Systemic Treatment for Brain Metastasis and Leptomeningeal Disease in Breast Cancer Patients.

PURPOSE OF REVIEW: Breast cancer with brain metastasis (BCBM) and leptomeningeal disease (LMD) are important clinical problems. Traditionally, patients with metastases to the brain and meninges were excluded from clinical trials; hence, robust, evidence-based treatment recommendations are lacking. In this review, we outline the systemic treatment options and ongoing clinical trials. RECENT FINDINGS: Several recent studies have added to the systemic treatment options available. Antibody-drug conjugates have changed the therapeutic landscape. Combination treatment modalities that target multiple mechanisms including disruption of the blood brain barrier are increasingly being studied. Breast cancer with brain metastases and LMD is a heterogenous disease. While the prognosis remains grim, with more systemic treatment options, patients with BCBM are now living longer. Many ongoing clinical trials hold promise to further improve outcomes.

Assessing Change in Exudative Age-Related Macular Degeneration With Macular Thickness Maps as a Surrogate Strategy for Remote Patient Monitoring.

PURPOSE: To determine if macular thickness maps (MTMs) are sufficient to guide management of eyes with exudative age-related macular degeneration (eAMD), we compared the ability to detect change using MTMs with the ability to detect change using the entire optical coherence tomography (OCT) scan in patients undergoing therapy. DESIGN: Retrospective, comparative diagnostic analysis. METHODS: Patients with eAMD were imaged using macula-centered 6 × 6-mm OCT scans (CIRRUS HD-OCT 5000; Zeiss). In each case, graders were asked to determine if there were changes that warranted a full clinical assessment after viewing 2 consecutive scans using one of 3 different imaging strategies: MTMs alone, individual foveal-centered B scans alone, or 5 macular B scans including the foveal-centered B scan. Graders were told the 2 scans were taken 2 weeks apart. The consensus ground truth was reached by the graders using a CIRRUS review station to evaluate all the information contained within the OCT scans. RESULTS: A total of 53 eyes were included in this study with 1385 imaging sessions. The Fleiss kappa was highest when graders were given MTMs alone compared with the ground truth. When the averages of all 5 graders were compared with the ground truth, the MTMs alone showed the highest level of agreement (90.05%, SD 0.78%) followed by the central B scans (87.87%, SD 1.59%) and the 5-B scan method (86.512%, SD 0.64%). CONCLUSION: MTMs alone provide sufficient information to easily identify recurrent exudation in patients with eAMD, and these maps may be all that is needed for remote monitoring.

High-grade B-cell lymphoma, not otherwise specified: a multi-institutional retrospective study.

In this multi-institutional retrospective study, we examined the characteristics and outcomes of 160 patients with high-grade B-cell lymphoma, not otherwise specified (HGBL-NOS)-a rare category defined by high-grade morphologic features and lack of MYC rearrangements with BCL2 and/or BCL6 rearrangements ("double hit"). Our results show that HGBL-NOS tumors are heterogeneous: 83% of patients had a germinal center B-cell immunophenotype, 37% a dual-expressor immunophenotype (MYC and BCL2 expression), 28% MYC rearrangement, 13% BCL2 rearrangement, and 11% BCL6 rearrangement. Most patients presented with stage IV disease, a high serum lactate dehydrogenase, and other high-risk clinical factors. Most frequent first-line regimens included dose-adjusted cyclophosphamide, doxorubicin, vincristine, and etoposide, with rituximab and prednisone (DA-EPOCH-R; 43%); rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP; 33%); or other intensive chemotherapy programs. We found no significant differences in the rates of complete response (CR), progression-free survival (PFS), or overall survival (OS) between these chemotherapy regimens. CR was attained by 69% of patients. PFS at 2 years was 55.2% and OS was 68.1%. In a multivariable model, the main prognostic factors for PFS and OS were poor performance status, lactate dehydrogenase >3 × upper limit of normal, and a dual-expressor immunophenotype. Age >60 years or presence of MYC rearrangement were not prognostic, but patients with TP53 alterations had a dismal PFS. Presence of MYC rearrangement was not predictive of better PFS in patients treated with DA-EPOCH-R vs R-CHOP. Improvements in the diagnostic criteria and therapeutic approaches beyond dose-intense chemotherapy are needed to overcome the unfavorable prognosis of patients with HGBL-NOS.

Highlights on Ocular Toxicity of Immune Checkpoint Inhibitors at a US Tertiary Cancer Center.

Introduction: Immune checkpoint inhibitors (ICIs) have improved prognosis in advanced malignancies; however, they may be associated with extensive ocular immune-related adverse events (irAEs) that are sight threatening. Our study aimed to identify the presentation, characteristics, management, and clinical outcomes of ocular irAEs. Methods: In this retrospective, observational case series, we reviewed the medical records of 1280 patients at a large US tertiary cancer center between 2010 and 2020. Results: We identified 130 patients who presented with ocular irAEs (10%) with 69 males (53%) and 61 females (47%). The mean time to toxicity was 6.1 months. Adverse events include corneal toxicity (31%), neuro-ophthalmic (14%), uveitis and scleritis (13%), retinopathy (13%), periocular disorders (11%), and others. IrAEs occurred most frequently with nivolumab (26%). Most ocular irAEs were treated with topical therapy. Advanced cases required systemic corticosteroids and even cessation of ICIs. Conclusion: Our cohort is a large case series highlighting the increased potential of ocular toxicity associated with ICIs. Prompt recognition and management of ocular irAEs can minimize their effect.

The Extent of Retinal Involvement of Canthaxanthin Crystalline Retinopathy Demonstrated by Multimodal Imaging.

Limited information is known about the extent of canthaxanthin crystalline retinopathy on the retinal layers. The authors describe a 51-year-old woman who was taking canthaxanthin for tanning purposes for 7 years. Three years after cessation of this agent, she presented with asymmetric crystalline retinopathy affecting both eyes. She was lost to follow-up, and upon returning 4 years later, the crystalline retinopathy persisted but the number of crystals had decreased. Using swept-source optical coherence tomography, the authors showed that the crystalline retinopathy affected all retinal layers. In addition, retinal pigmented epithelial detachments were present suggesting persistent damage caused by the canthaxanthin. [Ophthalmic Surg Lasers Imaging Retina. 2020;51:727-731.].

Usefulness of patient-reported outcomes to assess the effectiveness of topical hormonal therapy for gynecologic symptoms after antihormonal treatment for breast cancer.

The aim of this retrospective study was to assess the efficacy of topical hormonal therapy (THT) to relieve vaginal symptoms resulting from antihormonal therapy in women with hormone receptor-positive breast cancer. A total of 74 breast cancer patients who received THT for vaginal complaints were retrospectively identified and statistically matched with 74 control breast cancer patients with vaginal complaints with no documented use of THT. Symptom scores were recorded from the center's proprietary patient-reported outcomes database, Patient Care Monitor (ConcertoHealthAI, Boston). A baseline score was noted at the initiation of antihormonal therapy and was followed at 6 and 12 months. The median differences between baseline, 6-month, and 12-month scores were analyzed. Repeated measures analysis of variance assessed the impact of topical hormonal replacement. There was no statistically significant difference in score change between the two groups at 6 and 12 months. In the active THT group, there were no statistically significant differences in vaginal complaints or sexual problems over time: {F (2, 146) = 0.99, P = 0.369; and F (2, 146) = 1.56, P = 0.217}, respectively. In this study, the use of topical hormonal replacement was not effective in alleviating vaginal symptoms.

Unusual recurrent metastasizing benign breast papilloma: a case report.

BACKGROUND: Papillary breast lesions may be benign, atypical, and malignant lesions. Pathological and clinical differentiation of breast papillomas can be a challenge. Unlike malignant lesions, benign breast papillomas are not classically associated with lymph node and distant metastasis. We report a unique case of a recurrent, benign breast papilloma presenting as an aggressive malignant tumor. CASE PRESENTATION: Our patient was a 56-year-old postmenopausal African American woman who was followed in the breast clinic with a long history of multiple breast papillomas. She underwent multiple resections over the course of 7-9 years. After being lost to follow-up for 2 years, she once again presented with a slowly enlarging left breast mass. Subsequent imaging revealed a predominantly cystic mass in the left breast, as well as a suspicious hypermetabolic internal mammary node and a hypermetabolic nodule in the pretracheal space. Biopsy of the internal mammary node demonstrated papillary neoplasm with benign morphology and immunostains positive for estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2/Neu. Due to the clinical picture concerning for malignancy, the patient was then started on endocrine therapy with palbociclib and letrozole before surgery. She then underwent simple mastectomy and sentinel lymph node dissection with negative nodes and pathology once again revealing benign papillary neoplasm. She underwent adjuvant chest wall radiation for 6 weeks and received letrozole following completion of her radiation therapy. She was without evidence of disease 30 months after surgery. CONCLUSIONS: We present an unusual case of multiple recurrent peripheral papillomas with entirely benign histologic features exhibiting malignant behavior over a protracted period of many years, with an invasion of pectoralis musculature and possibly internal mammary and mediastinal nodes. Her treatment course included multiple surgeries (ultimately mastectomy), radiation therapy, and endocrine therapy.

Safety and efficacy of switching from unfractionated heparin to bivalirudin during primary percutaneous coronary intervention.

OBJECTIVES: To evaluate the safety and efficacy of switching to bivalirudin during primary percutaneous coronary intervention (PCI) for patients who received preprocedure unfractionated heparin (UFH). BACKGROUND: Current guidelines favor bivalirudin for primary PCI in patients at high risk of bleeding, particularly when femoral access is used. However, patients with ST-segment elevation myocardial infarction frequently receive UFH before arrival in the catheterization laboratory. METHODS: Scientific databases and websites were searched for randomized controlled trials. Patients were divided into those who received heparin with or without glycoprotein IIb/IIIa inhibitors (heparin group); those switched to bivalirudin during primary PCI from preprocedure UFH (switch group); and those who received bivalirudin without preprocedure UFH (Biv-alone group). Both traditional pairwise meta-analyses using moderator analyses and network meta-analyses using mixed-treatment comparison models were performed. RESULTS: Data from five trials including13,547 patients were analyzed. In mixed-comparison models, switching to bivalirudin during primary PCI was associated with lower rates for all-cause mortality and major adverse cardiovascular events (MACEs) compared to the other strategies. Rates for all-cause mortality, MACEs, and net adverse clinical events (NACEs) were similar for the heparin and Biv-alone groups. Switching strategies was also associated with lower major bleeding rates compared to heparin alone. Similarly, in a standard pairwise model, both the switch and Biv-alone groups were associated with decreased bleeding risk compared to the heparin group. However, only the switch strategy was associated with decreased all-cause mortality (RR, 0.47; 95% CI, 0.30-0.75; P = 0.001), MACE (RR, 0.67; 95% CI, 0.49-0.91; P = 0.012), and NACE (RR, 0.61; 95% CI, 0.41-0.92; P = 0.019) compared with heparin alone. CONCLUSIONS: During primary PCI, use of bivalirudin for those receiving preprocedure UFH was associated decreased rates for major bleeding, NACEs, MACEs, and all-cause mortality compared to heparin +/- GPI. This strategy was also associated with decreased rates for MACEs and all-cause mortality compared to bivalirudin alone without preprocedure UFH.

High-volume forced diuresis with matched hydration using the RenalGuard System to prevent contrast-induced nephropathy: A meta-analysis of randomized trials.

BACKGROUND: Contrast-induced nephropathy (CIN) is a well-recognized complication of coronary angiography that is associated with poor outcomes. Several small randomized controlled trials (RCTs) have recently shown that in patients with chronic kidney disease (CKD), furosemide-induced forced diuresis with matched hydration using the RenalGuard system can prevent its occurrence. However, individual studies have been underpowered and thus cannot show significant differences in major clinical endpoints. HYPOTHESIS: Forced diuresis with matched hydration using the RenalGuard system improves clinical outcomes in patients undergoing coronary angiography. METHODS: Scientific databases and websites were searched for relevant RCTs. The pooled risk ratios were calculated using random-effects models. The primary endpoint was CIN, and the secondary endpoints were major adverse clinical events (MACEs) and the need for renal replacement therapy. RESULTS: Data from 3 trials including 586 patients were analyzed. High-volume forced diuresis with matched hydration using the RenalGuard system decreased risk of CIN by 60% (risk ratio: 0.40, 95% confidence interval: 0.25 to 0.65, P < 0.001), MACE rate by 59%, and the need for renal replacement therapy by 78%, compared with the standard of care. CONCLUSIONS: In patients with CKD undergoing coronary angiography, high-volume forced diuresis with matched hydration using the RenalGuard system significantly reduces the risk of CIN, MACE rate, and the need for renal replacement therapy. Larger RCTs with sufficient power are needed to confirm these findings.

HIV and Hepatitis C Virus Screening Practices in a Geographically Diverse Sample of American Community Health Centers.

Because of the advent of highly effective treatments, routine screening for HIV and hepatitis C virus (HCV) has been recommended for many Americans. This study explored the perceived barriers surrounding routine HIV and HCV screening in a diverse sample of community health centers (CHCs). The Community Health Applied Research Network (CHARN) is a collaboration of CHCs, with a shared clinical database. In July, 2013, 195 CHARN providers working in 12 CHCs completed a survey of their attitudes and beliefs about HIV and HCV testing. Summary statistics were generated to describe the prevalence of HIV and HCV and associated demographics by CHCs. HIV and HCV prevalence ranged from 0.1% to 5.7% for HIV and from 0.1% to 3.7% for HCV in the different CHCs. About 15% of the providers cared for at least 50 individuals with HIV and the same was true for HCV. Two-thirds saw less than 10 patients with HIV and less than half saw less than 10 patients with HCV. Less than two-thirds followed USPHS guidelines to screen all patients for HIV between the ages of 13 and 64, and only 44.4% followed the guidance to screen all baby boomers for HCV. Providers with less HIV experience tended to be more concerned about routine screening practices. More experienced providers were more likely to perceive lack of time being an impediment to routine screening. Many US CHC providers do not routinely screen their patients for HIV and HCV. Although additional education about the rationale for routine screening may be indicated, incentives to compensate providers for the additional time they anticipate spending in counseling may also facilitate increased screening rates.

Age and gender considerations for technology-assisted delivery of therapy for substance use disorder treatment: A patient survey of access to electronic devices.

BACKGROUND: Technology-assisted treatment (TAT) can be an effective supplement to established face-to-face therapy modalities with a growing literature in substance use disorder (SUD) treatment. TAT access, interest, and familiarity are potential limitations to the use and efficacy of these approaches to treatment. METHODS: 174 participants in outpatient SUD treatment were administered a survey regarding technology device and Internet access, and interest in engaging in TAT SUD counseling (SUDC). The group was dichotomized by mean age and gender to examine potential variations in in these subgroups. RESULTS: Forty-three (43%) of participants were female, and the mean age was 44.8 years, and 89% of participants had Internet access. 83% of participants were interested in TAT for SUD counseling; 81% expected it to be at least "moderately helpful." 34% of participants noted they would choose to continue face-to-face therapy exclusively. 91% of participants had cell phones, but only 50% could access data or the Internet via their handheld device. 80% of participants stated they would be interested in trying SUDC via their phone. Women had a higher preference for computer-based SUDC than men, with gender being significantly correlated with TAT perceive helpfulness. CONCLUSION: These findings suggest that patients in outpatient SUD treatment have access to resources for TAT implementation, although access was not always readily available. Future research will be needed to determine whether the technology that this population possesses will be able to support the evolving TAT modalities and whether interest in TAT across age and gender groups equalizes over time.

Comparison of Surgical Outcomes Between Phacocanaloplasty and Phacotrabeculectomy at 12 Months' Follow-up: A Longitudinal Cohort Study.

PURPOSE: To compare operative outcomes of patients after phacocanaloplasty and phacotrabeculectomy through 12 months' follow-up. DESIGN: Retrospective, nonrandomized, comparative case series. MATERIALS AND METHODS: We included 36 eyes of 36 patients with open-angle glaucoma who underwent combined phacoemulsification and canaloplasty (phacocanaloplasty) and 41 eyes of 41 patients with open-angle glaucoma who underwent combined phacoemulsification and trabeculectomy with mitomycin C (phacotrabeculectomy) with 12 months' of postoperative follow-up. All surgeries were performed by a single surgeon (R.S.A.) between January 2007 and May 2011. MAIN OUTCOME MEASURES: Failure was based on intraocular pressure (IOP; >18 or <4 mm Hg at 1 y), second operative procedure (any eye requiring reoperation), or decrease in visual acuity by 0.20 logMAR. Change in IOP, visual acuity (VA), glaucoma medications, and complication rates at 12 months were analyzed. RESULTS: There were no differences in demographics other than the sex between the groups. There were also no significant differences in previous surgery or in preoperative VA, IOP, or use of glaucoma medications between the groups, though the phacotrabeculectomy group had a higher preoperative IOP at baseline and a larger SD. Both groups showed significant reduction in IOP from baseline at every time point (P<0.001). No significant difference in mean IOP at 12 months was found, with a mean of 14.1±4.4 mm Hg in the phacocanaloplasty group and 11.8±5.4 mm Hg in the phacotrabeculectomy group (P=0.07). The phacotrabeculectomy group showed a significantly greater median absolute (8 vs. 5 mm Hg) and percent (40% vs. 28%) reduction in IOP at 12 months (P=0.02). Postoperative glaucoma medication use was similar between the 2 groups.Overall failure rates at 1 year were comparable between the 2 groups: 22% for phacocanaloplasty versus 20% for phacotrabeculectomy (P=0.79). Phacotrabeculectomy eyes experienced more visual failures (5% vs. 0%, P=0.50), whereas phacocanaloplasty experienced more IOP failures (17% vs. 12%, P=0.75). No difference in operative failure rate was found between the phacocanaloplasty and phacotrabeculectomy groups (6% vs. 5%, P=1.00) and this held after controlling for covariates. Final VA was not statistically different between the 2 groups. CONCLUSIONS: Phacocanaloplasty and phacotrabeculectomy both achieved significant reduction in IOP and improvement in VA at 12 months with comparable success rates. Phacotrabeculectomy achieved a statistically greater median percentage decrease in IOP, but the 2 procedures resulted in comparable mean IOP at 12 months.

The impact of buprenorphine/naloxone treatment on HIV risk behaviors among HIV-infected, opioid-dependent patients.

BACKGROUND: Opioid dependence is a major risk factor for HIV infection, however, the impact of buprenorphine/naloxone treatment on HIV risk behaviors among HIV-infected opioid-dependent patients is unknown. METHODS: We conducted a longitudinal analysis of 303 HIV-infected opioid-dependent patients initiating buprenorphine/naloxone treatment. Outcomes included self-reported past 90-day needle-sharing and non-condom use. We assessed trends over the 12 months using the Cochran-Armitage trend test. Using generalized estimating equations, after multiple imputation, we determined factors independently associated with needle-sharing and non-condom use, including time-updated variables. We then conducted a mediation analysis to determine whether substance use explained the relationship between time since treatment initiation and needle-sharing. RESULTS: Needle-sharing decreased from baseline to the fourth quarter following initiation of buprenorphine/naloxone (9% vs. 3%, p<0.001), while non-condom use did not (23% vs. 21%, p=0.10). HIV risk behaviors did not vary based on the presence of a detectable HIV-1 RNA viral load. Patients who were homeless and used heroin, cocaine/amphetamines or marijuana were more likely to report needle-sharing. Heroin use fully mediated the relationship between time since treatment initiation and needle-sharing. Women, patients who identified as being gay/lesbian/bisexual, those married or living with a partner and who reported heroin or alcohol use were more likely to report non-condom use. Older patients were less likely to report non-condom use. CONCLUSIONS: While buprenorphine/naloxone is associated with decreased needle-sharing among HIV-infected opioid-dependent patients, sexual risk behaviors persist regardless of viral load. Targeted interventions to address HIV risk behaviors among HIV-infected opioid-dependent populations receiving buprenorphine/naloxone are needed.

Research design considerations for clinical studies of abuse-deterrent opioid analgesics: IMMPACT recommendations.

Opioids are essential to the management of pain in many patients, but they also are associated with potential risks for abuse, overdose, and diversion. A number of efforts have been devoted to the development of abuse-deterrent formulations of opioids to reduce these risks. This article summarizes a consensus meeting that was organized to propose recommendations for the types of clinical studies that can be used to assess the abuse deterrence of different opioid formulations. Because of the many types of individuals who may be exposed to opioids, an opioid formulation will need to be studied in several populations using various study designs to determine its abuse-deterrent capabilities. It is recommended that the research conducted to evaluate abuse deterrence should include studies assessing: (1) abuse liability, (2) the likelihood that opioid abusers will find methods to circumvent the deterrent properties of the formulation, (3) measures of misuse and abuse in randomized clinical trials involving pain patients with both low risk and high risk of abuse, and (4) postmarketing epidemiological studies.

Prolonged control of replication-competent dual- tropic human immunodeficiency virus-1 following cessation of highly active antiretroviral therapy.

BACKGROUND: While initiation of highly active antiretroviral therapy (HAART) during primary HIV-1 infection occasionally results in transient control of viral replication after treatment interruption, the vast majority of patients eventually experience a rebound in plasma viremia. RESULTS: Here we report a case of a patient who was started on HAART during symptomatic primary infection and who has subsequently maintained viral loads of < 50 copies/mL for more than nine years after the cessation of treatment. This patient had a high baseline viral load and has maintained a relatively high frequency of latently infected CD4(+) T cells. In addition, he does not have any known protective HLA alleles. Thus it is unlikely that he was destined to become a natural elite controller or suppressor. The mechanism of control of viral replication is unclear; he is infected with a CCR5/CXCR4 dual-tropic virus that is fully replication-competent in vitro. In addition, his spouse, who transmitted the virus to him, developed AIDS. The patient's CD4(+) T cells are fully susceptible to HIV-1 infection, and he has low titers of neutralizing antibodies to heterologous and autologous HIV-1 isolates. Furthermore, his CD8(+) T cells do not have potent HIV suppressive activity. CONCLUSION: This report suggests that some patients may be capable of controlling pathogenic HIV-1 isolates for extended periods of time after the cessation of HAART through a mechanism that is distinct from the potent cytotoxic T lymphocyte (CTL) mediated suppression that has been reported in many elite suppressors.

Comparison of surgical outcomes between canaloplasty and trabeculectomy at 12 months' follow-up.

PURPOSE: To compare operative outcomes of patients after canaloplasty and trabeculectomy through 12 months' follow-up. DESIGN: Retrospective, nonrandomized, comparative case series. PARTICIPANTS: We included 33 eyes of 33 patients who underwent canaloplasty and 46 eyes of 46 patients who underwent trabeculectomy with 12 months' of postoperative follow-up. METHODS: Patients with open-angle glaucoma who underwent either canaloplasty or trabeculectomy with mitomycin C to control the intraocular pressure (IOP) between January 2007 and December 2008 were included. All surgeries were performed by a single surgeon (R.S.A.). MAIN OUTCOME MEASURES: Change in IOP, visual acuity (VA), postoperative medications, failure based on IOP (>18 or <4 mmHg at 1 year) or second operative procedure (any eye requiring reoperation) and complication rates at 12 months. RESULTS: There were no differences in demographics, previous surgery, or preoperative and postoperative VA between the groups. The mean percentage reduction in IOP from preoperative values at 12 months after surgery was 32% (± 22%) for the canaloplasty group compared with 43% (± 28%) for the trabeculectomy group (P = 0.072, Student t test). The median reduction in the number of medications at 12 months' follow-up was 3 in the trabeculectomy group and 2 in the canaloplasty group (P = 0.064). A higher percentage of patients treated with canaloplasty than trabeculectomy (36% vs. 20%) required postoperative medications, although this did not attain significance (P = 0.12). Failure based on IOP (IOP >18 or <4 mmHg at 12 months) was 12.1% (4/33 patients) for the canaloplasty group and 4.3% (2/46 patients) for the trabeculectomy group (P = 0.23, Fisher exact test). There was no difference in surgical failure rates between the canaloplasty (n = 5; 15%) and trabeculectomy (n = 5; 11%) groups (P = 0.74). CONCLUSIONS: Canaloplasty and trabeculectomy both achieved significant reduction in IOP at 12 months. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.

Participant characteristics and HIV risk behaviors among individuals entering integrated buprenorphine/naloxone and HIV care.

OBJECTIVE: This study was part of a national, multisite demonstration project evaluating the impact of integrated buprenorphine/naloxone treatment and HIV care. The goals of this study were to describe the baseline demographic, clinical, and substance use characteristics of the participants and to explore HIV transmission risk behaviors in this group. METHODS: Nine sites across the United States participated. Data obtained by interview and chart review included demographic information, medical history, substance use, and risk behaviors.We performed a descriptive analysis of patient characteristics at entry and used logistic regression to evaluate factors associated with 1) unprotected anal or vaginal sex; and 2) needle-sharing within the previous 90 days. RESULTS: Three hundred eighty-six individuals were included in the study: 303 (78.5%) received buprenorphine/naloxone; 41 (10.6%) received methadone; and 42 (10.9%) received another form of treatment. The analysis of risk behaviors was limited to those in the buprenorphine group (n = 303). Among those reporting vaginal or anal sex in the previous 90 days, 24% had sex without a condom. Factors significantly associated with unprotected sex were: having a partner; female gender; and alcohol use in previous 30 days. A total of 8.9% of participants shared needles in the previous 90 days. Factors significantly associated with needle-sharing were: amphetamine use; marijuana use; homelessness; and anxiety. CONCLUSIONS: Addressing transmission risk behaviors is an important secondary HIV prevention strategy. In addition to treatment for opioid dependence, addressing other substance use, social issues, particularly housing, and mental health may have important implications for reducing HIV transmission in HIV-infected opioid-dependent patients.

Drug treatment outcomes among HIV-infected opioid-dependent patients receiving buprenorphine/naloxone.

BACKGROUND: Buprenorphine/naloxone allows the integration of opioid dependence and HIV treatment. METHODS: We conducted a prospective study in HIV-infected opioid-dependent patients to investigate the impact of buprenorphine/naloxone treatment on drug use. Self-report and chart review assessments were conducted every 3 months (quarters 1-4) for 1 year. Outcomes were buprenorphine/naloxone treatment retention, drug use, and addiction treatment processes. RESULTS: Among 303 patients enrolled between July 2005 and December 2007, retention in buprenorphine/naloxone treatment was 74%, 67%, 59%, and 49% during Quarters 1, 2, 3, and 4, respectively. Past 30-day illicit opioid use decreased from 84% of patients at baseline to 42% in retained patients over the year. Patients were 52% less likely to use illicit opioids for each quarter in treatment (Odds ratio = 0.66; 95% CI: 0.61 to 0.72). Buprenorphine/naloxone doses and office visits approximated guidelines published by the United States Department of Health and Human Services. Urine toxicology monitoring was less frequent than recommended. CONCLUSIONS: Buprenorphine/naloxone provided in HIV treatment settings can decrease opioid use. Strategies are needed to improve retention and address ongoing drug use in this treatment population.

Clinic-based treatment of opioid-dependent HIV-infected patients versus referral to an opioid treatment program: A randomized trial.

BACKGROUND: Opioid dependence is common in HIV clinics. Buprenorphine-naloxone (BUP) is an effective treatment of opioid dependence that may be used in routine medical settings. OBJECTIVE: To compare clinic-based treatment with BUP (clinic-based BUP) with case management and referral to an opioid treatment program (referred treatment). DESIGN: Single-center, 12-month randomized trial. Participants and investigators were aware of treatment assignments. (ClinicalTrials.gov registration number: NCT00130819) SETTING: HIV clinic in Baltimore, Maryland. PATIENTS: 93 HIV-infected, opioid-dependent participants who were not receiving opioid agonist therapy and were not dependent on alcohol or benzodiazepines. INTERVENTION: Clinic-based BUP included BUP induction and dose titration, urine drug testing, and individual counseling. Referred treatment included case management and referral to an opioid-treatment program. MEASUREMENTS: Initiation and long-term receipt of opioid agonist therapy, urine drug test results, visit attendance with primary HIV care providers, use of antiretroviral therapy, and changes in HIV RNA levels and CD4 cell counts. RESULTS: The average estimated participation in opioid agonist therapy was 74% (95% CI, 61% to 84%) for clinic-based BUP and 41% (CI, 29% to 53%) for referred treatment (P < 0.001). Positive test results for opioids and cocaine were significantly less frequent in clinic-based BUP than in referred treatment, and study participants receiving clinic-based BUP attended significantly more HIV primary care visits than those receiving referred treatment. Use of antiretroviral therapy and changes in HIV RNA levels and CD4 cell counts did not differ between the 2 groups. LIMITATION: This was a small single-center study, follow-up was only moderate, and the study groups were unbalanced in terms of recent drug injections at baseline. CONCLUSION: Management of HIV-infected, opioid-dependent patients with a clinic-based BUP strategy facilitates access to opioid agonist therapy and improves outcomes of substance abuse treatment. PRIMARY FUNDING SOURCE: Health Resources and Services Administration Special Projects of National Significance program.