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Background: Currently, two-drug antiretroviral regimens are emerging fields in life-long treatment in people living with HIV., Objectives: This randomized non-inferiority open-label controlled trial was designed to compare the 48-week efficacy and safety of tenofovir alafenamide plus dolutegravir versus the standard triple therapy in virologically suppressed people living with HIV. To the best of our knowledge this combination has not been studied before., Methods: This open-label randomized controlled trial was conducted in treatment-experienced people with HIV who had HIV-RNA < 47 copies/mL for at least two years. Patients received either tenofovir alafenamide plus dolutegravir combination (26 patients) or a standard three-drug regimen (29 patients). The primary outcome was the proportion of patients maintaining HIV-RNA < 47 copies/mL during 48 weeks, and the secondary outcomes were CD4 cell count changes, the adherence rate, and adverse drug reactions, all over 48 weeks of study., Results: HIV viral load remained undetectable (HIV-RNA < 47 copies/mL) during the 48 weeks of the study in both arms. The absolute CD4 cell count change was not significant between the two groups. The overall proportion of adverse effects in each group was comparable. The rate of adherence to treatment was acceptable in both groups, and no significant difference was observed., Conclusions: Treatment simplification with tenofovir alafenamide plus dolutegravir regimen as maintenance therapy was non-inferior in terms of efficacy and safety compared to the standard triple therapy. Comparing efficacy of antiretroviral therapy., (© 2023. The Author(s), under exclusive licence to Tehran University of Medical Sciences.)

Introduction: The coexistence of depression and HIV infection affects more than 9 million people worldwide. A literature review revealed a large gap regarding the pharmacotherapy of depression among patients dually diagnosed with HIV and depression. Areas covered: In this review, the authors covered the various dimensions of deploying integrated pharmacological treatment of HIV/AIDS and depression. This topic was addressed in two ways; first, the direct results of integrated pharmacotherapy in syndemic patients; second, the indirect effects of the integrated model on other outcomes of HIV care. Expert opinion : An integrated pharmacological response to the treatment of HIV and depression can bring substantial benefits to HIV outcomes and reduce the burden of both diseases. The direct advantages regarding pharmacological response to the treatment of depression along with HIV care are improving adherence to antiretroviral therapy, optimizing pharmacotherapy, minimizing drug interaction, and prevention of additive adverse drug reactions. Furthermore, in some cases, medication can target both depression and other neuropsychiatric or somatic comorbidities among people living with HIV/AIDS. The integrated pharmacotherapy also has some potential indirect advantages on HIV care outcomes like minimizing loss of care, reducing ongoing HIV transmission, and improving the outcomes of both diseases.

Objectives : We assessed the effect of selenium and zinc supplementation on CD4 cell count and the risk of developing opportunistic infections. Methods : In a double blind clinical trial, 146 HIV(+) patients receiving combination antiretroviral therapy with CD4(+) >200/cubic millimeter were screened for comorbidities and opportunistic infections, and randomized to receive daily selenium (200 µg), zinc (50 mg) or placebo for 6 months, before a 3-month follow-up period. CD4 cell counts were measured in the 3 th , 6 th and 9 th months. The serum selenium and zinc were measured in the 6 th month. The incidence of opportunistic infection was assessed monthly for 6 months and at the end of the 9 th month. Results : The final incidence of supplement deficiency for placebo, zinc and selenium were 46.7%, 44.7% and 50.0%, respectively. Overall compliance with supplementation was 99.42%. Although the changes from baseline were not statistically significant, zinc supplementation was significantly associated with reduced risk of opportunistic infections. Conclusion : Development of the opportunistic infections after zinc supplementation significantly decreased; however, significant improvement in CD4 count was not observed in this group.

Background: Several neuropsychiatric adverse effects of efavirenz are known. Preventing these adverse effects may improve patients' adherence to antiretroviral therapy (ART)., Objectives: To evaluate the efficacy and safety of valerian in preventing neuropsychiatric adverse effects of efavirenz in HIV-positive patients., Method: In this pilot randomized, double-blinded, placebo-controlled, clinical trial, 51 HIV-positive patients who were receiving efavirenz were recruited into the valerian (n = 25) or placebo (n = 26) group. Patients received valerian (530 mg) or placebo nightly 1 hour before sleep for 4 weeks. The neuropsychiatric status (sleep, anxiety, depression, suicidal thought, and psychosis) of patients was assessed at baseline and week 4 using validated questionnaires., Results: Sleep ( P ≤ 0.001) and anxiety ( P = 0.001) significantly improved in the valerian group compared with the placebo group. Dizziness was the most common complaint of patients in first days of the intervention. In the valerian and placebo groups, 92% and 84.6% of patients experienced dizziness, respectively ( P = 0.35). Nausea was the second common adverse effect that 84% and 76.9% of patients in the valerian and placebo groups experienced ( P = 0.39)., Conclusion: In the first 4 weeks of ART including efavirenz, valerian significantly improved sleep and anxiety in HIV-positive patients. Valerian may be considered as a potential option in preventing neuropsychiatric adverse effects of efavirenz in HIV-positive patients.

In this study, we evaluated the correlation between daily dietary antioxidant micronutrients intake and mental health outcomes in Iranians living with HIV infection. During an organized interview, daily dietary micronutrients intake of people living with HIV (PLWH; N = 100) was evaluated using a 168-item semi-quantitative food frequency questionnaire. A reliable psychiatric questionnaire was used to assess depression, anxiety, and stress of the patients as mental health outcomes. Significant negative correlations were found between daily dietary intake of zinc, selenium, and vitamin C with mental health outcomes, including depression, anxiety, and stress scores in Iranian PLWH. In our study, daily dietary intake of some antioxidant micronutrients correlated with the mental health outcomes of Iranian PLWH., (Copyright © 2016 Association of Nurses in AIDS Care. Published by Elsevier Inc. All rights reserved.)

We examined the impact of HBV/HIV coinfection on outcomes in hospitalized patients compared to those with HBV or HIV monoinfection. Using the 2011 US Nationwide Inpatient Sample, we identified patients who had been hospitalized with HBV or HIV monoinfection or HBV/HIV coinfection using ICD-9-CM codes. We compared liver-related admissions between the three groups. Multivariable logistic regression was performed to identify independent predictors of in-hospital mortality, length of stay and total charges. A total of 72 584 discharges with HBV monoinfection, 133 880 discharges with HIV monoinfection and 8156 discharges with HBV/HIV coinfection were included. HBV/HIV coinfection was associated with higher mortality compared to HBV monoinfection (OR 1.67, 95% CI 1.30-2.15) but not when compared to HIV monoinfection (OR 1.22, 95% CI 0.96-1.54). However, the presence of HBV along with cirrhosis or complications of portal hypertension was associated with three times greater in-hospital mortality in patients with HIV compared to those without these complications (OR 3.00, 95% CI 1.80-5.02). Length of stay and total hospitalization charges were greater in the HBV-/HIV-coinfected group compared to the HBV monoinfection group (+1.53 days, P < 0.001; $17595, P < 0.001) and the HIV monoinfection group (+0.62 days, P = 0.034; $8840, P = 0.005). In conclusion, HBV/HIV coinfection is a risk factor for in-hospital mortality, particularly in liver-related admissions, compared to HBV monoinfection. Overall healthcare utilization from HBV/HIV coinfection is also higher than for either infection alone and higher than the national average for all hospitalizations, thus emphasizing the healthcare burden from these illnesses., (© 2016 John Wiley & Sons Ltd.)

Background: The antidepressant effect of omega-3 fatty acids has been described in the non-HIV population. The effect of omega-3 fatty acid supplementation on the mood status of HIV-positive patients has not been evaluated yet., Objective: In this study, the effect of omega-3 fatty acids on depressive symptoms was evaluated in HIV-positive individuals., Method: A total of 100 HIV-positive patients with Beck Depression Score ≥16, were assigned to receive either omega-3 fatty acids or placebo twice daily for 8 weeks. Depressive symptoms of each participant were evaluated at baseline (month 0) and at the end of months 1 and 2 of the study. Beck Depression Inventory Second Edition, depression subscale of the Hospital Anxiety and Depression Scale, and Patient Health Questionnaire were used for assessment of depressive symptoms., Results: Reduction in mean ± SD of all depression scores during the study period was statistically significant within the omega-3 group and when compared with the placebo group (for both comparisons, P < 0.001). Also, the mean differences of all depression scores were decreased significantly during the intervals: months 0, 1, and 2 (P < 0.001 for all comparisons). Among the participants, 7 (7%) and 4 (4%) patients in the omega-3 and the placebo group, respectively, experienced mild gastrointestinal problems, but the incidence of adverse drug reactions related to the interventions was not statistically different between the groups (P = 0.09)., Conclusion: Omega-3 fatty acids improved depressive symptoms in HIV-positive individuals without any significant adverse reaction., (© The Author(s) 2016.)

Objective: To assess different aspects of potential drug-drug interactions (DDIs) including incidence, severity, level of evidence and probable associated factors in Iranian HIV-infected individuals receiving antiretroviral therapy., Methods: All adult HIV-infected patients under highly active antiretroviral therapy regimen attending a referral HIV clinic during 1 year were screened retrospectively for potential moderate or severe DDIs by the Lexi-Interact On-Desktop software., Results: Near seventy percent (69.89%) of detected DDIs in our population were major. The three most common detected potential DDIs were efavirenz + methadone (11 cases), lopinavir-ritonavir + sulfamethoxazole-trimethoprim, (10 cases) and lamivudine + ribavirin (7 cases). Lopinavir-ritonavir (27.96%) and citalopram (23.66%) were the most common offending antiretroviral and non-antiretroviral agents, respectively., Conclusion: Performing multicenter and prospective studies is warranted to assess the real clinical as well as economic impacts of DDIs on HIV-infected patients receiving antiretroviral agents in our population and also to develop efficient preventive strategies.

There are some evidences regarding beneficial effects of carnitine in improvement of depression symptoms. Incidence of depression is significantly higher among HIV positive individuals compared to HIV negative populations. Also carnitine deficiency is prevalent in HIV positive individuals. In a cross-sectional study correlation between serum carnitine level and depression severity based on the Beck Depression Inventory questionnaire was assessed in 100 HIV/AIDS (42 males and 58 females) patients. According to the Beck Depression Inventory definitions, 31%, 16%, and 21% of the patients experienced mild, moderate, and severe depression, respectively. The mean ± SD serum concentration of total carnitine in the patients was 37.96 ± 26.08 (µmol/L). Fifty-four (54%) patients were categorized as carnitine deficient. A non-statistically significant negative correlation between patients' depression scores and total levels of serum carnitine was found. Considering the prevalence of depression among HIV/AIDS patients and probable role of carnitine in the pathogenesis of depressive disorders, more studies are needed to reveal correlation between depression and the body storage of carnitine.

Cyproheptadine prevention of the neuropsychiatric adverse effects of an antiretroviral regimen including efavirenz has been evaluated in a randomized clinical trial. Twenty-five patients (16 males and 9 females with mean±SD ages of 36±9 years) in a cyproheptadine group, and 26 patients (17 males and 9 females with mean±SD ages of 34±7 years) in a control group completed the trial. Sexual contact and injection drug use were the main routs of HIV infection in both groups. The patients' neuropsychiatric adverse effects were evaluated based on the Hamilton Depression Rating Scale, Hamilton Anxiety Rating Scale, Positive and Negative Syndrome Scale, Beck Depression Scale, Pittsburgh Sleep Quality Inventory, Positive and Negative Suicide Ideation, and Somatization Subscale of Symptom Checklist 90 at baseline and 4 weeks after treatment. Cyproheptadine significantly decreased the scores of Hamilton Depression Rating Scale, Hamilton Anxiety Rating Scale, Positive and Negative Syndrome Scale, Beck Depression Scale, Pittsburgh Sleep Quality Inventory, Positive and Negative Suicide Ideation of the patients after 4 weeks in comparison with control group. All of the scores increased in control group following antiretroviral therapy. Although short duration of the patients' follow-up was a major limitation of the study, the results of the study showed that cyprohepradine is effective in prevention of depression, anxiety, hallucination, aggressive behaviors, emotional withdrawal, poor rapport, poor impulse control, active social avoidance, suicidal ideation, and improved sleep quality of HIV-positive patients after initiation of antiretroviral therapy including efavirenz.

Purpose: Treatment adherence of 95% or higher is recommended for appropriate therapeutic response and improving the function of immune system in HIV positive patients. To the best of our knowledge, there was report of adherence to HAART regimen from Iran. In the present study, we have reported the HAART adherence rate of Iranian HIV positive patients., Method: In a twelve-month period, all patients older than 18 years old who referred to HIV clinic were on HAART regimen enrolled in the study. Beside demographic and clinical characteristics of Iranian HIV positive patients, Adherence to HAART was assessed by self-report and pill count methods at during the three consecutive months of the patients’ visits., Results: The mean of patients’ adherence to HAART regimen based on the self-report method was 69.4%, 64.6% and 62.8% in the first, second and third month of follow up, respectively. The mean of adherence rates in three months followup assessed by self-report (65.5%) and pill count (60.4%) methods were correlated significantly (r=0.93 and p<0.001). Living with family members, changing the HAART regimen and stage of disease had a significant relationship with adherence rates., Conclusion: Although the adherence level of Iranian HIV infected patients is acceptable compared to other countries, the available antiretroviral medications are limited in our country, therefore, encouraging patients to have higher levels of adherence is more important.

Background: It was reported that antiretroviral drugs such as efavirenz can increase the catabolism of vitamin D in HIV infected individuals. We have not found any study that evaluated effects of vitamin D supplementation on the bone specific biomarkers in HIV positive patients under treatment with antiretroviral regimen containing efavirenz., Findings: Vitamin D deficiency was detected in 88.4 % of included patients. Baseline osteocalcin, but not collagen telopeptidase, serum levels were lower than normal range in all of these individuals. Both bone biomarkers' concentrations increased significantly (p < 0.001 for both of them) after supplementation of vitamin D and it was more predominant for osteocalcin., Conclusion: In the HIV-infected patients under treatment with efavirenz, vitamin D deficiency is prevalent. After supplementation with single dose of 300,000 IU vitamin D in this population, the activation of osteoblasts and osteoclasts stimulates bone formation and resorption respectively with favorable bone formation without any adverse event. Significant percent of HIV infected individuals are vitamin d deficient that could benefit from vitamin D supplementation.

Human immunodeficiency virus (HIV) infected individuals are prone to malnutrition, and deficiencies of some minerals and vitamins. The aim of this study is to evaluate the frequency of vitamin D deficiency and determine the possible risk factors associated with this problem in HIV-infected individuals. This cross-sectional study was performed on 98 adult patients referred to the Emam Khomeini Hospital Complex, Tehran, Iran. The patients' serum vitamin D concentration was determined using radioimmunoassay method. The possible correlations between demographic and clinical data with the level of vitamin D were evaluated. Vitamin D levels less than 35 nmol/l were considered as deficient in this study. Eighty-five (86.7%) of the patients had serum vitamin D deficiency (concentrations less than 35 nmol/l) in this study. Coinfection with hepatitis C virus (HCV) was present in 54 (55.1%) of the patients. Only daily intake of vitamin D (r = 0.304, p = 0.002), duration of sun exposure (r = 0.268, p = 0.009), the level of PTH (r = -0.459, p < 0.001), daily intake of calcium (r = 0.239, p = 0.018) and GFR of more than 90 ml/min (OR = 1.208, CI 95% = 1.080-1.350, p = 0.033) had a correlation with serum vitamin D concentration. Being female (OR = 7.224, CI 95% = 3.640-14.335, p < 0.001), unemployed (OR = 1.627, CI 95%= 1.209-2.190, p < 0.001) and infected with HCV (OR = 1.811, CI 95% = 1.331-2.465, p < 0.001) were related to the severe serum vitamin D deficiency. Vitamin D deficiency is a common problem in Iranian HIV-infected patients and with concern of this vitamin's important role in health issues, early evaluation of its status and providing appropriate nutritional support seems to be important.

Purpose: To our knowledge, there is no report regarding antiretroviral induced adverse drug reactions (ADRs) in Iranian patients who infected with human immunodeficiency virus (HIV). We have evaluated the frequency of antiretroviral therapy (ART) induced ADRs in this population and assessed some risk factors of these reactions., Methods: This is a prospective cohort study that was performed in Iranian Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome Research Center during years 2005-2007. Adult patients who infected with HIV and newly started on ART were included in this study and followed laboratory and clinically for the development of any ADRs for at least 6 months., Results: During this study 87.6% of patients showed at least one ADR. Prevalence of ADRs based on affected organ was: gastrointestinal (GI) (63.7%), hematological (32.6%), neurological (30%), cutaneous (22%), musculoskeletal (21.3%), hepatic (20%), metabolic (18.6%), and renal (2.6%) adverse effects., Conclusions: The most important results of this study were finding of hematological ADRs as the most common cause of ART interruption, supporting the hypersensitivity nature of antiretroviral induced hepatotoxicity especially cholestasis and new finding of the significant positive correlation between hepatitis C virus co-infection and the occurrence of ART induced skin reactions.

Background: Human immunodeficiency virus infected individuals are prone to malnutrition due to increased energy requirements, enteropathy and increased catabolism. Trace elements such as zinc and selenium have major role in maintaining a healthy immune system. This study was designed to evaluate the nutritional status of Iranian subjects who were newly diagnosed with human immunodeficiency virus infection and to compare serum level of zinc and selenium in these patients with those of the sex and aged match healthy subjects., Methods: After an interview and physical examination, nutritional assessment was done based on clinical and anthropometric parameters. Body mass index (normal range 18.5-27 kg/m2 based on age) of less than 16, 16-16.9 and 17-18.4 kg/m2 were considered as severe, moderate and mild malnutrition respectively. Serum level of zinc and selenium were measured by graphite furnace atomic absorption., Results: Severe, moderate and mild malnutrition were detected in 15%, 38% and 24% of human immunodeficiency virus infected individuals respectively. Compared with the healthy control group, serum level of zinc and selenium in the human immunodeficiency virus infected subjects were significantly lower (P = 0.01 and P = 0.02 respectively)., Conclusion: Malnutrition found to be prevalent in Iranian human immunodeficiency virus infected individuals and low serum zinc and selenium levels are common in this population.

We examined the impact of HBV/ HIV coinfection on outcomes in hospitalized patients compared to those with HBV or HIV monoinfection. Using the 2011 US Nationwide Inpatient Sample, we identified patients who had been hospitalized with HBV or HIV monoinfection or HBV/ HIV coinfection using ICD-9- CM codes. We compared liver-related admissions between the three groups. Multivariable logistic regression was performed to identify independent predictors of in-hospital mortality, length of stay and total charges. A total of 72 584 discharges with HBV monoinfection, 133 880 discharges with HIV monoinfection and 8156 discharges with HBV/ HIV coinfection were included. HBV/ HIV coinfection was associated with higher mortality compared to HBV monoinfection ( OR 1.67, 95% CI 1.30-2.15) but not when compared to HIV monoinfection ( OR 1.22, 95% CI 0.96-1.54). However, the presence of HBV along with cirrhosis or complications of portal hypertension was associated with three times greater in-hospital mortality in patients with HIV compared to those without these complications ( OR 3.00, 95% CI 1.80-5.02). Length of stay and total hospitalization charges were greater in the HBV-/ HIV-coinfected group compared to the HBV monoinfection group (+1.53 days, P < 0.001; $17595, P < 0.001) and the HIV monoinfection group (+0.62 days, P = 0.034; $8840, P = 0.005). In conclusion, HBV/ HIV coinfection is a risk factor for in-hospital mortality, particularly in liver-related admissions, compared to HBV monoinfection. Overall healthcare utilization from HBV/ HIV coinfection is also higher than for either infection alone and higher than the national average for all hospitalizations, thus emphasizing the healthcare burden from these illnesses. [ABSTRACT FROM AUTHOR]