, and the use of raltegravir- or dolutegravir-based antiretroviral therapy was associated with an adjusted odds ratio of 0.72 (95% confidence interval, .60–.88; P = .001) for red-flag DDI. Conclusions Polypharmacy was more frequent among PLWH across all age groups except those aged ≥75 years and was more common in women. The detection of contraindicated medications in PLWH suggests a likely disconnect between hospital and community prescriptions. Switching to alternative unboosted integrase regimens should be considered for patients with risk of harm from DDIs.


2017 ◽  
Vol 21 (2) ◽  
Author(s):  
Farhana E. Suleman ◽  
Mahmood M.T.M. Ally

The reported prevalence of articular manifestations of human immunodeficiency virus (HIV) varies, but with sub-Saharan Africa accounting for almost 70% of the people living with HIV, this results in a considerable burden of disease in the region. The spectrum of clinical presentation described, includes articular pain syndrome, HIV-associated arthropathy and seronegative spondyloarthropathies, among others. This brief review serves to create awareness of the clinical and imaging presentation of this spectrum of disease as there is significant morbidity associated with these conditions if treatment is delayed.


2015 ◽  
Vol 2 (1) ◽  
pp. 006-014
Author(s):  
Erni Setiyorini

Human Immunodeficiency Virus (HIV)is desease with high mortality and everyone have chancegot HIV. At Blitar HIV/AIDS prevalence increase since 2010. The incubation of HIV need long time tobecome AIDS. At this period PLWHA faced with physic, physichologic, sosial, environment problem andimpact to their quality of life. The purpose of this study was to describe quality of life PLWHA at physic,physichologic, sosial, environment dimension. Method: Research design was descriptive. Population ofthis study is PLWHA who receiving ARV at Cendana Clinic Ngudi Waluyo Wlingi Hospital. Samples 42respondent by using convenient sampling. Data collected at September 1st– 30, 2013 by questionaire.Result of this study in physic dimension much of them at good 16 peoples (38,1%), enough and less, eachof them 13 peoples (31%). Physhicology dimension at good and enough, each of them 20 peoples(47,6%) then at less 2 peoples (4,8%). Sosial dimension enough 25 peoples (59,5%), good 15 peoples(35,7%) and less 2 peoples (4,8%). Environment dimension enough 16 peoples (38,1%), good 15peoples (35,7%) dan kurang 11 orang (26,2%). It is suggested for nurse to implementation nursing careplan to PLWHA suitable with their quality of life dimension and enhance support to their sosial activity.


2020 ◽  
Vol 5 (1) ◽  
pp. 83
Author(s):  
Mugiarjo Mugiarjo

<div><em>Regarding the response to self-disclosure, a person needs to make an attribution in order to know whether the response is really an intention or just a diversion. This </em><em>article</em><em> </em><em>based on </em><em>qualitative methods. Data collect</em><em>ed by </em><em>observation,</em><em> </em><em>interview</em><em>, and documentation</em><em>. The results of this study indicate that </em><em>People Living With HIV/Aids (</em><em>PLWHA</em><em>)</em><em> carry out quite strict regulations by conducting an assessment first before disclosing their </em><em>Human Immunodeficiency Virus (</em><em>HIV</em><em>)</em><em> status. The response obtained after they opened the status to the significant others was attributed by. The basis of sincere acceptance and response, the stability of the relationship between PLWHA and significant others after opening the status can be maintained, even stronger. PLWHA rely heavily on the power of spirituality to be able to build themselves better. In addition, the ability to make peace with oneself over their circumstances also influenced by this spirituality. Appreciation of spirituality also indicate that their engagement with God strengthened. This strength is shown by their awareness of the meaning of life.</em></div>


2021 ◽  
Vol 8 ◽  
Author(s):  
Alejandro Diaz ◽  
Marina Grand ◽  
Juan Torrado ◽  
Federico Salazar ◽  
Yanina Zócalo ◽  
...  

Background: There are scarce and controversial data on whether human immunodeficiency virus (HIV) infection is associated with changes in aortic pressure (aoBP) and waveform-derived indexes. Moreover, it remains unknown whether potential differences in aoBP and waveform indexes between people living with HIV (PLWHIV) and subjects without HIV (HIV-) would be affected by the calibration method of the pressure waveform.Aims: To determine: (i) whether PLWHIV present differences in aoBP and waveform-derived indexes compared to HIV- subjects; (ii) the relative impact of both HIV infection and cardiovascular risk factors (CRFs) on aoBP and waveform-derived indexes; (iii) whether the results of the first and second aims are affected by the calibration method.Methods: Three groups were included: (i) PLWHIV (n = 86), (ii) HIV- subjects (general population; n = 1,000) and (iii) a Reference Group (healthy, non-exposed to CRFs; n = 398). Haemodynamic parameters, brachial pressure (baBP; systolic: baSBP; diastolic: baDBP; mean oscillometric: baMBPosc) and aoBP and waveform-derived indexes were obtained. Brachial mean calculated (baMBPcalc=baDBP+[baSBP-baDBP]/3) pressure was quantified. Three waveform calibration schemes were used: systolic-diastolic, calculated (baMBPcalc/baDBP) and oscillometric mean (baMBPosc/baDBP).Results: Regardless of CRFs and baBP, PLWHIV presented a tendency of having lower aoBP and waveform-derived indexes which clearly reached statistical significance when using the baMBPosc/baDBP or baMBPcalc/baDBP calibration. HIV status exceeded the relative weight of other CRFs as explanatory variables, being the main explanatory variable for variations in central hemodynamics when using the baMBPosc/baDBP, followed by the baMBPcalc/baDBP calibration.Conclusions: The peripheral waveform calibration approach is an important determinant to reveal differences in central hemodynamics in PLWHIV.


2019 ◽  
Vol 5 (4) ◽  
pp. 147-154
Author(s):  
Le Hieu Thuy Anh ◽  
Suchada Thaweesit

Background: Human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) are the leading causes of death from infectious diseases. Because of sharing same transmission routes, the co-infection of HIV with HBV or HCV is common. And the co-infections make HIV infected persons have higher morbidity and mortality than those who infected only with HIV. This study aims to investigate factors that may have influence on the co-infections of HBV or HCV among HIV positive individuals.Objective: The goals of this study were to identify factors associated with the co-infection of HBV or HCV among people living with HIV. Methods: Quantitative research method was applied in this study to examine factors associated with HBV or HCV co-infection among HIV infected people. A total of 250 HIV infected individuals in Khanh Hoa province, Vietnam were the sample of this study. It employed the Social Ecological Model (SEM) as a theoretical perspective that focused on multiple levels of factors. Descriptive statistic was used to describe the general characteristics of the respondents. And Binary logistic regression was carried out to measure the influence of factors on the co-infection. Results: The multivariate analysis of this study showed that HIV-HBV co-infection was associated significantly with residents of Nha Trang (OR= 7.179). Regarding HIV-HCV co-infection, being men (OR= 7.617), unemployed (OR= 4.013), a resident of Nha Trang (OR=10.894) and an injecting drug user (OR= 16.688) were risk factors of the co-infection.Conclusions: This study recommended that intervention strategies to prevent HIV-positive individuals from co-infection with either HBV or HCV should focuses on altering individuals’ risk behaviors and their socio-economic environments. Also, specific preventing programs should be implemented and focus on unemployed populations, injecting drug users, men in general, as well as people living in particular areas, especially cities having a large number of people living with HIV.


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