Real world community-based HIV Rapid Start Antiretroviral with B/F/TAF versus prior models of antiretroviral therapy start - the RoCHaCHa study, a pilot study.

BACKGROUND: The rapid start of antiretroviral therapy (RSA) model initiates antiretroviral therapy (ART) as soon as possible after a new or preliminary diagnosis of HIV, in advance of HIV-1 RNA and other baseline laboratory testing. This observational study aims to determine if RSA with a single tablet regimen of bictegravir, emtricitabine, and tenofovir alafenamide (B/F/TAF) is an effective regimen for achieving viral suppression and accepted by patients at the time of diagnosis. METHODS: Adults newly or preliminarily diagnosed with HIV were enrolled from October 2018 through September 2021. Real world advantage, measured in days between clinical milestones and time to virologic suppression, associated with B/F/TAF RSA was compared to historical controls. RESULTS: All Study RSA participants (n = 45) accepted treatment at their first visit and 43(95.6%) achieved virologic suppression by week 48. Study RSA participants had a significantly shorter time (median 32 days) from diagnosis to ART initiation and virologic suppression, in comparison to historical controls (median 181 days) (n = 42). Qualitative feedback from study RSA participants showed high acceptance positive response to RSA. CONCLUSIONS: RSA is feasible and well accepted by patients in a real-world community-based clinic setting. Promoting RSA in community-based clinics is an important tool in ending the HIV epidemic.

Efficacy and safety of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide in Asian participants with human immunodeficiency virus 1 infection: A sub-analysis of phase 3 clinical trials.

Background: The efficacy and safety of a single tablet regimen (STR) of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) was analyzed in Phase 3 clinical trials in antiretroviral therapy (ART)-naive and ART-experienced Asian participants infected with human immunodeficiency virus (HIV)-1 through 96 or 144 weeks.Objective: In Asian population requiring treatment, it is imperative to have data specific to this group, particularly as there is a general concern that Asians with lower body weight have increased risk of tenofovir disoproxil fumarate (TDF)-related renal dysfunction.Methods: Studies -104 and 111 were randomized, double-blind, placebo-controlled, 144-week studies conducted in ART-naive participants, comparing E/C/F/TAF versus E/C/F/TDF. Study 109 was a randomized, open-label, 96-week study conducted in virologically suppressed, ART-experienced participants, who switched to E/C/F/TAF from ritonavir/cobicistat-boosted atazanavir ATV+(RTV or COBI) + F/TDF regimens, from non-nucleoside reverse transcriptase inhibitors (NNRTI) + F/TDF regimens, or from E/C/F/TDF. Study 112 was a single arm, open-label, 144-week study conducted in HIV suppressed, ART-experienced participants with mild-moderate renal impairment, who switched to E/C/F/TAF.Results: Asian participants in these studies had sustained efficacy safety and tolerability. In Study 104/111, Asian participants achieved 93% virologic suppression on TAF vs 88% on TDF at week 144. At baseline, there were numerically more Asians with median CD4 counts < 200 cells/uL and VL > 100,000 c/mL. In Study 109, 95% of Asians on TAF vs 86% on TDF maintained virologic suppression at week 96. Lastly, in Study 112, 91% maintained virologic suppression at week 144. There were no discontinuations due to renal AE, no cases of PRT or Fanconi syndrome in any of the studies.

Willingness to Take PrEP for HIV Prevention: The Combined Effects of Race/Ethnicity and Provider Trust.

Blacks and Hispanics/Latinos are disproportionately burdened by HIV compared to non-Hispanic Whites, as evidenced by higher HIV incidence, prevalence, and deaths attributable to AIDS. Increasing the use of novel prevention techniques such as Truvada for pre-exposure prophylaxis (PrEP) could greatly help in reducing these disparities by lowering HIV incidence among these higher risk groups. Trust in providers, which may differ by race and ethnicity, may influence willingness to take PrEP. This study explores the moderating effect of race/ethnicity on trust in one's primary care provider (PCP) on PrEP willingness. This study found a significant association between PCP trust and PrEP willingness, with those with greater trust having 3.24 times the adjusted odds of being willing to try PrEP. Results regarding the effects of race and ethnicity on these outcomes, however, were inconclusive. Results indicate the importance of fostering trust between PrEP-prescribing PCPs and their patients.

Activation of persons living with HIV for treatment, the great study.

BACKGROUND: Patient empowerment represents a potent tool for addressing racial, ethnic and socioeconomic disparities in health care, particularly for chronic conditions such as HIV infection that require active patient engagement. This multimodal intervention, developed in concert with HIV patients and clinicians, aims to provide HIV patients with the knowledge, skills, attitudes and tools to become more activated patients. METHODS/DESIGN: Randomized controlled trial of a multimodal intervention designed to activate persons living with HIV. The intervention includes four components: 1) use of a web-enabled hand-held device (Apple iPod Touch) loaded with a Personal Health Record (ePHR) customized for HIV patients; 2) six 90-minute group-based training sessions in use of the device, internet and the ePHR; 3) a pre-visit coaching session; and 4) clinician education regarding how they can support activated patients. Outcome measures include pre- post changes in patient activation measure score (primary outcome), eHealth literacy, patient involvement in decision-making and care, medication adherence, preventive care, and HIV Viral Load. DISCUSSION: We hypothesize that participants receiving the intervention will show greater improvement in empowerment and the intervention will reduce disparities in study outcomes. Disparities in these measures will be smaller than those in the usual care group. Findings have implications for activating persons living with HIV and for other marginalized groups living with chronic illness. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02165735, 6/13/2014.

Hospitalization Rates and Reasons Among HIV Elite Controllers and Persons With Medically Controlled HIV Infection.

BACKGROUND: Elite controllers spontaneously suppress human immunodeficiency virus (HIV) viremia but also demonstrate chronic inflammation that may increase risk of comorbid conditions. We compared hospitalization rates and causes among elite controllers to those of immunologically intact persons with medically controlled HIV. METHODS: For adults in care at 11 sites from 2005 to 2011, person-years with CD4 T-cell counts ≥350 cells/mm(2) were categorized as medical control, elite control, low viremia, or high viremia. All-cause and diagnostic category-specific hospitalization rates were compared between groups using negative binomial regression. RESULTS: We identified 149 elite controllers (0.4%) among 34 354 persons in care. Unadjusted hospitalization rates among the medical control, elite control, low-viremia, and high-viremia groups were 10.5, 23.3, 12.6, and 16.9 per 100 person-years, respectively. After adjustment for demographic and clinical factors, elite control was associated with higher rates of all-cause (adjusted incidence rate ratio, 1.77 [95% confidence interval, 1.21-2.60]), cardiovascular (3.19 [1.50-6.79]) and psychiatric (3.98 [1.54-10.28]) hospitalization than was medical control. Non-AIDS-defining infections were the most common reason for admission overall (24.1% of hospitalizations) but were rare among elite controllers (2.7%), in whom cardiovascular hospitalizations were most common (31.1%). CONCLUSIONS: Elite controllers are hospitalized more frequently than persons with medically controlled HIV and cardiovascular hospitalizations are an important contributor.

Bridging the digital divide in HIV care: a pilot study of an iPod personal health record.

BACKGROUND: Persons living with HIV (PLWH) need practical tools to self-manage their condition. METHODS: We conducted a proof-of-concept study among PLWH to assess whether patients could learn to use a personal health record (PHR) on a hand-held device (iPod Touch) to manage their condition. We began individual trainings and later adapted this to group training. We assessed usability, acceptability and also effects on self-efficacy for treatment adherence using the HIV Treatment Adherence Self-Efficacy Scale (HIV-ASES). RESULTS: Nine PLWH participated in the individual training and 29 participated in the group sessions. The participants were largely middle aged, low-income and of racial/ethnic minorities. The sessions were well attended and participants fully engaged in tasks and shared learning. Most participants stated they intended to use the PHR and reported improved self-efficacy in treatment adherence (P = .05) particularly on the integration of treatment adherence into one's routine (P < .02). CONCLUSIONS: Training PLWH in use of a handheld PHR shows promise.

Anal cancer screening in HIV-infected patients: is it time to screen them all?

BACKGROUND: Annual screening for anal cancer is recommended only for HIV patients at increased risk: men who have sex with men, individuals with a history of anogenital warts, and women with cervical dysplasia. OBJECTIVE: The aim of this study was to examine the screening outcomes between HIV populations with and without these risk factors. METHODS: We reviewed the records of all HIV patients referred for anal cytology and high-resolution anoscopy from June 2009 to June 2010. Patients were stratified into an increased-risk group or a standard-risk group. MAIN OUTCOME: Of the 329 evaluable patients, 285 (89.8% men, 10.2% women, mean age 46 ± 10 years) were classified to the increased-risk group, whereas 44 (72.7% men, 27.3% women, mean age 52 ± 8 years) were included in the standard-risk group. Male sex, white race, sexual orientation, past and current receptive anal intercourse, noncompliance with condom use, and absence of a new sexual partner were significantly different in the increased-risk group in comparison with the standard-risk group. In the increased-risk group, 187 (66.5%) patients had biopsy-proven dysplasia of which 118 (42.0%) had high-grade disease. In the standard-risk group, 15 (34.9%) patients had biopsy-proven dysplasia of which 7 (16.3%) had high-grade disease. Cytology detected biopsy-confirmed high-grade dysplasia only in 23 of 118 (19.5%) patients in the increased-risk group and in 2 of 7 (28.6%) patients in the standard-risk group. Kappa agreement in detecting high-grade disease was low for both increased-risk and standard-risk groups: 0.16 (95% CI 0.07-0.23) and 0.40 (95% CI 0.02-0.40). LIMITATIONS: Our study is a chart-based retrospective review of data with a small female population. Histology reports came from 2 different laboratories. CONCLUSION: High-grade anal dysplasia was prevalent even among HIV patients who only have standard risk factors. Anal cytology and high-resolution anoscopy have poor agreement. We suggest considering annual screening by using high-resolution anoscopy in addition to cytology for all HIV patients regardless of risk factors.

Impact of switching virologically suppressed, HIV-1-infected patients from twice-daily fixed-dose zidovudine/lamivudine to once-daily fixed-dose tenofovir disoproxil fumarate/emtricitabine.

OBJECTIVE: Evaluate the impact of switching from twice-daily zidovudine/lamivudine (AZT/3TC) to once-daily tenofovir DF plus emtricitabine (TDF/FTC) with efavirenz (EFV). DESIGN: Prospective, multicenter, single-arm 24-week trial. METHODS: Patients on EFV + AZT/3TC for > or =8 weeks with HIV-1 RNA <400 copies/mL were switched to EFV + TDF/FTC and assessed for safety/tolerability, virologic and immunologic responses, adherence, and quality of life at 4, 12, and 24 weeks. RESULTS: Of 402 patients, 2% discontinued for an adverse event (AE) and 1 patient for virologic failure. At 24 weeks, 87% had HIV RNA <400 copies/mL, and 74% versus 71% at baseline had undetectable (HIV RNA <50 copies/mL) viral load (ITT; M=F). Treatment-emergent AEs were infrequent (< or = 5%) with gastrointestinal complaints being the most common. At 24 weeks compared to baseline, hemoglobin (Hb) increased by a median of 0.6 g/dL (p < .001), and a decrease in creatinine clearance of 7.6 mL/min (p < .001) was observed. Fasting lipids decreased slightly (p < .02) in a subset of patients studied (n = 160). A higher percentage of patients reported being "very satisfied" with treatment and the absence of regimen side effects at 24 weeks versus baseline (p < .001). At 24 weeks, 86% of patients took > or = 95% of doses versus 78% at baseline (p = .002). CONCLUSION: Patients switched to EFV + TDF/FTC maintained virologic suppression and the regimen was well tolerated. Patients reported increased satisfaction with treatment and fewer were bothered by side effects.

Raltegravir (MK-0518): a novel integrase inhibitor for the treatment of HIV infection.

Integrase is essential for HIV-1 replication; however, potent inhibition of the isolated enzyme in biochemical assays has not readily translated into antiviral activity in a manner consistent with inhibition of integration. Raltegravir is a novel HIV-1 integrase strand transfer inhibitor with potent in vitro activity against wild-type and multi-class resistant HIV-1 virus (in vitro IC(95) for HIV-1 in 50% normal human serum = 33 nM). Inhibition of integrase prevents insertion of HIV DNA into the human DNA genome, thus blocking the ability of HIV to replicate. Raltegravir is administered orally every 12 h and does not require boosting with low-dose ritonavir (RTV) to achieve therapeutic concentrations. Raltegravir is not a potent inhibitor or inducer of cytochrome P450 3A4, and it is predominantly metabolized by glucuronidation, specifically by the enzyme UDP-glucuronosyltransferase 1A1.