Overreporting of adherence to hepatitis C direct-acting antiviral therapy and sustained virologic response among people who inject drugs in the HERO study.

BACKGROUND: Self-reported adherence to direct-acting antivirals (DAAs) to treat hepatitis C virus (HCV) among persons who inject drugs (PWID) is often an overreport of objectively measured adherence. The association of such overreporting with sustained virologic response (SVR) is understudied. This study among PWID aimed to determine a threshold of overreporting adherence that optimally predicts lower SVR rates, and to explore correlates of the optimal overreporting threshold. METHODS: This study analyzed per-protocol data of participants with adherence data (N = 493) from the HERO (Hepatitis C Real Options) study. Self-reported and objective adherence to a 12-week DAA regimen were measured using visual analogue scales and electronic blister packs, respectively. The difference (Δ) between self-reported and objectively measured adherence was calculated. We used the Youden index based on receiver operating characteristic (ROC) curve analysis to identify an optimal threshold of overreporting for predicting lower SVR rates. Factors associated with the optimal threshold of overreporting were identified by comparing baseline characteristics between participants at/above versus those below the threshold. RESULTS: The self-reported, objective, and Δ adherence averages were 95.1% (SD = 8.9), 75.9% (SD = 16.3), and 19.2% (SD = 15.2), respectively. The ≥ 25% overreporting threshold was determined to be optimal. The SVR rate was lower for ≥ 25% vs. < 25% overreporting (86.7% vs. 95.8%, p <.001). The factors associated with ≥ 25% Δ adherence were unemployment; higher number of days and times/day of injecting drugs; higher proportion of positive urine drug screening for amphetamine, methamphetamine, and oxycodone, and negative urine screening for THC (tetrahydrocannabinol)/cannabis. CONCLUSIONS: Self-reported DAA adherence was significantly greater than objectively measured adherence among PWID by 19.2%. Having ≥ 25% overreported adherence was associated with optimal prediction of lower SVR rates. PWID with risk factors for high overreporting may need to be more intensively managed to promote actual adherence.

Buprenorphine treatment receipt characteristics and retention among people who inject drugs at Integrated Care Centers in India.

BACKGROUND: India is facing overlapping opioid injection and HIV epidemics among people who inject drugs (PWID) in several cities. Integrated Care Centers (ICCs) provide single-venue HIV and substance use services to PWID. We evaluated PWID engagement in daily observed buprenorphine treatment at 7 ICCs to inform interventions. METHODS: We analyzed 1-year follow-up data for PWID initiating buprenorphine between 1 January - 31 December 2018, evaluating receipt frequency, treatment interruptions (no buprenorphine receipt for 60 consecutive days with subsequent re-engagement), and drop-out (no buprenorphine receipt for 60 consecutive days without re-engagement). Using descriptive statistics, we explored differences between ICCs in the opioid-endemic Northeast region and ICCs in the emerging opioid epidemic North/Central region. We used a multivariable logistic regression model to determine predictors of treatment drop-out by 6 months. RESULTS: 1312 PWID initiated buprenorphine (76% North/Central ICCs vs. 24% Northeast ICCs). 31% of PWID in North/Central, and 25% in Northeast ICCs experienced ≥ 1 treatment interruption in 1 year. Over 6 months, 48% of PWID in North/Central vs. 60% in Northeast ICCs received buprenorphine ≤ 2 times/week (p < 0.0001). A third of PWID in North/Central vs. half in Northeast ICCs experienced treatment drop-out by 6 months (p < 0.001). In the multivariable model, living in Northeast cities was associated with increased odds of drop-out while counseling receipt was associated with decreased odds. CONCLUSIONS: Retention among PWID initiating buprenorphine at ICCs was comparable to global reports. However, regional heterogeneity in retention, and low daily buprenorphine receipt suggest patient-centered interventions adapted to regional contexts are urgently needed.

"Stigma is where the harm comes from": Exploring expectations and lived experiences of hepatitis C virus post-treatment trajectories among people who inject drugs.

BACKGROUND: The advent of direct-acting antiviral (DAA) medications has facilitated opportunities to treat hepatitis C virus (HCV) among people who inject drugs (PWID). However, there remains a need for data about how to optimally support PWID throughout DAA post-treatment trajectories, including with regard to re-infection prevention. The objective of this study is therefore to identify how PWID with lived experience of HCV describe their expectations and experiences related to health and social outcomes, contexts, and substance use practices following completion of DAA treatment. METHODS: We thematically analyzed data from in-depth, semi-structured interviews, conducted between January and June 2018, in Vancouver, Canada, with a purposive sample (n = 50) of PWID at various stages of DAA treatment (e.g., pre, peri, post). RESULTS: Our analysis yielded three themes. First, while participants had hoped to experience holistic enhancements in wellbeing following HCV cure, discussions of actual post-treatment experiences tended to be located in physical health (e.g., increased energy). Second, participants often pointed to the ways in which HCV-related and other stigmas had restricted opportunities for health and healthcare access. Participants therefore identified stigma-reduction as a key motivator of HCV cure, and while reductions in internalized stigma were sometimes achieved, participants underscored that other forms of enacted stigma (e.g., related to: substance use, HIV, poverty) had continued to feature prominently in their post-treatment lives. Third, participants described considerable knowledge about how to prevent HCV re-infection following cure, but they also expressed apprehensiveness about how socio-structural barriers, including stigma and criminalization, could interfere with harm reduction and re-infection prevention efforts. CONCLUSIONS: DAAs are transforming the health and wellbeing of some PWID. Yet, HCV-related policy must extend beyond the scale-up of DAAs to include concerted public health investments, including anti-stigma efforts and improvements to the social welfare system, to meaningfully advance equity in PWID's post-treatment trajectories and outcomes.

Life after hepatitis C cure in HIV-infected people who inject drugs and men who have sex with men treated with direct-acting antivirals in France: Health perceptions and experiences from qualitative and quantitative findings (ANRS CO13 HEPAVIH).

There remains a substantial gap in our understandings of the life experiences of patients following HCV cure among HIV-HCV-co-infected people who inject drugs (PWID) and men who have sex with men (MSM), two key populations targeted for HCV elimination. We described the experiences and perspectives of HIV-positive PWID and MSM, HCV-cured following treatment with direct-acting antivirals (DAA). We used an exploratory sequential mixed approach using both qualitative data (semi-structured interviews with 27 PWID and 20 MSM) and quantitative data (self-administered questionnaires with 89 PWID) via the prospective ANRS CO13 HEPAVIH cohort. PWID reported improvements in physical health-related quality of life (HRQL) and self-reported symptoms following treatment, but no significant change in mental HRQL. During interviews, several MSM, more recently diagnosed with HCV, expressed less concern regarding HCV than HIV infection and interpreted improvements in their overall well-being after HCV cure to be more related to a closer connection with healthcare providers than with viral elimination. By contrast, PWID, particularly those previously exposed to interferon-based treatments, described major improvements in their physical HRQL. Both MSM and PWID reported improvements in cognitive or psychological wellbeing, and a majority of them reported some degree of concern over potential HCV reinfection. To conclude, though health benefits of HCV cure concern both groups, HIV-infected PWID and MSM may have different representations and experiences following DAA treatment, related to their history with HCV. They are thus likely to benefit from holistic, post-treatment follow-up care that is responsive to their evolving health and social contexts.

Opportunistic treatment of hepatitis C virus infection (OPPORTUNI-C): study protocol for a pragmatic stepped wedge cluster randomized trial of immediate versus outpatient treatment initiation among hospitalized people who inject drugs.

BACKGROUND: Scaled-up direct-acting antiviral (DAA) treatment of hepatitis C virus (HCV) infection among people who inject drugs (PWID) is crucial to reach the World Health Organization HCV elimination targets within 2030. One of the critical obstacles to HCV care in this population is the lack of treatment models within specialist healthcare adapted to marginalized individuals. METHODS: OPPORTUNI-C is a pragmatic stepped wedge cluster randomized trial comparing the efficacy of immediate initiation of HCV treatment with the current standard of care among PWID admitted for inpatient care. Screening for HCV RNA will be performed as soon as possible after admission. The intervention includes immediate non-invasive liver disease assessment, counseling, and initiation of pan-genotypic DAA treatment with individualized follow-up. Standard of care is a referral to outpatient care at discharge. To mimic usual clinical practice as closely as possible, we will use a pragmatic clinical trial approach utilizing clinical infrastructure, broad eligibility criteria, flexible intervention delivery, clinically relevant outcomes, and collection of data readily available from the electronic patient files. The stepped wedge design involves a sequential rollout of the intervention over 16 months, in which seven participating clusters will be randomized from standard of care to intervention in a stepwise manner. Randomization will be stratified according to cluster size to keep high prevalence clusters separated. The trial will include approximately 220 HCV RNA positive individuals recruited from departments of internal medicine, addiction medicine, and psychiatry at Akershus University Hospital, Oslo University Hospital, and Lovisenberg Diaconal Hospital, Oslo, Norway. Individuals not able or willing to give informed consent and those with ongoing HCV assessment or treatment will be excluded. The primary outcome is treatment completion, defined as dispensing of the final prescribed DAA package from the pharmacy within 6 months after inclusion. Secondary outcomes include treatment uptake, virologic response, reinfection incidence, and resistance-associated substitutions. DISCUSSION: Representing a novel model of care suited to reach and engage marginalized PWID in HCV care, this study will inform HCV elimination efforts locally and internationally. If the model proves efficacious and feasible, it should be considered for broader implementation, replacing the current standard of care. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04220645. Registered on 7 January 2020.

Integrated treatment of hepatitis C virus infection among people who inject drugs: study protocol for a randomised controlled trial (INTRO-HCV).

BACKGROUND: A large proportion of people who inject drugs (PWID) living with hepatitis C virus (HCV) infection have not been treated. It is unknown whether inclusion of HCV diagnostics and treatment into integrated substance use disorder treatment and care clinics will improve uptake and outcome of HCV treatment in PWID. The aim is to assess the efficacy of integrating HCV treatment to PWID and this paper will present the protocol for an ongoing trial. METHODS: INTRO-HCV is a multicentre, randomised controlled clinical trial that will compare the efficacy of integrated treatment of HCV in PWID with the current standard treatment. Integrated treatment includes testing for HCV, assessing liver fibrosis with transient elastography, counselling, treatment delivery, follow-up and evaluation provided by integrated substance use disorder treatment and care clinics. Most of these clinics for PWID provide opioid agonist therapy while some clinics provide low-threshold care without opioid agonist therapy. Standard care involves referral to further diagnostics, treatment and treatment follow-up given in a hospital outpatient clinic with equivalent medications. The differences between the delivery platforms in the two trial arms involve use of a drop-in approach rather than specific appointment times, no need for additional travelling, less blood samples taken during treatment, and treatment given from already known clinicians. The trial will recruit approximately 200 HCV infected individuals in Bergen and Stavanger, Norway. The primary outcomes are time to treatment initiation and sustained virologic response, defined as undetectable HCV RNA 12 weeks after end of treatment. Secondary outcomes are cost-effectiveness, treatment adherence, changes in quality of life, fatigue and psychological well-being, changes in drug use, infection related risk behaviour, and risk of reinfection. The target group is PWID with HCV diagnosed receiving treatment and care within clinics for PWID. DISCUSSION: This study will inform on the effects of an integrated treatment program for HCV in clinics for PWID compared to standard care aiming to increase access to treatment and improving treatment adherence. If the integrated treatment model is found to be safe and efficacious, it can be considered for further scale-up. TRIAL REGISTRATION: ClinicalTrials.gov.no. NCT03155906.

Cost-effectiveness of integrating buprenorphine-naloxone treatment for opioid use disorder into clinical care for persons with HIV/hepatitis C co-infection who inject opioids.

BACKGROUND: Untreated opioid use disorder (OUD) affects the care of HIV/HCV co-infected people who inject opioids. Despite active injection opioid use, there is evidence of increasing engagement in HIV care and adherence to HIV medications among HIV/HCV co-infected persons. However, less than one-half of this population is offered HCV treatment onsite. Treatment for OUD is also rare and largely occurs offsite. Integrating buprenorphine-naloxone (BUP-NX) into onsite care for HIV/HCV co-infected persons may improve outcomes, but the clinical impact and costs are unknown. We evaluated the clinical impact, costs, and cost-effectiveness of integrating (BUP-NX) into onsite HIV/HCV treatment compared with the status quo of offsite referral for medications for OUD. METHODS: We used a Monte Carlo microsimulation of HCV to compare two strategies for people who inject opioids: 1) standard HIV care with onsite HCV treatment and referral to offsite OUD care (status quo) and 2) standard HIV care with onsite HCV and BUP-NX treatment (integrated care). Both strategies assume that all individuals are already in HIV care. Data from national databases, clinical trials, and cohorts informed model inputs. Outcomes included mortality, HCV reinfection, quality-adjusted life years (QALYs), costs (2017 US dollars), and incremental cost-effectiveness ratios. RESULTS: Integrated care reduced HCV reinfections by 7%, cases of cirrhosis by 1%, and liver-related deaths by 3%. Compared to the status quo, this strategy also resulted in an estimated 11/1,000 fewer non-liver attributable deaths at one year and 28/1,000 fewer of these deaths at five years, at a cost-effectiveness ratio of $57,100/QALY. Integrated care remained cost-effective in sensitivity analyses that varied the proportion of the population actively injecting opioids, availability of BUP-NX, and quality of life weights. CONCLUSIONS: Integrating BUP-NX for OUD into treatment for HIV/HCV co-infected adults who inject opioids increases life expectancy and is cost-effective at a $100,000/QALY threshold.

Integrated and differentiated methadone and HIV care for people who use drugs: a qualitative study in Kenya with implications for implementation science.

Integrating methadone and HIV care is a priority in many low- and middle-income settings experiencing a growing challenge of HIV epidemics linked to injecting drug use. There is as yet little understanding of how to integrate methadone and HIV care in these settings and how such services can be implemented; such a gap reflects, in part, limitations in theorizing an implementation science of integrated care. In response, we qualitatively explored the delivery of methadone after its introduction in Kenya to understand integration with HIV care. Semi-structured interviews with people using methadone (n = 30) were supplemented by stakeholder interviews (n = 2) and participant observation in one city. Thematic analysis was used, that also drew on Mol's logic of care as an analytical framework. Respondents described methadone clinic-based care embedded in community support systems. Daily observed clinic care was challenging for methadone and stigmatizing for HIV treatment. In response to these challenges, integration evolved and HIV care differentiated to other sites. The resulting care system was acceptable to respondents and allowed for choice over locations and approaches to HIV care. Using Mol's logic of care as an analytical framework, we explore what led to this differentiation in integrated care. We explore co-production and experimentation around HIV care that compares with more limited experimentation for methadone. This experimentation is bounded by available discourses and materials. The study supports continued integration of services whilst allowing for differentiation of these models to adapt to client preferences. Co-location of integrated services must prioritize clinic organization that prevents HIV status disclosure. Our analysis fosters a material perspective for theory of implementation science and integration of services that focuses attention on local experimentation shaped by context.

Why People Who Inject Drugs Voluntarily Transition Off Methadone in Ukraine.

Methadone maintenance therapy (MMT) treats opioid use disorder among people who inject drugs (PWID). To understand why PWID may voluntarily discontinue MMT, we analyzed data from 25 focus groups conducted in five Ukrainian cities from February to April 2013 with 199 participants who were currently, previously, or never on MMT. Using constant comparison method, we uncovered three themes explaining why PWID transition off MMT: (a) purposeful resistance to rigid social control associated with how MMT is delivered and to power asymmetries in provider-patient relationships, (b) self-management of a PWID's "wounded identity" that is common in socially stigmatized and physically sick persons-MMT serves as a reminder of their illness, and (c) the quest for a "normal life" uninterrupted by daily MMT site visits, harassment, and time inefficiencies, resources, and social capital. Focusing on holistic principles of recovery would improve addiction treatment and HIV prevention in Ukraine and globally.

Differences in polysubstance use patterns and drug-related outcomes between people who inject drugs receiving and not receiving opioid substitution therapies.

AIMS: To test if polysubstance use profiles and drug-related outcomes differ between those receiving and not receiving opioid substitution therapies (OST) among people who inject drugs (PWID). DESIGN: An annual cross-sectional, sentinel sample of PWID across Australia. SETTING: Data came from 3 years (2011-13) of the Illicit Drug Reporting System (IDRS). PARTICIPANTS: A total of 2673 participants who injected drugs from the combined national IDRS samples of 2011 (n = 868), 2012 (n = 922) and 2013 (n = 883). MEASUREMENTS: Latent class analysis (LCA) was used to summarize participants' self-reported use of 18 types of substances, with the resulting polysubstance use profiles then associated with participant experience of a number of drug-related outcomes. FINDINGS: Polysubstance use profiles exhibiting a broad range of substance use were generally at increased risk of negative drug-related outcomes, whether or not participants were receiving OST, including thrombosis among OST receivers [odds ratio (OR) = 2.13, 95% confidence intervals (CI) = 1.09-4.17], injecting with used needles among OST receivers and non-receivers, respectively (OR = 2.78, 95% CI = 1.50-5.13; OR = 2.15, 95% CI = 1.34-3.45) and violent criminal offences among OST receivers and non-receivers, respectively (OR =2.30, 95% CI = 1.16-4.58; OR = 1.87, 95% CI = 1.14-3.07). An important exception was non-fatal overdose which was related specifically to a class of PWID who were not receiving OST and used morphine frequently (OR = 1.83, 95% CI = 1.06-3.17) CONCLUSION: Regardless of opioid substitution therapies usage, people who inject drugs who use a broad-range of substances experience greater levels of injecting-related injuries and poorer health outcomes and are more likely to engage in criminal activity than other groups of people who inject drugs.

Biomedical HIV Prevention Including Pre-exposure Prophylaxis and Opiate Agonist Therapy for Women Who Inject Drugs: State of Research and Future Directions.

Women who inject drugs (WWID) are at higher risk of HIV compared with their male counterparts as a result of multiple factors, including biological, behavioral, and sociostructural factors, yet comparatively little effort has been invested in testing and delivering prevention methods that directly target this group. In this article, we discuss the need for expanded prevention interventions for WWID, focusing on 2 safe, effective, and approved, yet underutilized biomedical prevention methods: opiate agonist therapy (OAT) and oral pre-exposure prophylaxis (PrEP). Although both interventions are well researched, they have not been well examined in the context of gender. We discuss the drivers of women injectors' higher HIV risk, review the effectiveness of OAT and PrEP interventions among women, and explain why these new HIV prevention tools should be prioritized for WWID. There is substantial potential for impact of OAT and PrEP programs for WWID in the context of broader gender-responsive HIV prevention initiatives. Although awaiting efficacy data on other biomedical approaches in the HIV prevention research "pipeline," we propose that the scale-up and implementation of these proven, safe, and effective interventions are needed now.

Harm reduction--from a conceptual framework to practical experience: the example of Germany.

Drug demand reduction programs must be integrated into a comprehensive strategy aiming at preventing drug misuse, facilitating access to counseling, to treatment of dependence, and to rehabilitation; and establishing effective measures to reduce the adverse health and social consequences of drug misuse. The continuous and even rising spread of HIV/AIDS and other infectious diseases (e.g., hepatitis B and C) among injecting drug users is alarming. Although, in many countries the prevalence of HIV infections is decreasing due to the implementation of effective harm reduction measures, such as syringe exchange and opiate substitution treatment (OST), in other countries infections are on the rise. The lessons learnt indicate that only a comprehensive, evidence-based approach in prevention, treatment, care, and support is promising in combating the devastating effects of drug dependence.

Economic evaluation of methadone maintenance treatment in HIV/AIDS control among injecting drug users in Dehong, China.

The purpose of this study was to analyze the cost and cost-effectiveness of methadone maintenance treatment (MMT) program in Dehong prefecture, Yunnan province, China. The cost-effectiveness analysis used process data retrospectively collected from the MMT clinics in Dehong Prefecture, Yunnan Province, from July 2005 to December 2007, a 30-month period available at the time of the study. Alternative estimates of the number of HIV infections prevented were calculated using incidence rate from cohort studies and retrospective studies. Program costs were collected retrospectively following standard methods using an ingredients methodology. The cost for each participant treated in MMT clinics was about $9.1-16.7 per month and the intervention averted 8.4-87.2 HIV infections with a cost-effectiveness of US$ 2509.3-4609.3 per HIV infection averted. This research demonstrates that MMT is a cost-effective intervention for reducing HIV transmission among injecting drug users, but the coverage of MMT intervention should be matched with the designed volume of MMT clinics to make the best use of resources.

Self-reported side effects in buprenorphine and methadone patients receiving antiretroviral therapy: results from the MANIF 2000 cohort study.

AIMS: The aim of the study was to investigate the relationship between methadone and buprenorphine treatment and self-reported symptoms in HIV-infected opioid dependent individuals receiving antiretroviral therapy (ART). DESIGN: Longitudinal study. SETTING: The French MANIF2000 cohort was used to compare self-reported symptoms in buprenorphine and methadone patients also receiving ART. PARTICIPANTS: We selected individuals receiving ART and OAT (342 visits among 106 patients). MEASUREMENTS: Symptoms were self-reported using a list of 14 symptoms (e.g. nausea, fatigue, fever) perceived during the previous 4 weeks, including three painful symptoms (abdominal or muscular pain, headaches). A two-step Heckman approach enabled us to account for the non-random assignment of OAT: a probit model identified predictors of starting either buprenorphine or methadone. A Poisson regression based on generalized estimating equations (GEE) was then used to identify predictors of the number of symptoms while adjusting for the non-random assignment of OAT. FINDINGS: The median (interquartile range) number of symptoms was 4 (1-6) and 2 (1-6) among buprenorphine and methadone patients, respectively. After adjustment for non-random assignment of OAT type, depressive and opioid withdrawal symptoms, anxiolytics consumption and daily cannabis use, methadone patients were more likely to report a lower number of symptoms than those receiving buprenorphine. CONCLUSIONS: Methadone patients on ART report fewer symptoms than buprenorphine patients on ART under current treatment conditions in France. Further experimental research is still needed to identify an OAT-ART strategy which would minimize the burden of self-reported symptoms and potential interactions, while assuring sustainability and response to both treatments.

Reconciling conflicting clinical studies of antioxidant supplementation as HIV therapy: a mathematical approach.

BACKGROUND: Small, highly reactive molecules called reactive oxygen species (ROS) play a crucial role in cell signalling and infection control. However, high levels of ROS can cause significant damage to cell structure and function. Studies have shown that infection with the human immunodeficiency virus (HIV) results in increased ROS concentrations, which can in turn lead to faster progression of HIV infection, and cause CD4+ T-cell apoptosis. To counteract these effects, clinical studies have explored the possibility of raising antioxidant levels, with mixed results. METHODS: In this paper, a mathematical model is used to explore this potential therapy, both analytically and numerically. For the numerical work, we use clinical data from both HIV-negative and HIV-positive injection drug users (IDUs) to estimate model parameters; these groups have lower baseline concentrations of antioxidants than non-IDU controls. RESULTS: Our model suggests that increases in CD4+ T cell concentrations can result from moderate levels of daily antioxidant supplementation, while excessive supplementation has the potential to cause periods of immunosuppression. CONCLUSION: We discuss implications for HIV therapy in IDUs and other populations which may have low baseline concentrations of antioxidants.

An integrated supervised injecting program within a care facility for HIV-positive individuals: a qualitative evaluation.

While there has been growing interest in comprehensive models of treatment and care for individuals living with HIV/AIDS, little attention has been given to the potential role that supervised injecting programs could play in increasing access to prevention and care services for HIV-positive injection drug users (IDU). We conducted 22 semi-structured interviews with HIV-positive IDU regarding a supervised injection program integrated in an HIV focused care facility known as the Dr. Peter Centre (DPC). We also interviewed seven staff members who supervise injections within the facility. All interviews were audio recorded, transcribed verbatim, and a thematic analysis was conducted. Participant and staff reports indicated that the integrated supervised injection program influenced IDUs' access to care by building more open and trusting relationships with staff, facilitating engagement in safer injection education and improving the management of injection-related infections. Participants and staff viewed the program as facilitating the delivery of care through mediating overdose risks, reducing the need to punitively manage drug use on-site and reducing the risks of encountering used syringes on the premises. For some participants, however, feelings of shame and fear of judgment in relation to their drug use limited initial uptake of the program. Our findings identify mechanisms through which integrated supervised injection programs may serve to better facilitate access and delivery of comprehensive care for HIV-positive IDU and highlight the benefits of addressing HIV-positive IDUs' drug use in the context of comprehensive models of healthcare.

Improved antioxidant status among HIV-infected injecting drug users on potent antiretroviral therapy.

Low serum antioxidant levels in HIV-infected people have been attributed to altered metabolism associated with excess oxidative stress. We conducted a study to examine serum antioxidant levels in 175 HIV-positive and 210 HIV-negative injecting drug users (IDUs) in Baltimore, Maryland. At the time of data collection, 30 of the HIV-positive IDUs were receiving antiretroviral therapies (ART) including a protease inhibitor (PI), 43 ART without a PI, 22 monotherapies, and 80 not on any ART. Serum antioxidants examined included retinol, alpha-tocopherol and gamma-tocopherol, alpha-carotene and beta-carotene, lycopene, lutein/zeaxanthin, and beta-cryptoxanthin. Mean serum levels of lycopene and lutein/zeaxanthin were significantly lower in HIV-positive IDUs than HIV-negative IDUs. Contrary to the findings in other studies, however, levels of the remaining antioxidants in HIV-positive study subjects were not lower than in HIV-negative study subjects. In fact, serum alpha-tocopherol levels were significantly higher in HIV-positive IDUs than HIV-negative IDUs (medians = 744 microg/dl and 718 microg/dl, respectively; p = .04). Among HIV-positive study subjects, there were significant differences in antioxidant levels by ART regimen. In multivariate models adjusting for injecting drug use, dietary intake, supplement intake, gender, and alcohol intake, significant overall differences by ART regimen were observed for alpha-tocopherol, beta-carotene, and beta-cryptoxanthin. Serum levels of these three antioxidants were significantly higher in the PI group than in the other three ART groups combined (p = .0008, 0.02, and 0.02, respectively). These data provide indirect evidence of the effectiveness of PIs in lowering oxidative stress levels in HIV-positive IDUs.

HIV infection and AIDS risk behaviors among injecting drug users entering methadone treatment: an update.

Trends in HIV infection and AIDS risk behaviors among injecting drug users (IDUs) were assessed through a series of nonblinded point-prevalence surveys conducted between 1987 and 1991 with admissions to methadone treatment in eight areas, including New York City; Asbury Park and Trenton, New Jersey; Philadelphia; Baltimore; Chicago; San Antonio, Texas; and Los Angeles County. Over the 5-year period, significant changes in HIV seropositivity were found in two of the eight cities, with seroprevalence decreasing in Asbury Park from 43.1 to 21.2% and increasing from 10.1 to 17.6% in Chicago. Initially high levels of injection-related risk behaviors decreased substantially across cohorts in most cities, except for San Antonio and Los Angeles, where risk levels remained high. Sexual risk behaviors continued at high levels in all cities, suggesting relatively little sexual risk reduction during the course of the study.