Community oriented studies. New perspectives

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1 Community oriented studies. New perspectives

2 Swiss HIV Cohort Study Increased Viral Load Suppression in HIV+ Persons on ART Cohort size: Percent of individuals Stably suppressed Improving Unstable Failing Stable failure Interrupted Viral load categories in the Open Cohort A allowing for individuals to enter and leave the cohort Ledergerber B et al. CROI Poster 507

3 SPIRIT Patient reported outcomes at Week 24 per HIV symptom index Improvements per patient report for RPV/FTC/TDF subjects, baseline to Week 24 Percentage of Participants p< % 25.9% p< % 20.8% p< % 24.6% p< % 11.4% Baseline Week 24 p< % 19.2% p< % 25.2% 5 0 Anxiety or nervoursness Problems having sex Muscle aches or joint pain Loss appetite Difficulty falling or staying asleep Body perception P-value for comparison to baseline within each treatment group is from the McNemar test Shave A, et al. ANAC 2012; Tucson, Arizona. Oral C-9

4 From EFV to RPV: QoL Nelson M, et al. 53 rd ICAAC, Denver, Sep Abstract H-672-b.

5 QoL does it matter?

6 Community and patient oriented outcomes in large ongoing cohorts QoL Acceptability Preferences Adherence Convenience Health state Satisfaction Emotional state Self esteem Behaviour

7 Incidence of sexually transmitted diseases (STD) according with plasma HIV-RNA: which implications for HIV transmission? A. Cingolani, for the Community Oriented Studies Group in Icona

8 Background Sexually Transmitted Diseases (STD) can increase the shedding of HIV in semen, leading to an increase of HIV transmission (Johnson LF, Sex Transm Dis 2008) This aspect has been well demonstrated in people not assuming cart, whereas little is known whether the same increased risk is applicable to people on fully-suppressive cart. Considering that more than 85% of cart treated patients in Italy are nowaday on a fully suppressive cart, to undertand the epidemiologic evolution of STD within a cohort of HIV infected patients over the last 15 years, particularly in patients with undetectable plasma HIV-RNA, could represent an important issue for STD prevention program as intervention for reduction of HIV transmission.

9 Objectives To analyze temporal trend of any incident STD, according with plasma HIV-RNA level in the entire period of the Icona cohort. To evaluate factors associated with a new diagnosis of STD in patients according with level of HIV-RNA To analyze the role of cart on the onset of STD during time

10 Methods All HIV-infected patients enrolled in Icona Foundation Study from 1997 STD is defined as any-stage syphilis (primary, secondary, latent, tertiary, and unspecified), HPV-related diseases, urethritis (gonococcal, non-gonococcal), HSV-related genital ulcers, any genital ulcer disease not otherwise specified, vaginitis (trichomonas, bacteric, not specified, acute HBV- HAV-and HCVinfection (these two infections in the subset of MSM of the cohort) Data on STD are available at enrollment and they are updated at the occurrence of any clinical event or, in their absence, at least every 6 months STDs incidence rate (IR) were calculated according to current plasma viral load level (VL, 0-50, , ,000, 10, ,000, >100,001/mmc) and calendar period ( , , ). Predictors of STD occurrence were estimated using Poisson regression. Sandwich estimates were used when people had more than one event. As covariates will be used demographical, epidemiological and clinically relevant variables recorded in the database

11 Men, (%) Age, mean (SD) General characteristics of patients developing a STD (n=811 pts) during pyfu HIV transmission route (%) MSM IDU Heterosexual Other/unknown Ethnicity, (%) caucasian African-American Hispanic Asian Education, (%) primary middle school high school degree missing Crude IR: 17.3/1000 pyfu CD4 cell count levels/mmc, (%) < > Median CD4 cell count/mmc, (IQR) Plasma HIV-RNA levels/ml, (%) < > On cart, (%)

12 Increase of incidence in recent years in patients with high HIV-RNA (p-value for interaction p<0.001 * IRRs adjusted for mode of HIV transmission, current CD4, years from HIV+ test, year of enrollment, and instruction level

13 Predictors of STD occurrence Gender Women Men IRR 95%CI p Older age (10 y more) <0.001 HIV transmission route IDU MSM Heterosexual Other/unknown Plasma HIV-RNA group <50/mmc > CD4 cell count/mmc > <100 y from HIV diagnosis (for each y more) <0.001 <0.001 < <0.001 <0.001 < < <0.001 Y of enrollment Education primary middle high degree unknown 1 (ref.)

14 Conclusions The overall incidence of STD remained high even in the last years, particularly in patients with virologically uncontrolled HIV infection. A current low level of plasma HIV-RNA was associated with a lower risk of STD This may be due to a protective effect of viroimmunological response against the risk of acquiring some STD A possibly increased sexual risky behaviors in nonadherent patients may be the driver of the increased incidence of STD at high viral load. These patients could contribute to the spread of HIV infection. According to our findings, TasP could represent a further potential intervention in patients at risk for STD

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