Gilead Sciences

This sponsor has funded 35 studies across 46 countries.

PAS funded by this sponsor.
EU PAS ID Status Title Protocol uploaded Results uploaded
4215 Finalised VIR-Life: Prospective assessment of the real-life treatment outcomes of six years of Viread® in CHB following-up on the German Multicenter... Yes Yes
5440 Finalised Impact of single tablet regimens on adherence and prescription errors? How big an issue and how relevant in both clinical and economic terms (iSTRAP) Yes Yes
6118 Finalised Real-life study of single tablet regimen (STR) and multi tablet regimen (MTR) usage in Germany on persistency of initial therapy - STRingent Yes Yes
6524 Finalised An Observational Drug Utilization Study of Stribild® in Adults with HIV-1 Infection Yes Yes
6987 Finalised Viread Observational, Cross -Sectional Drug Utilisation Study in Children and Adolescents with Chronic Hepatitis B (Viread HBV DUS) Yes Yes
7814 Finalised An Observational, Drug Utilization Study of Viread® in Children and Adolescents with HIV-1 Infection (GS-EU-104-0433) Yes No
8598 Finalised A Randomized, Open Label, Phase 4 Study Evaluating the Renal Effect of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF or other Tenofovir... Yes Yes
9564 Finalised Prospective non-interventional post authorization safety study (PASS) of idelalisib in Germany Yes Yes
11010 Finalised Non-Interventional Real-Life Study of Effectiveness, Safety, Adherence, and Health-Related Quality of Life in Adult Patients receiving... Yes Yes
11074 Finalised A Prospective cohort study on the use of Sofosbuvir-based regimens in HCV-infected patients in clinical practice in France (HELIOS) Yes Yes
11551 Finalised Risk Evaluation and Mitigation Strategy (REMS) Assessment Protocol - Zydelig (idelalisib) tablets (Zydelig REMS KAB) Yes No
12725 Finalised An observational cohort study to evaluate the impact of the tenofovir-based single tablet regimens on adherence, quality of life and... Yes Yes
12897 Finalised Multicenter, Non-Interventional, Retrospective, Matched Cohort Study of Patients Monoinfected with Chronic Hepatitis B and with Moderate or Severe... Yes Yes
14114 Finalised GS-EU-337-1820 - An Observational Drug Utilization Study of Ledipasvir/Sofosbuvir and Tenofovir Disoproxil Fumarate + Pharmacokinetic Enhancer... Yes No
15103 Finalised Observational, Cross-Sectional Post-Authorisation Safety Study to Assess Healthcare Provider Awareness of Risks Related to Sofosbuvir and... Yes Yes
16212 Finalised Prospective Non-Interventional Real-Life Study of Effectiveness, Safety, Adherence, and Health-Related Quality of Life in Adult Patients receiving... Yes Yes
16606 Finalised A Cross-Sectional Post-Authorization Safety Study to Assess Healthcare Provider Awareness of Risks Associated with Zydelig® in the European Union Yes Yes
17875 Finalised A Long Term Follow-up Registry for Adolescent and Pediatric Subjects Who Received a Gilead Hepatitis C Virus Direct Acting Antiviral (DAA) in... Yes Yes
18825 Finalised Pharmacoepidemiology study to define the long-term safety profile of tenofovir disoproxil fumarate (Tenofovir DF, Viread®) and describe the management... Yes Yes
19479 Finalised GS-EU-276-4027: A Cross Sectional Post Authorization Safety Study to Assess Healthcare Provider’s Level of Awareness of Risk Minimisation Materials... Yes Yes
19618 Finalised Non-interventional study to assess the safety profile of idelalisib in patients with refractory follicular lymphoma (FL) Yes Yes
19711 Finalised Non-interventional retrospective study evaluating the real-life idelalisib use in the population enrolled in the French cohort Temporary Authorization... Yes Yes
22185 Ongoing Multi-country, non-interventional, cohort study of the effectiveness, safety, adherence, and health-related quality of life in HIV-1 infected adult... Yes No
24332 Finalised Adherence, HIV-1 Infection, Resistance, and Renal and Skeletal Adverse Event in Individuals Taking Emtricitabine/Tenofovir Disoproxil Fumarate... Yes Yes
24374 Finalised A Prospective, Observational Study of Individuals Who Seroconvert While Taking Truvada for Pre-Exposure Prophylaxis (PrEP) Yes Yes
28523 Finalised Quantitative Testing of Healthcare Provider Knowledge about YESCARTA® (axicabtagene ciloleucel) Risk Minimisation Measures Yes Yes
30818 Finalised A study to evaluate the risk of de novo hepatocellular carcinoma in patients with compensated cirrhosis treated with direct-acting antivirals for... Yes Yes
34303 Finalised A Multicenter, Multi-countiy Retrospective Cohort Study to Evaluate the Clinical Outcomes in Adults with Severe COVID-19 Yes Yes
35465 Finalised A Multi-center, Longitudinal, Clinical Real-World Study to Evaluate Mortality and Clinical Outcomes in Hospitalized Adults with COVID-19 Infection in... Yes No
38242 Finalised A Retrospective Observational Cohort Study to Evaluate the Effectiveness of Azacitidine Monotherapy in Treatment-naive Patients With Intermediate,... Yes Yes
38678 Ongoing A Multinational Observational Registry Collecting Data on the Profile of Patients with Chronic Hepatitis D Virus Infection Receiving Treatment with... Yes No
41657 Finalised Direct-acting antivirals (DAAs) for the treatment of chronic hepatitis C virus (HCV) infection and the risk of hepatocellular carcinoma (HCC)... Yes Yes
42517 Ongoing COVID-19 International Drug Pregnancy Registry (COVID-PR) No No
104818 Ongoing A Multi-country, Non-interventional, Retrospective Drug Utilization Study in Haematological Malignancy Patients Treated for Probable or Proven... Yes No
108061 Ongoing Study of Bictegravir/Emtricitavine/Tenofovir alafenamide in HIV-1 infected naïve patients using test and treat stategy rapid-initiation model of care:... No No

PAS by Risk Management Plan (RMP) requirement

Gilead Sciences

The RMP for a medical product outlines strategies to identify, assess, and mitigate risks, including PAS for further evaluation.

Category 1 studies are imposed as condition of marketing authorisation.
Category 2 studies are imposed as specific obligation of marketing authorisation.
Category 3 studies are required under other circumstances.