Effectiveness, safety and discontinuation rates of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) in people with HIV using real-world data: a systematic review and meta-analysis.

BACKGROUND: The use of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) is based on the results of robust clinical trials. OBJECTIVES: To assess the effectiveness and safety of BIC/FTC/TAF in treatment-naïve (TN) and treatment-experienced (TE) people with HIV using available real-world cohort studies. METHODS: Systematic review and meta-analysis of publications and communications identified via Boolean search in Medline, PubMed and Embase, and conference abstracts reporting retrospective real-world use of BIC/FTC/TAF, published until 31 January 2024. The primary endpoint was the proportion of TN and TE people with HIV with viral load (VL) < 50 copies/mL at 48 weeks while on treatment. RESULTS: Of the 38 identified publications and conference abstracts, for the present analysis we included 12 publications (comprising 792 TN and 6732 TE individuals). For the three publications including 507 TN participants reporting the primary outcome, VL suppression was 97% [95% confidence intervals (CI): 89-100]. For the nine publications including 4946 TE participants reporting the primary outcome, VL suppression was 95% (95% CI: 94-96), with suppression >93% in all studies. Total discontinuations at 48 weeks in TE individuals were 3% (95% CI: 2-5), 1% (95% CI: 0-2) due to side effects. A total of four publications with 151 TE individuals with previous presence of M184V substitution were identified, reporting a suppression rate at 48 weeks of 95% (95% CI: 88-100). CONCLUSIONS: Real-world studies demonstrate low discontinuation rates and high rates of virologic suppression in individuals treated with BIC/FTC/TAF, both TN and TE with and without previous detection of M184V substitution.

Unsafe Injection Is Associated with Higher HIV Testing after Bayesian Adjustment for Unmeasured Confounding.

BACKGROUND: To apply a novel method to adjust for HIV knowledge as an unmeasured confounder for the effect of unsafe injection on future HIV testing. METHODS: The data were collected from 601 HIV-negative persons who inject drugs (PWID) from a cohort in San Francisco. The panel-data generalized estimating equations (GEE) technique was used to estimate the adjusted risk ratio (RR) for the effect of unsafe injection on not being tested (NBT) for HIV. Expert opinion quantified the bias parameters to adjust for insufficient knowledge about HIV transmission as an unmeasured confounder using Bayesian bias analysis. RESULTS: Expert opinion estimated that 2.5%-40.0% of PWID with unsafe injection had insufficient HIV knowledge; whereas 1.0%-20.0% who practiced safe injection had insufficient knowledge. Experts also estimated the RR for the association between insufficient knowledge and NBT for HIV as 1.1-5.0. The RR estimate for the association between unsafe injection and NBT for HIV, adjusted for measured confounders, was 0.96 (95% confidence interval: 0.89,1.03). However, the RR estimate decreased to 0.82 (95% credible interval: 0.64, 0.99) after adjusting for insufficient knowledge as an unmeasured confounder. CONCLUSION: Our Bayesian approach that uses expert opinion to adjust for unmeasured confounders revealed that PWID who practice unsafe injection are more likely to be tested for HIV - an association that was not seen by conventional analysis.

Estimation of HIV incidence and its trend in three key populations in Iran.

In Iran, People Who Inject Drugs (PWID), Female Sex Workers (FSW), and prisoners are the main key populations at risk of HIV infection. This study aimed to evaluate the trend of HIV incidence among PWID, FSW and prisoners as an impact measure of HIV harm reduction and prevention efforts in Iran. Data were obtained from the two rounds of national bio-behavioral surveillance surveys among FSW (2010 (n = 872), 2015 (n = 1339)), PWID (2010 (n = 2417), 2014 (n = 2307)), and prisoners (2009 (n = 4536), 2013 (n = 5390)) through facility-based (FSW and PWID surveys) and cluster sampling (prisoner surveys). Time-at-risk was calculated assuming the age at first sex or drug injection as the beginning of the at-risk period and the age at the time of the interview or date when they received a positive HIV test result as the end of this period, adjusted for interval censoring. HIV incidence among PWID in 2014 was 5.39 (95% CI 4.71, 6.16) per 1,000 person-years (PY), significantly lower than in 2009 (17.07, 95% CI 15.34, 19.34). Similarly, HIV incidence was 1.12 (95% CI 0.77, 1.64) per 1,000 PY among FSW in 2015, a significant drop from 2010 (2.38, 95% CI 1.66, 3.40). Also, HIV incidence decreased among prisoners from 1.34 (95% CI: 1.08, 1.67) in 2009 to 0.49 (95% CI: 0.39, 0.61) per 1,000 PY in 2013. Our findings suggest that after an increase in the 2000s, the HIV incidence may have been decreased and stabilized among key populations in Iran.

Underreporting in HIV-related high-risk behaviors: comparing the results of multiple data collection methods in a behavioral survey of prisoners in Iran.

We explored the potentials of using three indirect methods including crosswise, proxy respondent method, and network scale-up (NSU) in comparison to direct questioning in collecting sensitive and socially stigmatized HIV-related risk behaviors information from prisoners (N=265). Participants reported more sexual contact in prison for their friends than they did for themselves (10.6% vs. 3.8% in men, 13.7% vs. 0% in women). In men, NSU provided lower estimates than direct questioning, while in women NSU estimates were higher. Different data collection methods provide different estimates, and collectively offer a more comprehensive picture of HIV-related risk behaviors in prisons.

Prevalence of Active and Passive Smoking among Adult Population: Findings of a Population-Based Survey in Kerman (KERCADRS), Iran.

BACKGROUND: Smoking is one of the major modifiable risk factors for non-communicable diseases. Our aim was to report the pattern of active and passive smoking using the data collected through a population-base household survey in Kerman, Iran [(KERCADRS) Kerman Coronary Artery Disease Risk Factors Study]. METHODS: Using a cluster random sampling design, we recruited 5900 adult persons (15-75 years old) into our survey. After consenting, every participant was interviewed by a trained interviewer. The section for smoking included questions about daily (smoking at least one cigarette per day), non-daily, past and passive cigarette smoking as well as the duration of the exposure. We used Kerman population distribution (as the target population) to adjust our estimates using direct standardization method. FINDINGS: Overall, 8.3% of study participants (15.5% in men vs. 0.8% in women, P = 0.010) reported themselves as daily smokers and an additional 1.7% (2.9% in men vs. 0.4% in women, P = 0.010) as non-daily smokers. The passive smoking was common in total (27.5%), while women experienced more exposure than men (30.1% vs. 25.0%, P = 0.010). In daily smokers, 3.2% smoked more than 20 cigarettes per day. Among passive smokers, 62.6% were exposed to cigarette smoke more than 6 days per week. CONCLUSION: Smoking is pretty common among adult populations, particularly in men. A majority of tobacco-free young adult women are exposed to passive smoking. Age and gender oriented interventions are required to change this risk pattern in Kerman community to prevent from further smoking related morbidities and mortalities.

Using expert opinion to quantify unmeasured confounding bias parameters.

OBJECTIVE: To develop and apply a method to quantify bias parameters in the case example of the association between alcohol use and HIV-serodiscordant condomless anal sex with potential confounding by sensation seeking among men who have sex with men (MSM), using expert opinion as an external data source. METHODS: Through an online survey, we sought the input of 41 epidemiologist and behavioural scientists to quantify six parameters in the population of MSM: the proportion of high sensation seeking among heavy-drinking MSM, the proportion of sensation seeking among low-level drinking MSM, and the risk ratio (RR) of the association between sensation seeking and condomless anal sex, for HIV-positive and HIV-negative MSM. RESULTS: Eleven experts responded. For HIV-positive heavy drinkers, the proportion of high sensation seeking was 53.6% (beta distribution [α=5.50, ß=4.78]), and 41.1% (beta distribution [α=3.10, ß=4.46]) in HIV-negative heavy drinkers. In HIV-positive low-level alcohol drinkers, high sensation seeking was 26.9% (beta distribution [α=1.81, ß=4.92]), similar to high sensation seeking among HIV-negative low-level alcohol drinkers (25.3%) (beta distribution [α=2.00, ß=5.89]). The lnRR for the association between sensation seeking and condomless anal sex was ln(2.4) (normal distribution [µ=0.889, σ=0.438]) in HIV-positive and ln(1.5) (normal distribution [µ=0.625, σ=0.391]) in HIV-negative MSM. CONCLUSION: Expert opinion can be a simple and efficient method for deriving bias parameters to quantify and adjust for hypothesized confounding. In this test case, expert opinion confirmed sensation seeking as a confounder for the effect of alcohol on condomless anal sex and provided the parameters necessary for probabilistic bias analysis.

Effectiveness of Policies on Reducing Exposure to Ionizing Radiation From Medical Imaging: A Systematic Review.

PURPOSE: The use of medical imaging has expanded greatly in the past three decades, raising concern about potential unwanted carcinogenic harms associated with exposure to ionizing radiation among patients. This study summarizes evidence of efficacy of interventions that have prompted policies, and structural-level interventions aimed at reducing radiation dose and risk of cancer, especially among women. METHODS: Using standard terms, we conducted searches in MEDLINE, Scopus, and Web of Science, and de-duplicated retrieved citations. We hand-searched the reference section of eligible studies and contacted radiology experts to identify studies missed from electronic searches. Two reviewers screened retrieved citations based on predefined eligibility criteria, to identify relevant studies, extract key information from each, rate the quality of evidence, and summarize data in tabular and graphical format. RESULTS: From a total of 1,543 unique citations identified from all sources, 16 were included for data extraction. Half of the studies focused on reduction of ionizing exposure from CT, and half on x-ray or fluoroscopy. Identified interventions were broadly categorized as: policy or structural intervention (two; 13%); multipronged (four; 25%); dose-feedback system (five; 31%); provision of training (four; 25%); and quality-control audit (one; 6%). In general, multipronged programs had a higher range for dose reduction (22%-74%), followed by policy/structural interventions (37%-50%). CONCLUSIONS: Existing evidence on the effectiveness of policies aimed at reducing patient radiation dose is disperse and low in quality. Compared with other approaches, multipronged efforts may offer more patient protection.

High hepatitis C virus prevalence among drug users in Iran: systematic review and meta-analysis of epidemiological evidence (2001-2012).

OBJECTIVE: Drug users, particularly drug injectors, are at elevated risk of blood-borne diseases. This study systematically reviewed the prevalence of hepatitis C virus (HCV) mono-infection and its co-infections with human immunodeficiency virus (HIV) and hepatitis B virus (HBV) in drug users in Iran. METHODS: Searches were conducted in international, regional, and Iranian databases. Documents were screened, data extracted, and pooled point prevalence and 95% confidence intervals (CI) were calculated. RESULTS: Overall, 13,821 subjects (87.4% male) with an average age of 32.4 years (95% CI 31-33 years) from 24 original studies were included in the analysis. The pooled HCV prevalence (95% CI) among drug users with and without an injection history was 45% (37-54%) and 8% (4-13%), respectively. The pooled HCV prevalences (95% CI) among individuals with vs. without a history of imprisonment and needle sharing were 58% (39-77%) vs. 44% (20-68%) and 56% (41-71%) vs. 49% (26-71%), respectively. The prevalence of HCV/HIV co-infection among injectors was 11% (95% CI 5-16%). CONCLUSIONS: HCV prevalence is high in drug users in Iran, especially among those with a history of injection drug use, needle sharing, and imprisonment. Drug user-focused HCV prevention and treatment programs are urgently needed.

Risk and vulnerability of key populations to HIV infection in Iran; knowledge, attitude and practises of female sex workers, prison inmates and people who inject drugs.

UNLABELLED: Background In this study data of three national surveys conducted among female sex workers (FSW), prison inmates and people who inject drugs (PWID) were presented and compared in relation to knowledge, attitude, and practises. METHODS: The surveys were conducted in 2009 and 2010 and included 2546 PWID, 872 FSW and 5530 prison inmates. Knowledge, attitude and practises towards HIV were measured through similar questions for each category. RESULTS: Over 90% of all participants had ever heard of HIV/AIDS, although only approximately half of them perceived themselves at risk of contracting HIV. More than 80% were able to correctly identify the ways of preventing the sexual transmission of HIV; while more than two-thirds did not use condom in their last sexual contact. Approximately 20% of prisoners and FSW had a history of injecting drugs. Among all participants who have injected drugs, prisoners had the highest unsafe injecting behaviour at the last injection (61%), followed by FSW (11%) and PWID (3%). CONCLUSIONS: Despite major efforts to control the HIV epidemic in Iran, the level of risk and vulnerability among prisoners, FSW and PWID is still high. The level of comprehensive knowledge about HIV/AIDS is relatively good; however, their risk perception of contracting HIV is low and high-risk behaviours are prevalent. Therefore, HIV prevention programs should be redesigned in a more comprehensive way to identify the best venues to reach the largest number of people at a higher risk of contracting HIV and decrease their risk overlaps and vulnerability factors.

HIV and related risk behaviors among female sex workers in Iran: bias-adjusted estimates from the 2010 National Bio-Behavoral Survey.

In a national, facility-based survey of female sex workers in 14 cities of Iran (N = 872), HIV prevalence was measured at 4.5 % (95 % CI, 2.4-8.3) overall and at 11.2 % (95 % CI, 3.4-18.9) for FSW with a history of injection drug use. Using methods to correct for biases in reporting sensitive information, the estimate of unprotected sex in last act was 35.8 %, ever injecting drugs was 37.6 %, sexually transmitted disease symptoms was 82.1 %, and not testing for HIV in the last year was 64.0 %. The amount of bias correction ranged from <1 to >30 %, in parallel with the level of stigma associated with each behavior. Considering the current upward trajectory of HIV infection in the Middle East and North Africa region, as well as the ongoing high level of risky behaviors and considerable underreporting of many such behaviors in surveys, bias corrections may be needed, especially in the context of Iran, to obtain more accurate information to guide prevention and care responses to stop the growing HIV epidemic in this vulnerable group of women.

HIV prevalence and related risk behaviours among female sex workers in Iran: results of the national biobehavioural survey, 2010.

OBJECTIVES: To determine the prevalence of HIV and related behavioural risks among Iranian female sex workers (FSW) via the first national biobehavioural surveillance survey. METHODS: In 2010, 1005 FSW were approached and 872 recruited using facility-based sampling from 21 sites in 14 cities in Iran. We collected dried blood samples and conducted face-to-face interviews using a standardised questionnaire. Data were weighted based on the response rate and adjusted for the clustering effect of the sampling site. Adjustment was performed by weighting based on the sampling fraction of each site using a prior estimate of its total size of the FSW population. RESULTS: The prevalence of HIV infection (95% CI) was 4.5% (2.4 to 8.3) overall, 4.8% (2.2 to 9.8) among those who had reported a history of drug use and 11.2% (5.4 to 21.5) among those who had a history of injection drug use. The frequencies of condom use in the last sexual act with paying clients and non-paying partners were 57.1% and 36.3%, respectively. Any drug use was reported by 73.8% of participants, and among this subgroup, 20.5% had a history of injection drug use. CONCLUSIONS: The prevalence of HIV was considerable among FSW particularly those who had a history of drug injection. A combination of prevention efforts addressing unsafe sex and injection are needed to prevent further transmission of HIV infection.

HIV prevalence and related risk behaviours among prisoners in Iran: results of the national biobehavioural survey, 2009.

OBJECTIVES: To estimate the prevalence of HIV and related risk behaviours among prisoners in Iran in 2009. METHODS: Using multistage random sampling, we recruited 5,530 prisoners from 27 prisons in Iran. Behavioural data were collected using a face-to-face questionnaire-based interview, and HIV status was determined by ELISA of dried blood spots. Weighted estimates were calculated based on the sampling probability and response rate. RESULTS: HIV prevalence was 2.1% (95% CI 1.2 to 3.6). One in eight prisoners (12.3%, 95% CI 8.0% to 16.6%) had been tested for HIV in the last year and received results, 20.5% (95% CI 15.1 to 27.4%) had comprehensive knowledge about HIV and 24.7% (95% CI 17.9% to 32.9%) reported condom use at last vaginal/anal sex in prison. Although 16.5% (95% CI 12.5% to 21.5%) acknowledged a lifetime history of drug injection, only 22 prisoners reported drug injection inside the prison in the month preceding the interview. Of note, 12.9% (95% CI 10.6% to 15.6%) had been tattooed in prison. There were significant associations between HIV prevalence and a history of drug injection (adjusted odds ratio (AOR): 7.8, 95% CI 4.7 to 13.2), tattooing (AOR: 2.1, 95% CI 1.1 to 4.2) and age over 30 years (AOR: 1.4, 95% CI 1.1 to 1.9). CONCLUSIONS: Considerable HIV prevalence among prisoners is found in Iran. Expanding harm reduction programmes inside prisons with inclusion of sexual risk reduction programmes and post-release programmes will help directly prevent acquisition and transmission of infection inside prisons and indirectly slow onward transmission in the outside communities.

Bias analysis to improve monitoring an HIV epidemic and its response: approach and application to a survey of female sex workers in Iran.

BACKGROUND: We present probabilistic and Bayesian techniques to correct for bias in categorical and numerical measures and empirically apply them to a recent survey of female sex workers (FSW) conducted in Iran. METHODS: We used bias parameters from a previous validation study to correct estimates of behaviours reported by FSW. Monte-Carlo Sensitivity Analysis and Bayesian bias analysis produced point and simulation intervals (SI). RESULTS: The apparent and corrected prevalence differed by a minimum of 1% for the number of 'non-condom use sexual acts' (36.8% vs 35.8%) to a maximum of 33% for 'ever associated with a venue to sell sex' (35.5% vs 68.0%). The negative predictive value of the questionnaire for 'history of STI' and 'ever associated with a venue to sell sex' was 36.3% (95% SI 4.2% to 69.1%) and 46.9% (95% SI 6.3% to 79.1%), respectively. Bias-adjusted numerical measures of behaviours increased by 0.1 year for 'age at first sex act for money' to 1.5 for 'number of sexual contacts in last 7 days'. CONCLUSIONS: The 'true' estimates of most behaviours are considerably higher than those reported and the related SIs are wider than conventional CIs. Our analysis indicates the need for and applicability of bias analysis in surveys, particularly in stigmatised settings.

Accuracy of HIV-related risk behaviors reported by female sex workers, Iran: a method to quantify measurement bias in marginalized populations.

We quantified discrepancies in reported behaviors of female sex workers (FSW) by comparing 63 face-to-face interviews (FTFI) to in-depth interviews (IDI), with corroboration of the directions and magnitudes of reporting by a panel of psychologists who work with FSW. Sensitivities, specificities, positive and negative predictive values (PPV and NPV) were assessed for FTFI responses using IDI as a "gold standard". Sensitivities were lowest in reporting symptoms of sexually transmitted infections (63.9 %), finding sex partners in venues (52.4 %) and not receiving HIV test results (66.7 %). Specificities (all >83 %) and PPVs (all >74.0 %) were higher than NPV. FSW significantly under-reported number of clients, sexual contacts and non-condom use sex acts with clients and number of days engaging in sex work in the preceding week. This study provides a quantified gauge of reporting biases in FSW behaviors. Such estimates and methods help better understand true HIV risk in marginalized populations and calibrate survey estimates accordingly.

Trends of Obesity in Iranian Adults from 1990s to late 2000s; a Systematic Review and Meta-analysis.

BACKGROUND: Obesity is currently emerging as a global epidemic, affecting 10% of adultpopulation worldwide. The primary objective of the current systematic reviewis to describe the trend of overall prevalence of obesity in Iranian women andmenthrough a meta-analysis. METHODS: We searched the medical literature published from 1990 to 2007 in Medline(PubMed), EMBASE database, and the Iranian digital library. All publishedreports of research projects, papers in relevant congresses, unpublished crudedata analysis, proceedings, books and dissertations were reviewed. Data fromeligible papers that fulfilled the qualification criteria entered meta-analysis(Random Model). RESULTS: Data from 209,166 individuals were analyzed. The overall prevalence ofobesity in adults was 18.5% (95%CI: 15.1-21.8), respectively. The prevalenceof obesity in men and women was 12.9% (95%CI: 10.9-14.9) and 26.2%(95%CI: 21.3-30.5), respectively. The trend of obesity was similar in both genders;women had almost a constantly higher risk of obesity than men duringthe recent two decades. CONCLUSION: Data from 209,166 individuals were analyzed. The overall prevalence ofobesity in adults was 18.5% (95%CI: 15.1-21.8), respectively. The prevalenceof obesity in men and women was 12.9% (95%CI: 10.9-14.9) and 26.2%(95%CI: 21.3-30.5), respectively. The trend of obesity was similar in both genders;women had almost a constantly higher risk of obesity than men duringthe recent two decades.

Research priorities in the field of HIV and AIDS in Iran.

BACKGROUND: HIV is a multidimensional problem. Therefore, prioritization of research topics in this field is a serious challenge. We decided to prioritize the major areas of research on HIV/AIDS in Iran. MATERIALS AND METHODS: In a brain-storming session with the main national and provincial stakeholders and experts from different relevant fields, the direct and indirect dimensions of HIV/AIDS and its related research issues were explored. Afterward, using the Delphi method, we sent questionnaires to 20 experts (13 respondents) from different sectors. In this electronic based questioner, we requested experts to evaluate main topics and their subtopics. The ranges of scores were between 0 and 100. RESULTS: The score of priorities of main themes were preventive activities (43.2), large scale planning (25.4), the estimation of the HIV/AIDS burden (20.9), and basic scientific research (10.5). The most important priority in each main theme was education particularly in high risk groups (52.5), developing the national strategy to address the epidemic (31.8), estimation of the incidence and prevalence among high-risk groups (59.5) and developing new preventive methods (66.7), respectively. CONCLUSIONS: The most important priorities of researches on HIV/AIDS were preventive activities and developing national strategy. As high risk groups are the most involved people in the epidemic, and they are also the most hard-to-reach sub-populations, a national well designated comprehensive strategy is essential. However, we believe with a very specific and directed scheme, special attention to research in basic sciences is necessary, at least in limited number of institutes.