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.

Change in quality of life after being diagnosed with HIV: a multicenter longitudinal study.

The objective of this study was to assess in patients with HIV perceptions of life pre-HIV versus post-HIV diagnosis and examine whether such perceptions change over time. We conducted interviews and chart reviews of 347 outpatients with HIV from three cities in 2002-2004. In two interviews 12-18 months apart, patients compared their life now with their life before HIV was diagnosed. Independent variables included demographic and clinical characteristics; HIV-specific health status, symptoms, and concerns; spirituality/religion; social support; self-perception; and optimism. The patients' mean (standard deviation [SD]) age was 44.8 (8.3) years; half were minorities; and 269 (78%) were taking antiretroviral therapy. Comparing life at time 1 versus before diagnosis, 109 (31%) patients said their life was better at time 1, 98 (28%) said it was worse, and the rest said it was about the same or did not know. By time 2, approximately one fifth of the patients changed their answers to indicate life improvement and one sixth changed them to indicate life deterioration. In multivariable analysis, change in perception for the better between time 1 and time 2 (versus prediagnosis) was positively associated with time 1 positive religious coping scores, whereas change in perception for the worse was associated with study site, heterosexual orientation, a detectable viral load, shorter duration of HIV, lower spirituality scores, and lower positive religious coping scores. We conclude that many patients with HIV feel that their life is better than it was before their diagnosis, although results of such comparisons often change over time.

Changes in religiousness and spirituality attributed to HIV/AIDS: are there sex and race differences?

BACKGROUND/OBJECTIVE: Having a serious illness such as HIV/AIDS raises existential issues, which are potentially manifested as changes in religiousness and spirituality. The objective of this study was (1) to describe changes in religiousness and spirituality of people with HIV/AIDS, and (2) to determine if these changes differed by sex and race. METHODS: Three-hundred and forty-seven adults with HIV/AIDS from 4 sites were asked demographic, clinical, and religious/spiritual questions. Six religious/spiritual questions assessed personal and social domains of religiousness and spirituality. RESULTS: Eighty-eight participants (25%) reported being "more religious" and 142 (41%) reported being "more spiritual" since being diagnosed with HIV/AIDS. Approximately 1 in 4 participants also reported that they felt more alienated by a religious group since their HIV/AIDS diagnosis and approximately 1 in 10 reported changing their place of religious worship because of HIV/AIDS. A total of 174 participants (50%) believed that their religiousness/spirituality helped them live longer. Fewer Caucasians than African Americans reported becoming more spiritual since their HIV/AIDS diagnosis (37% vs 52%, respectively; P<.015), more Caucasians than African Americans felt alienated from religious communities (44% vs 21%, respectively; P<.001), and fewer Caucasians than African Americans believed that their religiousness/spirituality helped them live longer (41% vs 68% respectively; P<.001). There were no significantly different reported changes in religious and spiritual experiences by sex. CONCLUSIONS: Many participants report having become more spiritual or religious since contracting HIV/AIDS, though many have felt alienated by a religious group-some to the point of changing their place of worship. Clinicians conducting spiritual assessments should be aware that changes in religious and spiritual experiences attributed to HIV/AIDS might differ between Caucasian and African Americans.

Spirituality and religion in patients with HIV/AIDS.

BACKGROUND: Spirituality and religion are often central issues for patients dealing with chronic illness. The purpose of this study is to characterize spirituality/religion in a large and diverse sample of patients with HIV/AIDS by using several measures of spirituality/religion, to examine associations between spirituality/religion and a number of demographic, clinical, and psychosocial variables, and to assess changes in levels of spirituality over 12 to 18 months. METHODS: We interviewed 450 patients from 4 clinical sites. Spirituality/religion was assessed by using 8 measures: the Functional Assessment of Chronic Illness Therapy-Spirituality-Expanded scale (meaning/peace, faith, and overall spirituality); the Duke Religion Index (organized and nonorganized religious activities, and intrinsic religiosity); and the Brief RCOPE scale (positive and negative religious coping). Covariates included demographics and clinical characteristics, HIV symptoms, health status, social support, self-esteem, optimism, and depressive symptoms. RESULTS: The patients' mean (SD) age was 43.3 (8.4) years; 387 (86%) were male; 246 (55%) were minorities; and 358 (80%) indicated a specific religious preference. Ninety-five (23%) participants attended religious services weekly, and 143 (32%) engaged in prayer or meditation at least daily. Three hundred thirty-nine (75%) patients said that their illness had strengthened their faith at least a little, and patients used positive religious coping strategies (e.g., sought God's love and care) more often than negative ones (e.g., wondered whether God has abandoned me; P<.0001). In 8 multivariable models, factors associated with most facets of spirituality/religion included ethnic and racial minority status, greater optimism, less alcohol use, having a religion, greater self-esteem, greater life satisfaction, and lower overall functioning (R2=.16 to .74). Mean levels of spirituality did not change significantly over 12 to 18 months. CONCLUSIONS: Most patients with HIV/AIDS belonged to an organized religion and use their religion to cope with their illness. Patients with greater optimism, greater self-esteem, greater life satisfaction, minorities, and patients who drink less alcohol tend to be both more spiritual and religious. Spirituality levels remain stable over 12 to 18 months.

Drug evaluation: bevirimat--HIV Gag protein and viral maturation inhibitor.

Panacos Pharmaceuticals Inc is developing the HIV Gag protein and viral maturation inhibitor bevirimat for the potential oral treatment of HIV infection. Phase II clinical trials are underway and phase III trials expected to commence in 2007.