Study in HIV1-Positive, Virosuppressed Patients Currently inTreatment With Ritonavir-Boosted Protease Inhibitors (PI/r) Starting Cobicistat-Boosted Darunavir (DRV/c - Rezolsta)

Janssen-Cilag S.p.A.337 enrolled

Overview

The purpose of this study is to describe the effectiveness of darunavir/cobicistat (DRV/c)-based regimens, measured as maintenance of virological suppression 48 weeks after baseline, defined as the day when the treatment with DRV/c-based regimen is started, through collection of daily practice data in the Italian setting.

Study Type

OBSERVATIONAL

Enrollment

337

Conditions

Human Immunodeficiency Virus

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult greater than or equal to (\>=18 years), male and female patients * Documented Human Immunodeficiency Virus-1 (HIV-1) infection * Eligible to darunavir/cobicistat (DRV/c) treatment according to Summary of Product Characteristics * Patients who are able to understand the nature of the study and to provide their consent voluntarily having signed an Informed Consent Form (ICF) allowing data collection and source data verification in accordance with local requirements * Patients in stable (\>= 12 months) treatment with an Antiretroviral (ARV) therapy PI/ritonavir (PI/r)-based, being prescribed Rezolsta (DRV/c) by treating physician * Patients virosuppressed (HIV-RNA less than \[\<\] 50 copies/milliliters) since at least 6 months, within their HIV treatment at the moment of enrollment; single values of HIV-RNA more than \[\>\] 50 copies/ml not confirmed (blips) will be considered acceptable; last value collected being \< 50 copies/ml Exclusion Criteria: * Patient currently enrolled in an interventional study * Patient currently enrolled in an observational study sponsored or supported by Janssen * Estimated Glomerular Filtration Rate (eGFR) \< 70 milliliters per minute (ml/min) if any co-administered agent (example emtricitabine, lamivudine, tenofovir disoproxil fumarate, or adefovir dipivoxil) requires dose adjustment based on creatinine clearance * Pregnancy or breast feeding at enrollment * Allergy or intolerance to sulphonamides * Switch from darunavir/ritonavir (DRV/r) 600/100 bis in die (bid) * Patient currently in mono PI/r therapy * Patients to be treated within one year with Direct Acting Antivirals (DAAs) for Hepatitis C Virus (HCV) infection * Chemotherapy scheduled

Outcomes

Primary Outcomes

Percentage of Patients With Human Immunodeficiency Virus - RiboNucleic Acid (HIV-RNA) Less Than (<)50 Copies/Milliliters (copies/mL) Measured at Week 48

The percentage of patients with plasma HIV-RNA\<50 copies/mL will be analyzed by FDA snapshot analysis (FDA Snapshot Approach is based on the last observed viral load data within the Week 48 window: virologic response is defined as HIV-1 RNA \<50 copies/mL (observed case); If there are no data in the defined time window, the proportion of missing data and relative reason will be provided") and Time to loss of virologic response (TLOVR) method algorithm requires sustained HIV-1 RNA \< 50 copies/mL; confirmed HIV-1 RNA more than or equal to (\>=) 50 copies/mL is considered as non-response (rebound); patients considered non-responder after permanent discontinuation).

Time frame: At Visit 4 (Week 48)

Secondary Outcomes

Change From Baseline in HIV-Symptoms Distress Module (HIV-SDM) Score

HIV-SDM is a questionnaire consisting of 20 questions related to all the symptoms which the patient might have had during the past four weeks. For each question patient has to select appropriate answer related to the symptoms: "0 = I do not have this symptom; 1 = I have this symptom and it doesn't bother me; 2 = it bothers me a little; 3 = it bothers me; 4 = it bothers me a lot".

Time frame: Baseline, Up to Visit 4 (Week 48)

Change From Baseline in HIV-Treatment Satisfaction Questionnaire (HIV-TSQ) Score

The HIV Treatment Satisfaction Questionnaire (HIV-TSQ) is a 10-item instrument that is supported by evidence of good internal consistency reliability. The total score ranges from 0 to 60, with higher scores indicating greater treatment satisfaction. Score change ranges from -30 to +30, with scores\<0 and \>0 indicating a decrease and increase in treatment satisfaction, respectively.

Time frame: Baseline, Up to Visit 4 (Week 48)

Percentage of Patients with HIV-RNA <50 copies/mL Measured at Week 24

Time frame: At Visit 3 (Week 24)

Data from ClinicalTrials.gov

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