Influence of gender on receipt of guideline-based antiretroviral therapy in the era of HAART.

United States HIV guidelines delineate preferred antiretroviral treatment (ART) and discourage use of sub-potent, toxic, or adversely interacting combinations. It is unclear how often patients receive guideline concordant ART and what factors are correlated with receiving guideline-inconsistent ART. The objective of this study was to assess ART reported by participants of the Women's Interagency HIV Study (WIHS) and the Multicenter AIDS Cohort Study (MACS) to determine whether gender is associated with receipt of guideline-inconsistent ART. ART reported by WIHS and MACS participants from 1 January 2001, to 31 December 2007, was assessed for concordance with HIV guidelines. Logistic regression with generalized estimating equations estimated the crude and adjusted odds ratios and 95% confidence intervals associated with guideline-inconsistent regimens. Of 2937 participants, 463 subjects (WIHS n = 263; MACS n = 200) reported guideline-inconsistent ART during the study period. Age > 50 years (aOR = 2.22, 95% CI 1.14, 4.33) and HIV-1 RNA (aOR = 1.17, 95% CI 1.08, 1.25) but not participant gender (aOR = 1.21, 95% CI 0.88, 1.65) were associated with guideline-inconsistent ART. The prevalence of guideline-inconsistent ART peaked in 2004; however, there was not a statistically significant increase or decrease over time. Guideline-inconsistent ART was not related to gender, but was often used by older patients and patients with higher viral loads. Monitoring ART quality based on concordance with expert guidelines could improve treatment outcomes in a substantial number of patients.

Improved antiretroviral refill adherence in HIV-focused community pharmacies.

OBJECTIVE: To determine differences in patient characteristics, antiretroviral therapy (ART) regimen characteristics, and regimen refill adherence for human immunodeficiency virus (HIV)-focused pharmacy (HIV-P) versus traditional pharmacy (TP) users. DESIGN: Retrospective cohort study. SETTING: California Walgreens pharmacies from May 2007 to August 2009. PARTICIPANTS: HIV-positive patients with greater than 30 days of antiretroviral prescription claims. INTERVENTION: Deidentified prescription records for patients filling any ART prescription at any California Walgreens pharmacy during the study period were assessed. MAIN OUTCOME MEASURES: ART regimen refill adherence (calculated by modified medication possession ratio [mMPR]) and dichotomous measure of optimal adherence of 95% or greater. RESULTS: 4,254 HIV-P and 11,679 TP users were included. Compared with TP users, HIV-P users traveled farther to pharmacies (5.03 vs. 1.26 miles, P < 0.01). A greater proportion of HIV-P users filled prescriptions for chronic diseases (35% vs. 30%) and received fixed-dose combination antiretroviral tablets (92% vs. 83%) (all P < 0.01). Median mMPR was higher for HIV-P users (90% vs. 77%, P < 0.0001). After adjusting for age, gender, insurance, medication use, and distance from pharmacy, use of HIV-P (odds ratio 1.90 [95% CI 1.72-2.08]) and fixed-dose combination antiretroviral tablets (3.34 [2.84-3.96]) were most strongly associated with having 95% or greater ART regimen refill adherence. CONCLUSION: For HIV-positive patients struggling with antiretroviral adherence, clinicians may consider minimizing pill burden with combination tablets and referral to an HIV-focused pharmacy.

Antiretroviral Therapy Efficacy Post-Bariatric Weight Loss Surgery: A Case Series of Persons Living with Human Immunodeficiency Virus.

PURPOSE: Human immunodeficiency virus (HIV)-related mortality has decreased secondary to advances in antiretroviral therapy (ART), and the incidence of obesity in this population is increasing. Bariatric surgery is an effective method of weight loss, though changes in the gastrointestinal tract may affect ART absorption and virologic suppression. Existing data are limited to case reports studying outdated therapeutic regimens; studies evaluating modern ART regimens are needed. The objective of this study was to determine if undergoing bariatric surgery impacts HIV virologic failure rate at 12 months post-surgery and to characterize the failure population. MATERIALS AND METHODS: This retrospective case series included adults with virologically suppressed HIV on ART who underwent roux-en-y gastric bypass (RYGB) or sleeve gastrectomy (SG) surgery between 2000 and 2019 (n=20) at one of three medical centers within one academic medical system. The primary outcome was proportion of patients with ART failure at 12 months post-surgery. Select additional data collected included CD4+ count, metabolic parameters, postoperative complications, and medication non-adherence. RESULTS: A total of 18 patients were included in this analysis. Seventeen of 18 patients (94%) maintained virologic suppression within 12 months post-surgery. There were no significant changes in CD4+ counts before and after surgery. The one failure was an African American woman who underwent sleeve gastrectomy surgery. This patient's baseline viral load was undetectable and CD4+ count was 263 cells/mm3. CONCLUSION: Undergoing bariatric surgery did not increase virologic failure rate in a small cohort of persons living with HIV, and ART non-adherence was associated with virologic failure.

Health care provider satisfaction with telephone consultations provided by pharmacists and physicians at the National HIV/AIDS Clinicians' Consultation Center.

BACKGROUND: The federally funded National HIV/AIDS Clinicians' Consultation Center (NCCC) offers US health care providers expert telephone consultations for managing HIV/AIDS and occupational exposures to blood-borne pathogens through 3 telephone services: the National Clinicians' Post-Exposure Prophylaxis Hotline (PEPline), the National HIV Telephone Consultation Service (Warmline), and the Perinatal HIV Hotline. Callers to the NCCC receive consultation from either a clinical pharmacist (PharmD) or a physician (MD) with HIV expertise. OBJECTIVE: To compare the satisfaction of NCCC callers who received clinical consultations from clinical pharmacists and physicians with HIV expertise. METHODS: We prospectively mailed 1256 satisfaction surveys to NCCC health care provider callers during a 7-month period. Survey recipients were not aware that satisfaction surveys compared PharmD and MD consultation services. Respondents rated their level of agreement with 8 statements about the quality of consultation, the quality of clinical information given, and future calls to the NCCC. RESULTS: Survey return rates were 43% for PEPline and 40% for Warmline and Perinatal HIV Hotline combined. Overall, caller satisfaction with the telephone consultation service was extremely high (>4 in all categories on a 1-5 Likert scale). There was no significant difference in PEPline caller satisfaction ratings between PharmD and MD consultations. Callers to the Warmline and Perinatal HIV Hotline agreed with all 8 satisfaction statements. For the following 3 statements, however, satisfaction was higher when Warmline and Perinatal HIV Hotline consultation was provided by an MD: "Overall, I was pleased with the quality of my consultation" (p = 0.04); "I would use this service again" (p < 0.02); and "I am likely to recommend this service to my colleagues" (p = 0.02). CONCLUSIONS: Health care provider callers to the NCCC were highly satisfied with the information obtained from this HIV/AIDS telephone consultation service. By measuring callers' survey response to PharmD and MD consultations, the importance of the clinicians' contributions to this advanced HIV/AIDS consultation service is documented.

Analysis of COVID-19 Vaccine Type and Adverse Effects Following Vaccination.

Importance: Little is known about the factors associated with COVID-19 vaccine adverse effects in a real-world population. Objective: To evaluate factors potentially associated with participant-reported adverse effects after COVID-19 vaccination. Design, Setting, and Participants: The COVID-19 Citizen Science Study, an online cohort study, includes adults aged 18 years and older with a smartphone or internet access. Participants complete daily, weekly, and monthly surveys on health and COVID-19-related events. This analysis includes participants who provided consent between March 26, 2020, and May 19, 2021, and received at least 1 COVID-19 vaccine dose. Exposures: Participant-reported COVID-19 vaccination. Main Outcomes and Measures: Participant-reported adverse effects and adverse effect severity. Candidate factors in multivariable logistic regression models included age, sex, race, ethnicity, subjective social status, prior COVID-19 infection, medical conditions, substance use, vaccine dose, and vaccine brand. Results: The 19 586 participants had a median (IQR) age of 54 (38-66) years, and 13 420 (68.8%) were women. Allergic reaction or anaphylaxis was reported in 26 of 8680 participants (0.3%) after 1 dose of the BNT162b2 (Pfizer/BioNTech) or mRNA-1273 (Moderna) vaccine, 27 of 11 141 (0.2%) after 2 doses of the BNT162b2 or mRNA-1273 vaccine or 1 dose of the JNJ-78436735 (Johnson & Johnson) vaccine. The strongest factors associated with adverse effects were vaccine dose (2 doses of BNT162b2 or mRNA-1273 or 1 dose of JNJ-78436735 vs 1 dose of BNT162b2 or mRNA-1273; odds ratio [OR], 3.10; 95% CI, 2.89-3.34; P < .001), vaccine brand (mRNA-1273 vs BNT162b2, OR, 2.00; 95% CI, 1.86-2.15; P < .001; JNJ-78436735 vs BNT162b2: OR, 0.64; 95% CI, 0.52-0.79; P < .001), age (per 10 years: OR, 0.74; 95% CI, 0.72-0.76; P < .001), female sex (OR, 1.65; 95% CI, 1.53-1.78; P < .001), and having had COVID-19 before vaccination (OR, 2.17; 95% CI, 1.77-2.66; P < .001). Conclusions and Relevance: In this real-world cohort, serious COVID-19 vaccine adverse effects were rare and comparisons across brands could be made, revealing that full vaccination dose, vaccine brand, younger age, female sex, and having had COVID-19 before vaccination were associated with greater odds of adverse effects. Large digital cohort studies may provide a mechanism for independent postmarket surveillance of drugs and devices.

Trends in Nonlipid Cardiovascular Disease Risk Factor Management in the Women's Interagency HIV Study and Association with Adherence to Antiretroviral Therapy.

Cardiovascular disease (CVD) is increasingly common among women with HIV, but literature on nonlipid CVD risk factor management is lacking. We examined semiannual trends from 2006 to 2014 in hypertension treatment and control (blood pressure <140/90 mmHg), diabetes treatment and control (fasting glucose <130 mg/dL), and smoking quit rates in the Women's Interagency HIV Study. Unadjusted and adjusted Poisson regression models tested time trends and differences between HIV+ and HIV- women. Among antiretroviral therapy (ART) users, we examined the association of ART adherence and virologic suppression with each outcome. We evaluated 1636 HIV+ and 683 HIV- women, with a hypertension prevalence of 40% and 38%, respectively; diabetes prevalence of 21% and 22%; and smoking prevalence of 37% and 48%. Hypertension treatment was higher among HIV+ than HIV- women (77% vs. 67%, p < 0.001) and increased over time with no difference in trend by HIV status. Hypertension control was greater among HIV+ women (56% vs. 43%, p < 0.001) and increased over time among HIV+ but not HIV- women. Diabetes treatment was similar among HIV+ and HIV- women (48% vs. 49%) and increased over time in both groups. Diabetes control was greater among HIV+ women (73% vs. 64%, p = 0.03) and did not change over time. The percent of recent smokers who reported no longer smoking was similar between HIV+ and HIV- women (10% vs. 9%), with no differences over time. Virologic suppression was significantly associated with increased hypertension treatment and greater control. HIV+ women have better control of hypertension and diabetes than HIV- women, but many are still not at target levels.

Perceptions and Cost-Analysis of a Multiple Mini-Interview in a Pharmacy School Admissions Process.

OBJECTIVE: To improve the quality of admissions interviews for a doctor of pharmacy program, using a multiple mini-interview (MMI) in place of the standard interview. METHODS: Stakeholders completed an anonymous web-based survey. This study characterized perceptions of the MMI format across 3 major stakeholders (candidates, interviewers, admissions committee members) and included comparative cost estimates.Costs were estimated using human and facility resources from the 2012 cycle (standard format) and the 2013 cycle (MMI format). RESULTS: Most candidates (65%), interviewers (86%), and admissions committee members (79%) perceived the MMI format as effective for evaluating applicants, and most (59% of candidates, 84% of interviewers, 77% of committee members) agreed that the MMI format should be continued. Cost per candidate interviewed was $136.34 (standard interview) vs $75.30 (MMI). CONCLUSION: Perceptions of the MMI process were favorable across stakeholder groups, and this format was less costly per candidate interviewed.

Increase in single-tablet regimen use and associated improvements in adherence-related outcomes in HIV-infected women.

INTRODUCTION: The use of single-tablet antiretroviral therapy (ART) regimens and its implications on adherence among HIV-infected women have not been well described. METHODS: Participants were enrolled in the Women's Interagency HIV Study, a longitudinal study of HIV infection in US women. We examined semiannual trends in single-tablet regimen use and ART adherence, defined as self-reported 95% adherence in the past 6 months, during 2006-2013. In a nested cohort study, we assessed the comparative effectiveness of a single-tablet versus a multiple-tablet regimen with respect to adherence, virologic suppression, quality of life, and AIDS-defining events, using propensity score matching to account for demographic, behavioral, and clinical confounders. We also examined these outcomes in a subset of women switching from a multiple- to single-tablet regimen using a case-crossover design. RESULTS: We included 15,523 person-visits, representing 1727 women (53% black, 29% Hispanic, 25% IDU, median age 47). Use of single-tablet regimens among ART users increased from 7% in 2006% to 27% in 2013; adherence increased from 78% to 85% during the same period (both P < 0.001). Single-tablet regimen use was significantly associated with increased adherence (adjusted risk ratio: 1.05; 95% confidence interval: 1.03 to 1.08) and virologic suppression (risk ratio: 1.06; 95% confidence interval: 1.01 to 1.11), while associations with improved quality of life and fewer AIDS-defining events did not achieve statistical significance. Similar findings were observed among the subset of switchers. CONCLUSIONS: Single-tablet regimen use was associated with increased adherence and virologic suppression. Despite this, 15% of women prescribed ART were still not optimally adherent; additional interventions are needed to maximize therapeutic benefits.

The impact of HIV clinical pharmacists on HIV treatment outcomes: a systematic review.

OBJECTIVE: Due to the rapid proliferation of human immunodeficiency virus (HIV) treatment options, there is a need for health care providers with knowledge of antiretroviral therapy intricacies. In a HIV multidisciplinary care team, the HIV pharmacist is well-equipped to provide this expertise. We conducted a systematic review to assess the impact of HIV pharmacists on HIV clinical outcomes. METHODS: We searched six electronic databases from January 1, 1980 to June 1, 2011 and included all quantitative studies that examined pharmacist's roles in the clinical care of HIV-positive adults. Primary outcomes were antiretroviral adherence, viral load, and CD(4) (+) cell count and secondary outcomes included health care utilization parameters, antiretroviral modifications, and other descriptive variables. RESULTS: Thirty-two publications were included. Despite methodological limitation, the involvement of HIV pharmacists was associated with statistically significant adherence improvements and positive impact on viral suppression in the majority of studies. CONCLUSION: This systematic review provides evidence of the beneficial impact of HIV pharmacists on HIV treatment outcomes and offers suggestions for future research.

Pharmacist counseling in a cohort of women with HIV and women at risk for HIV.

BACKGROUND AND METHODS: Achieving high adherence to antiretroviral therapy for human immunodeficiency virus (HIV) is challenging due to various system-related, medication-related, and patient-related factors. Community pharmacists can help patients resolve many medication-related issues that lead to poor adherence. The purpose of this cross-sectional survey nested within the Women's Interagency HIV Study was to describe characteristics of women who had received pharmacist medication counseling within the previous 6 months. The secondary objective was to determine whether HIV-positive women who received pharmacist counseling had better treatment outcomes, including self-reported adherence, CD4(+) cell counts, and HIV-1 viral loads. RESULTS: Of the 783 eligible participants in the Women's Interagency HIV Study who completed the survey, only 30% of participants reported receiving pharmacist counseling within the last 6 months. Factors independently associated with counseling included increased age (odds ratio [OR] 1.28; 95% confidence interval [CI] 1.07-1.55), depression (OR 1.75; 95% CI 1.25-2.45), and use of multiple pharmacies (OR 1.65; 95% CI 1.15-2.37). Patients with higher educational attainment were less likely to report pharmacist counseling (OR 0.68; 95% CI 0.48-0.98), while HIV status did not play a statistically significant role. HIV-positive participants who received pharmacist counseling were more likely to have optimal adherence (OR 1.23; 95% CI 0.70-2.18) and increased CD4(+) cell counts (+43 cells/mm(3), 95% CI 17.7-104.3) compared with those who had not received counseling, though these estimates did not achieve statistical significance. CONCLUSION: Pharmacist medication counseling rates are suboptimal in HIV-positive and at-risk women. Pharmacist counseling is an underutilized resource which may contribute to improved adherence and CD4(+) counts, though prospective studies should be conducted to explore this effect further.

Effects of HIV antiretrovirals on the pharmacokinetics of hormonal contraceptives.

OBJECTIVES: To review available information on pharmacokinetic effects of HIV antiretrovirals on hormonal contraceptives. METHODS: A PubMed search was conducted from 1964 to 2006 using each antiretroviral generic name and the keywords contraceptive, contraception, ethinyl oestradiol, oestrogen, and progestin. Abstracts from the annual Conference on Retroviruses and Opportunistic Infections and International AIDS Society Conferences from 1998-2006 as well as package product inserts were reviewed for completeness. RESULTS: Antiretroviral regimens containing protease inhibitors and non-nucleoside reverse transcriptase inhibitors may decrease the area under the curve (AUC) levels of steroids released by hormonal contraceptives. Some antiretroviral-hormonal contraceptive pairs do not decrease steroid hormone levels. CONCLUSION: Pharmacokinetic interactions of antiretrovirals on hormonal contraceptives are specific to the type of antiretroviral and hormonal contraceptive being utilized. HIV-positive women may be counselled to use dual methods of hormonal and barrier contraception to prevent pregnancy with maximal efficacy as well as to reduce possibility of HIV transmission. Oral contraceptives might be administered with non-ritonavir boosted atazanavir or non-ritonavir boosted indinavir without a loss of contraceptive efficacy. Depot medroxyprogesterone acetate may be safe to administer with efavirenz, nevirapine, and nelfinavir. However, further studies are needed to determine the clinical relevance of the interactions between hormonal contraceptives and antiretrovirals and to explore potential dose adjustments to improve contraceptive efficacy.

Tipranavir: a protease inhibitor for HIV salvage therapy.

OBJECTIVE: To review the efficacy, safety, pharmacology, virology, pharmacokinetics, and resistance of the nonpeptidic protease inhibitor (PI) tipranavir. DATA SOURCES AND STUDY SELECTION: A PubMed search (1966-February 2006) was conducted using the key words tipranavir or PNU-140690, with the limitation of English-language reports. Pharmacokinetic and randomized clinical trials originating from major HIV conferences, such as the Conference on Retroviruses and Opportunistic Infections, International AIDS Society, European AIDS Conference, and Interscience Conference on Antimicrobial Agents and Chemotherapy, published only in abstract form, from 2000 to February 2006, were reviewed for relevance and included in this review. DATA SYNTHESIS: Phase III studies have shown that tipranavir is effective in the treatment of PI-resistant HIV compared with other PI-containing regimens. Adverse effects associated with tipranavir/ritonavir therapy include gastrointestinal reactions, hepatotoxicity, and elevations in cholesterol and triglyceride levels. Resistance data suggest that tipranavir/ritonavir should be reserved for salvage therapy in antiretroviral-experienced patients who have previously failed standard PI therapies. The potential for hepatotoxicity and drug interactions and the expense of tipranavir due to required ritonavir boosting may limit its widespread use. CONCLUSIONS: Tipranavir/ritonavir is an essential addition to the antiretroviral armamentarium for HIV-infected patients with limited treatment options.

Valganciclovir: an advance in cytomegalovirus therapeutics.

OBJECTIVE: To review the pharmacology, pharmacokinetics, and preliminary clinical data for valganciclovir, a new oral agent for the therapy of cytomegalovirus (CMV) retinitis. DATA SOURCES: Relevant literature was extracted via MEDLINE/PUBMED and searchable abstracts from infectious diseases conferences covering the period from January 1990 to April 2002. Tertiary references provided background information. DATA SYNTHESIS: Current standard treatment for CMV retinitis consists of intravenous therapy, intraocular implant, and intraocular injection. The low bioavailability of oral ganciclovir restricts its use to prophylaxis and maintenance treatment. Oral valganciclovir, recently approved for both induction and maintenance therapy of CMV retinitis, may fill a niche for this disease. CONCLUSIONS: Although only 1 clinical study has been published for valganciclovir, its favorable pharmacokinetic profile, encouraging preliminary efficacy data, ease of administration, and lack of potential catheter-related complications make it a favorable option for the treatment of CMV retinitis in HIV-positive patients.