Lenacapavir: A Novel Long-Acting Capsid Inhibitor for HIV.

OBJECTIVE: To review the efficacy, safety, and role of lenacapavir (LEN) in the treatment of HIV-1 infection. DATA SOURCES: A literature search was performed using PubMed and Google Scholar (through March 2023) with the search term LEN and GS-6207. Other resources included abstracts presented at recent conferences, the manufacturer's Web site, and prescribing information. STUDY SELECTION AND DATA EXTRACTION: All relevant articles, trial updates, and conference abstracts in the English language were included. DATA SYNTHESIS: Lenacapavir represents a new class of antiretrovirals (ARVs) with a novel mechanism of action as a capsid inhibitor and a unique twice-a-year subcutaneous administration schedule. Lenacapavir when combined with other ARVs has proven to benefit heavily treatment-experienced (HTE) patients with HIV-1 infection in achieving viral suppression and immune restoration. RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE IN COMPARISON WITH EXISTING DRUGS: Lenacapavir is a new treatment option that patients who are HTE can consider adding as part of an ARV regimen. CONCLUSIONS: Lenacapavir is an effective and well-tolerated option for HTE patients which is a valuable addition to the arsenal of ARVs.

Personalizing prevention: Advances in pharmacotherapy for HIV prevention.

The HIV epidemic continues to pose a significant burden on the healthcare system. Although the incidence of annual new infections is decreasing, health disparities persist and most new infections remain concentrated into different racial, ethnic, and minority groups. Pre-exposure prophylaxis (PrEP), which involves those at high risk of acquiring HIV to take chronic medications to prevent acquisition of the virus, is key to preventing new HIV infections. The purpose of this article is to review medication therapies for PrEP and examine their role in personalizing PrEP in different patient populations. Additionally, new medications currently under development for PrEP are reviewed, as well as treatment as prevention (TasP) and post-exposure prophylaxis (PEP). There are currently four medications available for PrEP: the oral options of co-formulated emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or emtricitabine/tenofovir alafenamide (FTC/TAF); injectable long-acting cabotegravir (CAB-LA); and the vaginal ring dapivirine (DPV-VR). FTC/TAF is not currently indicated for persons at risk for HIV through vaginal sex due to lack of studies, but trials are currently ongoing. DPV-VR is available in Zimbabwe and South Africa and has been endorsed by the World Health Organization but is not currently available in the United States. Several agents are also in development for use in PrEP: the novel long-acting injectable lenacapavir, a first-in-class capsid inhibitor, which has no cross-resistance to any existing HIV drug class; the subdermal implant islatravir, a first-in-class translocation inhibitor; and VRC01, a broadly neutralizing antibody (bnAb) which has been evaluated in proof-of-concept studies that may lead to the development of more potent bnAbs. Overall, PrEP is highly effective at preventing HIV infection in high-risk populations. Identifying optimal PrEP regimens in different patient populations is complex and must consider patient-specific factors and medication cost and access considerations. Lastly, providers should consider individual patient preferences with regard to prevention to improve access, retention in care, and adherence.

Bictegravir/emtricitabine/tenofovir alafenamide in a virologically suppressed adult with HIV and end-stage renal disease on chronic peritoneal dialysis: A case report.

Despite increasing rates of renal replacement therapy, data supporting the safe and effective use of HIV treatment guidelines preferred regimens in people on hemodialysis or peritoneal dialysis is limited. Bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) is a guideline recommended initial regimen for most people with HIV with FDA-approval for use in virologically suppressed people receiving chronic hemodialysis; however, the safety and efficacy of BIC/FTC/TAF remains unknown when used in patients on chronic ambulatory peritoneal dialysis (CAPD). We report the first case of BIC/FTC/TAF use in CAPD.

Reprint of Implementation of a pharmacist-led ARVSP in an academic hospital to reduce ART errors.

OBJECTIVES: The primary objective was to compare the percentage of Antiretroviral Therapy (ART) uncorrected errors during hospital admission before and after the implementation of an Antiretroviral Stewardship Program (ARVSP). PRACTICE DESCRIPTION: This was a 2-year single-center, pre-post quality improvement study. Included in the study were admitted patients at least 18 years of age, diagnosed with human immunodeficiency virus (HIV), and taking at least 1 antiretroviral. The baseline percentage of uncorrected ARV errors was retrospectively determined during the first year. The second year consisted of implementing an ARVSP that prospectively audited ART orders. The ARVSP consisted of a pharmacy resident, a medical resident, an infectious disease, HIV trained pharmacist, an infectious disease physician, and ancillary health care providers. The impact of the ARVSP was assessed by comparing the percentage of uncorrected errors between the 2 time periods. RESULTS: The number of uncorrected errors were 64.1% versus 31.1% before and after ARVSP implementation, respectively (P < 0.05). Delay in therapy errors were statistically significantly reduced (30.1% vs. 22.2%; P < 0.05). The time to overall correction of any error before ARVSP was 3.1 days, and after ARVSP, it was 1.8 days (P = 0.11). CONCLUSION: Implementation of an ARVSP reduces the number of uncorrected antiretroviral-related errors. Because health care resources are finite and focused on the acute care of hospitalized patients, this multidisciplinary practice model may provide a practical approach for similar institutions to improve antiretroviral stewardship surveillance in the inpatient setting.

Implementation of a pharmacist-led ARVSP in an academic hospital to reduce ART errors.

OBJECTIVES: The primary objective was to compare the percentage of Antiretroviral Therapy (ART) uncorrected errors during hospital admission before and after the implementation of an Antiretroviral Stewardship Program (ARVSP). PRACTICE DESCRIPTION: This was a 2-year single-center, pre-post quality improvement study. Included in the study were admitted patients at least 18 years of age, diagnosed with human immunodeficiency virus (HIV), and taking at least 1 antiretroviral. The baseline percentage of uncorrected ARV errors was retrospectively determined during the first year. The second year consisted of implementing an ARVSP that prospectively audited ART orders. The ARVSP consisted of a pharmacy resident, a medical resident, an infectious disease, HIV trained pharmacist, an infectious disease physician, and ancillary health care providers. The impact of the ARVSP was assessed by comparing the percentage of uncorrected errors between the 2 time periods. RESULTS: The number of uncorrected errors were 64.1% versus 31.1% before and after ARVSP implementation, respectively (P < 0.05). Delay in therapy errors were statistically significantly reduced (30.1% vs. 22.2%; P < 0.05). The time to overall correction of any error before ARVSP was 3.1 days, and after ARVSP, it was 1.8 days (P = 0.11). CONCLUSION: Implementation of an ARVSP reduces the number of uncorrected antiretroviral-related errors. Because health care resources are finite and focused on the acute care of hospitalized patients, this multidisciplinary practice model may provide a practical approach for similar institutions to improve antiretroviral stewardship surveillance in the inpatient setting.

Iatrogenic Cushing syndrome following lumbar medial branch block in a patient with HIV on ritonavir and darunavir.

We present a case report of a 62-year old female with HIV and chronic facetogenic back pain who underwent bilateral L3-L4 and L4-L5 medial branch nerve blocks using triamcinolone acetonide 80 mg. 2 weeks later she presented to the emergency department with acute anxiety/depression and was discharged with psychiatric follow-up. 2 weeks after this she presented to the outpatient HIV clinic with persistent uncontrolled depression alongside classic cushingoid features (e.g., buffalo hump, moon facies). She was diagnosed with iatrogenic Cushing syndrome caused by a drug-drug interaction between triamcinolone and ritonavir, a protease inhibitor and a CYP3A4 enzyme inhibitor. While the literature describes the interaction of ritonavir with intra-articular/intranasal/epidural triamcinolone, this is the first documented occurrence following a nerve block procedure. Symptoms resolved within 6 months alongside discontinuation of protease inhibitor therapy.

Lay abstract We report a 62-year old woman with history of HIV and depression who developed Cushing syndrome, which is a state of steroid excess in the body, after a nerve block procedure for treatment of back pain. Her first symptoms were worsening anxiety and depression, causing her to go to the emergency department. Unfortunately, the relationship to the steroids was not identified at the time. Later, she developed increased fat deposition in her face and upper neck, which is characteristic of Cushing syndrome. The HIV medications responsible for this adverse event were determined to be ritonavir and darunavir, which are classified as protease inhibitors. Her symptoms improved within 6 months in association with discontinuation of ritonavir and darunavir. This is the first known case of Cushing syndrome following a nerve block procedure for back pain, although previous cases have documented this occurrence following other forms of steroid treatments.

Incidence and Severity of Drug Interactions Before and After Switching Antiretroviral Therapy to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Treatment-Experienced Patients.

BACKGROUND: Switching antiretroviral therapy (ART) in people with HIV (PWH) can influence their risk for drug-drug interactions (DDIs). The purpose of this study was to assess changes in the incidence and severity of DDIs among PWH who switched their ART to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). METHODS: This was a multicenter retrospective cohort study of PWH on ART and at least 1 concomitant medication (CM) who switched to BIC/FTC/TAF between 3/2018 and 6/2019. Using the University of Liverpool's HIV Drug Interaction Database, 2 DDI analyses were performed for each patient. The first assessed patients' preswitch ART regimens with their CM list. The second assessed the same CM list with BIC/FTC/TAF. Each ART-CM combination was given a score of 0 (no or potential weak interaction), 1 (potential interaction), or 2 (contraindicated interaction). A paired t test analyzed changes in total DDI scores following ART switches, and linear regression examined factors contributing to DDI score reductions. RESULTS: Among 411 patients, 236 (57%) had at least 1 DDI present at baseline. On average, baseline DDI scores (SD) were 1.4 (1.8) and decreased by 1 point (95% CI, -1.1 to -0.8) after patients switched to BIC/FTC/TAF (P < .0001). After adjusting for demographics, baseline ART, and CM categories, switching to BIC/FTC/TAF led to significant DDI score reductions in patients receiving CMs for cardiovascular disease, neurologic/psychiatric disorders, chronic pain, inflammation, gastrointestinal/urologic conditions, and conditions requiring hormonal therapy. CONCLUSIONS: Treatment-experienced PWH eligible to switch their ART may experience significant declines in number and severity of DDIs if switched to BIC/FTC/TAF.

Effect of mobile text messages on antiretroviral medication adherence and patient retention in early HIV care: an open-label, randomized, single center study in south Florida.

BACKGROUND: People with HIV (PHIV) with limited access to health services often experience suboptimal antiretroviral therapy (ART) adherence. We investigated whether a daily text messaging intervention improves ART adherence and retention in early HIV care in PHIV in a south Florida hospital-based clinic. METHODS: ART-naïve PHIV receiving care through the clinic's Ryan White HIV/AIDS Program were enrolled and randomly assigned to the intervention or control groups with a 1:1 ratio. The intervention group received a 1-way text message daily and the control group received standard care without receiving text message reminders for 6 months. HIV RNA and CD4 cell count were measured at baseline and post-intervention. Adherence to ART was defined as a visual analog scale of ≥ 90%. Retention in care was defined as continued engagement at study end. RESULTS: 94 ART-naïve patients were randomized and 83 (85.6%) completed the study, of which 44 were in the intervention group and 39 were in the control group. At the end of the 6-month study period, adherence to ART was 84.4% in the intervention group versus 73.5% in the control group (OR, 1.9; 95% CI 0.7-5.0; p = 0.194). Retention in care significantly improved in the intervention group compared to the control group with the odds of retention increasing by 20% (OR, 1.2; 95% CI 1.1-1.5; p = 0.006). Undetectable HIV RNA (< 50 copies/mL) was 86.7% in the intervention group versus 73.5% in the control group (OR, 2.3; 95% CI 0.8-6.9; p = 0.112). A significant increase in CD4 cell count and a decrease in HIV RNA were found at study end, with no differences between the two groups. CONCLUSIONS: In this pilot study, a one-way daily text messaging intervention did not improve ART adherence over a 6-month study period, but significantly enhanced patient retention in early HIV care. Implementation of interventions to improve adherence in this population is required.

Integrase Inhibitors: After 10 Years of Experience, Is the Best Yet to Come?

The era of the integrase strand transfer inhibitors (INSTIs) for the treatment of human immunodeficiency virus (HIV) infection began with raltegravir in 2007. Since that time, several other INSTIs have been introduced including elvitegravir, dolutegravir, and, most recently, bictegravir, that have shown great utility as part of antiretroviral regimens in both treatment-naive and treatment-experienced patients. At present, antiretroviral guidelines fully endorse the INSTI class as part of all first-line treatment regimens. After 10 years of experience with INSTIs, newer agents are on the horizon such as cabotegravir and MK-2048 for potential use as either HIV pre-exposure prophylaxis or maintenance therapy. This review provides a brief overview of the INSTI class including agents currently available and those still in development, reviews available data from both completed and ongoing clinical trials, and outlines simplification strategies using INSTIs.

Role of Residency Interview Preparatory Activities as a Determinant on Pharmacy Residency Match Rates.

PURPOSE: Different strategies have been implemented to assist students in securing residency positions. The purpose of this study was to explore the impact of student participation in residency preparation activities on match rates. METHODS: A retrospective observational study was conducted to explore the effect of participation in residency preparation activities and grade point average (GPA) on residency match rate. Match rates for students participating in the Residency Interview Preparation Seminar (RIPS) or mock interviews (ie, intervention group) were compared with students who participated in neither activity (ie, control group). RESULTS: A total of 118 individuals were included in the comparison. Forty-eight students participated in RIPS (n = 29) or mock interviews (n = 19), while 70 students were in the control group. The intervention group had a statistically larger proportion of students securing residency than the control group (81% vs 57%; P = .009). Match rates between students enrolled in RIPS versus those in the mock interview group were not significant. No statistically significant differences were observed based on GPA. CONCLUSION: Students receiving additional preparation prior to interviews when seeking postdoctoral training were significantly more likely to obtain a residency position. In academic settings with limited resources, mock interviews may be preferred over comprehensive preparatory courses.

Elvitegravir for the treatment of HIV.

INTRODUCTION: Current antiretrovirals (ARVs) have demonstrated the ability to prolong the life of an HIV infected individual via suppression of the virus and subsequent restoration of immune function. Despite significant advancement, there remains an opportunity for improvement. One ARV that attempts to fill global HIV therapeutic needs by balancing convenience, safety, and efficacy is elvitegravir (EVG). Areas covered: Using MEDLINE/PubMed, a literature search was conducted for published articles on the safety and efficacy of EVG in the treatment of HIV infection. Expert opinion: EVG offers clinicians a convenient choice for HIV-positive patients that is safe and effective for both treatment-naïve and experienced patients, as well as an option for regimen simplification in virologically suppressed patients. EVG is conveniently co-formulated in fixed dose combination tablets to be taken once daily with food. EVG does not require dose adjustment for patients with severe renal impairment or mild to moderate liver disease. Importantly, EVG requires co-administration with a pharmacokinetic enhancer (i.e., ritonavir or cobicistat) in order to achieve therapeutic levels and facilitate once daily dosing. As a consequence, clinicians must carefully review concomitant medications and navigate potential drug-drug interactions mediated through potent inhibition of cytochrome P450 3A enzymes by ritonavir and cobicistat.

Pharmacist engagement within a hepatitis C ambulatory care clinic in the era of a treatment revolution.

OBJECTIVES: To describe an innovative hepatitis C virus (HCV) care program and treatment outcomes resulting from pharmacist services. SETTING: Adult ambulatory care HCV clinic within the Miami Veteran Affairs Healthcare System. PRACTICE DESCRIPTION: Pharmacists with limited prescriptive authority are integrated into a medical hepatology care team. PRACTICE INNOVATION: Pharmacists screen patients with HCV infection for treatment eligibility, counsel patients upon treatment initiation, assess ongoing treatment success and toxicity through patient appointments, telephone calls, and the ordering of pertinent laboratory data, and provide oversight of all patients on HCV therapies. Treatment outcomes are reported to the institutional Antimicrobial Stewardship Program. EVALUATION: Data produced from a continuous quality assurance initiative were utilized. Descriptive statistics were used to present data. RESULTS: From January 2014 through September 2015 there were 1619 pharmacist encounters for 532 unique patients and 597 screenings (including 578 approvals) were completed by a pharmacist. During this time 555 patients were initiated on at least 1 HCV treatment course, with 565 total treatment courses initiated. As new agents became available for use, fluctuation in regimen selection was seen. The most commonly prescribed medications were sofosbuvir (46%), ledipasvir/sofosbuvir (37%), and simeprevir (33%). Of the 565 HCV treatment courses initiated, 360 were completed, 29 were stopped early during treatment, and 176 were ongoing. Of the 360 completed courses, 249 had sustained virologic response at week 12 results available, of which 225 (90%) achieved treatment success and 24 (10%) relapsed. Of the 29 courses stopped early, 11 were due to poor medication adherence and 8 were due to adverse drug reaction. CONCLUSION: Through a structured process employing a scope of practice, pharmacists can extend the capacity of medical hepatology providers and provide pharmacotherapy services to enhance care. Information provided here may serve beneficial to others looking to initiate or expand existing HCV pharmacist services.

Cobicistat: Review of a Pharmacokinetic Enhancer for HIV Infection.

PURPOSE: This article reviews the clinical pharmacology, pharmacodynamic and pharmacokinetic (PK) properties, clinical efficacy and tolerability, drug interactions, and dosing and administration of cobicistat. METHODS: Searches of MEDLINE and International Pharmaceutical Abstracts from 1964 to February 2015 were conducted using the search terms cobicistat and GS-9350. Relevant information was extracted from the identified clinical trials and review articles. Abstracts from the Conference on Retroviruses and Opportunistic Infections (2014-2015) and the Interscience Conference on Antimicrobial Agents and Chemotherapy (2013-2014) were also searched. FINDINGS: Cobicistat is a PK enhancer lacking antiviral activity that, via selective cytochrome P-450 (CYP) 3A inhibition, inhibits the metabolism of certain antiretroviral medications and is used for prolonging their effect. Cobicistat has been studied as a booster of elvitegravir, a second-generation integrase inhibitor, and of the protease inhibitors atazanavir and darunavir. Data on its clinical efficacy and tolerability have been presented in 2 Phase II trials and in 9 Phase III trials, which reported durable efficacy in terms of achievement of sustained suppression of HIV-1 RNA levels to <50 copies/mL for at least 48 weeks. Cobicistat was generally well-tolerated in these studies. Cobicistat may increase serum creatinine levels via the inhibition of proximal renal tubular cell transporters and thus reduce estimated glomerular filtration rate, although it does not appear to affect actual glomerular filtration rate. Given the potent CYP3A inhibition by cobicistat, its coadministration with drugs metabolized by CYP3A may result in increased plasma concentrations of such agents. Moreover, as cobicistat is metabolized predominantly by CYP3A, plasma concentrations may increase or decrease on coadministration with CYP3A inhibitors or inducers, respectively. IMPLICATIONS: With potent durability through 48 weeks, a tolerability profile comparable to other first- and second-line antiretroviral therapies, and a convenient dosing schedule with low daily pill burden in fixed-dose combination tablets, cobicistat is a potential addition to the management of HIV infection as a PK enhancer. However, the effects of cobicistat on serum creatinine and its considerable drug-interaction potential may warrant additional monitoring.

An Elective Course on Antimicrobial Stewardship.

OBJECTIVE: To implement an antimicrobial stewardship (AS) elective course for second-year and third-year pharmacy students and to assess its impact on students' perceptions regarding the application of AS principles. DESIGN: A 2-credit elective course focusing on principles of AS incorporated prelecture didactic recordings with primary literature and guideline-based reading assignments, in-class active-learning group work and student-led presentations, and student-generated examination items. ASSESSMENT: Perceptions were assessed by precourse and postcourse survey items. Graded course assessments included completion of preclass assignments (readings, prerecorded lecture and writing assessment items), in-class active participation and group presentations, a midpoint examination, and a final examination. CONCLUSION: An AS-themed elective course in a doctor of pharmacy curriculum incorporating preclass, self-directed learning and in-class group-based active-learning strategies positively impacted students' perceived understanding of AS strategies.

Exploratory survey of Florida pharmacists' experience, knowledge, and perception of HIV pre-exposure prophylaxis.

OBJECTIVE: To assess Florida pharmacists' experience, knowledge, and perception of human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP) and to identify areas for pharmacist training. DESIGN: Cross-sectional survey. SETTING: Florida in March through July 2013. PARTICIPANTS: Florida pharmacists. INTERVENTION: In-person and online anonymous survey. MAIN OUTCOME MEASURE: Florida pharmacists' experience, knowledge, and perceptions of PrEP. RESULTS: 225 completed surveys were analyzed. Survey respondents were predominantly community pharmacists with mean age of 45.7 years and less than 20 years of experience. Only 22% of respondents reported dispensing PrEP to patients. Although 75% had completed HIV-related continuing education in the last 2 years, 63% were unaware of Centers for Disease Control and Prevention PrEP guidelines and 71% answered that they did not have sufficient knowledge to counsel patients with PrEP prescriptions. Importantly, 47% of respondents answered they were uncomfortable counseling patients about PrEP. By self-report, most pharmacists agreed PrEP leads to risky behavior (68%) and increased rates of sexually transmitted infections (65%), and is too costly to promote patient access (92%). CONCLUSION: Surveyed Florida pharmacists reported limited understanding of PrEP. As a widely accessible health care counseling resource, pharmacists are positioned to improve patient understanding, promote medication adherence, and enhance PrEP efficacy. Especially during PrEP implementation, when patients may receive PrEP prescriptions from non-HIV specialist prescribers, improving pharmacists' PrEP education presents a salient opportunity.

Pharmacist testers in multidisciplinary health care team expand HIV point-of-care testing program.

Knowledge of HIV serostatus is the first step to accessing treatment, reducing transmission, and mitigating public health challenges. We describe the expansion of an HIV point-of-care testing (POCT) program within a health care system utilizing pharmacists as testers. The testing program's expansion is detailed and its impact assessed. The POCT program was evaluated by comparing the number of traditional HIV venipuncture tests to the number of POCTs performed across the health system as well as comparing the number of POCTs performed by clinical pharmacists to the number of tests at other POCT locations. Although pharmacists' contributions to HIV prevention are well documented, pharmacists' involvement in HIV testing initiatives is still nascent. Our POCT program demonstrates an effective HIV testing initiative driven by pharmacists and other health care providers.

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.

Heat-stable ritonavir tablets: a new formulation of a pharmacokinetic enhancer for HIV.

IMPORTANCE OF THE FIELD: HIV is a worldwide epidemic that can be managed by combination antiretroviral therapy. Effective regimens commonly include the use of a ritonavir-boosted protease inhibitor (PI). In February 2010, the FDA approved heat-stable ritonavir tablets for management of HIV; these do not require refrigeration and may improve patient access. AREAS COVERED IN THIS REVIEW: The goal of this article is to review the ritonavir 100 mg heat-stable tablet formulation for the treatment of HIV, focusing on recent pharmacokinetic studies, safety and tolerability data, administration, and storage. WHAT THE READER WILL GAIN: With recent FDA approval, it is important that clinicians and pharmacists are knowledgeable about the differences between heat-stable ritonavir tablets and the previous soft-gel-capsule (SGC) formulation. TAKE HOME MESSAGE: Heat-stable ritonavir tablets are not bioequivalent to previous SGC and differ in regards to storage requirements. Despite this, ritonavir tablets appear to be well tolerated and may provide additional options for selected patients with HIV.