scholarly journals Patient-Reported Outcomes Through 1 Year of an HIV-1 Clinical Trial Evaluating Long-Acting Cabotegravir and Rilpivirine Administered Every 4 or 8 Weeks (ATLAS-2M)

2021 ◽  
Author(s):  
Vasiliki Chounta ◽  
Edgar T. Overton ◽  
Anthony Mills ◽  
Susan Swindells ◽  
Paul D. Benn ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Patient Reported Outcomes ◽  
Patient Reported ◽  
Long Acting ◽  
Hiv 1

Patient-reported outcomes for HIV: the future of long-acting injectables and antiretroviral therapy evaluations

2021 ◽  
Author(s):  
Richard Leong ◽  
Leon Owusu ◽  
Jerrica Tang ◽  
Neeraj John ◽  
Kira E Voyer ◽  
...  
Keyword(s):  
Antiretroviral Therapy ◽  
Treatment Satisfaction ◽  
Patient Reported Outcomes ◽  
Potential Role ◽  
Drug Regimen ◽  
Patient Reported ◽  
Immunodeficiency Virus ◽  
Long Acting ◽  
Hiv 1 ◽  
Human Immunodeficiency Virus 1

Patient-reported outcomes (PROs) are an increasingly important aspect of patient care, as they offer a perspective from the patient themselves in the treatment and management of a particular disease state. They have a potential role in helping clinicians select an appropriate drug regimen in human immunodeficiency virus-1 (HIV-1)-infected individuals, as well as those with HIV/hepatitis C (HCV) co-infection. They can also provide insight for individuals receiving long-acting (LA) injectable antiretroviral therapy (ART). Studies found from PROs that participants on an LA injectable ART regimen reported greater preference and treatment satisfaction compared with those on an oral ART regimen. Some additional studies have also used PROs to evaluate the switch to single-tablet regimens and compare different ART in treating HIV-1. Current PROs and how they can be improved for LA injectables were also discussed.

scholarly journals 1035. Patient-Reported Outcomes on Long-Acting Cabotegravir + Rilpivirine as Maintenance Therapy: FLAIR 96-Week Results

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S548-S548
Author(s):  
Vasiliki Chounta ◽  
Enrique Bernal ◽  
Johan Lombaard ◽  
Harold P Katner ◽  
Sharon Walmsley ◽  
...  
Keyword(s):  
Treatment Satisfaction ◽  
Patient Reported Outcomes ◽  
Hiv Treatment ◽  
Virologic Suppression ◽  
Research Support ◽  
Treatment Groups ◽  
Patient Reported ◽  
The Difference ◽  
Long Acting ◽  
Hiv 1

Abstract Background In the phase 3 FLAIR study, switching to monthly injectable long-acting (LA) cabotegravir (CAB) + rilpivirine (RPV) was noninferior to continued daily oral dolutegravir/abacavir/lamivudine (DTG/ABC/3TC) for the maintenance of virologic suppression over 96 weeks in adults with HIV-1. Key patient-reported outcomes (PROs) through Week 96 are presented. Methods In FLAIR, ART-naive adult participants received induction therapy with oral DTG/ABC/3TC for 20 weeks. Those with HIV-1 RNA < 50 c/mL at 16 weeks were randomized (1:1) to continue DTG/ABC/3TC or receive monthly CAB + RPV LA injections after a 4-week lead-in with daily oral CAB + RPV through Week 96. Treatment satisfaction (HIV Treatment Satisfaction Questionnaire status version [HIVTSQs]) and acceptability of injections (Perception of Injection [PIN] Questionnaire) up to Week 96 were secondary endpoints. Results A total of 566 participants were randomized (median age, 34 years; 22% female); baseline characteristics were similar between treatment groups. At Week 96, significantly greater improvement from baseline in total treatment satisfaction score was observed in the CAB + RPV LA vs DTG/ABC/3TC treatment group (adjusted mean difference, 2.3 [95% CI, 1.1-3.5]; P< 0.001), further increasing from Weeks 24 (2.1 [0.9-3.3]) and 44 (0.7 [−0.4, 1.9]). Key drivers for the difference in HIVTSQs between treatment groups were items assessing convenience, flexibility, and satisfaction to continue with LA therapy. In participants receiving CAB + RPV LA, mean score for the “Acceptability of ISRs” dimension of PIN (scale, 1-5) significantly decreased (improved) from Week 5 to Weeks 41, 48, and 96 (2.08 to 1.71, 1.66, and 1.71, respectively; P< 0.001 for all). In addition, 82% and 85% of LA participants, respectively, rated pain and local reactions due to injections as “totally” or “very acceptable” at Week 96. Conclusion At Week 96, FLAIR participants receiving LA therapy reported greater improvement in treatment satisfaction compared with participants continuing on daily oral medication as well as overall good acceptability of injections with improvement over time. Overall, these results support monthly CAB + RPV LA as an alternative to daily oral regimens for adults with HIV-1. Disclosures Vasiliki Chounta, MSc, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee) Sharon Walmsley, FRCPC, MD, MSC, GSK (Grant/Research Support)ViiV Healthcare (Grant/Research Support) David Dorey, MMATH, GlaxoSmithKline Inc. (Employee, Shareholder) William Spreen, PharmD, ViiV Healthcare (Employee, Shareholder) Sandy Griffith, PharmD, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee) David Margolis, MD, MPH, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee)

Comparison of a Novel Tazarotene 0.045% Lotion to Tazarotene 0.1% Cream: Patient-Reported Outcomes from a Phase 2 Clinical Trial

2019 ◽  
Vol 3 ◽  
pp. S9
Author(s):  
Zoe Draelos ◽  
Fran Cook-Bolden ◽  
Lawrence Green ◽  
Eric Guenin ◽  
Gina Martin ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Patient Reported Outcomes ◽  
Phase 2 ◽  
Patient Reported ◽  
Phase 2 Clinical Trial

Abstract not available.

scholarly journals Longitudinal Analysis of Patient-Reported Outcomes in Clinical Trials: Applications of Multilevel and Multidimensional Item Response Theory

Psychometrika ◽  
2021 ◽  
Author(s):  
Li Cai ◽  
Carrie R. Houts
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Latent Variable ◽  
Patient Reported Outcomes ◽  
Multilevel Models ◽  
Latent Variable Models ◽  
Trial Data ◽  
Regulatory Science ◽  
Measurement Information ◽  
Patient Reported

AbstractWith decades of advance research and recent developments in the drug and medical device regulatory approval process, patient-reported outcomes (PROs) are becoming increasingly important in clinical trials. While clinical trial analyses typically treat scores from PROs as observed variables, the potential to use latent variable models when analyzing patient responses in clinical trial data presents novel opportunities for both psychometrics and regulatory science. An accessible overview of analyses commonly used to analyze longitudinal trial data and statistical models familiar in both psychometrics and biometrics, such as growth models, multilevel models, and latent variable models, is provided to call attention to connections and common themes among these models that have found use across many research areas. Additionally, examples using empirical data from a randomized clinical trial provide concrete demonstrations of the implementation of these models. The increasing availability of high-quality, psychometrically rigorous assessment instruments in clinical trials, of which the Patient-Reported Outcomes Measurement Information System (PROMIS®) is a prominent example, provides rare possibilities for psychometrics to help improve the statistical tools used in regulatory science.

scholarly journals End points for sickle cell disease clinical trials: patient-reported outcomes, pain, and the brain

2019 ◽  
Vol 3 (23) ◽  
pp. 3982-4001 ◽  
Author(s):  
Ann T. Farrell ◽  
Julie Panepinto ◽  
C. Patrick Carroll ◽  
Deepika S. Darbari ◽  
Ankit A. Desai ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Sickle Cell Disease ◽  
Sickle Cell ◽  
Patient Reported Outcomes ◽  
Cell Disease ◽  
End Points ◽  
Additional Clinical Trial ◽  
Patient Reported ◽  
The Brain

Abstract To address the global burden of sickle cell disease (SCD) and the need for novel therapies, the American Society of Hematology partnered with the US Food and Drug Administration to engage the work of 7 panels of clinicians, investigators, and patients to develop consensus recommendations for clinical trial end points. The panels conducted their work through literature reviews, assessment of available evidence, and expert judgment focusing on end points related to: patient-reported outcomes (PROs), pain (non-PROs), the brain, end-organ considerations, biomarkers, measurement of cure, and low-resource settings. This article presents the findings and recommendations of the PROs, pain, and brain panels, as well as relevant findings and recommendations from the biomarkers panel. The panels identify end points, where there were supporting data, to use in clinical trials of SCD. In addition, the panels discuss where further research is needed to support the development and validation of additional clinical trial end points.

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