Impact of atrial fibrillation and oral anticoagulation on hospital costs and length of stay.

Am J Health Syst Pharm. 2012 Feb 15;69(4):329-38

Authors: Song X, Sander SD, Johnson BH, Varker H, Amin AN

Abstract
Purpose The results of a study assessing hospital length of stay (LOS) and inpatient costs associated with nonvalvular atrial fibrillation (AF) and AF-related warfarin use during hospitalization are presented. Methods Managed care administrative claims data were used to construct cohorts of patients hospitalized with AF as a primary (n = 1,868) or secondary (n = 11,200) discharge diagnosis and control groups of patients with similar demographics and clinical characteristics who were hospitalized during the same period (2002-07). Multivariate regression analyses were performed to estimate the incremental impact of AF on hospital LOS and costs per admission, as well as the incremental impact of inhospital warfarin use on the evaluated LOS and cost outcomes. Results The cohort of patients with AF as a secondary discharge diagnosis had a mean LOS 1.84 days greater (p < 0.001) and a mean hospital costs $3,146 higher (p < 0.001) than the control cohort; inhospital warfarin use in those patients was associated with a mean increase in LOS of 1.45 days (p < 0.001) and a mean increase inhospital costs of $1,761 per admission (p < 0.001). In the cohort of patients with AF as a primary discharge diagnosis, inpatient warfarin therapy was also associated with longer hospital stays (mean increase, 1.26 days; p < 0.001) and higher hospital costs (mean increase, $678; p = 0.031). Conclusion Hospitalizations of patients with a secondary diagnosis of AF are significantly longer and more costly than those of patients without a secondary diagnosis of AF, especially when warfarin is used during the hospital stay. Among patients with a primary diagnosis of AF, warfarin therapy during hospitalization is associated with significant increases in mean LOS and hospital costs.

PMID: 22302258 [PubMed - in process]

Comparison of rates of reported adverse events associated with i.v. iron products in the United States.

Am J Health Syst Pharm. 2012 Feb 15;69(4):310-20

Authors: Bailie GR

Abstract
Purpose An analysis of reported adverse events (AEs) among patients using i.v. iron products, including the newer agent ferumoxytol, is presented. Methods All AE reports to the Food and Drug Administration (FDA) citing iron sucrose, ferric gluconate, high- and low-molecular-weight iron dextran products, or ferumoxytol from October 2009 through June 2010 were evaluated. The rates of various classifications of reported AEs were calculated on a per-unit-sold basis and, for comparison of products supplied in different unit sizes, also in terms of 100-mg dose equivalents (DEq) of iron. Results A total of 197 reported AEs were identified (a cumulative rate of 14.1 AEs per million units sold). The rates of all AE classifications combined ranged from 5.25 to 746 per million units sold for iron sucrose and ferumoxytol, respectively; using the other method of calculation, the rates ranged from 5.24 per million DEq (iron sucrose) to 147 per million DEq (ferumoxytol). Relative to iron sucrose and sodium ferric gluconate, ferumoxytol was associated with significantly elevated risks of death (odds ratio [OR], 475 and 156, respectively; p < 0.0001), serious nonfatal AEs (OR, 263 and 121, respectively; p < 0.0001), and all evaluated AE classifications combined (OR, 142 and 109, respectively; p < 0.05). Conclusion Analysis of reports submitted to FDA revealed large differences among i.v. iron products in reported deaths, serious AEs, other major AEs, and other AEs. Iron sucrose and sodium ferric gluconate were associated with much lower rates of AEs per million units sold than iron dextran or ferumoxytol, which were associated with the highest rates of all reported AE classifications.

PMID: 22302256 [PubMed - in process]

Development and implementation of a comprehensive heparin-induced thrombocytopenia recognition and management protocol.

Am J Health Syst Pharm. 2012 Feb 1;69(3):241-8

Authors: Smythe MA, Mehta TP, Koerber JM, Forsyth LL, Sykes E, Corbets LR, Melendy SM, Parikh R

Abstract
Purpose A quality initiative to improve the management of heparin-induced thrombocytopenia (HIT) at an academic medical center, including the development of guidelines on the use of direct thrombin inhibitors (DTIs), is described. Summary In keeping with the Joint Commission's National Patient Safety Goal (NPSG) for anticoagulant therapy (goal 03.05.01), a multidisciplinary working group conducted a needs assessment to identify areas for improvement in the center's HIT management practices, particularly the use of DTI therapy (an issue not specifically addressed by NPSG 03.05.01). The resulting action steps included (1) the implementation of a detailed protocol for the recognition and management of HIT, as well as guidelines on the use of the DTIs argatroban and lepirudin, (2) more efficient use and optimized documentation of initial and confirmatory tests in the electronic medical record (EMR), and (3) the education of pharmacists, nurses, and physicians on the use of the HIT protocol, with initial and ongoing case-based competency testing of pharmacy staff. Early postimplementation experience indicated that the protocol and associated activities have resulted in improved DTI prescribing and dosing, HIT documentation, and patient education practices while expanding pharmacists' involvement in ensuring optimal, cost-effective management of patients with HIT. Conclusion In one institution, an HIT working group extended the scope of NPSG 03.05.01 to include the parenteral DTIs. The implementation of the HIT protocol has resulted in greater compliance with appropriate DTI dosing and improved EMR documentation of HIT.

PMID: 22261947 [PubMed - in process]

Aztreonam lysine for inhalation: New formulation of an old antibiotic.

Am J Health Syst Pharm. 2012 Jan 15;69(2):107-15

Authors: Zeitler K, Salvas B, Stevens V, Brown J

Abstract
Purpose The pharmacology, safety, efficacy, pharmacokinetics, pharmacodynamics, current place in therapy, and potential future therapeutic uses of inhaled aztreonam are reviewed. Summary Inhaled aztreonam, a newly formulated lysine salt of the original monobactam antibiotic, is approved for the treatment of respiratory symptoms in patients with cystic fibrosis (CF) who are colonized with Pseudomonas aeruginosa. Its spectrum of activity is limited to susceptible gram-negative organisms, including P. aeruginosa. Lyophilized aztreonam lysine is diluted with 0.17% sodium chloride and administered using the Altera nebulizer system, which produces appropriate-sized particles for proper deposition in the lungs to achieve high sputum and low systemic concentrations. Mean sputum drug concentrations are highest 10 minutes after dose administration, and plasma concentrations peak one hour after inhalation. Aztreonam is excreted via active tubular secretion and glomerular filtration. Caution is advised in patients with renal or hepatic impairment, breastfeeding women, and patients age 65 years or older. Like the older i.v. formulation, inhaled aztreonam displays time-dependent killing. Phase III clinical trials have shown improvements in respiratory symptoms, decreased P. aeruginosa sputum density, prolonged time intervals between antibiotic treatments, and efficacy without the development of resistance in the face of repeated exposures. This formulation is available only from select specialty pharmacies and should only be used with the Altera nebulizer system. Conclusion Inhaled aztreonam has shown efficacy and safety in patients seven years of age or older with CF who have P. aeruginosa airway infections. This product may complement existing therapies and offers the advantage of a new inhaled formulation to aid in treatment regimens.

PMID: 22215356 [PubMed - in process]

Inpatient warfarin: Experience with a pharmacist-led anticoagulation management service in a tertiary care medical center.

Am J Health Syst Pharm. 2012 Jan 1;69(1):44-8

Authors: Fowler S, Gulseth MP, Renier C, Tomsche J

Abstract
Purpose The implementation of a pharmacist-led anticoagulation management service (AMS) and the clinical outcomes of inpatients receiving warfarin management are described. Summary An AMS was established at St. Mary's Medical Center (SMMC) in Duluth, Minnesota, in November 2003 at the request of orthopedic surgeons to manage warfarin for their patients postoperatively. The AMS was also available to other inpatients by physician request. All AMS pharmacists received didactic and experiential training. Each day, the managing pharmacist, usually the decentralized pharmacist, was responsible for checking the patients' International Normalized Ratio (INR); reviewing other pertinent laboratory test values, any medication changes, and vital signs; monitoring changes in the patients' clinical status, and writing an order for a warfarin dose. A database was created to help monitor patients managed by the AMS and to analyze monthly outcomes data. Clinical outcomes data were evaluated to identify areas of improvement for the AMS. All hospitalizations for patients who received anticoagulation therapy with warfarin managed by the AMS from January 1, 2006, through August 31, 2007, were analyzed. Primary endpoints, including thrombosis and bleeding complications during hospitalization, were identified for inclusion in the final hospital discharge data. Of the 2794 hospitalizations for patients managed by the AMS evaluated, 59 complications were identified. Of these, 14 (0.5%) were thrombosis events and 45 (1.6%) were bleeding events. INR results were also analyzed as secondary endpoints. Conclusion The evaluation of outcomes of the inpatient-based AMS at SMMC provided critical information to the anticoagulation subcommittee for consideration of quality-improvement efforts.

PMID: 22180551 [PubMed - in process]

New treatment options for acute edema attacks caused by hereditary angioedema.

Am J Health Syst Pharm. 2011 Nov 15;68(22):2129-38

Authors: Thomas MC, Shah S

Abstract
Purpose New treatment options for acute edema attacks caused by hereditary angioedema (HAE) are reviewed. Summary HAE is characterized by mutations in the C1 inhibitor gene leading to either a reduced expression of C1 inhibitor in the plasma or expression of a functionally impaired C1 inhibitor. HAE is classified into two major types based on the cause of the C1 inhibitor deficiency. Type I HAE is defined by a reduced expression of C1 inhibitor in the plasma, whereas type II HAE is characterized by the expression of a dysfunctional C1 inhibitor protein. Clinical data were reviewed for C1 inhibitor, ecallantide, and icatibant in the treatment of acute edema attacks caused by HAE. C1 inhibitor leads to a faster onset of edema relief and is effective in decreasing the duration of edema. Dosing strategies include fixed dosing and weight-based dosing. Optimal dosing strategies have not been established, but fixed dosing (500-1000 units) or 20 units/kg has been effective in clinical trials and reports. No comparative trials suggest that one strategy is superior to another; however, the approved labeling for acute treatment is based on weight. Ecallantide is also efficacious for treating acute episodes; however, the available evidence is limited to a single published trial. Icatibant has shown variable effects in two trials with placebo and active controls. Conclusion In patients with HAE, most edema episodes only involve the skin and gastrointestinal tract, though airway obstruction caused by laryngeal angioedema is the most common cause of death. I.V. C1 inhibitor should be considered first-line treatment for acute edema attacks because of its fast onset of action and effective-ness, though it is not clear whether fixed or weight-based dosing is preferred. Ecallantide can be considered as a second-line treatment option.

PMID: 22058099 [PubMed - in process]

Improving adherence to best-practice guidelines for venous thromboembolism risk assessment and prevention.

Am J Health Syst Pharm. 2011 Nov 15;68(22):2184-8

Authors: Schiro TA, Sakowski J, Romanelli RJ, Jukes T, Newman J, Hudnut A, Leonard T

Abstract
Purpose The effectiveness of a program to improve adherence to best-practice guidelines for venous thromboembolism (VTE) risk assessment and prevention in a community hospital setting was evaluated. Summary Variation in the use of best-practice guidelines for VTE risk assessment and prevention with regard to the frequency of VTE risk assessment and the risk score assigned, as well as the communication of the risk of VTE and the need for prophylaxis to treating physicians, was found. To improve adherence to established guidelines, the responsibilities of a nurse case manager were expanded to serve as a single point of contact who was accountable for identifying high-risk patients and advocating for appropriate pharmacologic prophylaxis in the absence of contraindications. To facilitate the role of the nurse case manager, an automated VTE-risk-assessment tool was developed to reliably identify high-risk patients in real time. This intervention was evaluated from January 1 to June 30, 2010. Before the intervention, contraindications to anticoagulation were reported for 19.1% of high-risk patients not receiving prophylaxis and pharmacologic prophylaxis was ordered for 47.9% of high-risk patients without contraindications. During the course of the intervention, contraindications to anticoagulation were reported for 36.2% of high-risk patients not receiving prophylaxis and pharmacologic prophylaxis was ordered for 64.9% of high-risk patients without contraindications. Conclusion The appointment of a nurse case manager trained in anticoagulation and the development of an automated VTE-risk-assessment tool to identify patients at high risk of VTE were associated with improved adherence to best-practice guidelines for VTE risk assessment and prevention.

PMID: 22058105 [PubMed - in process]

Improving adherence to best-practice guidelines for venous thromboembolism risk assessment and prevention.

Am J Health Syst Pharm. 2011 Nov 15;68(22):2184-8

Authors: Schiro TA, Sakowski J, Romanelli RJ, Jukes T, Newman J, Hudnut A, Leonard T

Abstract
Purpose The effectiveness of a program to improve adherence to best-practice guidelines for venous thromboembolism (VTE) risk assessment and prevention in a community hospital setting was evaluated. Summary Variation in the use of best-practice guidelines for VTE risk assessment and prevention with regard to the frequency of VTE risk assessment and the risk score assigned, as well as the communication of the risk of VTE and the need for prophylaxis to treating physicians, was found. To improve adherence to established guidelines, the responsibilities of a nurse case manager were expanded to serve as a single point of contact who was accountable for identifying high-risk patients and advocating for appropriate pharmacologic prophylaxis in the absence of contraindications. To facilitate the role of the nurse case manager, an automated VTE-risk-assessment tool was developed to reliably identify high-risk patients in real time. This intervention was evaluated from January 1 to June 30, 2010. Before the intervention, contraindications to anticoagulation were reported for 19.1% of high-risk patients not receiving prophylaxis and pharmacologic prophylaxis was ordered for 47.9% of high-risk patients without contraindications. During the course of the intervention, contraindications to anticoagulation were reported for 36.2% of high-risk patients not receiving prophylaxis and pharmacologic prophylaxis was ordered for 64.9% of high-risk patients without contraindications. Conclusion The appointment of a nurse case manager trained in anticoagulation and the development of an automated VTE-risk-assessment tool to identify patients at high risk of VTE were associated with improved adherence to best-practice guidelines for VTE risk assessment and prevention.

PMID: 22058105 [PubMed - in process]

Implementation of an inpatient anticoagulation teaching service: Expanding the role of pharmacy students and residents in patient education.

Am J Health Syst Pharm. 2011 Nov 1;68(21):2086-93

Authors: Wilhelm SM, Petrovitch EA

Abstract
Purpose The implementation of and early experience with an anticoagulation teaching service managed by pharmacy students and residents are described. Summary A structured anticoagulation teaching program was established to improve the provision of education services to inpatients scheduled for discharge home on anticoagulant therapy (consistent with the Joint Commission's National Patient Safety Goal 03.05.01). The program served patients at three affiliated institutions and was designed to supplement pharmacists' usual anticoagulation education activities. After completing supervised training in anticoagulation education and documentation procedures, pharmacy students and residents on rotation at the facilities staffed the service three days per week for five hours per day. In the first five months of operation, the teaching service significantly increased the rate of anticoagulation patient education (to 59.2%, compared with 39.1% during a specified five-month preimplementation period; p < 0.0001). Among patients educated through the teaching service, 60-day readmission rates for both anticoagulation-related and nonanticoagulation-related problems were lower than readmission rates among patients not receiving the structured education services. Conclusion Implementing an anticoagulation teaching service provided by pharmacy students and residents significantly increased the rate of patient education and lowered readmission rates.

PMID: 22011988 [PubMed - in process]

Drug-induced heart failure.

Am J Health Syst Pharm. 2011 Oct 1;68(19):1791-804

Authors: Maxwell CB, Jenkins AT

Abstract
Purpose The published evidence on the role of various drugs and medication classes in causing or exacerbating heart failure (HF) is reviewed, with discussion of precautions and management strategies for use in clinical practice. Summary A literature search was conducted to identify reports of new-onset HF and exacerbations of HF associated with medication use published from 1960 to January 2011. A large body of evidence from controlled clinical trials has led to an improved understanding of well-established causes of drug-induced HF symptoms (e.g., thiazolidinediones, certain older chemotherapy agents) while implicating a wide range of other commonly used drugs and drug classes (e.g., tyrosine kinase inhibitors, biological response modifiers) as having causal or contributory roles. Among the various medications cited in cases of drug-induced HF, some have been linked to significantly increased risks of stroke, myocardial infarction, and death, particularly in patients with existing cardiovascular (CV) disorders or CV risk factors. In recent years, postmarketing and surveillance data have linked a number of newer medications-including the antiarrhythmic dronedarone, the antifungal itraconazole, and the anti-cancer drugs trastuzumab, lapatinib, and bevacizumab-to serious cardiac effects not reported during clinical trials. Conclusion A variety of agents have been associated with drug-induced HF. Patients receiving agents that have been implicated in cases of new-onset HF or exacerbations of HF should be monitored for signs and symptoms of CV effects.

PMID: 21930637 [PubMed - in process]

Effect of fondaparinux prophylaxis on anti-factor Xa concentrations in patients with morbid obesity.

Am J Health Syst Pharm. 2011 Sep 15;68(18):1716-22

Authors: Martinez L, Burnett A, Borrego M, Streeter JC, Townsend K, Garcia D

Abstract
Purpose Anti-factor Xa values in morbidly obese patients receiving standard doses of fondaparinux sodium for the prevention of venous thromboembolism (VTE) were analyzed in a retrospective chart evaluation. Summary The administration of low-molecular-weight heparins to obese patients (body mass index [BMI] of ?30 kg/m(2)) at the dose recommended for VTE prophylaxis has been reported to result in increased thromboembolic events and decreased anti-factor Xa levels, and some evidence indicates that weight-based dosing adjustments may be appropriate. To study this phenomenon among morbidly obese patients (BMI of ?40 kg/m(2)), a review of the charts of 45 adult patients for whom steady-state anti-factor Xa laboratory values were obtained after at least four fondaparinux injections was conducted; in all instances, fondaparinux sodium was given at the standard dose (2.5 mg once daily). Of the total of 47 anti-factor Xa values analyzed, 22 (47%) were below the study institution's target peak range (0.3-0.5 mg/L), 20 values (43%) were within the range, and 5 (11%) were above the range. No documented thromboembolic events occurred during hospitalization in the cases evaluated. A stepwise linear regression analysis of selected demographic and clinical variables indicated that better renal function, male sex, increased BMI, and fewer fondaparinux doses were associated with a greater likelihood of diminished anti-factor Xa activity in the cases evaluated. Conclusion Anti-factor Xa concentrations in morbidly obese patients receiving fondaparinux sodium 2.5 mg subcutaneously daily for VTE prophylaxis were within or above the target range in 53% of the instances evaluated.

PMID: 21880887 [PubMed - in process]

Development and implementation of an interdisciplinary oncology program in a community hospital.

Am J Health Syst Pharm. 2011 Sep 15;68(18):1740-7

Authors: Chung C, Collins A, Cui N

Abstract
Purpose The development and implementation of an interdisciplinary oncology program in a community hospital are described. Summary Before the program was established, clinical pharmacists responsible for order entry and verification did not have a defined structure and resource to effectively communicate with medical oncologists and nurses on patient care issues and oncology drug information. The practice model did not meet practice needs, departmental safety, quality, or cost-saving goals. An interdisciplinary team was established to determine where current processes and procedures were needed to decrease errors and improve efficiency associated with chemotherapy services. Three stages of practice development were planned, and an interdisciplinary oncology program involving nursing and pharmacy team members and medical oncologists was established. Standardized order forms, various pharmacy collaborative agreements, protocols, improved oncology nursing and pharmacy processes, and established standards in order writing, dispensing, administration, and monitoring were developed. An oncology pharmacist specialist position was requested, and this pharmacist played an essential role in helping the hospital realize significant cost savings and improve the quality of care provided to patients receiving chemotherapy services. Data were collected for 96 chemotherapy orders before program implementation and for 75 orders after program implementation, and a 45% reduction in total error related to chemotherapy drugs was observed (p < 0.0625). The most common cause of errors was missing information, typically an omitted duration or frequency, dose, route, or premedication (63% of all errors documented). Conclusion The development and implementation of an interdisciplinary oncology program resulted in decreased medication-error rates, expanded pharmacy services, and cost savings.

PMID: 21880891 [PubMed - in process]

Dabigatran etexilate: A novel oral direct thrombin inhibitor.

Am J Health Syst Pharm. 2011 Aug 15;68(16):1506-19

Authors: Blommel ML, Blommel AL

Purpose The pharmacology, pharmacokinetics, clinical efficacy, tolerability, dosage and administration, and place in therapy of dabigatran etexilate are reviewed. Summary Dabigatran is a reversible direct thrombin inhibitor (DTI) that has rapid and predictable anticoagulant effects and does not require the anticoagulation monitoring seen with oral vitamin K antagonists. Dabigatran etexilate has demonstrated efficacy in several clinical studies in preventing venous thromboembolism (VTE) for patients undergoing total hip or knee replacement, in preventing strokes in patients with nonvalvular atrial fibrillation, and in treating acute VTE. Dabigatran etexilate is a prodrug that is orally absorbed and completely converted to the active form dabigatran by carboxylesterases. Neither the conversion of dabigatran etexilate nor the metabolism of active dabigatran involves the cytochrome P-450 isoenzyme system. Other than hemorrhage, dabigatran is generally well tolerated, with gastrointestinal effects being the most commonly reported adverse events. All dosages should be adjusted in patients with reduced renal function. Dabigatran is currently being investigated for several thromboembolic disorders. It was approved by the Food and Drug Administration in October 2010 for stroke and VTE prevention in adult patients with nonvalvular atrial fibrillation, and it was approved by the European Medicines Agency in March 2009 for the prevention of VTE in adult patients undergoing elective total hip or knee replacement. Conclusion Dabigatran etexilate, the first oral DTI marketed in the United States, is indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. Dabigatran may be a viable option for anticoagulation in some patients due to its oral administration, rapid onset of action, and predictable anticoagulant effects.

PMID: 21817082 [PubMed - in process]

Anticoagulation therapy for hospitalized patients: Patterns of use, compliance with national guidelines, and performance on quality measures.

Am J Health Syst Pharm. 2011 Jul 1;68(13):1239-44

Authors: Tiryaki F, Nutescu EA, Hennenfent JA, Karageanes AM, Koesterer LJ, Lambert BL, Schumock GT

Purpose The use of anticoagulant therapy for the prevention and treatment of venous thromboembolism (VTE) and acute coronary syndrome (ACS) among hospital inpatients was evaluated. Methods Medication-use data were retrospectively collected on 1716 patients who received anticoagulants for VTE or ACS at 42 community hospitals during the period April-June 2009; all hospitals in the sample were members of the same large health care organization. Descriptive analyses were performed to characterize anticoagulant use, patient safety, compliance with national prescribing guidelines, and performance on relevant Joint Commission quality measures. Results The most common indications for anticoagulant use were VTE prophylaxis (67.5% of cases), ACS (13.5% of cases), and VTE treatment (11.9% of cases). The agents most commonly used for VTE prophylaxis were subcutaneous enoxaparin (70% of cases) and subcutaneous unfractionated heparin (UFH). Overall, the anticoagulant regimen used was consistent with national prescribing guidelines in 67.5% of cases; however, rates of appropriate prescribing were lower in subgroups of patients with renal impairment, obesity, or both (63.6%, 42.5%, and 63.6%, respectively). Reported anticoagulant-related adverse events during the study period mainly involved minor or major bleeding, which occurred in 36% and 32% of cases, respectively. Compliance with Joint Commission core measures ranged from 49.1% for core measure VTE-3 (warfarin overlap therapy) to 72.3% for VTE-4 (monitoring of UFH dosages and platelet counts by protocol). Conclusion Among hospitals in a large national health care system, the most common use of anticoagulants in hospitalized patients was for VTE prevention, followed by ACS and VTE treatment. Enoxaparin and UFH were the most commonly used agents for each indication, and the selection and use of anticoagulants were in compliance with national guidelines in the majority of patients for whom those drugs were prescribed.

PMID: 21690430 [PubMed - in process]

Management of HIV infection in treatment-naive patients: A review of the most current recommendations.

Am J Health Syst Pharm. 2011 Jun 1;68(11):991-1001

Authors: Boyd SD

Purpose The most current guidelines issued by the Department of Health and Human Services (DHHS) on the management of human immunodeficiency virus (HIV) infection in treatment-naive patients are reviewed. Summary Treatment guidelines are updated frequently because of the emergence of data demonstrating the risks and benefits of antiretroviral therapy. The DHHS guidelines strongly recommend initiating therapy in patients with certain conditions regardless of CD4 cell count and in patients with CD4 cell counts of <350 cells/mm(3). Although supporting data are less definitive, treatment is also recommended for patients with CD4 cell counts of 350-500 cells/mm(3). Treatment for patients with CD4 cell counts of >500 cells/mm(3) is controversial. Although cumulative observational data and biological evidence support treatment at higher CD4 cell counts, randomized controlled trial data to support this are not available, and the risk of antiretroviral toxicities, resistance, non-adherence, and cost should be considered in individual patients. The preferred regimens have been consolidated to four options, including a dual-nucleoside reverse transcriptase inhibitor backbone (tenofovir plus emtricitabine) with a nonnucleoside reverse transcriptase inhibitor (efavirenz), a ritonavir-boosted protease inhibitor (atazanavir plus ritonavir or darunavir plus ritonavir), or an integrase strand-transfer inhibitor (raltegravir). Regimens are classified as alternative or acceptable when they have potential safety or efficacy concerns, have higher pill burdens, or require more-frequent administration compared with preferred regimens. Conclusion The DHHS 2011 guidelines advocate earlier antiretroviral therapy initiation than recommended in recent years, and preferred regimens have been refined to maximize efficacy, safety, and quality of life for treatment-naive HIV-infected patients.

PMID: 21593227 [PubMed - in process]