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1.  Simplification to Abacavir/Lamivudine + Atazanavir Maintains Viral Suppression and Improves Bone and Renal Biomarkers in ASSURE, a Randomized, Open Label, Non-Inferiority Trial 
PLoS ONE  2014;9(5):e96187.
Objective
Simplification of antiretroviral therapy in patients with suppressed viremia may minimize long-term adverse effects. The study’s primary objective was to determine whether abacavir/lamivudine + atazanavir (ABC/3TC+ATV) was virologically non-inferior to tenofovir/emtricitabine + atazanavir/ritonavir (TDF/FTC+ATV/r) over 24 weeks in a population of virologically suppressed, HIV-1 infected patients.
Design
This open-label, multicenter, non-inferiority study enrolled antiretroviral experienced, HIV-infected adults currently receiving a regimen of TDF/FTC+ATV/r for ≥6 months with no history of virologic failure and whose HIV-1 RNA had been ≤75 copies/mL on 2 consecutive measurements including screening. Patients were randomized 1∶2 to continue current treatment or simplify to ABC/3TC+ATV.
Methods
The primary endpoint was the proportion of patients with HIV-RNA<50 copies/mL at Week 24 by the Time to Loss of Virologic Response (TLOVR) algorithm. Secondary endpoints included alternative measures of efficacy, adverse events (AEs), and fasting lipids. Exploratory endpoints included inflammatory, coagulation, bone, and renal biomarkers.
Results
After 24 weeks, ABC/3TC+ATV (n = 199) was non-inferior to TDF/FTC+ATV/r (n = 97) by both the primary analysis (87% in both groups) and all secondary efficacy analyses. Rates of grade 2–4 AEs were similar between the two groups (40% vs 37%, respectively), but an excess of hyperbilirubinemia made the rate of grade 3–4 laboratory abnormalities higher in the TDF/FTC+ATV/r group (30%) compared with the ABC/3TC+ATV group (13%). Lipid levels were stable except for HDL cholesterol, which increased significantly in the ABC/3TC+ATV group. Bone and renal biomarkers improved significantly between baseline and Week 24 in patients taking ABC/3TC+ATV, and the difference between groups was significant at Week 24. No significant changes occurred in any inflammatory or coagulation biomarker within or between treatment groups.
Conclusions
After 24 weeks, simplification to ABC/3TC+ATV from TDF/FTC+ATV/r maintained viral suppression was well-tolerated, and led to improvements in bone and renal biomarkers and HDL cholesterol.
Trial Registration
ClinicalTrials.gov NCT01102972
GlaxoSmithKline Clinical Study Register #113734
doi:10.1371/journal.pone.0096187
PMCID: PMC4019479  PMID: 24825167
2.  Patient and Provider Characteristics Associated with the Decision of HIV Coinfected Patients to Start Hepatitis C Treatment 
AIDS Patient Care and STDs  2011;25(9):533-538.
Abstract
Hepatitis C (HCV) and HIV coinfection is common and liver disease is a leading cause of morbidity and mortality among coinfected patients. Despite advances in HCV treatment, few HIV coinfected patients actually initiate treatment. We examined patient and provider characteristics associated with a patient's decision to accept or refuse HCV treatment once offered. We conducted patient chart abstraction and surveys with 127 HIV coinfected patients who were offered HCV treatment by their provider and surveys of their HCV care providers at three HIV clinics. Participants were mostly male (87%), minority (66%), and had a history of injection drug use (60%). Most had been diagnosed with HIV for several years (X=13.7 years) and reported HIV transmission through unprotected sex (47%). Of the 127 patients, 79 accepted treatment. In multivariate analysis, patients who had a CD4 greater than 200 cells/mm3 and a provider with more confidence about HCV treatment were more likely to accept the recommendation to start treatment; younger age was marginally associated with treatment acceptance. In bivariate analysis, added correlates of treatment acceptance included male gender, no recent drug use, and several provider attitudes regarding treatment and philosophy about determination of patient treatment readiness. Patient and provider characteristics are important when understanding a patient's decision to start or defer HCV treatment. Further research is needed to better understand barriers to treatment uptake as new and more effective HCV treatments will soon be available.
doi:10.1089/apc.2011.0048
PMCID: PMC3157303  PMID: 21823907
3.  Provider and Patient Correlates of Provider Decisions to Recommend HCV Treatment to HIV Co-Infected Patients 
Despite low uptake of HCV treatment among HIV co-infected patients, few studies have examined the factors that contribute to provider decisions to recommend treatment.
Surveys of 173 co-infected patients and their primary care providers, as well as patient chart data, were collected at three HIV clinics in Los Angeles; 73% of the patients had any history of being recommended HCV treatment. Multivariate predictors of being offered treatment included being Caucasian, greater HCV knowledge, receiving depression treatment if depressed, and one's provider having a lower weekly patient load and more years working at the study site. These findings suggest that provider decisions to recommend HCV treatment are influenced by patient factors including race and psychosocial treatment readiness, as well as characteristics of their own practice and treatment philosophy. With changes to HCV treatment soon to emerge, further evaluation of factors influencing treatment decisions is needed to improve HCV treatment uptake.
doi:10.1177/1545109712444163
PMCID: PMC3419326  PMID: 22564797
Hepatitis C; provider treatment decision making; treatment readiness
4.  Patient Characteristics Associated with HCV Treatment Adherence, Treatment Completion, and Sustained Virologic Response in HIV Coinfected Patients 
AIDS Research and Treatment  2011;2011:903480.
Background. Hepatitis C (HCV) treatment efficacy among HIV patients is limited by poor treatment adherence and tolerance, but few studies have examined the psychosocial determinants of treatment adherence and outcomes. Methods. Chart abstracted and survey data were collected on 72 HIV patients who had received pegylated interferon and ribavirin to assess correlates of treatment adherence, completion, and sustained virologic response (SVR). Results. Nearly half (46%) the sample had active psychiatric problems and 13% had illicit drug use at treatment onset; 28% reported <100% treatment adherence, 38% did not complete treatment (mostly due to virologic nonresponse), and intent to treat SVR rate was 49%. Having a psychiatric diagnosis was associated with nonadherence, while better HCV adherence was associated with both treatment completion and SVR. Conclusions. Good mental health may be an indicator of HCV treatment adherence readiness, which is in turn associated with treatment completion and response, but further research is needed with new HCV treatments emerging.
doi:10.1155/2011/903480
PMCID: PMC3205594  PMID: 22110904
5.  Factors That Influence an HIV Coinfected Patient's Decision to Start Hepatitis C Treatment 
AIDS Patient Care and STDs  2009;23(12):993-999.
Abstract
Liver disease is a leading cause of morbidity and mortality among patients coinfected with HIV and hepatitis C (HCV), yet few HIV coinfected patients actually receive HCV treatment. Providers must first be willing to prescribe treatment, but the patient ultimately makes the decision to accept or decline a treatment recommendation. We used a process model framework to explore the factors influencing patients' treatment decision-making. We conducted semistructured interviews with 35 HIV coinfected patients and 11 primary care providers at three HIV clinics in Los Angeles, California. Patients reported that stability of HIV disease, perceived need for HCV treatment, treatment readiness, willingness to deal with side effects, absence of substance abuse, and stability of mental health and overall life circumstances are key factors influencing treatment decision-making. Patients also spoke of the influence of the trusting relationship that many had with their provider, and providers acknowledged an awareness of the influence of how they present the risks and benefits of HCV treatment and the overall tone of their recommendation (encouraging, dissuasive, or neutral). These results speak to a social decision-making process between the patient and provider—a partnership that involves sequential interactions whereby both the patient and provider may influence the other's evaluation of the patient's readiness for treatment, with treatment initiation dependent on both agreeing on the need for treatment and the patient's readiness for treatment.
doi:10.1089/apc.2009.0153
PMCID: PMC2832645  PMID: 19929229
6.  Treat Early or Wait and Monitor? A Qualitative Analysis of Provider Hepatitis C Virus Treatment Decision-Making in the Context of HIV Coinfection 
AIDS Patient Care and STDs  2009;23(9):715-725.
Abstract
Liver disease is a leading cause of death among patients with HIV coinfected with hepatitis C (HCV); yet, studies show that less than 10% receive HCV treatment, in part because of limited treatment response, high treatment toxicity, and psychosocial barriers to treatment readiness. Using a process model framework, we sought to explore the factors and processes by which providers make HCV treatment decisions for HIV-coinfected patients. We conducted 22 semistructured interviews with primary care providers and support staff at three HIV clinics in Los Angeles, California, in which rates of HCV treatment uptake varied from 10% to 38%. Providers agreed that stable HIV disease, favorable genotype, and significant signs of liver disease progression are all signs of need for treatment. However, two divergent treatment approaches emerged for genotype 1 and 4 patients with minimal disease, and in definitions of patient readiness. Providers with lower treatment rates preferred to delay treatment in hopes of better future treatment options, and were more conservative in requiring complete mental health screens and treatment and abstinence from substance use. Conversely, providers with higher treatment rates viewed all patients as needing treatment as soon as possible, and defined readiness more leniently, with some willing to treat even in the context of untreated depression and drug use, so long as ability to adhere well was demonstrated. Regardless of whether an aggressive or cautious approach to treatment is used, development of effective programs for promoting patient treatment readiness is critical to ensuring greater treatment uptake.
doi:10.1089/apc.2009.0049
PMCID: PMC2832644  PMID: 19663714
7.  Hepatitis C Patients' Self-reported Adherence to Pegylated Interferon and Ribavirin 
Background
Prior research on adherence to Hepatitis C treatment has documented rates of dose reductions and early treatment discontinuation, but little is known about patients' dose-taking adherence.
Aims
To assess the prevalence of missed doses of pegylated interferon and ribavirin and examine the correlates of dose-taking adherence in clinic settings.
Methods
180 patients on treatment for Hepatitis C (23% co-infected with HIV) completed a cross-sectional survey at the site of their Hepatitis C care.
Results
Seven percent of patients reported missing at least one injection of pegylated interferon in the last four weeks and 21% reported missing at least one dose of ribavirin in the last 7 days. Dose-taking adherence was not associated with HCV viral load.
Conclusions
Self-reported dose nonadherence to Hepatitis C treatment occurs frequently. Further studies of dose nonadherence (assessed by method other than self-report) and its relationship to HCV virologic outcome are warranted.
PMCID: PMC2891196  PMID: 19086329
Adherence; HCV; HIV; co-infection; interferon; ribavirin

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