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Abstract In this study, the manufacturing process of lamivudine (3TC) and zidovudine (AZT) tablets (150+300 mg respectively) was evaluated using statistical process control (SPC) tools. These medicines are manufactured by the Fundação para o Remédio Popular "Chopin Tavares de Lima" (FURP) laboratory, and are distributed free of charge to patients infected with HIV by the Ministry of Health DST/AIDS national program. Data of 529 batches manufactured from 2012 to 2015 were collected. The critical quality attributes of weight variation, uniformity of dosage units, and dissolution were evaluated. Process stability was assessed using control charts, and the capability indices Cp, Cpk, Pp, and Ppk (process capability; process capability adjusted for non-centered distribution; potential or global capability of the process; and potential process capability adjusted for non-centered distribution, respectively) were evaluated. 3TC dissolution data from 2013 revealed a non-centered process and lack of consistency compared to the other years, showing Cpk and Ppk lower than 1.0 and the chance of failure of 2,483 in 1,000,000 tablets. Dissolution data from 2015 showed process improvement, revealed by Cpk and Ppk equal to 2.19 and 1.99, respectively. Overall, the control charts and capability indices showed the variability of the process and special causes. Additionally, it was possible to point out the opportunities for process changes, which are fundamental for understanding and supporting a continuous improvement environment.

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Introduction: HIV is considered one of the most important chronic transmitted diseases worldwide. The Joint United Nations Program on HIV/AIDS in 2020 proposed the strategy "95-95-95" which goals to achieve a 95% of cases identified, receives ART, and will have achieved suppression of the virus. In Ecuador by 2020, according to the Ministry of Public Health, 45,056 persons are living with HIV, principally men between 15 and 49 years, and a mortality rate of 4.8/100,000 habitats. This study aims to determine the cost-utility of applying an early screening to a sexually active population vs. only a high-risk population and if the use of PrEP is justified depending on different contexts. Methods: For the cost-utility evaluation, it was compared: (a) HIV screening performed only in the high-risk population vs. HIV screening in all population sexually active; and (b) the use of ART only for HIV treatment vs. ART as a treatment in diagnosed cases and the use of PrEP (only at a high-risk population of acquiring HIV). Calculation and weight of DALYs for HIV/SIDA were obtained through WHO guidelines. To generate the Markov model for HIV/AIDS, subjects were classified as symptomatic or asymptomatic, as well as the HIV deaths. Results: Cost-benefit analysis (CUA) showed that ICER for early diagnosis had a negative value which means a saving if the strategy will be implemented as a regular test (-$591, -$4,360) and -108 and -934 DALYs, in the case of ART and PrEP, ICER the $30,541-$59,410, which resulted in more than the GDP's threshold and health years between 2,511 and 10,635 in the general population. With a reduction of 70% in the assigned budget for the early diagnosis, Ecuadorian people could lose between 4 and 6 DALYs, while if the budget reduces more than 50% to ART, it will generate a loss of 10-12 years of healthy life. Conclusion: CUA demonstrates that an early diagnosis in a sexually active population is cost-beneficial. This, combined with ART or PrEP, is ideal to add years of healthy life.

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The Dominican Republic (DR) has the second-highest prevalence of HIV infection in the Caribbean, but viral suppression and treatment adherence are not well understood. We conducted a cross-sectional study among people living with HIV/AIDS(PLWHA) to fill in the knowledge gap. Questionnaire was used to collect demographic data, antiretroviral therapy (ART) adherence, and barriers and facilitators to HIV care. Viral load and other clinical information were extracted through chart reviews. Descriptive analyzes and logistic regression were conducted to explore factors associated with non-viral suppression and imperfect ART adherence. Of 193 PLWHA 83.9% were virally suppressed. Those that were non-virally suppressed were more likely of being male (odds ratio [OR]: 2.55, 95% confidence interval [CI]: 1.17-5.58) and less likely of being unemployed (OR: 0.28, 95% CI: 0.08-0.96). However, being male (OR: 0.78, 95% CI:0.40-1.53) and unemployed (OR: 0.28, 95% CI:0. 08-1.21) were less likely to report imperfect adherence. Tailored interventions are needed to improve adherence and viral suppression in DR.

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BACKGROUND: Epidemiologic research among migrant populations is limited by logistical, methodological, and ethical challenges, but it is necessary for informing public health and humanitarian programming. OBJECTIVE: We describe a methodology to estimate HIV prevalence among Venezuelan migrants in Colombia. METHODS: Respondent-driven sampling, a nonprobability sampling method, was selected for attributes of reaching highly networked populations without sampling frames and analytic methods that permit estimation of population parameters. Respondent-driven sampling was modified to permit electronic referral of peers via SMS text messaging and WhatsApp. Participants complete sociobehavioral surveys and rapid HIV and syphilis screening tests with confirmatory testing. HIV treatment is not available for migrants who have entered Colombia through irregular pathways; thus, medicolegal services integrated into posttest counseling provide staff lawyers and legal assistance to participants diagnosed with HIV or syphilis for sustained access to treatment through the national health system. Case finding is integrated into respondent-driven sampling to allow partner referral. This study is implemented by a local community-based organization providing HIV support services and related legal services for Venezuelans in Colombia. RESULTS: Data collection was launched in 4 cities in July and August 2021. As of November 2021, 3105 of the target 6100 participants were enrolled, with enrollment expected to end by February/March 2022. CONCLUSIONS: Tailored methods that combine community-led efforts with innovations in sampling and linkage to care can aid in advancing health research for migrant and displaced populations. Worldwide trends in displacement and migration underscore the value of improved methods for translation to humanitarian and public health programming. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/36026.

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Pre-exposure prophylaxis (PrEP) is a drug regimen recommended for anyone at high risk of getting HIV to prevent them from being infected. Little research exists on how state-level policies might be related to differential PrEP uptake across the United States. To better understand the associations between state-level policies and PrEP uptake, we examined HIV criminalization, nondiscrimination laws for sexual and gender minorities, Medicaid expansion, Ryan White funding, and sociodemographic characteristics in relation to the PrEP-to-need ratio, a measure of PrEP uptake. Using a cross-sectional design, we analyzed data from all fifty states; Washington, D.C.; and Puerto Rico (all of which we categorize as states here) regarding policy, socioeconomic factors, and PrEP-to-need ratio in 2018. States with HIV criminalization laws had lower PrEP-to-need ratio, and states with more nondiscrimination laws for sexual and gender minorities had higher PrEP-to-need ratio. We found no association between Medicaid expansion, Ryan White funding, percentage Hispanic, percentage uninsured, median household income, percentage with high school education, or state population and PrEP uptake. Legislators should consider how laws concerning HIV and sexual and gender minorities might protect against discrimination and subvert fear and stigma, given the potential impact of these policies on HIV prevention.

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Since its first isolation in 1983, over 77 million people became infected with the human immunodeficiency virus (HIV), and only one case has been reported in which the virus was completely removed from the body. A recent second case was reported that remains to be confirmed. Antiretroviral therapy (ART) manages to control blood viral replication and, consequently, to restore -at least partially- the functions of the immune system, with a notable positive impact on the morbidity and mortality associated with the virus. However, given the difficulty in eliminating the virus from the body, treatment should be given for life. This long-term exposure to antiretroviral drugs implies the risk of generating intolerance, toxic effects, gaps in adherence and the potential selection of resistance mutations. Another limitation is the high cost of treating 37 million persons living with HIV, most of whom are living in resource-limited countries and relying on international aid initiatives. Having these challenges in mind, there is general agreement that new approaches for preventing and treating HIV infection are needed to control the epidemic, while vaccine development efforts continue. In this regard, new generation broadly neutralising monoclonal antibodies (bnMAbs) against the HIV viral envelope protein can prevent virus acquisition, reduce viremia, enhance immunity, and induce the killing of infected cells in animal models of HIV infection. Most importantly, some clinical trials have shown that bnMAbs could effectively d ecrease viremia and delay viral rebound in people chronically infected with HIV.

Desde su primer aislamiento en 1983, el virus de la inmunodeficiencia humana (HIV) ha infectado a más de 77 millones de personas y solo se ha documentado un caso en el cual el virus fue removido completamente del organismo; aún resta confirmar un segundo caso informado recientemente. El tratamiento antirretroviral logra controlar la replicación viral en el plasma y en consecuencia recuperar (al menos parcialmente) la actividad del sistema inmune, con una notable reducción de la morbilidad y la mortalidad asociadas a la infección por HIV. Sin embargo, ante la dificultad para eliminar completamente el virus del organismo, es necesario continuar el tratamiento de por vida. Esto implica la exposició n a largo plazo a drogas antirretrovirales con riesgo de generar intolerancia, efectos tóxicos, brechas en la adherencia y selección de mutantes resistentes. Otro aspecto a considerar es la carga económica que implica tratar a 37 millones de personas infectadas con HIV, la mayoría de ellas en países que solo pueden afrontar esos costos con ayuda internacional. Por ello, hasta tanto se disponga de una vacuna capaz de prevenir la infección de todas las formas circulantes del HIV, es necesario desarrollar nuevas herramientas terapéuticas capaces de complementar y potenciar los efectos del tratamiento antirretroviral. Diversos ensayos preclínicos sugieren que la administración pasiva de anticuerpos monoclonales dirigidos contra la glicoproteína de envoltura viral podría prevenir la infección, reducir la carga viral, estimular la respuesta inmune y favorecer la eliminación de células infectadas con HIV.

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Introduction: Besides the well-known increased risk of developing HIV-related infectious comorbidities; compared with the general population, people living with HIV (PLHIV) may also have an increased risk of developing noninfectious comorbidities (NICMs). This is the first study intended to determine the NICMs rates affecting PLHIV who were under cART regimen in Ecuador. Methods: A total of 503 HIV-positive patients were evaluated during the period June 2015-November 2016 and included in a multicenter retrospective, cross-sectional study conducted in seven main government and nongovernment community-based hospitals in Ecuador. Results: The average age of the participants was 39.2±11.9 years old and the majority of them were male (67.2%). The average age at HIV diagnosis was 34.1 years old and cART in average was started 15.9 months after HIV-diagnosis. Recruited patients were receiving cART for an average of 59.2±40.2 months. Only 9.9% (n=50) of the patients did not show any NICMs. Diabetes and pre-diabetes was found in 6% (n=30) and 16.3% (n=82) patients, respectively; however, dyslipidemia and overweight/obesity was frequent, as they affected 41.4% (n=208) and 36.4% (n=183) patients, respectively. Sixty patients (11.9%) were diagnosed with depression and 28.2% (n=142) of the studied subjects were found to have other NICMs. Conclusion: Prevalence of NICMs among subjects under cART was greater than that reported among the Ecuadorian general population, therefore specific public health actions are required to make patients aware of and prevent NICMs among PLHIV in Ecuador.

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In Brazil, little data is available to inform HIV prevention programming for travestis and transgender ('trans') women, despite the existence of a social movement that has gained strength in recent years. We conducted formative research in Rio de Janeiro to gather trans women's perspectives on combination HIV prevention approaches. Framing the analysis within the model of gender affirmation, we found that several social and contextual factors inhibited participants' access to HIV prevention and treatment. Experienced and anticipated gender-related discrimination and HIV stigma were linked to the avoidance of HIV testing, health services and HIV status disclosure. Participants recommended HIV prevention interventions which combined socio-structural interventions, such as peer-based empowerment and social support, with biomedical interventions such as pre-exposure prophylaxis (PrEP). Participants expressed a preference for programmes and interventions that emphasised a gender-affirmative approach, promoted autonomy and aimed to reduce stigma and discrimination in public health services.

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Stigma is a primary barrier to care and support for people living with HIV (PLWH). We explored relationships between HIV-related stigma and treatment adherence and the effects of psychological and structural factors on these relationships. HIV treatment adherence, stigma, and coping strategies were measured with questionnaires. Participants included 285 PLWH in Haiti. Multivariable linear regression was used to estimate predictors of treatment adherence. Structural equation modeling was used to determine whether relationships between stigma and treatment adherence variables were mediated by coping variables. Mean adherence was 93.1%; 72.3% of participants reported ≥ 95% adherence. Perceived stigma and quality-of-care satisfaction scores significantly predicted treatment adherence. Maladaptive coping did not act as a mediator between perceived stigma and treatment adherence, which could be due to stronger effects of perceived stigma on treatment adherence. Our study may help to improve treatment adherence and the care and quality of life for PLWH.

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The aim of this study is to investigate HIV-related healthcare needs and access barriers for Brazilian transgender and gender diverse people. Data were collected from gender identity clinics and the questionnaire was also made available on the Internet. Out of the 543 participants-62.1% (n = 337) transgender women, 28.7 (n = 156) transgender men and 9.2% (n = 50) gender diverse people, 63.7% had been tested at least once in their lives. The prevalence of self-reported HIV-positive status among transgender women was 16.5%, of which 92.0% reported having a physician with whom they regularly consulted about HIV, whereas none of the transgender men or gender diverse people reported HIV-positive status. In addition, 8.2% of transgender men and 12.5% of gender diverse people did not know their serological status. Finally, 71.0% of the participants were unfamiliar with post-exposure prophylaxis. The study discusses the need for adequate behavior-oriented HIV health policies and training of healthcare professionals regarding the needs of Brazilian transgender and gender diverse people.

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The use of alternative medicines, including herbs, is common among HIV-positive patients, even in those on antiretroviral treatment. Equisetum arvense, known as "horsetail," is mainly used for its diuretic properties. There are limited data about the pharmacological properties of this compound and the potential drug-herb interactions. The authors report 2 cases in which a possible drug-herb interaction may have led to virological breakthrough in patients who were maintained on the same regimen for many years, including lamivudine (3TC)/zidovudine (ZDV)/efavirenz (EFV) and emtricitabine (FTC)/tenofovir (TDF)/EFV, respectively. Therefore, a drug-herb interaction may be expected when these agents are taken concurrently. Until additional data are available, the authors advise clinicians to avoid this combination when possible.

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