bluuebunny/crossref_metadata_2025_split huggingface dataset:
Anterior Segment Parameters Measured with 2 Optical Devices Compared to Ultrasonic Data
Authors: Nemeth Gabor , Hassan Ziad , Szalai Eszter , Berta Andras , Modis Laszlo 
Published: November 2012

Purpose. Ophthalmic parameters can be measured with different techniques and devices. Our aim was to measure anterior segment parameters using 2 optical devices and to compare the data to ultrasonic technique. Methods. Axial length (AL) was measured with IOLMaster; anterior chamber depth (ACD) was determined using IOLMaster, Visante® optical coherence tomography (OCT), and Pentacam® HR; and central corneal thickness (CCT) were measured with Pentacam® HR and with ultrasound. Results. In 45 eyes of 45 patients (age 62.73±15.31), the AL was 23.35±1.49 mm. The CCT was 541.7±39.9 μm with Visante OCT, 549.7±39.2 μm with Pentacam® HR, and 534.3±41.3 μm with ultrasonic device. The ACD was 3.0±0.42 mm with IOLMaster, 3.26±0.95 mm with Visante OCT, and 3.06±0.41 mm with Pentacam® HR. In case of CCT measurements, data obtained with Pentacam HR correlated with the results of ultrasonic measurements (r=0.89; p<0.001) and Visante OCT measurements (r=0.88; p<0.001). Regarding ACD results, a significant correlation was observed between Pentacam HR and IOLMaster (r=0.95; p<0.0001) but they did not significantly correlate to Visante OCT data (r=0.23; p=0.12). Correlation was significant between AL and ACD measured with IOLMaster (r=0.67; p<0.001). Conclusions. The CCT and ACD data show strong correlation between different devices.
Aging‐associated symptoms in the physician‐patient dialogue in a group of long‐term diagnosed HIV‐infected individuals
Authors: Fumaz C , Muñoz‐Moreno J , Ferrer M , Gonzalez‐Garcia M , Perez‐Alvarez N , Negredo E , Chamorro A , Clotet B 
Published: November 2012

BackgroundThe significant decrease in mortality has resulted in a large number of individuals aged over 50 living with HIV infection. Additionally, the coexistence of certain pathologies suggests premature aging. In this scenario, the presence of aging‐associated symptoms in the physician‐patient dialogue is yet to be explored.MethodsCross‐sectional observational study to evaluate the presence of aging‐associated symptoms in the physician‐patient dialogue and to explore the possible differences between genders in a sample of 100 HIV‐1 infected subjects diagnosed at least 15 years ago. The survey assessed questions/comments made by the patient, questions/comments made by the physician and patients’ interest in obtaining more information than was provided. Number of patients and percentages were given and compared using the w2 or Fisher exact test (as appropriate).ResultsParticipants were 60 men and 40 women, diagnosed with HIV infection a median (IQ) of 18 (15.7–21) years ago, who had a nadir CD4 and CD4 cell count at the study entry of 172 (95–272) and 543 (403–677), respectively. Eighty percent of the subjects had VL <25 copies and 42% were HCV/HIV co‐infected (31 subjects with low fibrosis stage). The infection route had been mainly intravenous drug use (37%) and MSM (32%). Men and women had similar demographic and clinical characteristics. Sixty‐two percent of the participants acknowledged asking their physicians about aging‐associated symptoms (58% men vs 66% women; p=0.50), 48% reported that their physicians had provided information without having been asked (48% men vs 55% women; p=0.51) and 75% confirmed that they would like to have more information about aging‐associated symptoms (22% men vs 80% women; p<0.001).ConclusionsAround half of the men and women interviewed had discussed aging‐associated symptoms with their physician. However, this seemed insufficient for four‐fifths of the women, who would have liked to have obtained more information about aging.
Is there a relationship between HIV tropism and historical genotypic resistance in treatment‐experienced patients?
Authors: Zaccarelli M , Sterrantino G , Francisci D , Di Biagio A , Di Giambenedetto S , De Luca A , Punzi G , Bruzzone B , Meini G , Zazzi M ,   ARCA Database Study Group
Published: November 2012

Purpose of the studySince X4/DM HIV‐1 tropism is associated with poorer prognosis and worse response to treatment, the aim of this study was to assess whether X4/DM HIV‐1 tropism is also related with a higher accumulation of resistance in patients experiencing treatment failure.MethodsHIV protease (PR) and reverse transcriptase (RT) resistance mutations and tropism test results were extracted from a national database. Viral tropism data included enhanced sensitivity Trofile assay (ESTA) and geno2pheno results at 10% false positive rate. Historical resistance mutations (HRM) for PI, NRTI and NNRTI, detected in all genotypic tests performed during patient treatment history, were selected according to IAS‐USA indications.Summary of resultsOverall, 1280 patients were included: males 65%, median age 45 years (IQR: 40–50), median CD4 nadir 116 (IQR: 34–272), median past regimens 7 (IQR: 3–12), median previous NRTI used 5 (IQR: 4–7), median previous NNRTI used 1 (IQR 1–2) and median previous PI used 3 (IQR 1–5). HIV tropism was assessed by ESTA in 271 patients (21.2%) and by geno2pheno in 1009 patients (78.8%). Four hundred and fifteen patients (32.4%) carried X4/DM virus and 321 (25.1%) had ≥1 HRM for each antiretroviral class. The mean number of HRM was higher in patients harboring X4/DM virus than in patients harboring R5 virus (5.1±6.4 vs. 4.3±5.9, p = 0.02 at ANOVA test). X4/DM strains also harbored a higher mean number of PI‐related HRM (1.8±2.8 vs. 1.5±2.6, p = 0.003) and NNRTI‐related HRM (1.2±1.6 vs. 0.9±1.4, p = 0.001), but not of NRTI‐related HRM (2.2±2.6 vs. 2.0±2.6). At logistic regression, patients with HRM for all the 3 classes had a significant higher risk of also harboring X4/DM virus (OR: 1.6, 95% CI: 1.0–2.4, p = 0.04). Moreover, X4/DM virus was found to be associated with previous use of NNRTI‐containing regimens (OR: 1.4, 95% CI: 1.1–1–9, p = 0.03) and lower CD4 nadir (OR: 0.9, 95% CI: 0.9–1.0, p = 0.001, per 50‐CD4 increase). The analysis was adjusted by number of genotypic tests, number of treatment lines, age and HV subtype. Single mutations significantly associated with X4/DM tropism were: for PI, V32I and L76V; for NRTI: M41L, K70R, L74V and T215Y and for NNRTI: E138G and V179T.ConclusionsOur data suggest that X4/DM tropism is associated with accumulation of resistance mutations during treatment history. X4/DM tropism is also confirmed to be a marker of a more compromised clinical and immune‐virological condition.
The incidence of complications after cesarean section in HIV‐infected women with advanced WHO stages of HIV disease
Authors: Posokhova S , Shevchenko S , Popova T 
Published: November 2012

Prevalence of HIV infection in Ukraine is 1.6% overall, with antenatal prevalence of 0.52%, the highest in Europe. According to national protocol, cesarean section has been recommended for women with viral load above 50 copies/mL to further prevent vertical transmission of HIV. The aim of our study was to compare the infectious complication rates after cesarean delivery in HIV‐infected women with advanced WHO stages of HIV disease who received HAART, and HIV‐infected women with I or II WHO stages.Materials and methodsA retrospective analysis was performed on data derived from 150 HIV‐infected women with advanced WHO stages of HIV disease (group I) and 150 HIV‐infected women with I or II WHO stages (group II), who underwent cesarean delivery. Postoperative infectious morbidity in both groups was analyzed according to whether the cesarean section was an elective or emergent delivery. Descriptive, comparison analyses were performed.ResultsThere was no significant difference between the both groups in terms of gravidity, parity, number of previous cesarean sections, estimated gestational age at time of delivery. It has been shown that HIV‐infected women from the group I have 2 times more factors for the appearance of postpartum infectious complications, such as anemia, the urinary tract infection, sexually transmitted infections. Both groups of women were statistically more likely to experience postpartum endometritis when being delivered by emergent cesarean section than by elective cesarean section (14.6% versus 4.6%, respectively in the group I and 5.3% versus 0.5%, respectively, in the group II), superficial or deep wound breakdown (22.6% versus 4.6%, respectively, in the first group and 5.3% versus 2.6%, respectively, in the second group). Septic pelvic thrombophlebitis was only in 2% of HIV‐infected women from the group I. Urinary tract infection had 25% HIV‐infected women in the both groups. Overall, the rate of postpartum infectious complications in the first group consist 28%, which was 2 times higher compared the second group.ConclusionAccording to our study, there was no significant difference in infectious postoperative morbidity in HIV‐infected women who delivered by elective cesarean section in the both groups. But HIV‐infected women with advanced WHO stages of HIV disease undergoing emergency cesarean section are at increased risk for post‐operative infectious complications.
Analysis of enfuvirtide resistance mutations prevalence among HIV‐1 variants circulating in Russia and CIS countries
Authors: Vasilyev A , Kazennova E , Bobkova M , Salamov G 
Published: November 2012

BackgroundEnfuvirtide (ENF/Fuzeon/T‐20) was the first member of the class ‘fusion inhibitors’. This was approved for the treatment of HIV infection in the year 2003 in Europe and the USA. Fuzeon has not yet approved in Russia but in the near future his introduction expected. Resistance to ENF has been associated with mutations in the HR1 domain at codons 36–45. Mutations outside of this region and in the HR2 domain may also serve as secondary mutations. Unique and highly homogeneous HIV‐1 subtype A variant‐IDU‐A is the most prevailing in Russia and CIS countries. HIV‐1 genetic variants circulating in Russia and CIS countries and, in particular, variant IDU‐A are poorly studied on resistance mutations to enfuvirtide. The aim of this work was to study the prevalence of mutations associated to HIV fusion inhibitor enfuvirtide resistance in Russia and CIS countries.MethodsWe used 40 proviral DNA samples (12 IDU‐A sequences, 8 subtype B sequences, 6 subtype G sequences, 8 CRF03_AB recombinant sequences and 6 CRF02_AG recombinant sequences) isolated from peripheral blood mononuclear cells of HIV‐infected patients. All the samples belonged to enfuvirtide‐naïve patients. Fragments of env gene with coordinates 7754–8342 (corresponding to strain HXB2) were sequenced. Phylogenetic analysis was carried out using DNASTAR program package.ResultsEnfuvirtide resistance mutations were not found among viruses studied in Russia and CIS countries. The frequencies of natural polymorphism mutations associated with enfuvirtide hypersusceptibility were found to consist up to 35%, and the frequencies of accessory mutations N126K and E137K in the HR2 region‐up to 27.5%.ConclusionsEnfuvirtide resistance mutations are rare in Russia and CIS countries. HIV‐1 genetic variants circulating in Russia and CIS countries should be sensitive to enfuvirtide. However, accessory mutations in HR2 the case of HR1 resistance mutations may contribute to resistance development by improving viral fitness.
Indirect treatment comparison of efficacy, safety and resistance of EVG/COBI/FTC/TDF (Quad) vs. RAL+FTC/TDF in treatment‐naïve HIV patients
Authors: DeJesus E , Felix J , Vandewalle B , Rabiais S , Silva M , Ferreira D , Almeida J , Piontkowsky D , Szwarcberg J 
Published: November 2012

PurposeTo compare the efficacy, tolerability and resistance profile at week 48 of elvitegravir 150 mg/ cobicistat 150 mg/ emtricitabine 200 mg/ tenofovir DF 300 mg qd (QUAD) relative to raltegravir 400 mg bid + emtricitabine 200 mg/ tenofovir DF 300 mg qd (RAL+FTC/TDF) in treatment‐naïve, HIV‐1‐infected adults based on an indirect treatment comparison.MethodsUsing the phase 3 studies GS‐US‐236‐0102 (102) and STARTMRK, outcomes examined were viral suppression (HIV RNA <50 cps/mL), mean CD4+ cell count (cells/µL) change from baseline, discontinuation due to any reason and due to adverse events (AE) and resistance to EVG and RAL. Efavirenz/emtricitabine/tenofovir DF was used as the common comparator. A Bayesian generalized linear model framework for indirect treatment comparison was adopted to estimate relative and absolute treatment effects, using QUAD as baseline value.ResultsThe odds ratio (OR) of viral suppression with QUAD relative to RAL+FTC/TDF was 0.98 (CI: 0.52; 1.86). Discontinuations due to any reason or AE were comparable. The OR of resistance with QUAD relative to RAL+FTC/TDF was 0.63 (CI: 0.09; 4.21). The estimated probability of viral suppression was 88.8% (CI: 85.3%; 91.9%) for QUAD; 88.8% (CI: 82.7%; 93.4%) for RAL+FTC/TDF. Mean CD4+ cell count change from baseline was estimated at 239.0 cells/µL (CI: 220.9; 257.1) for QUAD and 232.0 cells/µL (CI: 204.9; 259.2) for RAL+FTC/TDF. The estimated probability of discontinuation due to any reason is 10.6% (CI: 7.6%; 14.1%) for QUAD and 9.2% (CI: 4.9%; 15.4%) for RAL+FTC/TDF and due to AE 3.7% (CI: 2.0%; 6.0%) for QUAD and 2.9% (CI: 1.0%; 6.4%) for RAL+FTC/TDF. Integrase resistance is estimated at 2.0% (CI: 1.0%; 4.0%) for QUAD and 4.3% (CI: 1.0%; 16.0%) for RAL+FTC/TDF.ConclusionComparable results were found between QUAD and RAL+FTC/TDF for the studied outcomes analyzed at week 48, in treatment‐naïve, HIV‐1‐infected patients.
Long‐term efficacy and safety of atazanavir/ritonavir treatment in a cohort of treatment‐naïve HIV patients: an interim analysis of the REMAIN study
Authors: Teófilo E , Knechten H , Antela A , Aleixo M , Santos J , Barlet M , Jimenez‐Exposito M 
Published: November 2012

PurposeCombined antiretroviral therapy has dramatically improved HIV‐infected individuals survival. Long‐term strategies are currently needed to achieve the goal of durable virologic suppression. However, long‐term available data for specific antiretrovirals (ARV) are limited. In clinical trials, boosted atazanavir (ATV/r) regimens has shown good efficacy and tolerability in ARV‐naïve patients for up to 4 years. The REMAIN study aimed to evaluate the long‐term outcomes of ATV/r regimens in ARV‐naïve patients in a real life setting.MethodsNon‐comparative, observational study conducted in Germany, Portugal and Spain. Historical and longitudinal follow‐up data was extracted six monthly from the medical record of HIV‐infected, treatment‐naïve patients, who initiated an ATV/r‐regimen between 2008 and 2010. The primary endpoint was the proportion of patients remaining on ATV treatment over time. Secondary endpoints included virologic response (HIV‐1 RNA <50 c/mL and <500 c/mL), reasons for discontinuation and long‐term safety. The duration of treatment and time to virologic failure (VF) were analyzed using the Kaplan‐Meier method. Data from an interim analysis including patients with at least one year of follow‐up are reported here.ResultsA total of 411 patients were included in this interim analysis [median (Q1, Q3) follow‐up: 23.42 (16.25, 32.24) months]: 77% male; median age 40 years [min, max: 19, 78]; 16% IDUs; 18% CDC C; 18% hepatitis C. TDF/FTC was the most common backbone (85%). At baseline, median (Q1, Q3) HIV‐RNA and CD4 cell count were 4.91 (4.34, 5.34) log10 c/mL and 256 (139, 353) cells/mm3, respectively. The probability of remaining on treatment was 0.84 (95% CI: 0.80, 0.87) and 0.72 (95% CI: 0.67, 0.76) for the first and second year, respectively. After 2 years of follow‐up, 84% (95% CI: 0.79, 0.88) of patients were virologically suppressed (<50 c/mL). No major protease inhibitors mutations were observed at VF. Overall, 125 patients (30%) discontinued ATV therapy [median (Q1, Q3) time to discontinuation: 11.14 (6.24, 19.35) months]. Adverse events (AEs) were the main reason for discontinuation (n = 47, 11%). Hyperbilirubinaemia was the most common AE leading to discontinuation (14 patients). No unexpected AEs were reported.ConclusionsIn a real life clinical setting, ATV/r regimens showed durable virologic efficacy with good tolerability in an ARV‐naïve population. Data from longer follow‐up will provide additional valuable information.
Rilpivirine efficacy, virology and safety in ARV treatment‐naïve patients with viral load≤100,000 HIV‐1 RNA c/mL: ECHO and THRIVE 96‐week results
Authors: Molina J‐M , Clumeck N , Orkin C , Rimsky L , Vanveggel S , Stevens M 
Published: November 2012

BackgroundIn the ECHO and THRIVE Phase III, randomised, double‐blind trials, rilpivirine (RPV, TMC278, EDURANT) 25 mg qd showed non‐inferiority compared to efavirenz (EFV) 600 mg qd in antiretroviral (ARV) treatment‐naïve, HIV‐1‐infected adults at Weeks 48 and 96. In Europe, RPV combined with other ARVs is approved for the treatment of ARV‐naïve adults with a viral load (VL) ≤100,000 c/mL. We present results from a pooled analysis of Week 96 data from this patient subgroup.MethodsPatients received RPV 25 mg qd or EFV 600 mg qd, both with TDF/FTC (ECHO) or TDF/FTC, AZT/3TC or ABC/3TC (THRIVE). Response rate (% VL <50 c/mL, intent‐to‐treat‐time‐to‐loss‐of‐virologic response [ITT‐TLOVR]), virologic failure in the resistance analysis (VFres) and resistance development, as well as safety and tolerability were evaluated.ResultsBaseline characteristics were similar between the 368 RPV and 329 EFV patients with baseline VL ≤100,000 c/mL. At Week 96, response rates (RPV 84% vs EFV 80%; difference 4.0% [95% CI: −1.7%, 9.7%]) and VFres percentages (8% vs 6%, respectively; p=0.46) (Table) were similar in each treatment group. A comparable proportion of VFres developed NNRTI resistance‐associated mutations (RAMs) in each group. More RPV than EFV VFres developed N(t)RTI RAMs (p=0.02). The increase in mean (95% CI) CD4+ cell count from baseline to Week 96 was 224 (208; 240) cells/mm3 for RPV and 206 (188; 225) cells/mm3 for EFV. Treatment‐related grade 2–4 overall AEs, any rash, and neurologic AEs, including dizziness were less frequent for RPV than EFV (all p<0.0001, Fisher's Exact test) (Table).

RPV N=368
EFV N=329

All
Up to Week 48
Weeks 48–96
All
Up to Week 48
Weeks 48–96

Resistance at time of failure

VFres, n (%)
28 (7.6)
20 (5.4)
7 (1.9)
20 (6.1)
14 (4.3)
6 (1.8)

VFres with genotypic data
N’=27
N’=19
N’=7
N’=17
N’=11
N’=6

developing NNRTI RAMs, n
10
7
2
6
5
1

developing N(t)RTI RAMs, n
12
8
3
2
2
0

Safety

AEs leading to discontinuation, n (%)
18 (4.9)
13 (3.5)
3 (0.8)
22 (6.7)
18 (5.5)
2 (0.6)

Grade 2–4 AEs at least possibility related to treatment,  n (%)
66 (17.9)
56 (15.2)
5 (1.4)
104 (32)
97 (29.5)
12 (3.6)

AEs of interest at least possibly related to treatment, n (%)

Any neurological AE
70 (19.0)
67 (18.2)
1 (0.3)
135 (41.0)
132 (40.1)
2 (0.6)

Dizziness
35 (9.5)
35 (9.5)
0
97 (29.5)
97 (29.5)
1 (0.3)

Any psychiatric AE
61 (16.6)
54 (14.7)
2 (0.5)
75 (22.8)
68 (20.7)
5 (1.5)

Abnormal dreams/nightmares
27 (7.3)
25 (6.8)
0
38 (11.6)
36 (10.9)
1 (0.3)

Rash (grouped term)
9 (2.4)
8 (2.2)
1 (0.3)
43 (13.1)
43 (13.1)
0

ConclusionsAt Week 96, in ARV treatment‐naïve adults with baseline VL ≤100,000 c/mL, RPV demonstrated sustained antiviral efficacy similar to EFV. There were similar frequencies of RPV and EFV VFres, and RPV had a more favourable safety/tolerability profile than EFV.
Sustained virological response on second‐line antiretroviral therapy following virological failure in HIV‐infected patients in rural South Africa
Authors: Schoffelen A , Wensing A , Tempelman H , Geelen S , Hoepelman A , Barth R 
Published: November 2012

Purpose of the studyOver the last decade, a massive roll‐out of antiretroviral drugs in resource‐limited settings has taken place. In general, good virological responses on first‐line antiretroviral therapy (ART) are achieved in most HIV‐infected patients residing there. Still, a growing number of patients experience virological failure over time, resulting in an increasing need for second‐line regimens [1]. This study describes the clinical, immunological and virological efficacy of protease inhibitor (PI)‐based second‐line ART in a clinic in rural South Africa.MethodsAn observational cohort study was performed on 210 patients (including 39 children) who initiated PI‐based second‐line ART at least 12 months prior to data collection. Biannual clinical, immunological and virological monitoring was performed. Primary endpoints were adequate virological response (HIV‐RNA<400 copies/ml), full virological suppression (HIV‐RNA<50 copies/ml), virological failure (HIV‐RNA>1000 after initial virological response) and on‐going viremia (HIV‐RNA never<400 copies/ml for more than six months). Data were analyzed by an on‐treatment (OT) and intention‐to‐treat (ITT) approach.ResultsMedian duration of follow‐up after switch to second‐line treatment was 21 months [IQR 14–37]. 150/210 patients (71%, ITT) were in care and on treatment at the end of follow‐up and 16/210 (8%, ITT) had died. After twelve months, an adequate virological response was seen in 106/143 patients (74%, OT), of which 86/143 (60%, OT) experienced full virological suppression and 20/143 (14%, OT) showed persisting low‐level viremia (HIV‐RNA between 50 and 400 copies/ml). Furthermore, virological responses remained stable after 24 months of second‐line ART. Virological efficacy was similar amongst adult and pediatric patients. Median increase in CD4 counts from switch until end of follow‐up was 145 cells/mm3 [IQR 1–397] in adults. As in first‐line ART, we observed a lack of correlation between virological treatment failure and WHO‐defined immunological failure in PI‐based therapy.ConclusionsPromising virological outcomes are achieved with PI‐based, second‐line antiretroviral therapy in adult and pediatric patients in rural South Africa. Results were sustainable during the two‐year follow‐up period with a high retention rate, although persisting low‐level viremia occurred in a subset of patients. The observed viro‐immunological dissociation emphasizes the need for virological monitoring.