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  1. Vagenas P, Azar MM, Copenhaver MM, Springer SA, Molina PE, Altice FL
    Curr HIV/AIDS Rep, 2015 Dec;12(4):421-36.
    PMID: 26412084 DOI: 10.1007/s11904-015-0285-5
    Alcohol use is highly prevalent globally with numerous negative consequences to human health, including HIV progression, in people living with HIV (PLH). The HIV continuum of care, or treatment cascade, represents a sequence of targets for intervention that can result in viral suppression, which ultimately benefits individuals and society. The extent to which alcohol impacts each step in the cascade, however, has not been systematically examined. International targets for HIV treatment as prevention aim for 90 % of PLH to be diagnosed, 90 % of them to be prescribed with antiretroviral therapy (ART), and 90 % to achieve viral suppression; currently, only 20 % of PLH are virally suppressed. This systematic review, from 2010 through May 2015, found 53 clinical research papers examining the impact of alcohol use on each step of the HIV treatment cascade. These studies were mostly cross-sectional or cohort studies and from all income settings. Most (77 %) found a negative association between alcohol consumption on one or more stages of the treatment cascade. Lack of consistency in measurement, however, reduced the ability to draw consistent conclusions. Nonetheless, the strong negative correlations suggest that problematic alcohol consumption should be targeted, preferably using evidence-based behavioral and pharmacological interventions, to indirectly increase the proportion of PLH achieving viral suppression, to achieve treatment as prevention mandates, and to reduce HIV transmission.
  2. Springer SA, Di Paola A, Azar MM, Barbour R, Krishnan A, Altice FL
    Drug Alcohol Depend, 2017 05 01;174:158-170.
    PMID: 28334661 DOI: 10.1016/j.drugalcdep.2017.01.026
    BACKGROUND: Alcohol use disorders (AUDs) are highly prevalent among persons living with HIV (PLH) within the criminal justice system (CJS). Extended-release naltrexone (XR-NTX) has not been previously evaluated among CJS-involved PLH with AUDs.

    METHODS: A randomized, double-blind, placebo-controlled trial was conducted among 100 HIV+ prisoners with AUDs. Participants were randomized 2:1 to receive 6 monthly injections of XR-NTX or placebo starting one week prior to release. Using multiple imputation strategies for data missing completely at random, data were analyzed for the 6-month post-incarceration period. Main outcomes included: time to first heavy drinking day; number of standardized drinks/drinking day; percent of heavy drinking days; pre- to post-incarceration change in average drinks/day; total number of drinking days; and a composite alcohol improvement score comprised of all 5 parameters.

    RESULTS: There was no statistically significant difference overall between treatment arms for time-to-heavy-drinking day. However, participants aged 20-29 years who received XR-NTX had a longer time to first heavy drinking day compared to the placebo group (24.1 vs. 9.5days; p<0.001). There were no statistically significant differences between groups for other individual drinking outcomes. A sub-analysis, however, found participants who received ≥4 XR-NTX were more likely (p<0.005) to have improved composite alcohol scores than the placebo group. Post-hoc power analysis revealed that despite the study being powered for HIV outcomes, sufficient power (0.94) was available to distinguish the observed differences.

    CONCLUSIONS: Among CJS-involved PLH with AUDs transitioning to the community, XR-NTX lengthens the time to heavy drinking day for younger persons; reduces alcohol consumption when using a composite alcohol consumption score; and is not associated with any serious adverse events.

  3. Springer SA, Di Paola A, Barbour R, Azar MM, Altice FL
    J Acquir Immune Defic Syndr, 2018 09 01;79(1):92-100.
    PMID: 29781884 DOI: 10.1097/QAI.0000000000001759
    OBJECTIVE: To determine whether extended-release naltrexone (XR-NTX) would improve or maintain viral suppression (VS) among incarcerated individuals with HIV and alcohol use disorders (AUDs) transitioning to the community.

    DESIGN: A randomized, double-blind, placebo-controlled trial was conducted among incarcerated individuals with HIV and AUDs transitioning to the community from 2010 through 2016.

    METHODS: Eligible participants (N = 100) were randomized 2:1 to receive 6 monthly injections of XR-NTX (n = 67) or placebo (n = 33) starting at release and continued for 6 months. The primary and secondary outcomes were the proportion that maintained or improved VS at <200 and <50 copies per milliliter from baseline to 6 months, respectively, using an intention-to-treat analysis.

    RESULTS: Participants allocated to XR-NTX improved VS from baseline to 6 months for <200 copies per milliliter (48.0%-64.2%, P = 0.024) and for <50 copies per milliliter (31.0%-56.7%, P = 0.001), whereas the placebo group did not (<200 copies/mL: 64%-42.4%, P = 0.070; <50 copies/mL: 42.0%-30.3%, P = 0.292). XR-NTX participants were more likely to achieve VS than the placebo group at 6 months (<200 copies/mL: 64.2% vs. 42.4%; P = 0.041; <50 copies/mL: 56.7% vs. 30.3%; P = 0.015). XR-NTX independently predicted VS [<200 copies/mL: adjusted odds ratio (aOR) = 2.68, 95% confidence interval (CI) = 1.01 to 7.09, P = 0.047; <50 copies/mL: aOR = 4.54; 95% CI = 1.43 to 14.43, P = 0.009] as did receipt of ≥3 injections (<200 copies/mL: aOR = 3.26; 95% CI = 1.26 to 8.47, P = 0.010; <50 copies/mL: aOR = 6.34; 95% CI = 2.08 to 19.29, P = 0.001). Reductions in alcohol consumption (aOR = 1.43, 95% CI = 1.03 to 1.98, P = 0.033) and white race (aOR = 5.37, 95% CI = 1.08 to 27.72, P = 0.040) also predicted VS at <50 copies per milliliter.

    CONCLUSIONS: XR-NTX improves or maintains VS after release to the community for incarcerated people living with HIV and AUDs.

  4. Wickersham JA, Zahari MM, Azar MM, Kamarulzaman A, Altice FL
    Drug Alcohol Depend, 2013 Sep 01;132(1-2):378-82.
    PMID: 23414931 DOI: 10.1016/j.drugalcdep.2013.01.005
    OBJECTIVE: To evaluate the impact of methadone dose on post-release retention in treatment among HIV-infected prisoners initiating methadone maintenance treatment (MMT) within prison.

    METHODS: Thirty HIV-infected prisoners meeting DSM-IV pre-incarceration criteria for opioid dependence were enrolled in a prison-based, pre-release MMT program in Klang Valley, Malaysia; 3 died before release from prison leaving 27 evaluable participants. Beginning 4 months before release, standardized methadone initiation and dose escalation procedures began with 5mg daily for the first week and 5mg/daily increases weekly until 80 mg/day or craving was satisfied. Participants were followed for 12 months post-release at a MMT clinic within 25 kilometers of the prison. Kaplan-Meier survival analysis was used to evaluate the impact of methadone dose on post-release retention in treatment.

    FINDINGS: Methadone dose ≥80 mg/day at the time of release was significantly associated with retention in treatment. After 12 months of release, only 21.4% of participants on <80 mg were retained at 12 months compared to 61.5% of those on ≥80 mg (Log Rank χ(2)=(1,26) 7.6, p<0.01).

    CONCLUSIONS: Higher doses of MMT at time of release are associated with greater retention on MMT after release to the community. Important attention should be given to monitoring and optimizing MMT doses to address cravings and side effects prior to community re-entry from prisons.

  5. Springer SA, Di Paola A, Azar MM, Barbour R, Biondi BE, Desabrais M, et al.
    J Acquir Immune Defic Syndr, 2018 05 01;78(1):43-53.
    PMID: 29373393 DOI: 10.1097/QAI.0000000000001634
    OBJECTIVE: To determine whether extended-release naltrexone (XR-NTX) would improve or maintain viral suppression (VS) among prisoners or jail detainees with HIV and opioid use disorder (OUD) transitioning to the community.

    DESIGN: A 4-site, prospective randomized double-blind, placebo-controlled trial was conducted among prison and jail inmates with HIV and OUD transitioning to the community from September 2010 through March 2016.

    METHODS: Eligible participants (N = 93) were randomized 2:1 to receive 6 monthly injections of XR-NTX (n = 66) or placebo (n = 27) starting at release and observed for 6 months. The primary outcome was the proportion that maintained or improved VS (<50 copies/mL) from baseline to 6 months.

    RESULTS: Participants allocated to XR-NTX significantly improved to VS (<50 copies/mL) from baseline (37.9%) to 6 months (60.6%) (P = 0.002), whereas the placebo group did not (55.6% at baseline to 40.7% at 6 months P = 0.294). There was, however, no statistical significant difference in VS levels at 6 months between XR-NTX (60.6%) vs. placebo (40.7%) (P = 0.087). After controlling for other factors, only allocation to XR-NTX (adjusted odds ratio = 2.90; 95% confidence interval = 1.04 to 8.14, P = 0.043) was associated with the primary outcome. Trajectories in VS from baseline to 6 months differed significantly (P = 0.017) between treatment groups, and the differences in the discordant values were significantly different as well (P = 0.041): the XR-NTX group was more likely than the placebo group to improve VS (30.3% vs. 18.5%), maintain VS (30.3% vs. 27.3), and less likely to lose VS (7.6% vs. 33.3%) by 6 months.

    CONCLUSIONS: XR-NTX improves or maintains VS after release to the community for incarcerated people living with HIV with OUD.

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