An Italian Observation of Antiretroviral Treatment in Participants Taking Darunavir/ Cobicistat Plus Emtricitabine and Tenofovir Alafenamide Fumarate

Janssen-Cilag S.p.A.246 enrolled

Overview

The purpose of this study is to describe the effectiveness of Darunavir/ Cobicistat/ Emtricitabine/ Tenofovir Alafenamide (D/C/F/TAF), measured as virological response at Week 48 as per Food and Drug Administration (FDA) snapshot algorithm through collection of daily practice data in the Italian setting.

Study Type

OBSERVATIONAL

Enrollment

246

Conditions

Human Immunodeficiency Virus (HIV)

Interventions

D/C/F/TAF Fixed-Dose Combination (FDC)DRUG

Participants in treatment with D/C/F/TAF FDC, coming from different treatment histories will be observed in this study. No interventions will be administered as a part of this study.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Having a confirmed diagnosis of Human Immunodeficiency Virus-1 (HIV-1) * Must sign a participation agreement/Informed Consent Form (ICF) allowing data collection and source data verification in accordance with local requirements * Taking Darunavir/ Cobicistat/ Emtricitabine/ Tenofovir Alafenamide (D/C/F/TAF) as per Summary of Product Characteristics (SmPCs) since at least one month before enrollment: i) Experienced participants \[Group 1 and 2\]: a) started their antiretroviral (ARV) treatment not before 1/1/2015, b) having at least 1 year of ARV treatment history at study enrollment, c) Group 1, having always been treated with Darunavir (DRV) since the start of ARV treatment as naïve, d) Group 2, not having been treated with DRV before starting of D/C/F/TAF, ii.) Naive (any Viral Load (VL) participants (Group 3) Exclusion Criteria: * Participants unable to read, to write, to understand and sign the ICF * Currently enrolled in an interventional study * Currently enrolled in an observational study sponsored or supported by Janssen * Chemotherapy scheduled during study observation

Locations (18)

Azienda Ospedaliera Papa Giovanni XXIII

Bergamo, Italy

Azienda Ospedaliera Spedali Civili di Brescia

Brescia, Italy

Outcomes

Primary Outcomes

Percentage of Participants with Virological Response at Week 48

Percentage of participants with virologic response defined as plasma Human Immunodeficiency Virus-Ribonucleic Acid (HIV-RNA) Viral Load (VL) less than (\<) 50 copies per milliliter (cp/mL) measured according to Food and Drug Administration (FDA) snapshot algorithm will be reported.

Time frame: At Week 48

Secondary Outcomes

Participant's Previous Antiretroviral (ARV) Treatment History Determined Using the Web-Based Electronic Case Report Form (eCRF)

Participants previous antiretroviral (ARV) treatment history will be determined using the web-based electronic case report form (eCRF) which will be prepared based on the study flow chart.

Time frame: At Baseline (Visit 1)

Time to Virosuppression

For participants entering with VL greater than (\>) 50cp/mL, the time to virosuppression will be recorded.

Time frame: At Baseline (Visit 1)

Number of Participants with Detectability Below Level of Quantification <50 copies/mL

Number of participants with detectability below level of quantification \<50 copies/mL will be reported.

Time frame: At Baseline (Visit 1)

Cluster Differentiation 4 (CD4) Cells Nadir Count

CD4 cells nadir count will be reported.

Time frame: At Baseline (Visit 1)

CD4 Cell Count

CD4 cells count will be reported.

Time frame: At Baseline (Visit 1)

Cluster Differentiation 4/ Cluster Differentiation 8 (CD4/CD8) Ratio

Data from ClinicalTrials.gov

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ASST Valle Olona - P.O. di Busto Arsizio

Busto Arsizio, Italy

Ente Ospedaliero Ospedeli Galliera

Genova, Italy

Ospedale San Raffaele

Milan, Italy

Ospedale San Paolo Clinica Universitaria Malattie Infettive E Tropicali

Milan, Italy

A.O. Ospedale L. Sacco - Polo Universitario

Milan, Italy

Div Malattie Infettive - Ospedale L. Sacco

Milan, Italy

Azienda Ospedaliero Universitaria di Cagliari - Policlinico Duilio Casula di Monserrato

Monserrato, Italy

Azienda Ospedaliera dei Colli - P.O. 'D. Cotugno'

Naples, Italy

...and 8 more locations

CD4/CD8 ratio will be reported.

Time frame: At Baseline (Visit 1)

Percentage of Participants with VL<50cp/mL Measured by the FDA Snapshot Algorithm and Stratified by Age

The percentage of participants having virological response defined as plasma HIV-RNA VL\< 50 cp/mL measured by the FDA snapshot algorithm, stratified by age \[\<50, greater than (\>) 50 and \< 65, \> 65 years according to participants' number\] will be reported.

Time frame: Up to Week 48

Percentage of Participants with VL < 50 cp/mL Measured by the FDA Snapshot Algorithm and Stratified by Gender at Birth

The percentage of participants having virological response defined as plasma HIV-RNA VL\< 50 cp/mL measured by the FDA snapshot algorithm, stratified by gender at birth will be reported.

Time frame: Up to Week 48

Percentage of Participants with VL < 50 cp/mL Measured by the FDA Snapshot Algorithm and Stratified by Original Group

The percentage of participants having virological response defined as plasma HIV-RNA VL\< 50 cp/mL measured by the FDA snapshot algorithm, stratified by original group will be reported.

Time frame: Up to Week 48

Percentage of Participants Withdrawing From the Study for any Reason

The percentage of participants withdrawing from the study for any reason will be reported.

Time frame: Up to Week 48

Percentage of Participants who are Virologic Responders (VL<50 cp/mL) Measured by the Time to Loss of Virological Response (TLOVR) Algorithm

The percentage of participants having virological response defined as VL\< 50 cp/mL, measured by the TLOVR algorithm dataset will be reported. In the TLOVR dataset, participant responses at a specified threshold of HIV-1 RNA (\<50 copies/mL) are determined by using the Food and Drug Administration's TLOVR algorithm. Using the TLOVR algorithm, participants are considered to have failed on therapy if they never achieved confirmed RNA levels below the threshold, if they had confirmed rebound of RNA above the threshold, if they made a non-permitted change in background regimen, or if they permanently discontinued investigational product for any reason.

Time frame: Up to Week 48

Percentage of Participants with Virological Failure in Virosuppressed Participants

Percentage of participants with virological failure (two consecutive measures of VL greater than or equal to (\>=) 50cp/mL) in virosuppressed participants with virological rebound will be calculated and reported.

Time frame: Up to Week 48

Change from Baseline in Human Immunodeficiency Virus-Treatment Satisfaction Questionnaire Score (HIV-TSQs) at Week 48

The HIV-TSQ is a 10-item self-reported scale that measures overall satisfaction with treatment by specific items that includes current treatment, control, side effects, demands, convenience, flexibility, understanding, lifestyle, recommend to others, continue. The HIV-TSQ items are summed up to produce a treatment satisfaction total score (0 to 60) and an individual satisfaction rating for each item (0 to 6). The higher the score, the greater the improvement in treatment satisfaction as compared to the past few weeks. A smaller score represents a decline in treatment satisfaction compared to the past few weeks. HIV-TSQs will be recorded onto paper forms and will be considered as source data.

Time frame: Baseline and Week 48

Change from Baseline in Participants Reported Outcome Based on Narrative Plots at Week 48

Narrative plots will be recorded onto paper forms and will be considered as source data to describe the participants experience during treatment.

Time frame: Baseline and Week 48