Long-term Efficacy and Safety of Raltegravir, Etravirine, and Darunavir/Ritonavir in Treatment-Experienced Patients: Week 96 Results from the ANRS 139 TRIO Trial.
J Acquir Immune Defic Syndr. 2012 Jan 30;
Authors: Fagard C, Colin C, Charpentier C, Rami A, Jacomet C, Yeni P, Vittecoq D, Katlama C, Molina JM, Descamps D, Chene G, Yazdanpanah Y
Abstract
ABSTRACT: Among 103 patients with multidrug-resistant HIV who initiated raltegravir, etravirine, and darunavir/ritonavir-containing regimen in the ANRS 139 TRIO trial, 100 participated in extended follow-up and continued study treatment until W96. Among them, 87 (87%) received an optimized background therapy including either nucleoside reverse transcriptase inhibitors or enfuvirtide, they were 78 (78%) at W96. At W96, 88% achieved durable virologic response (<50 copies/mL). CD4 response was maintained (median change of +150 cells/mm). No major toxicity was reported. This triple drug combination showed sustained efficacy and thus, should be strongly considered for patients with multi-class resistant virus.
PMID: 22293546 [PubMed - as supplied by publisher]
Analysis of a previously identified ‘pain protective’ haplotype and individual polymorphisms in the GCH1 gene in Africans with HIV-associated sensory neuropathy: a genetic association study.
ABSTRACT: We analysed GCH1 in symptomatic HIV-associated sensory neuropathy (HIV-SN) in Southern Africans including a ‘pain protective’ 3-SNP haplotype and 6 SNPs, analysed individually and in a 6-SNP haplotype. The ‘pain protective’ 3-SNP haplotype and a 6-SNP haplotype containing these alleles associated with a reduced risk of pain. Another 3-SNP haplotype associated with increased presence of pain. Associations were lost after correction for age, gender and CD4 T-cell count. Linkage disequilibrium differed between our cohort and Caucasians suggesting that these SNPs may not be ideal markers in Africans. Subsequently the role of GCH1 in painful HIV-SN remains possible.
PMID: 22293547 [PubMed - as supplied by publisher]
Predictors of 5-years mortality in HIV-infected adults starting highly active antiretroviral therapy (HAART) in Thailand.
J Acquir Immune Defic Syndr. 2012 Jan 30;
Authors: Fregonese F, Collins IJ, Jourdain G, Lecoeur S, Cressey TR, Ngo-Giang-Houng N, Banchongkit S, Chutanunta A, Techapornroong M, Lallemant M,
Abstract
OBJECTIVE: To estimate early and long-term mortality and associated risk factors in adults receiving highly active antiretroviral therapy (HAART) in Thailand. DESIGN: Prospective observational cohort. METHODS: Previously untreated adults starting HAART in 2002-2009 were followed in 43 public hospitals. Kaplan-Meier probability of survival was estimated up to 5 years of therapy. Factors associated with early (≤6 months) and long-term (>6 months) mortality were assessed using Cox regression analyses. RESULTS: A total of 1578 adults received HAART, 74% women, median age 33 years, CD4 count 124 cells/mL, median follow-up was 50 months (IQR 41-66). Eighty-nine (6%) patients died (37 occurred ≤6 months and 52 >6 months) and 183 (12%) were lost to follow-up. Probability of survival (95%CI) was 97.5% (96.7-98.2) at 6 months; 96.6% (95.6-97.4) at 1 year and 93.5% (91.9-94.8%) at 5 years. Probability of being alive and on follow-up was 80.8% (78.5-82.8) at 5 years.Early mortality was associated with anemia (aHR 3.6, 95%CI 1.7-7.5) and low CD4 (aHR 1.6, 95%CI 1.1-2.2, per 50 cells decrease) at treatment initiation. Long-term mortality was associated with persistent anemia (aHR, 4.9; 95%CI 2.1-11.6); CD4 increase from baseline <50cells/mm (aHR 3.1; 95%CI 1.6-5.7) and viral load >1000 copies/mL (aHR 2.8; 95%CI 1.3-6.1) at 6 months of HAART; male gender and calendar year of enrollment. CONCLUSION: Early mortality was associated with anemia and severe immunosuppression at initiation of therapy. Long-term mortality was associated with persistent anemia, CD4 and virologic response at 6 months of therapy over baseline characteristics, highlighting the importance of laboratory monitoring.
PMID: 22293548 [PubMed - as supplied by publisher]
Risk Factors Associated with Inpatient Hospital Utilization in HIV-positive Individuals and Relationship to HIV Care Engagement.
J Acquir Immune Defic Syndr. 2012 Jan 30;
Authors: Kerr J, Stephens T, Gibson JJ, Duffus WA
Abstract
BACKGROUND: Prompt linkage to HIV primary care may reduce the need for inpatient hospitalization. METHODS: Retrospective cohort study of South Carolina HIV-infected individuals diagnosed from January 1986-December 2006 who utilized 62 inpatient facilities from (January 2007-June 2010). Suboptimal primary care engagement was defined as <2 reports of a CD4T-cell count or viral load value to surveillance in each calendar year from January 2007-June 2010. Multivariable logistic regression explored associations of HIV primary care engagement with inpatient hospitalization after accounting for socio-demographic characteristics and disease stage. Poisson and negative binominal regression examined primary care engagement, socio-demographic characteristics, and disease stage on frequency of inpatient hospitalization and total inpatient days. RESULTS: Individuals presenting to the hospital with an AIDS-defining illness had greater risk of suboptimal HIV primary care engagement (aOR=1.58; 95%CI=1.23-2.04) more inpatient hospitalizations (IRR=1.74; 95%CI=1.65-1.83) and inpatient days (IRR=2.17; 95%CI=2.00-2.36). Blacks demonstrated greater suboptimal care risk (aOR=1.61; 95%CI=1.15-2.25) more inpatient visits (IRR=1.09; 95%CI=1.01-1.17), and inpatient days (IRR=1.21; 95%CI=1.09-1.34). Medicare protected against suboptimal primary care engagement (aOR=0.66; 95%CI=0.46-0.95) but was associated with more hospitalizations (IRR=1.09; 95%CI=1.01-1.18). AIDS disease stage was associated with decreased suboptimal care risk (AIDS ≤1 year, aOR=0.05; 95%CI=0.02-0.12; AIDS >1 year, aOR=0.11; 95%CI=0.06-0.20) but more hospitalizations (AIDS ≤1 year, IRR=1.12; 95%CI=1.04-1.21; AIDS >1 year, IRR=1.12; 95%CI=1.04-1.21) and inpatient days (AIDS ≤1 year, IRR=1.22; 95%CI=1.08-1.37; AIDS >1 year, IRR=1.35; 95%CI=1.21-1.50). CONCLUSIONS: Disease stage, race and insurance status strongly influence HIV primary care engagement and inpatient hospitalization. Admissions may be related to general medical conditions, substance abuse, or antiretroviral therapy.
PMID: 22293549 [PubMed - as supplied by publisher]
Psychometric validation of the PROQOL-HIV questionnaire, a new health-related quality of life instrument specific to HIV disease.
J Acquir Immune Defic Syndr. 2012 Jan 30;
Authors: Duracinsky M, Lalanne C, Le Coeur S, Herrmann S, Berzins B, Armstrong AR, Fai Lau JT, Fournier I, Chassany O
Abstract
OBJECTIVES: This study reports the psychometric validation of a new HIV/AIDS-specific Health-Related Quality of Life (HRQL) questionnaire, the Patient Reported Outcomes Quality of Life- HIV or PROQOL-HIV. The instrument was developed simultaneously across Europe, North and South America, Africa, Asia and Australia to assess multi-dimensional quality of life impairments in the era of highly active anti-retroviral therapy (HAART). METHOD: A cross-sectional study was performed in eight countries. The pilot 70-item questionnaire was co-administered with the HIV symptoms index, the EQ-5D and MOS-HIV questionnaires. Demographic and biomedical data were collected. Following item analysis and reduction, convergent, discriminant, concurrent validity and known-group validity were examined. Internal consistency and reliability scores were assessed using Cronbach’s alpha and intraclass correlation. RESULTS: The final sample of 791 patients was composed of 64% males (median age 41 years, HIV diagnosis = 5 years), 13.8% were treatment naive. Item reduction yielded a 43-item form surveying eight dimensions and one global health item that showed good convergent and discriminant validity and reliability (98% scaling success; Cronbach’s alphas 0.77-0.89). Correlations with EQ-5D and MOS-HIV complied with concurrent validity expectations; likewise, correlations against the number of self-reported symptoms and depression showed good support for criterion validity. A test-retest study on French patients (N=34) showed temporal stability (ICC=0.86). Significant and meaningful differences of HRQL scores between countries were found. CONCLUSIONS: The PROQOL-HIV questionnaire is a valid and reliable instrument for assessing HRQL specific to HIV disease in different cultures and healthcare systems.
PMID: 22293550 [PubMed - as supplied by publisher]
OBJECTIVE: We seek to determine the optimized multidisciplinary care team (MDCT) composition for antiretroviral therapy (ART) adherence. METHODS: We analyzed all new regimen starts (n=10,801; 7,071 ART naïve, 3,730 ART experienced) among HIV+ patients in Kaiser Permanente California from 1996-2006. We measured 12-month adherence to ART (pharmacy refill methodology) and medical center-specific patient exposure to HIV/ID specialist (reference group), non-HIV primary care provider (PC), clinical pharmacist, nurse case manager, non-nurse care coordinator, dietician, social worker/benefits coordinator, health educator, and mental health. We used recursive partitioning to ascertain potential MDCT compositions associated with maximal mean ART adherence. We then employed mixed linear regression with clustering by provider and medical center (adjusting for ART experience, age, gender, race/ethnicity, HIV risk, HCV+, ART regimen class and calendar year) to test which potential MDCT identified had statistically significant association with ART adherence. RESULTS: We found maximal increase in adherence with pharmacist +coordinator +PC (+8.1% ART adherence difference compared to reference; 95%CI: +2.7-+13.5%). Other MDCT teams with significant (p<0.05) improved adherence compared to specialist only were: nurse +social work +PC (+7.5%; +5.4-+9.7%); specialist +mental health (+6.5%; +2.6-+10.4%); pharmacist +social work +PC (+5.7%; +4.1-+7.4%); pharmacist +PC (+3.3%; +0.8-+5.8%). Among these MDCTs, there were no significant differences in mean adherence, odds maximal viral control, or change CD4+ at 12 months (except pharmacist +PC). CONCLUSIONS: Various MDCTs were associated with improved adherence, including ones that did not include HIV specialist but included primary care plus other health professionals. These findings have application to HIV care team design.
PMID: 22293551 [PubMed - as supplied by publisher]
BACKGROUND: In HIV-infected patients, data on immunogenicity of Yellow fever (YF) immunization are scarce, and there is conflicting evidence of the influence of CD4-T cell count and plasma HIV-RNA on neutralizing antibody titer (NT) following vaccine injection. METHODS: In this prospective cohort study, NT was measured in all consecutive HIV outpatients who had previously received at least one injection of YF vaccine. Risk factors for vaccine failure (NT <1:10) and magnitude of NT according to dates of HIV diagnosis and immunization were assessed by logistic regression and general linear models. RESULTS: Among 364 included patients, 24 (7%) had NT <1:10 after a mean delay of 8.4 years following immunization. Among patients immunized after HIV diagnosis (n=240), NT <1:10 was associated only with detectable plasma HIV-RNA at immunization. Among 79 patients with primary vaccination following diagnosis of HIV infection, higher HIV-RNA at immunization was the unique independent risk factor for NT <1:10 (adjusted OR=3.73 per log10, 95% CI 1.14-12.28). Lower values of NT were independently associated with a shorter duration of undetectable plasma HIV-RNA (OR=1.05 per year, 95% CI 1.005-1.09) and higher plasma HIV-RNA (OR=0.91 per log10, 95% CI 0.84-0.99) at immunization. CONCLUSIONS: The key determinant of antibody response was the HIV replication status at immunization. No association was found between antibody response and CD4-T cell count.
PMID: 22267015 [PubMed - as supplied by publisher]
Retention in Care of Adults and Adolescents living with HIV in 13 U.S. Areas.
J Acquir Immune Defic Syndr. 2012 Jan 19;
Authors: Hall HI, Gray KM, Tang T, Li J, Shouse L, Mermin J
Abstract
BACKGROUND: Monitoring immunologic and virologic response to antiretroviral therapy in HIV-1-infected patients is an important component of treatment in the United States. However, little population-based information is available on whether HIV-infected persons receive the recommended tests or continuous care. METHODS: Using data from 13 areas reporting relevant HIV-related tests to national HIV surveillance, we determined retention in care in persons >12 years old living with HIV at the end of 2009. We assessed retention in care, defined as ≥2 CD4 or viral load tests at least 3 months apart in the past year, by demographic, clinical, and risk characteristics, and calculated prevalence ratios (PR) and 95% confidence intervals (CI). We also assessed the percentage established in care within 12 months after HIV diagnosis in 2008 (≥2 tests, ≥3 months apart). RESULTS: Among 100,375 persons living with HIV, 45% had ≥2 tests at least 3 months apart. A higher percentage of whites was retained in care (50%) compared with blacks/African Americans (41%, PR 0.83, 95% CI 0.82, 0.84) and Hispanics/Latinos (40%, PR 0.90, 95% CI 0.87, 0.92). Compared with heterosexual women (50%), fewer men who have sex with men (48%), heterosexual males (45%), and male (37%) and female (43%) injection-drug users had ≥2 tests. About 64% established care within 12 months of diagnosis. CONCLUSIONS: Less than half of persons living with HIV had laboratory evidence of ongoing clinical care and only two-thirds established care after diagnosis. Further assessments determining modifiable barriers to accessing care could assist with achieving public health targets.
PMID: 22267016 [PubMed - as supplied by publisher]
RALTEGRAVIR, TENOFOVIR DF, AND EMTRICITABINE FOR POST-EXPOSURE PROPHYLAXIS TO PREVENT THE SEXUAL TRANSMISSION OF HIV: SAFETY, TOLERABILITY AND ADHERENCE.
J Acquir Immune Defic Syndr. 2012 Jan 19;
Authors: Mayer KH, Mimiaga MJ, Gelman M, Grasso C
Abstract
ABSTRACT: Antiretroviral drugs have been recommended for post-exposure prophylaxis (PEP) after high-risk sexual exposures for more than a decade. Three drug regimens could offer the highest levels of protection, particularly if the infectious source is taking medication, but drug intolerance has often led to suboptimal adherence. The current study evaluated a novel three drug PEP regimen, consisting of Raltegravir, Tenofovir DF and Emtricitabine. Of 100 participants enrolled in this study at a Boston community health center that has had a comprehensive PEP program for more than a decade, 85 were evaluable at 3 months and none became HIV-infected. Fifty seven percent of those enrolled completed the regimen as prescribed, and 27% took their medicine daily, but sometimes missed the second daily dose of Raltegravir. The most common side effects reported included nausea or vomiting (27%), diarrhea (21%), headache (15%), fatigue (14%), abdominal symptoms (including pain, gas, or bloating) (16%), and myalgias or arthralgias (8%), all of which were mild and tended to be self-limited, not resulting in drug discontinuation. The side effects were significantly less common than those reported by historical controls, who used a three drug PEP regimen including Zidovudine, Lamivudine, and a Ritonavir-Boosted Protease Inhibitor. Raltegravir, Tenofovir DF and Emtricitabine may be useful as a three drug regimen for PEP.
PMID: 22267017 [PubMed - as supplied by publisher]
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