Annotated Abstracts of Journal Articles
2013, 3rd Quarter
Annotations by Oliver Freudenreich, MD, FAPM and Mary Ann Cohen, MD, FAPM
December 22, 2013
ANNOTATION (Freudenreich & Cohen)
The Finding: Almost 1 in 5 (20%) of marginally housed patients (i.e., those living in SROs) in Vancouver, British Columbia were HIV positive (in addition to having drug addictions (almost 100%) and MRI abnormalities (1 in 3)).
Strength and Weaknesses: The sample was exceptionally well characterized neurologically (e.g., MRIs and neurocognitive testing done for everybody in a “tough” clinical sample) and psychiatrically (in addition to obtaining HIV serology). However, it was also a small and selective sample from one city in Canada.
Relevance: Psychiatrists treating patients with homelessness, prior homelessness, or patients who are marginally housed (e.g., in SROs) should consider the strong possibility of HIV/AIDS. Any psychiatrist working in a major urban area in the US who looks at this study from Canada will easily see that the results are applicable to his/her own work. The medical/
Objective: The health of people living in marginal housing is not well characterized, particularly from the perspective of multimorbid illness. The authors investigated this population in a community sample.
Method: A prospective community sample (N=293) of adults living in single-room occupancy hotels was followed for a median of 23.7 months. Assessment included psychiatric and neurological evaluation, multimodal MRI, and viral testing.
Results: Previous homelessness was described in 66.6% of participants. Fifteen deaths occurred during 552 person-years of follow-up. The standardized mortality ratio was 4.83 (95% CI=2.91-8.01). Substance dependence was ubiquitous (95.2%), with 61.7% injection drug use. Psychosis was the most common mental illness (47.4%). A neurological disorder was present in 45.8% of participants, with definite MRI findings in 28.0%. HIV serology was positive in 18.4% of participants, and hepatitis C virus serology in 70.3%. The median number of multimorbid illnesses (from a list of 12) was three. Burden of multimorbidity was significantly correlated with lower role functioning score. Comorbid addiction or physical illness significantly decreased the likelihood of treatment for psychosis but not the likelihood of treatment for opioid dependence or HIV disease. Participants who died during follow-up appeared to have profiles of multimorbidity similar to those of the overall sample.
Conclusions: This marginally housed cohort had greater than expected mortality and high levels of multimorbidity with adverse associations with role function and likelihood of treatment for psychosis. These findings may guide the development of effective health care delivery in the setting of marginal housing.
ANNOTATION (Freudenreich & Cohen)
The Finding: In a pooled analysis from 2 phase III trials, regimens containing the second-generation NNRTI, rilpivirine showed a reduced rate of neurologic and psychiatric side effects (about 50% reduction on average) when compared to regimens containing the first-generation NNRTI, efavirenz.
Strength and Weaknesses: Neuropsychiatric symptoms were systematically collected. However, there is no easy and agreed-upon assessment of neuropsychiatric symptoms, many of which are rather subjective in severity, fluctuate over time and depend on prior psychiatric status.
Relevance: The potent NNRTI, efavirenz has been the backbone of HAART regimens despite having the most problematic side effect profile with regards to neuropsychiatric symptoms. Second-generation NNRTIs like rilpivirine (formulated with emtricitabine and tenofovir as a single pill, brand named “Complera” which was FDA-approved in 2011) seem to be better tolerated with regards to neuropsychiatric symptoms (and broadly as effective) when compared to the gold-standard efavirenz for NNRTI-based regimens. Eventually, efaviranz will likely be relegated to a second-line agent.
Objectives: The aim of the study was to compare the neuropsychiatric safety and tolerability of rilpivirine (TMC278) vs. efavirenz in a preplanned pooled analysis of data from the ECHO and THRIVE studies which compared the safety and efficacy of the two drugs in HIV-1 infected treatment naïve adults.
Methods: ECHO and THRIVE were randomized, double-blind, double-dummy, 96-week, international, phase 3 trials comparing the efficacy, safety and tolerability of rilpivirine 25 mg vs. efavirenz 600 mg once daily in combination with two background nucleoside/tide reverse transcriptase inhibitors. Safety and tolerability analyses were conducted when all patients had received at least 48 weeks of treatment or discontinued earlier. Differences between treatments in the incidence of neurological and psychiatric adverse events (AEs) of interest were assessed in preplanned statistical analyses using Fisher’s exact test.
Results: At the time of the week 48 analysis, the cumulative incidences in the rilpivirine vs. efavirenz groups of any grade 2-4 treatment-related AEs and of discontinuation because of AEs were 16% vs. 31% (P<0.0001) and 3% vs. 8% (P=0.0005), respectively. The incidence of treatment-related neuropsychiatric AEs was 27% vs. 48%, respectively (P<0.0001). The incidence of treatment-related neurological AEs of interest was 17% vs. 38% (P<0.0001), and that of treatment-related psychiatric AEs of interest was 15% vs. 23% (P=0.0002). Dizziness and abnormal dreams/nightmares occurred significantly less frequently with rilpivirine vs. efavirenz (P<0.01). In both groups, patients with prior neuropsychiatric history tended to report more neuropsychiatric AEs but rates remained lower for rilpivirine than for efavirenz.
Conclusions: Rilpivirine was associated with fewer neurological and psychiatric AEs of interest than efavirenz over 48 weeks in treatment-naïve, HIV-1-infected adults.
ANNOTATION (Freudenreich & Cohen)
Using peer outreach/education via Facebook this RTC led to more subjects in the intervention group (Facebook group focussing on HIV education) to ask for and returned HIV home-based kits than subjects in a control group (Facebook group focussing on general health education).
Strength and Weaknesses: The acceptance was very high for this randomized trial and succeeded in engaging a difficult to reach group of HIV patients. However, the intervention was very brief (3 months) and cannot be generalized (the sample was recruited from the MSM African-American and Latino community in LA). It remains to be seen how tools like Facebook etc. can be used routinely and be effective in the long run with regards to HIV prevention.
Relevance: Increasingly, psychiatrists need to become familiar with social media as they can be effective tools for HIV prevention (such as increasing the use of home-based HIV testing, the result of this trial). An important opportunity is lost (and the digital divide between the generation of clinicians and their younger patients widened) if psychiatrists do not use the tools that patients routinely use.
Background: Social networking technologies are an emerging tool for HIV prevention.
Objective: To determine whether social networking communities can increase HIV testing among African American and Latino men who have sex with men (MSM).
Design: Randomized, controlled trial with concealed allocation. (ClinicalTrials.gov: NCT01701206)
Patients: 112 MSM based in Los Angeles, more than 85% of whom were African American or Latino.
Intervention: Sixteen peer leaders were randomly assigned to deliver information about HIV or general health to participants via Facebook groups over 12 weeks. After participants accepted a request to join the group, participation was voluntary. Group participation and engagement were monitored. Participants could request a free, home-based HIV testing kit and completed questionnaires at baseline and 12-week follow-up.
Measurements: Participant acceptance of and engagement in the intervention and social network participation, rates of home-based HIV testing, and sexual risk behaviors.
Results: Almost 95% of intervention participants and 73% of control participants voluntarily communicated using the social platform. Twenty-five of 57 intervention participants (44%) requested home-based HIV testing kits compared with 11 of 55 control participants (20%) (difference, 24 percentage points [95% CI, 8 to 41 percentage points]). Nine of the 25 intervention participants (36%) who requested the test took it and mailed it back compared with 2 of the 11 control participants (18%) who requested the test. Retention at study follow-up was more than 93%.
Limitation: Only 2 Facebook communities were included for each group.
Conclusion: Social networking communities are acceptable and effective tools to increase home-based HIV testing among at-risk populations.