Daily Pill Research Articles

Long-acting antiretrovirals: a new era for the management and prevention of HIV infection.

The long-acting antiretroviral cabotegravir and rilpivirine combination has just received FDA, EMA and Health Canada approval. This novel drug delivery approach is about to revolutionize the therapy of people living with HIV, decreasing the 365 daily pill burden to only six intramuscular injections per year. In addition, islatravir, a first-in-class nucleoside reverse transcriptase translocation inhibitor, is intended to be formulated as an implant with a dosing interval of 1 year or more. At present, long-acting antiretroviral therapies (LA-ARTs) are given at fixed standard doses, irrespectively of the patient’s weight and BMI, and without consideration for host genetic and non-genetic factors likely influencing their systemic disposition. Despite a few remaining challenges related to administration (e.g. pain, dedicated medical procedure), the development and implementation of LA-ARTs can overcome long-term adherence issues by improving patients’ privacy and reducing social stigma associated with the daily oral intake of anti-HIV treatments. Yet, the current ‘one-size-fits-all’ approach does not account for the recognized significant inter-individual variability in LA-ART pharmacokinetics. Therapeutic drug monitoring (TDM), an important tool for precision medicine, may provide physicians with valuable information on actual drug exposure in patients, contributing to improve their management in real life. The present review aims to update the current state of knowledge on these novel promising LA-ARTs and discusses their implications, particularly from a clinical pharmacokinetics perspective, for the future management and prevention of HIV infection, issues of ongoing importance in the absence of curative treatment or an effective vaccine.

Patterns of drug therapy, glycemic control, and predictors of escalation- non-escalation of treatment among diabetes outpatients at a tertiary care center.

The study was conducted to assess patterns of prescribed drug therapy and clinical predictors of need for therapy escalation in outpatients with diabetes mellitus (DM). This was a prospective cohort study, conducted at an apex tertiary care teaching hospital in central India for a period of 18months. The demographic, clinical, and treatment details on the baseline and follow up visits were collected from the patients' prescription charts. Glycemic control, adherence, pill burdens along with pattern of antidiabetic therapy escalation, and deescalations were analyzed. A total of 1,711 prescriptions of 925 patients of diabetes with a mean age of 53.81±10.42years and duration of disease of 9.15±6.3years were analyzed. Approximately half of the patients (n=450) came for≥1 follow up visits. Hypertension (59.35%) was the most common comorbidity followed by dyslipidemia and hypothyroidism. The mean total daily drugs and pills per prescription were 4.03±1.71 and 4.17±1.38, respectively. Metformin (30.42%) followed by sulphonylureas (SUs) (21.39%) constituted majority of the AHA's and dual and triple drug therapy regimens were most commonly prescribed. There were improvements in HbA1c, fasting/postprandial/random blood sugar (FBS/PPBS/RBS) as well as adherence to medication, diet, and exercise in the follow up visits. Among patients with follow ups, therapy escalations were found in 31.11% patients, among whom dose was increased in 12.44% and drug was added in 17.28%. Apart from Hb1Ac, FBS, and PPBS levels (p<0.001), characteristics such as age, BMI, duration of diagnosed diabetes, presence of hypertension and dyslipidemia, and daily pill burdens were found to be significantly higher in the therapy escalation group (p<0.05). Inadequate medication adherence increased the relative risk (RR) of therapy escalation by almost two times. Disease and therapy patterns are reflective of diabetes care as expected at a tertiary care center. Higher BMI, age, pill burden, duration of diabetes, presence of comorbidities, and poor medication adherence may be the predictors of therapy escalation independent of glycemic control and such patients should be more closely monitored.

The price tag of a potential cure for chronic hepatitis B infection: A cost threshold analysis for USA, China and Australia.

We aim to capture the economic impact of a potential cure for chronic hepatitis B infection (CHB) in three countries (USA, China and Australia) with different health systems and epidemics to estimate the threshold drug prices below which a CHB cure would be cost-saving and/or highly cost-effective. We simulated patients' hepatitis B progression, under three scenarios: current long-term suppressive antiviral therapy, functional cure defined as sustained undetectable HBsAg and HBV DNA, and partial cure defined as sustained undetectable HBV DNA only after a finite, 48-week treatment. Compared with current long-term antiviral therapy, a 30% effective functional cure among patients with and without cirrhosis in the USA, China and Australia would yield 17.50, 17.32 and 20.42 QALYs per patient, and 20.61, 20.42 and 20.62 QALYs per patient respectively. In financial terms, for CHB patients with and without cirrhosis, this would be cost-saving at a one-time treatment cost under US$11944 and US$6694, respectively, in the USA, US$1744 and US$1001 in China, and US$12063 and US$10983 in Australia. We show that in purely economic terms, a CHB cure will be highly cost-effective even if effective in only 30% of treated patients. The threshold price for cure is largely determined by the current antiviral drug costs, since it will replace a daily antiviral pill that is inexpensive and effective, although not curative. The likely need for combination therapies to achieve cure will also present cost challenges. While cost-effectiveness is important, it cannot be the only consideration, as cure will provide many benefits in addition to reduced liver disease and HCC, including eliminating the need for a long-term daily pill and reducing stigma often associated with chronic viral infection.

Electronic pill bottles to monitor and promote medication adherence for people with multiple sclerosis: A randomized, virtual clinical trial

ObjectiveWe perform a randomized trial to test the impact of electronic pill bottles with audiovisual reminders on oral disease modifying therapy (DMT) adherence in people with MS (PwMS). MethodsAdults with multiple sclerosis (MS) taking an oral DMT were randomized 1:1 for 90 days to remote smartphone app- and pill bottle-based (a) adherence monitoring, or (b) adherence monitoring with audiovisual medication reminders. Optimal adherence was defined as the proportion of doses taken ±3 h of the scheduled time. Numbers of missed pills and pills taken early, on time, late, and extra were recorded. A multivariable regression model tested possible associations between optimal adherence and age, MS duration, cognitive functioning, and number of daily prescription pills. Results85 participants (66 female; mean age 44.9 years) took dimethyl/diroximel fumarate (n = 49), fingolimod (n = 26), or teriflunomide (n = 10). Optimal adherence was on average higher in the monitoring with reminders arm (71.4%) than the monitoring only arm (61.6%; p = 0.033). In a multivariable model, optimal adherence was less likely in younger participants (p < 0.001) and those taking more daily prescription pills (p < 0.001). In the monitoring only arm, 4.0% of doses were taken early, 61.6% on time, 5.6% late, 4.4% in excess, and 24.4% were missed. In the reminders arm, these proportions were 3.4%, 71.4%, 3.7%, 8.7%, and 12.8%, respectively. ConclusionWe map real-world oral DMT adherence patterns using mHealth technology. PwMS who received medication reminders had higher optimal adherence. Nonadherence was more nuanced than simply missing pills. Developing strategies to improve adherence remains important in longitudinal MS care.

Detection of Nonadherence to Antihypertensive Treatment by Measurements of Serum Drug Concentrations.

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Integration of HIV Prevention With Sexual and Reproductive Health Services: Evidence for Contraceptive Options and HIV Outcomes Study Experience of Integrating Oral Pre-exposure HIV Prophylaxis in Family Planning Services in Lusaka, Zambia.

The WHO guideline on the integration of family planning (FP) and pre-exposure HIV prophylaxis (PrEP) to enhance the health of women and adolescent girls is reflected in the Zambia Consolidated Guidelines for Treatment and Prevention of HIV Infection, 2020. There is however a dearth of data on the integration of PrEP and FP in Zambia. We describe the integration of oral PrEP in FP services using the Evidence for Contraceptive Options and HIV Outcomes (ECHO) study experience at Kamwala District Health Center in Lusaka, Zambia. The provision of oral PrEP at Kamwala started in October 2017, lasting for ~11 months, and utilized the model where initial processes to offer PrEP were on-site followed by off-site referral to laboratory and PrEP provider services. The characteristics of 658 women who enrolled in ECHO at Kamwala are representative of women accessing FP services in Lusaka. About 644 of the enrollees were offered oral PrEP. The proportion of women accepting PrEP was low at 1.08% and the proportion of study visits at which PrEP was requested was also low at 0.57%. Those who accepted PrEP were above 20 years old, married, with at least primary education, sexual behavior, and risk comparable to decliners. The ECHO study experience indicates that the setup and integration of oral PrEP and FP services are feasible in the setting. However, uptake of PrEP was very low. Possible contributory factors were as follows: (1) timing of introduction of PrEP midway in the study, (2) PrEP being a new intervention, (3) challenges of autonomy of young women to include a daily pill into their lives and anticipated challenges to adherence because of fear of adverse events, (4) possible underdetermined risk due to use of an unvalidated risk assessment tool and assessment by health care provider vs. self-assessment, and (5) extra layer of challenges to negotiate due to needing for off-site referrals. Following these findings, we conclude that further research through demonstration projects of integration of oral PrEP and FP may provide solutions to low uptake. This information is critical for scaling up of integration HIV prevention services and sexual and reproductive health (SRH) services.

The role of the clinical pharmacist in guiding adjuvant hormonal therapy in patients with breast cancer.

Breast cancer is the most prevalent type of cancer among women, affecting about 2.1 million worldwide and is responsible for the highest number of cancer-related deaths among women. Approximately 80% of breast cancers express on the surface of hormone receptor cells, such as progesterone and estrogen. In these cases, Adjuvant Hormonal Therapy (AHT) is indicated for a period of five to ten years and consists of taking a daily oral pill. The two most used drugs in AHT are tamoxifen and Aromatase Inhibitors. One of the issues most faced by individuals who are subjected to long periods of treatment is the lack of medication adherence and, consequently, therapeutic inefficiency. It is believed that the monitoring by the pharmacist can contribute to the reduction of errors inherent to the medication, making the treatment more effective and improving the patient's quality of life. The present study aimed to know the perception of patients who live with breast cancer and who do AHT in relation to the educational performance of the clinical pharmacist. This is a qualitative, descriptive and exploratory study, carried out from March to October 2020, with 15 women undergoing treatment at the oncology unit of a tertiary-care hospital in south of Brazil. The data were obtained through a semi-structured interview using an instrument composed of two parts, one referring to the characterization of the participants and the other with the guiding question of the research: "How do you perceive the role of the pharmacist in relation to the guidelines for the use of adjuvant hormonal therapy?". The method of theoretical saturation was used to perform the sample closure and the thematic analysis was used to analyze the data. The participants were between 32 and 74 years old, seven were on tamoxifen therapy and eight on anastrozole, ten were on the first year of treatment, two on the second and three on the third year. The themes that emerged were: pharmacist-patient interaction as a safety factor in hormone therapy; role of the pharmacist in the development of strategies for self-management of the patients during hormone therapy; and, challenges for the pharmacist in relation to hormone therapy through continued guidance. It was evident that the pharmacist's educational action encouraged the participants to carry out the treatment in a more confident and assertive manner according to their particularities and beliefs.

MHealth for pre-exposure prophylaxis adherence by young adult men who have sex with men.

Young adult men who have sex with men (YMSM) are at increased risk for HIV, especially minority YMSM. Pre-exposure prophylaxis (PrEP) is a breakthrough daily pill to prevent HIV. Consistent adherence is key to PrEP effectiveness, which is why the CDC recommends adherence support be provided to all PrEP patients. Mobile health can overcome barriers to the delivery of adherence support, particularly for YMSM who may be most in need of it due, at least in part, to their young age. We created a culturally- and developmentally-sensitive PrEP adherence mobile app (called "Dot") that was tailored for culturally-diverse young adult MSM. After formative research and usability testing, we conducted a 6-week pre-post study to evaluate the impact of Dot on self-reported PrEP adherence, PrEP treatment self-efficacy, PrEP knowledge, and intention to practice safe sex among culturally-diverse YMSM, age 20-29. At 6 weeks, there were significant improvements in PrEP adherence, PrEP self-efficacy, and intention to practice safe sex. PrEP knowledge scores did not significantly change. The Dot app proved feasible and effective at improving PrEP adherence among culturally-diverse YMSM. Moreover, the app had a high-degree of user appeal, which is foundational to success of an mhealth intervention.

The Effect of Combined Oral Contraceptive Pills on Beclin-1 and LC3B Transcript Levels in Ovarian Endometrioma.

Background Autophagy is likely altered in patients with endometriosis. Ovarian steroid hormones seem to affect this changing of the autophagic process. Objective To study the effect of combined oral contraceptive (COC) pills on the expression of autophagic-related gene BECN1 and LC3B in the ectopic and eutopic endometria of patients with endometriosis. Material and Methods. The present quasiexperimental study recruited 36 women (18–45 years old) with endometrioma and nonendometrioma who were scheduled for surgery. Patients with endometrioma were randomly assigned to either a no-treatment group (n = 12) or a COC group (n = 12). The COC group was prescribed a daily oral pill composed of 3 mg drospirenone and 0.03 mg ethinyl estradiol for 6 weeks before surgery. The control group (n = 12) was composed of women without endometrioma. Ectopic endometriotic and endometrium tissues were collected from the no-treatment and COC groups, whereas the only endometrium was collected from the control group. These tissues were used for real-time PCR to measure the expression of the BECN1 and LC3B genes. Results The baseline demographic data were not different among the three groups. The BECN1 gene expression in endometrium tissue in the COC group was significantly less than that in the no-treatment and control groups (P = 0.011 and 0.029, respectively). No significant difference of endometriotic cyst BECN1 and LC3B gene expression was found between COC and no treatment. Conclusions Oral COC pills for 6 weeks continuously before surgery decreased the eutopic endometrial expression (mRNA) of the BECN1 gene compared to those from healthy normal women and nontreated patients with an endometriotic cyst. The change in the expression of autophagy-related genes was more distinct in eutopic than ectopic endometria. This trial is registered with TCTR20170720002. Registered and enrolled the first patient on 20 July 2017.

Acceptability of the oral hormonal male contraceptive prototype, 11β-methyl-19-nortestosterone dodecylcarbonate (11β-MNTDC), in a 28-day placebo-controlled trial

ObjectiveTo determine men's satisfaction with and the potential acceptability of 11β-methyl-19-nortestosterone dodecylcarbonate (11β-MNTDC) when used for 28 days as an experimental, once-daily, oral hormonal male contraceptive (HMC). Study designWe surveyed participants from a double-blind, randomized, placebo-controlled, phase 1 clinical trial, examining their experience with and willingness to use daily oral 11β-MNTDC for male contraception. ResultsOf 42 trial participants, 40 (30 11β-MNTDC, 10 placebo) completed baseline and end-of-treatment surveys. Based on a 28-day experience, few cited any baseline concerns about safety and drug adherence. Following treatment, nearly three-quarters (72.5%) of participants reported satisfaction with the study drug and nearly all (92.5%) would recommend the method to others. More than half of participants would be willing to pay for the study drug (62.5%) and indicated that the method exceeded initial expectations (53.9%). Nearly 90% reported that taking the pill was easy to remember and did not interfere with their daily routines. Approximately one-third of participants reported bothersome side effects (37% 11β-MNTDC vs. 20% placebo, p = 0.45). Given the option, 42% of participants would prefer a daily HMC pill over injectable regimens or a daily topical gel. ConclusionA majority of participants in this short-term trial of daily oral 11β-MNTDC reported satisfaction with the regimen, would recommend it to others, and would pay to use the drug as HMC despite some bothersome side effects. ImplicationsOral 11β-MNTDC would be an acceptable and preferable method among men desiring reversible hormonal male contraception (HMC). These data support further trials of novel oral HMCs such as 11β-MNTDC.

Awareness and acceptability of HIV pre-exposure prophylaxis (PrEP) among students at two historically Black universities (HBCU): a cross-sectional survey

BackgroundDespite young African American adults (ages 18–24) being among the highest risk groups for HIV infection, little is known about their awareness of HIV pre-exposure prophylaxis (PrEP) – a once daily pill shown to be > 90% effective in preventing HIV. To explore awareness and acceptability of PrEP among college students in this demographic, we conducted a survey of attendees at two large historically Black universities (HBCU) in North Carolina.MethodsWe administered a 14-item questionnaire to students at two HBCUs in North Carolina between February and April 2018. Questions were formatted in a yes/no or multiple choice format. Questionnaire items specifically addressed PrEP awareness and acceptability. Surveys were administered to students at a campus health fair and while transiting the campus student union via iPad. Response to all questions was optional. We fit a logistic regression model to determine association of key demographic determinants with PrEP acceptability and awareness. Statistical analyses were conducted using SAS 9.4 (SAS, Cary, NC).ResultsOverall, 210 students participated in the survey, of which 60 completed all survey items as presented. The survey cohort was 75% female, 89% heterosexual and 39% freshmen. The mean age of respondents was 19.8 years (SD: 1.8). Fifty-two percent of survey respondents reported that they were aware of PrEP prior to the time of survey administration. Only 3% of respondents reported that they were on PrEP. The most common sources of information on PrEP were campus health services (24%) and non-social media advertising (15%). Of respondents who were aware of PrEP, 61% reported that they had heard about in the 6 months prior to survey administration, while only 19% say they were aware of it for more than a year. Regarding acceptability of PrEP, 58% of respondents reported that they would take a once a day pill for HIV if they were at risk. Our logistic regression analysis found no statistically significant associations between key demographic factors and PrEP awareness. However, persons who perceived themselves to be at risk for HIV acquisition were more likely to find once daily oral PrEP (relative risk 2.66 (95% CI 1.31–5.42)) as an acceptable prevention strategy than the rest of the survey cohort.ConclusionsAfrican American HBCU students are becoming aware of PrEP, and generally perceive the intervention as acceptable and worth consideration.

Awareness and Knowledge of Pre-exposure Prophylaxis Among Sexual and Gender Minority Adolescents Assigned Male at Birth in the United States.

Sexual and gender minority (SGM) adolescents assigned male at birth are at increased risk for HIV infection. Pre-exposure prophylaxis (PrEP) is a daily pill taken to prevent HIV, which the United States Food and Drug Administration approved for minors under age 18years weighing at least 77.5lb in 2018. A lack of awareness and knowledge of PrEP are barriers to uptake among adults and adolescents, but SGM adolescents' awareness and knowledge about PrEP remain underexplored and no studies have assessed SGM adolescents' informational needs. We collected data on 59 SGM adolescents' (ages 14-18years) awareness, knowledge, and questions about PrEP in an online survey and six online focus groups. Although a majority of SGM adolescents (83.1%) were aware of PrEP before the study, many wanted more information about side effects and how to navigate potential barriers to PrEP initiation. Findings can inform public health efforts to promote PrEP knowledge and uptake among SGM adolescents.

Antiretroviral Therapy-Related Problems among Human Immunodeficiency Virus-Infected Patients

Background: There are problems associated with antiretroviral therapy despite its achievement. Poor medication adherence and inability to tolerate large pill burden are major problems facing patients with chronic illnesses. These drug therapy problems are under-studied among people living with human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS) in Nigeria. We evaluated adherence and pill burden among this set of patients in a tertiary hospital in Lagos. Methods: Data for eligible HIV-infected adults were documented from case notes and through interviews using a well-structured questionnaire. Important details extracted were sociodemographics, pills information, and CD4 counts. The main outcome measures were drug adherence, as assessed by the four-item Morisky Medication Adherence Scale and pill burden, as measured by daily pill &gt;5. Results: Of the 296 patients, 219 (74%) were females. Median age (interquartile range) was 40 (35.0–47.7) years. Majority (262; 88.5%) were married, had at least a secondary education (142:48.0%), and CD4 count &gt;500 cells/ml (215; 72.6%). Pill burden &gt;5 pills/day was observed in 12.2% of the patients, while adherence was documented for 83.4% of the patients. Majority (259; 87.5%) were receiving fixed-dose combination of antiretroviral drugs. Forgetfulness (16.5%) and being too busy to take pills (10.5%) were the most common reasons for nonadherence. Pill burden in those who were not receiving fixed-dose combination was significantly associated with medication nonadherence. However, only pill burden was found to be an independent prognosticator of non-adherance. (Odd ratio = 0.67, confidence interval = 0.03–1.66, P &lt; 0.00). Conclusion: Medication nonadherence and pill burden were observed in more than one-tenth of patients. These were the two major antiretroviral therapy-related problems reported in this study.

Smart about medications (SAM): a digital solution to enhance medication management following hospital discharge.

ObjectiveTo outline the development of a software solution to improve medication management after hospital discharge, including its design, data sources, intrinsic features, and to evaluate the usability and the perception of use by end-users.Materials and MethodsPatients were directly involved in the development using a User Center Design (UCD) approach. We conducted usability interviews prior to hospital discharge, before a user started using the application. A technology acceptance questionnaire was administered to evaluate user self-perception after 2 weeks of use.ResultsThe following features were developed; pill identification, patient-friendly drug information leaflet, side effect checker, and interaction checker, adherence monitoring and alerts, weekly medication schedule, daily pill reminders, messaging service, and patient medication reviews. The usability interviews show a 98.3% total success rate for all features, severity (on a scale of 1–4) 1.4 (SD 0.79). Regarding the self-perception of use (1–7 agreement scale) the 3 highest-rated domains were: (1) perceived ease of use 5.65 (SD 2.02), (2) output quality 5.44 (SD 1.65), and (3) perceived usefulness 5.29 (SD 2.11).DiscussionMany medication management apps solutions have been created and most of them have not been properly evaluated. SAM (Smart About Medications) includes the user perspective, integration between a province drug database and the pharmacist workflow in real time. Its features are not limited to maintaining a medication list through manual entry.ConclusionWe can conclude after evaluation that the application is usable and has been self-perceived as easy to use by end-users. Future studies are required to assess the health benefits associated with its use.

Evaluating the combination of emtricitabine/ tenofovir alafenamide fumarate to reduce the risk of sexually acquired HIV-1-infection in at-risk adults

ABSTRACT Introduction Pre-exposure prophylaxis with a single daily pill of emtricitabine (F) plus tenofovir disoproxil fumarate (TDF) is highly efficacious at preventing HIV acquisition. Tenofovir alafenamide (TAF) is another tenofovir prodrug that delivers higher intracellular levels of active tenofovir diphosphate in blood cells and has an improved safety profile compared to TDF. Given the recent regulatory approval of the F/TAF combination for prophylaxis, it is important to review its safety and efficacy. Areas covered In this review, the author examines the safety and efficacy of F/TAF for pre-exposure prophylaxis. Both published manuscripts and conference papers are reviewed. F/TAF is non-inferior to F/TDF at preventing HIV acquisition in men and transgender women with a trend toward superiority. F/TAF has yet to be tested against HIV exposure via injection or vaginal intercourse. Expert opinion Within these limitations, F/TAF may be particularly advantageous for older individuals thanks to improved kidney safety compared to F/TDF. F/TAF did not possess the hypolipidemic properties of F/TDF and was associated with weight gains.

Cost-effectiveness of statins for primary prevention of atherosclerotic cardiovascular disease among people living with HIV in the United States.

BackgroundExpanding statin use may help to alleviate the excess burden of atherosclerotic cardiovascular disease in people living with HIV (PLHIV). Pravastatin and pitavastatin are preferred agents due to their lack of substantial interaction with antiretroviral therapy. We aimed to evaluate the cost‐effectiveness of pravastatin and pitavastatin for the primary prevention of atherosclerotic cardiovascular disease among PLHIV in the United States.MethodsWe developed a microsimulation model that randomly selected (with replacement) individuals from the Data‐collection on Adverse Effects of Anti‐HIV Drugs study with follow‐up between 2013 and 2016. Our study population was PLHIV aged 40 to 75 years, stable on antiretroviral therapy, and not currently using lipid‐lowering therapy. Direct medical costs and quality‐adjusted life‐years (QALYs) were assigned in annual cycles and discounted at 3% per year. We assumed a willingness‐to‐pay threshold of $100,000/QALY gained. The interventions assessed were as follows: (1) treating no one with statins; (2) treating everyone with generic pravastatin 40 mg/day (drug cost $236/year) and (3) treating everyone with branded pitavastatin 4 mg/day (drug cost $2,828/year). The model simulated each individual’s probability of experiencing atherosclerotic cardiovascular disease over 20 years.ResultsPersons receiving pravastatin accrued 0.024 additional QALYs compared with those not receiving a statin, at an incremental cost of $1338, giving an incremental cost‐effectiveness ratio of $56,000/QALY gained. Individuals receiving pitavastatin accumulated 0.013 additional QALYs compared with those using pravastatin, at an additional cost of $18,251, giving an incremental cost‐effectiveness ratio of $1,444,000/QALY gained. These findings were most sensitive to the pill burden associated with daily statin administration, statin costs, statin efficacy and baseline atherosclerotic cardiovascular disease risk. In probabilistic sensitivity analysis, no statin was optimal in 5.2% of simulations, pravastatin was optimal in 94.8% of simulations and pitavastatin was never optimal.ConclusionsPravastatin was projected to be cost‐effective compared with no statin. With substantial price reduction, pitavastatin may be cost‐effective compared with pravastatin. These findings bode well for the expanded use of statins among PLHIV in the United States. To gain greater confidence in our conclusions it is important to generate strong, HIV‐specific estimates on the efficacy of statins and the quality‐of‐life burden associated with taking an additional daily pill.

Real-world safety and effectiveness of sucroferric oxyhydroxide for treatment of hyperphosphataemia in dialysis patients: a prospective observational study.

BackgroundThe iron-based phosphate binder (PB), sucroferric oxyhydroxide (SFOH), is indicated to control serum phosphorus levels in patients with chronic kidney disease on dialysis.MethodsThis non-interventional, prospective, multicentre, cohort study conducted in seven European countries evaluated the safety and effectiveness of SFOH in dialysis patients with hyperphosphataemia in routine practice. Safety outcomes included adverse drug reactions (ADRs) and changes in iron-related parameters. SFOH effectiveness was evaluated by changes-from-baseline (BL) in serum phosphorus and percentage of patients achieving in-target phosphorus levels.ResultsThe safety analysis set included 1365 patients (mean observation: 420.3 ± 239.3 days). Overall, 682 (50.0%) patients discontinued the study. Mean SFOH dose during the observation period was 1172.7 ± 539.9 mg (2.3 pills/day). Overall, 617 (45.2%) patients received concomitant PB(s) during SFOH treatment. ADRs and serious ADRs were observed for 531 (38.9%) and 26 (1.9%) patients. Most frequent ADRs were diarrhoea (194 patients, 14.2%) and discoloured faeces (128 patients, 9.4%). Diarrhoea generally occurred early during SFOH treatment and was mostly mild and transient. Small increases from BL in serum ferritin were observed (ranging from +12 to +75 µg/L). SFOH treatment was associated with serum phosphorus reductions (6.3 ± 1.6 mg/dL at BL versus 5.3 ± 1.8 mg/dL at Month 30; ΔBL: −1.0 mg/dL, P < 0.01). Percentage of patients achieving serum phosphorus ≤4.5 mg/dL increased from 12.0% at BL to 34.8% at Month 30, while the percentage achieving serum phosphorus ≤5.5 mg/dL increased from 29.9% to 63.0%.ConclusionsSFOH has a favourable safety and tolerability profile in a real-world setting, consistent with results of the Phase 3 study. Moreover, SFOH improved serum phosphorus control with a low daily pill burden.

Prescription characteristics of phosphate binders in a high pill burden for hemodialysis patients

BackgroundDialysis patients have to take many oral drugs, causing a high pill burden. Phosphate binders (PBs) account for a large proportion of daily pill burden; however, the relationship between patient background and prescription status of PBs is not clear.MethodsWe clarified the characteristics of PBs in the total daily pill burden by analyzing the drugs prescribed for 533 chronic hemodialysis patients in our facility.ResultsAn average of nine different types of oral drugs was prescribed for each patient. The mean and median values of total pill burden were 15.1 and 14.1 pills/day/patient, respectively. The total pill burden showed a significant negative correlation with age and a significant positive correlation with dialysis vintage. In addition, the total pill burden was significantly higher in males than in females. However, there was no difference in the pill burden between patients with and without diabetes mellitus (DM). PBs were prescribed to 409 patients (76.7%), and the mean pill burden derived from PBs was 6.44 pills/day/patient. This was by far the highest of all 35 different drug categories and accounted for 32.84% of all pills. Multiple regression analysis demonstrated that independent predictors of total pill burden were age, dialysis vintage, DM, and serum phosphorus (P) levels, and all these variables, except DM, were also independent predictors of pill burden from PBs. These variables were also selected when considering the use of calcimimetics.ConclusionsA high pill burden is more likely to occur in younger patients with longer dialysis vintage, DM, higher serum P levels, and prescription of calcimimetics. In addition, PB was the single largest contributor to the total pill burden that positively and linearly linked to serum P levels. Therefore, P management is a high-priority issue in the mitigation of high pill burdens in dialysis patients.

Injectable Antiretroviral Drugs: Back to the Future.

Current HIV treatment regimens provide sustained virologic suppression, at least partially restore the immune system and have limited side effects; however, they do not allow viral eradication and they are burdened by daily pill intake with a life-long commitment for the people living with HIV (PHIV). Injectable agents might represent a turning point in the care of PHIV, allowing less frequent administration of antiretroviral treatment (ART), more widespread use of pre-exposure prophylaxis (PrEP) and more stable drug levels in the blood, thus increasing the odds to get closer to end the HIV pandemic. The aim of this manuscript is to give a comprehensive review of injectable antiretrovirals that have been used in the past, which are available now, will be available in the future, and their role in the treatment of HIV infection

Intention to initiate and uptake of PrEP among women who injects drugs in a demonstration project: an application of the theory of planned behavior

ABSTRACT Some women who inject drugs (WWID) would benefit from pre-exposure prophylaxis (PrEP), yet there are few studies of issues related to uptake in real-world settings. In this study, participants (n = 95) were offered PrEP and responded to items measuring PrEP-related attitudes, norms, and perceived behavioral control based on the Theory of Planned Behavior. We tested associations with intention to initiate PrEP and uptake. Most WWID (88%) intended to initiate PrEP and 78% accepted a prescription. Compared to WWID who did not express PrEP intentions, those who did were less concerned about attitudinal and perceived behavioral control constructs such as temporary (75% vs. 36%, p = 0.01) and long-term (63% vs. 27%, p = 0.05) side effects, negative interactions with their birth control (93% vs. 38%, p < 0.01), their ability to take a daily pill (80% vs. 36%, p < 0.01), and the cost of PrEP (87% vs. 36%, p < 0.01). WWID who went on to take PrEP had fewer concerns with subjective norms constructs such as talking to health care providers about sex (91% vs. 65%, p < 0.01) and drug use (88% vs. 55%, p < 0.01) compared to those who did not. Attitudes and perceived behavioral control influenced intention while subjective norms had a greater impact on actual uptake.