Validation of a questionnaire to monitor symptoms in HIV-infected patients during hepatitis C treatment.

BACKGROUND: Clinicians are incorporating patient-reported outcomes in the management of HIV-infected persons co-infected with hepatitis C virus (HCV), but there are no validated inventories to monitor symptoms of patients during HCV therapy. DESIGN: Five-year retrospective cohort analysis of persons living with HIV (PLWH) treated for HCV. METHODS: The HCV symptom-inventory (HCV-SI) was administered before, during, and after HCV treatment. Discriminant validity was assessed, separately, in mixed model linear regression of HCV-SI T-scores on treatment regimens (pegylated-interferon and ribavirin; pegylated-interferon, ribavirin, and telaprevir; and interferon-free antivirals); and side effect-related premature treatment discontinuation (SE-DC). RESULTS: From the 103 patients who completed the HCV-SI, 7% were female, 26% non-white, 32% cirrhotics and 91% had undetectable HIV viral loads. Most had genotype 1 (83%) and were HCV treatment-naïve (78%). We treated 19% of patients with pegylated-interferon and ribavirin, 22% with pegylated-interferon, ribavirin, and telaprevir and 59% received interferon-free antivirals. Overall, 77% achieved a sustained virologic response, and 6% discontinued HCV treatment due to side effects. In the treatment discrimination model, compared to the no treatment period, HCV-SI scores were significantly (p < 0.01) lower for interferon-free antivirals and higher for interferon-containing regimens. In the SE-DC model, the total HCV-SI, somatic and neuropsychiatric scores significantly predicted those patients who prematurely discontinued HCV treatment (P < 0.05). CONCLUSIONS: The HCV-SI effectively differentiated among treatment regimens known to vary by side effect profiles and between patients with and without treatment discontinuation due to side effects. The HCV-SI may have value as a patient-reported outcome instrument predicting the risk of HCV treatment discontinuation.

Randomized trial of central nervous system-targeted antiretrovirals for HIV-associated neurocognitive disorder.

BACKGROUND: Antiretroviral (ARV) medications differentially penetrate across the blood-brain barrier into central nervous system (CNS) tissues, potentially influencing their effectiveness in treating brain infection. METHODS: This randomized controlled clinical trial (RCT) called for 120 participants at 5 study sites to be randomized 1:1 to CNS-targeted (CNS-T) or non-CNS-T ART. Entry clinical factors such as ARV experience were balanced across arms using an adaptive randomization approach. The primary outcome, change in neurocognitive performance, was measured as the difference in global deficit score (GDS) from baseline to week 16. RESULTS: The study was terminated early on the recommendation of its data safety monitoring board on the basis of slow accrual and a low likelihood of detecting a difference in the primary outcome. No safety concerns were identified. Of 326 participants screened, 59 met entry criteria and were randomized. The primary intent-to-treat analysis included 49 participants who completed week 16. These comprised 39 men and 10 women with a mean age of 44 years (SD, 10 years), and median nadir and current CD4(+) T-cell counts of 175 cells/µL and 242 cells/µL, respectively. The proportional improvement in GDS from baseline was nonsignificantly larger (7%; 95% confidence interval [CI], -31% to 62%) in the CNS-T arm than in the non-CNS-T arm, representing a treatment effect size of 0.09 (95% CI, -.48 to .65). Prespecified secondary analysis showed a trend interaction (P = .087), indicating that participants who had baseline plasma virologic suppression may have benefited from CNS-T. CONCLUSIONS: This study found no evidence of neurocognitive benefit for a CNS-T strategy in HIV-associated neurocognitive disorders. A benefit for a subgroup or small overall benefits could not be excluded. Clinical Trials Registration NCT00624195.

Increasing Hepatitis C treatment uptake among HIV-infected patients using an HIV primary care model.

BACKGROUND: Access to Hepatitis C (HCV) care is low among HIV-infected individuals, highlighting the need for new models to deliver care for this population. METHODS: Retrospective cohort analysis that compared the number of HIV patients who initiated HCV therapy: hepatology (2005-2008) vs. HIV primary care model (2008-2011). Logistic-regression modeling was used to ascertain factors associated with HCV therapy initiation and achievement of sustained viral response (SVR). RESULTS: Of 196 and 163 patients that were enrolled in the HIV primary care and hepatology models, 48 and 26 were treated for HCV, respectively (p = 0.043). The HIV/HCV-patient referral rate did not differ during the two study periods (0.10 vs. 0.12/patient-yr, p = 0.18). In unadjusted analysis, predictors (p < 0.05) of HCV treatment initiation included referral to the HIV primary care model (OR: 1.7), a CD4+ count ≥400/mm3 (OR: 1.8) and alanine aminotranferase level ≥63U/L (OR: 1.9). Prior psychiatric medication use correlated negatively with HCV treatment initiation (OR: 0.6, p = 0.045). In adjusted analysis the strongest predictor of HCV treatment initiation was CD4+ count (≥400/mm3, OR: 2.1, p = 0.01). There was no significant difference in either clinic model (primary care vs. hepatology) in the rates of treatment discontinuation due to adverse events (29% vs. 16%), loss to follow-up (8 vs. 8%), or HCV SVR (44 vs. 35%). CONCLUSIONS: Using a HIV primary care model increased the number of HIV patients who initiate HCV therapy with comparable outcomes to a hepatology model.

Duplication of the Hypoglossal Nerve Branch to the Thyrohyoid Muscle: A Case Report.

The motor fibers to the thyrohyoid muscle are provided by the anterior ramus of C1 via the hypoglossal nerve rather than via the ansa cervicalis. Knowledge of possible variations in the branching patterns of the nerves attached to the hypoglossal nerve is necessary to minimize iatrogenic injury to these structures during surgical procedures. We describe a rare anatomical variant of the nerve branch to the thyrohyoid muscle. To our knowledge, this particular variant has not been previously reported.

The first report of the buckled thyroid cartilage in a human cadaver.

We present the first case of buckled thyroid cartilage identified in a human cadaver. This rare anatomical variant, in patients, often produces dysphonia and is a potential source for diagnostic confusion. In the cadaveric case described, the laryngeal prominence is deviated to the left without deviation of the internal structures of the larynx, such as vocal folds and vocalis muscles. The medical history of the patient is not known. Finally, a review of current literature on the buckled thyroid cartilage is presented. Such a case represents a rare opportunity to visualize this deformity via anatomical dissection.

Enhanced Recovery After Surgery Protocols for Head and Neck Cancer: Systematic Review and Meta-analysis.

OBJECTIVE: Enhanced recovery after surgery (ERAS) protocols aim to optimize the pre-, intra-, and postoperative care of patients to improve surgery outcomes, reduce complications, decrease length of stay, and more. We aim to perform a systematic review and meta-analysis of ERAS protocols for head and neck cancer surgery with or without microvascular reconstruction. DATA SOURCES: PubMed, Embase, and Web of Science databases were queried, and abstracts were screened independently by 2 investigators. REVIEW METHODS: This review was conducted in accordance with the PRISMA guidelines. We included comparative observational studies but excluded animal studies, case reports, and case series. RESULTS: Of 557 articles initially reviewed by title and/or abstract, we identified 30 for full-text screening, and 9 met the criteria for qualitative synthesis. Meta-analysis of length of stay revealed a mean decrease of 1.37 days (95% CI, 0.77-1.96; I2 = 0%; P < .00001) with the ERAS group as compared with non-ERAS controls. The standardized mean difference of the morphine milligram equivalent was 0.72 lower (95% CI, 0.26-1.18; I2 = 82%; P = .002) in the ERAS group vs controls. The quality of studies was moderate with a median MINORS score of 18.5 (range, 13.5-21.5). CONCLUSION: Implementation of ERAS protocols can lead to decreases in length of stay and opioid drug utilization. However, further high-quality prospective studies of ERAS protocols are needed, especially with stratified analysis of outcomes based on the type of head and neck cancer surgery.

Postnatal growth restriction impairs rat lung structure and function.

The negative impact of nutritional deficits in the development of bronchopulmonary dysplasia is well recognized, yet mechanisms by which nutrition alters lung outcomes and nutritional strategies that optimize development and protect the lung remain elusive. Here, we use a rat model to assess the isolated effects of postnatal nutrition on lung structural development without concomitant lung injury. We hypothesize that postnatal growth restriction (PGR) impairs lung structure and function, critical mediators of lung development, and fatty acid profiles at postnatal day 21 in the rat. Rat pups were cross-fostered at birth to rat dams with litter sizes of 8 (control) or 16 (PGR). Lung structure and function, as well as serum and lung tissue fatty acids, and lung molecular mediators of development, were measured. Male and female PGR rat pups had thicker airspace walls, decreased lung compliance, and increased tissue damping. Male rats also had increased lung elastance, increased lung elastin protein abundance, and lysol oxidase expression, and increased elastic fiber deposition. Female rat lungs had increased conducting airway resistance and reduced levels of docosahexaenoic acid in lung tissue. We conclude that PGR impairs lung structure and function in both male and female rats, with sex-divergent changes in lung molecular mediators of development.

Bilateral Coronal Synostosis and Mega Cisterna Magna: A Case Report.

Craniosynostosis is often associated with raised intracranial pressure (ICP), especially when multiple sutures are involved. In this report, we discuss an unusual association in a patient with craniosynostosis. We report a case of a two-year-old Caucasian male with bilateral coronal synostosis (BCS) who was found to have a concomitant mega cisterna magna (MCM). Although counterintuitive, even in the presence of craniosynostosis, patients with this finding can also have intracranial CSF fluid collections such as the MCM reported here. We hope this report will enhance our understanding of some similar cases that are equivocal regarding raised ICP.

Reliability and predictive validity of a hepatitis-related symptom inventory in HIV-infected individuals referred for Hepatitis C treatment.

BACKGROUND: We aimed to determine the reliability and validity of a hepatitis symptom inventory and to identify predictors of hepatitis C (HCV) treatment initiation in a cohort of HIV-infected patients. METHODS: Prospective clinic based study that enrolled patients referred for HCV therapy consideration. A hepatitis symptom inventory and the Center for Epidemiologic Studies Depression Scale (CES-D) were administered to HIV/HCV individuals. The symptom inventory was factor analyzed and subscale reliability estimated with Cronbach's alpha. Predictive validity was evaluated using generalized estimating equations (GEE). Predictors of HCV treatment were identified using logistic regression. RESULTS: Between April 2008 to July 2010, 126 HIV/HCV co-infected patients were enrolled in the study. Factor analysis using data from 126 patients yielded a three-factor structure explaining 60% of the variance for the inventory. Factor 1 (neuropsychiatric symptoms) had 14 items, factor 2 (somatic symptoms) had eleven items, and factor 3 (sleep symptoms) had two items, explaining 28%, 22% and 11% of the variance, respectively. The three factor subscales demonstrated high intrinsic consistency reliability. GEE modeling of the 32 patients who initiated HCV therapy showed that patients developed worsening neuropsychiatric and somatic symptoms following HCV therapy with stable sleep symptoms. Bivariate analyses identified the following as predictors of HCV therapy initiation: lower HIV log10 RNA, lower scores for neuropsychiatric, somatic and sleep symptoms, lower CES-D scores and white ethnicity. In stepwise multiple logistic regression analysis, low neuropsychiatric symptom score was the strongest independent predictor of HCV therapy initiation and HIV log10 RNA was inversely associated with a decision to initiate HCV treatment. CONCLUSIONS: A 41-item hepatitis-related symptom inventory was found to have a clinically meaningful 3-factor structure with excellent internal consistency reliability and predictive validity. In adjusted analysis, low neuropsychiatric symptom scores and controlled HIV infection were independent predictors of HCV treatment initiation. The usefulness of the HCV symptom inventory in monitoring HCV treatment should be evaluated prospectively.

The Role of the Clinical Pharmacist in the Management of People Living with HIV in the Modern Antiretroviral Era.

As the HIV epidemic has evolved, so too has the role of the clinical pharmacist (CP) in the management of people living with HIV (PLWH). The modern antiretroviral therapy (ART) era has resulted in PLWH living normal life spans with resulting increased comorbidities. CPs have long been a part of the multidisciplinary management of ART. However, with the changing demographics of PLWH and health-care system dynamics, CPs have had the opportunity to expand their role. This includes involvement in managing increasing comorbidities with expanding and more complicated medication regimens, drug interaction monitoring, and optimizing transitions of care, all while recognizing and addressing barriers to successful HIV and hepatitis C virus (HCV) treatment. In addition, with the expansion of HIV prevention and pre-exposure prophylaxis (PrEP) services, CPs have the opportunity to be involved in HIV prevention. This study summarizes the literature evaluating the impact of CPs in the management of PLWH in the era of modern ART. We conducted a literature search to identify studies that assessed the CP role in HIV clinical practice since 2006. The identified studies were grouped into two categories. The first was HIV related outcomes, including interventions on regimen selection, adherence, regimen optimization, and management of treatment failure. The second group of studies pertained to aging and vulnerable populations, including management of comorbidities, transitions of care, medication-assisted treatment, hepatitis C, and HIV screening and PrEP. We concluded that the evidence supports the expanding role of CPs to positively impact a variety of aspects related to the care of PLWH.

Predictors of Hepatitis C Treatment Failure After Using Direct-Acting Antivirals in People Living With Human Immunodeficiency Virus.

BACKGROUND: Little is known about the influence of ongoing barriers to care in the persistence of hepatitis C virus (HCV) viremia after treatment with direct-acting antivirals (DAAs) among people living with human immunodeficiency virus (PLWH). METHODS: We conducted a retrospective cohort analysis of PLWH treated through the standard of care in 3 Western countries, to investigate the predictors of HCV treatment failure (clinical or virologic), defined as having a detectable serum HCV ribonucleic acid within 12 weeks after DAA discontinuation. In addition to HCV and liver-related predictors, we collected data on ongoing illicit drug use, alcohol abuse, mental illness, and unstable housing. Logistic regression analyses were used to identify predictors of HCV treatment failure. RESULTS: Between January 2014 and December 2017, 784 PLWH were treated with DAA, 7% (n = 55) of whom failed HCV therapy: 50.9% (n = 28) had a clinical failure (discontinued DAA therapy prematurely, died, or were lost to follow-up), 47.3% (n = 26) had an HCV virologic failure, and 1 (1.8%) was reinfected with HCV. Ongoing drug use (odds ratio [OR] = 2.60) and mental illness (OR = 2.85) were independent predictors of any HCV treatment failure. Having both present explained 20% of the risk of any HCV treatment failure due to their interaction (OR = 7.47; P < .0001). Predictors of HCV virologic failure were ongoing illicit drug use (OR = 2.75) and advanced liver fibrosis (OR = 2.29). CONCLUSIONS: People living with human immunodeficiency virus with ongoing illicit drug use, mental illness, and advanced liver fibrosis might benefit from enhanced DAA treatment strategies to reduce the risk of HCV treatment failure.

Predictive validity of a brief antiretroviral adherence index: retrospective cohort analysis under conditions of repetitive administration.

BACKGROUND: Newer antiretroviral (ARV) agents have improved pharmacokinetics, potency, and tolerability and have enabled the design of regimens with improved virologic outcomes. Successful antiretroviral therapy is dependent on patient adherence. In previous research, we validated a subset of items from the ACTG adherence battery as prognostic of virologic suppression at 6 months and correlated with adherence estimates from the Medication Event Monitoring System (MEMS). The objective of the current study was to validate the longitudinal use of the Owen Clinic adherence index in analyses of time to initial virologic suppression and maintenance of suppression. RESULTS: 278 patients (naïve n = 168, experienced n = 110) met inclusion criteria. Median [range] time on the first regimen during the study period was 286 (30 - 1221) days. 217 patients (78%) achieved an undetectable plasma viral load (pVL) at median 63 days. 8.3% (18/217) of patients experienced viral rebound (pVL > 400) after initial suppression. Adherence scores varied from 0 - 25 (mean 1.06, median 0). The lowest detectable adherence score cut point using this instrument was >/= 5 for both initial suppression and maintenance of suppression. In the final Cox model of time to first undetectable pVL, controlling for prior treatment experience and baseline viral load, the adjusted hazard ratio for time updated adherence score was 0.36(score >/= 5) (95% CI: 0.19-0.69) [reference: <5]. In the final generalized estimating equations (GEE) logistic regression model the adjusted odds ratio for time-updated adherence score was 0.17(score >/= 5) (0.05-0.66) [reference: <5]. CONCLUSION: A brief, longitudinally administered self report adherence instrument predicted both initial virologic suppression and maintenance of suppression in patients using contemporary ARV regimens. The survey can be used for identification of sub-optimal adherence with subsequent appropriate intervention.

Predictors of Missed Hepatitis C Intake Appointments and Failure to Establish Hepatitis C Care Among Patients Living With HIV.

BACKGROUND: We estimated and characterized the proportion of patients living with HIV (PLWH) who missed hepatitis C (HCV) intake appointments and subsequently failed to establish HCV care. METHODS: Logistic regression analyses were used to identify factors associated with missed HCV intake appointments and failure to establish HCV care among PLWH referred for HCV treatment between January 2014 and December 2017. In addition to demographics, variables included HIV treatment characteristics, type of insurance, liver health status, active alcohol or illicit drug use, unstable housing, and history of a mental health disorder (MHD). RESULTS: During the study period, 349 new HCV clinic appointments were scheduled for 202 unduplicated patients. Approximately half were nonwhite, and 80% had an undetectable HIV viral load. Drug use (31.7%), heavy alcohol use (32.8%), and MHD (37.8%) were prevalent. Over the 4-year period, 21.9% of PLWH referred for HCV treatment missed their HCV intake appointment. The proportion increased each year, from 17.2% in 2014 to 25.4% in 2017 (P = .021). Sixty-six of the 202 newly referred HCV patients (32.7%) missed their first HCV appointment, and 28 of these (42.4%) failed to establish HCV care. Having a history of MHD, CD4 <200, ongoing drug use, and being nonwhite were independent predictors of missing an intake HCV appointment. The strongest predictor of failure to establish HCV care was having a detectable HIV viral load. CONCLUSIONS: The proportion of PLWH with missed HCV appointments increased over time. HCV elimination among PLWH may require integrated treatment of MHD and substance use.

Outcomes of pharmacist-assisted management of antiretroviral therapy in patients with HIV infection: A risk-adjusted analysis.

PURPOSE: The impact of pharmacist-assisted management (PAM) of pharmacotherapy for patients with human immunodeficiency virus (HIV) infection was investigated. METHODS: A retrospective cohort analysis was conducted to evaluate antiretroviral therapy (ART) outcomes in treatment-naive patients initiated on ART at an HIV clinic. Eligible patients enrolled in the clinic during the period 1999-2013 were classified into two groups: those referred to a clinic-based HIV pharmacist for initiation of ART (the PAM group) and those managed by a primary care provider (the control group). The primary study objective was the median time to viral suppression; secondary objectives included the durability of response to the first ART regimen. Relative hazards for the events of interest were estimated using a marginal structural Cox proportional hazards model and Kaplan-Meier curves, with inverse probability weights used to control for selection and confounding bias. RESULTS: Patients referred for PAM services (n = 819) typically had higher baseline viral loads and lower CD4+ cell counts than those in the control group (n = 436). The likelihood of viral suppression during the first two years after ART initiation was significantly higher in the PAM group versus the control group (hazard ratio, 1.37; 95% confidence interval, 1.18-1.59; p < 0.0001). The median durability of the first ART regimen was 100 months in the PAM group versus 44 months in the control group (p > 0.05). CONCLUSION: In treatment-naive patients, suppression of HIV viral load occurred earlier when pharmacists assisted with initiating ART than when ART was initiated without that assistance.

The Impact of Direct-Acting Antivirals in the Hepatitis C-Sustained Viral Response in Human Immunodeficiency Virus-Infected Patients With Ongoing Barriers to Care.

Background. Access to hepatitis C virus (HCV) medications for human immunodeficiency virus (HIV)-infected patients with ongoing barriers to care is restricted by healthcare payers in the absence of HCV treatment outcomes data in the era of direct-acting antivirals (DAA). Methods. Retrospective analysis of HCV treatment outcomes using interferon (IFN)-free DAA regimens and an inclusive treatment protocol in an urban HIV clinic where ongoing barriers to care (drug or alcohol use, psychiatric disease, and/or unstable housing) are common. Then, using logistic regression analysis, we compared the proportion of HIV-infected patients who achieved HCV sustained viral response (SVR) in the pegylated-IFN plus ribavirin (PEG-IFN/RBV, 2008-2011), pegylated-IFN plus ribavirin and telaprevir (PEG-IFN/RBV/PI, 2011-2013), and IFN-free DAA therapy eras (2014). Results are displayed using forest plots. Results. The proportion of patients who achieved HCV SVR in the PEG-IFN/RBV, PEG-IFN/RBV/PI, and IFN-free DAA therapy eras increased from 38.4% (95% confidence interval [CI], 23.2-53.7) and 48% (95% CI, 28.4-67.6) to 83.3% (95% CI, 70.0-96.7), respectively. Similar proportions of patients with ongoing barriers to care were treated during the PEG-IFN/RBV (25 of 39 [64%]), PEG-IFN/RBV/PI (14 of 25 [56%]), and IFN-free DAA (16 of 30 [53%]) eras. Hepatitis C virus SVR among patients with ongoing barriers to care improved from 40% (95% CI, 21-59) to 76.5% (95% CI, 56-97) in the PEG-IFN/RBV and IFN-free DAA eras, respectively. After stratification for factors associated with HCV SVR such as HCV genotype and cirrhosis, HCV SVR were similar in patients regardless of the presence of ongoing barriers to care. Conclusions. Using IFN-free DAA and an inclusive HCV treatment protocol, 76.5% of HIV/HCV-treated patients with ongoing barriers to care achieved HCV SVR.

Early adoption of HIV-1 resistance testing in the San Diego County Ryan White CARE Act Program: predictors and outcome.

This research identifies predictors and outcomes of early use of human immunodeficiency virus type 1 (HIV-1) resistance testing in the San Diego County Ryan White CARE Act program. Between January and November 2000, 98 patients receiving care in 7 clinics participated in the resistance testing program. Provider characteristics predictive of participation included number of patients and percent of practice devoted to HIV care and number of HIV-related continuing medical education hours over the preceding 12 months. Providers rarely requested expert panel review of test results, and expert review was not predictive of better viral load responses. Regimens specified before knowledge of resistance results had more active drugs than those prescribed after knowledge of test results. Phenotypic susceptibility was predictive of virologic response, as was degree of prior nucleoside analogue exposure. There was little relationship between phenotypic susceptibility and a clinician's decision to prescribe a drug. Early adopters of this technology were more experienced HIV providers than their colleagues and utilized susceptibility information using reasoning processes in which resistance was a contributory but not necessarily dominating factor.

Prevalence, predictors, and outcomes of early adherence after starting or changing antiretroviral therapy.

The objectives of this research were to assess prevalence and predictors of early antiretroviral therapy adherence using multiple indicators and to estimate effects of early adherence on subsequent HIV viral load and CD4+ lymphocyte responses. Study subjects were adults with HIV infection referred to an antiretroviral therapy-monitoring clinic for initiation or change in therapy between March 1998 and June 1999. The design was a prospective observational cohort involving baseline interview followed by 30 days of electronic adherence monitoring (MEMS), 30-day interview, and follow-up viral load at 1, 3, and 6 months. Adherence indicators included MEMS therapeutic coverage, observed/expected cap openings, and self-reported adherence assessed at 30 days. Of 235 consenting patients, 60 (26%) failed to complete 30 days of electronic monitoring (noncompleters). At 6 months, mean change from baseline plasma viral load was inferior among noncompleters (0.5 log vs. 1.7 log). Predictors of adherence, varying by adherence metric, included: gender, race, prior antiretroviral therapy experience, substance abuse, prior adherence behavior, health beliefs, and pharmacist prediction of adherence. Self-reported adherence was more sensitive in predicting viral load responses than MEMS-based measures and identified poor adherence at earlier time points. Approximately a quarter of consenting patients were unable to complete 30 days of MEMS monitoring, and early drop out was a poor prognostic sign. Predictors of adherence varied depending upon how adherence was measured. Differences in virologic response between patients with optimal or poor adherence may not emerge until several months after regimen change or initiation. Structured assessment of self-reported adherence is an inexpensive and useful tool to assist clinicians in monitoring adherence.

The hepatitis C cascade of care among HIV infected patients: a call to address ongoing barriers to care.

BACKGROUND: The aims were to investigate the hepatitis C (HCV) cascade of care among HIV-infected patients and to identify reasons for not referring for and not initiating HCV therapy after completion of HCV treatment staging. DESIGN AND METHODS: Retrospective cohort analysis of HIV-infected patients under care at the University of California, San Diego (UCSD). We identified patients screened for and diagnosed with active HCV infection. Logistic regression analyses were used to identify factors associated with lack of referral for HCV therapy. Electronic medical records were reviewed to ascertain reasons for not initiating HCV therapy. RESULTS: Between 2008 and 2012, 4725 HIV-infected patients received care at the UCSD Owen clinic. Most patients [4534 (96%)] were screened for HCV, 748 (16%) patients had reactive serum HCV antibodies but only 542 patients had active HCV infection. Lack of engagement in care was the most important predictor of non-referral for HCV therapy [odds ratio (OR): 5.08, 95% confidence interval 3.24-6.97, p<0.00001]. Other significant predictors included unstable housing (OR: 2.26), AIDS (OR: 1.83), having a detectable HIV viral load (OR: 1.98) and being non-white (OR: 1.67). The most common reason (40%) for not initiating or deferring HCV therapy was the presence of ongoing barriers to care. CONCLUSIONS: Screening for HCV in HIV-infected patients linked to care is high but almost half of patients diagnosed with HCV are not referred for HCV therapy. Despite improvements in HCV therapy the benefits will not be realized unless effective measures for dealing with barriers to care are implemented.

High incidence of serious adverse events in HIV-infected patients treated with a telaprevir-based hepatitis C virus treatment regimen.

OBJECTIVES: To report the rates of grade IV adverse events and hepatitis C virus (HCV) treatment discontinuation associated with the use of telaprevir, pegylated interferon, and ribavirin. DESIGN: Retrospective cohort analysis. METHODS: The study included patients coinfected with HIV and HCV who underwent HCV treatment in a clinic-based setting with telaprevir, pegylated interferon, and ribavirin. The United States of America National Institutes of Health Division of AIDS grading system was used to rate severity of adverse events. RESULTS: Of the 24 consecutive patients treated for HCV using telaprevir/pegylated interferon/ribavirin, 50% (12/24) developed serious adverse events and 29% (7/24) discontinued HCV treatment due to adverse events, despite an intensive multidisciplinary monitoring approach. CONCLUSION: In this HIV clinic-based experience, a high rate of grade IV adverse events and treatment discontinuations were observed associated with HCV telaprevir-based treatment. Careful consideration of the risks and benefits of telaprevir-based therapy should be undertaken, given prospects for interferon-sparing therapy in the near future.