PAS funded by this sponsor. EU PAS ID Status RMP requirementTitle Protocol uploaded Results uploaded 4215 Finalised Not included in RMP 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 Not included in RMP 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 Not included in RMP 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 EU RMP category 3 An Observational Drug Utilization Study of Stribild® in Adults with HIV-1 Infection Yes Yes 6987 Finalised EU RMP category 3 Viread Observational, Cross -Sectional Drug Utilisation Study in Children and Adolescents with Chronic Hepatitis B (Viread HBV DUS) Yes Yes 7814 Finalised EU RMP category 3 An Observational, Drug Utilization Study of Viread® in Children and Adolescents with HIV-1 Infection (GS-EU-104-0433) Yes No 8598 Finalised EU RMP category 3 A Randomized, Open Label, Phase 4 Study Evaluating the Renal Effect of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF or other Tenofovir... Yes Yes 9564 Finalised Not included in RMP Prospective non-interventional post authorization safety study (PASS) of idelalisib in Germany Yes Yes 11010 Finalised Not included in RMP Non-Interventional Real-Life Study of Effectiveness, Safety, Adherence, and Health-Related Quality of Life in Adult Patients receiving... Yes Yes 11074 Finalised Not included in RMP 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 Not included in RMP Risk Evaluation and Mitigation Strategy (REMS) Assessment Protocol - Zydelig (idelalisib) tablets (Zydelig REMS KAB) Yes No 12725 Finalised Not included in RMP 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 EU RMP category 3 Multicenter, Non-Interventional, Retrospective, Matched Cohort Study of Patients Monoinfected with Chronic Hepatitis B and with Moderate or Severe... Yes Yes 14114 Finalised EU RMP category 3 GS-EU-337-1820 - An Observational Drug Utilization Study of Ledipasvir/Sofosbuvir and Tenofovir Disoproxil Fumarate + Pharmacokinetic Enhancer... Yes No 15103 Finalised EU RMP category 3 Observational, Cross-Sectional Post-Authorisation Safety Study to Assess Healthcare Provider Awareness of Risks Related to Sofosbuvir and... Yes Yes 16212 Finalised Not included in RMP Prospective Non-Interventional Real-Life Study of Effectiveness, Safety, Adherence, and Health-Related Quality of Life in Adult Patients receiving... Yes Yes 16606 Finalised EU RMP category 3 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 Non-EU RMP-only 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 EU RMP category 3 Pharmacoepidemiology study to define the long-term safety profile of tenofovir disoproxil fumarate (Tenofovir DF, Viread®) and describe the management... Yes Yes 19479 Finalised EU RMP category 3 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 EU RMP category 3 Non-interventional study to assess the safety profile of idelalisib in patients with refractory follicular lymphoma (FL) Yes Yes 19711 Finalised Not included in RMP Non-interventional retrospective study evaluating the real-life idelalisib use in the population enrolled in the French cohort Temporary Authorization... Yes Yes 22185 Ongoing Not included in RMP 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 EU RMP category 3 Adherence, HIV-1 Infection, Resistance, and Renal and Skeletal Adverse Event in Individuals Taking Emtricitabine/Tenofovir Disoproxil Fumarate... Yes Yes 24374 Finalised EU RMP category 3 A Prospective, Observational Study of Individuals Who Seroconvert While Taking Truvada for Pre-Exposure Prophylaxis (PrEP) Yes Yes 28523 Finalised EU RMP category 3 Quantitative Testing of Healthcare Provider Knowledge about YESCARTA® (axicabtagene ciloleucel) Risk Minimisation Measures Yes Yes 30818 Finalised EU RMP category 3 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 Not included in RMP A Multicenter, Multi-countiy Retrospective Cohort Study to Evaluate the Clinical Outcomes in Adults with Severe COVID-19 Yes Yes 35465 Finalised Not included in RMP 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 Not included in RMP A Retrospective Observational Cohort Study to Evaluate the Effectiveness of Azacitidine Monotherapy in Treatment-naive Patients With Intermediate,... Yes Yes 38678 Ongoing EU RMP category 3 A Multinational Observational Registry Collecting Data on the Profile of Patients with Chronic Hepatitis D Virus Infection Receiving Treatment with... Yes No 41657 Finalised Not included in RMP 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 EU RMP category 3 COVID-19 International Drug Pregnancy Registry (COVID-PR) No No 104818 Ongoing Not included in RMP A Multi-country, Non-interventional, Retrospective Drug Utilization Study in Haematological Malignancy Patients Treated for Probable or Proven... Yes No 108061 Ongoing Not included in RMP Study of Bictegravir/Emtricitavine/Tenofovir alafenamide in HIV-1 infected naïve patients using test and treat stategy rapid-initiation model of care:... No No