Odefsey (emtricitabine/rilpivirine/tenofovir alafenamide) / J&J, Gilead - LARVOL DELTA

Adherence and Forgiveness of Two Modern ART Regimens: Lamivudine/Dolutegravir and Emtricitabine/Tenofovir Alafenamide/Rilpivirine. (PubMed, J Acquir Immune Defic Syndr) - "In this study, we found a similar and high level of forgiveness with the INSTI-based 2-drug regimen 3TC/DTG and the NNRTI-based 3-drug regimen FTC/TAF/RPV."

Journal • Observational data • Retrospective data • Human Immunodeficiency Virus • Infectious Disease • CD4

Metabolic Outcomes of Changing From Rilpivirine/Tenofovir Disoproxil Fumarate/Emtricitabine to Rilpivirine/Tenofovir Alafenamide/Emtricitabine: A Longitudinal Study. (PubMed, Health Sci Rep) - "A gradually higher prevalence of metabolic syndrome among PLWH occurred with changes from RPV/TDF/FTC to RPV/TAF/FTC but plateaued beyond 2 years. However, fewer drugs for dyslipidemia, diabetes, and hypertension were prescribed within the first year after changing cART."

Journal • Observational data • Cardiovascular • Diabetes • Dyslipidemia • Human Immunodeficiency Virus • Hypertension • Infectious Disease • Metabolic Disorders

Rapid Detection of Entamoeba histolytica Using FilmArray Gastrointestinal Panel: Enhancing Early Treatment and Outcomes. (PubMed, Clin Lab) - "This case underscores the critical role of the FilmArray GI Panel in the rapid detection of E. his-tolytica, facilitating timely and effective treatment. Early diagnosis using advanced molecular diagnostics significantly improves patient outcomes and should be incorporated into routine clinical practice for managing gastrointestinal infections."

Journal • Gastroenterology • Gastrointestinal Disorder • Human Immunodeficiency Virus • Immunology • Infectious Disease • Pain • CRP

Effectiveness, safety, and patient-reported outcomes of emtricitabine/tenofovir alafenamide-based regimens for the treatment of HIV-1 infection: Final 24-month results from the prospective German TAFNES cohort study. (PubMed, HIV Med) - "Real-world data confirmed a favorable safety profile and high virologic effectiveness with high treatment satisfaction on F/TAF-based ART."

Journal • Patient reported outcomes • Chronic Kidney Disease • Human Immunodeficiency Virus • Infectious Disease • Nephrology • Renal Disease • CD4

Impact of switching to injectables cabotegravir and rilpivirine on sleep disturbances in a cohort of people living with HIV. (PubMed, HIV Res Clin Pract) - "Baseline antiretroviral regimens were mostly: tenofovir alafenamide/emtricitabine/rilpivirine (39.1%) and dolutegravir/lamivudine (32.6%). Despite integrase inhibitor have been associated with SD, we did not observed a negative impact on sleep quality after the switch to ICAB/RPV. More studies and with larger number of people are necessary to confirm our results."

Journal • CNS Disorders • Human Immunodeficiency Virus • Infectious Disease • Insomnia • Sleep Disorder • CD4

Acute IRIS-Related HBV Flare Unmasked After Antiretroviral Therapy Initiation in a HIV/HBV Coinfected Patient (ACG 2023) - "ART was continued but switched to Rilpivirine/Tenofovir Alafenamide/Emtricitabine, considering the hypothetical risk of hepatotoxicity from Bictegravir/Emtricitabine/Tenofovir Alafenamide. Management usually involves continuation of ART targeting both viruses as discontinuation could worsen the flare and increase the risk of drug resistance with steroids reserve for severe cases only. Figure: Liver biopsy showing acute inflammation with lymphocyte predominance (Hematoxylin & Eosin stain)"

Clinical • Cholestasis • Hepatitis B • Hepatitis C • Hepatology • Human Immunodeficiency Virus • Immunology • Infectious Disease • Inflammation • Musculoskeletal Pain • CD4

Acute Immune Reconstitution Inflammatory Syndrome-HBV Flare in an HIV/HBV Coinfected Patient After Antiretroviral Therapy Initiation: Case Report and Literature Review. (PubMed, Am J Case Rep) - "He came to establish care and was started on bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF)...ART was switched to rilpivirine/emtricitabine/tenofovir alafenamide (RPV/FTC/TAF), considering the hypothetical risk of hepatotoxicity from BIC/F/TAF...Liver biopsy is indicated for definitive diagnosis. ART directed against both viruses should be continued."

Journal • Review • Hepatitis B • Hepatitis C • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Inflammation • Musculoskeletal Pain

Bictegravir/Emtricitabine/Tenofovir Alafenamide Plus Doravirine in Highly Treatment-Experienced Men With Multidrug-Resistant HIV. (PubMed, AIDS) - "Switching from RPV/FTC/TAF plus DTG to BIC/FTC/TAF plus DOR was well tolerated and efficacious in HTE men aged ≥45 years with HIV."

Journal • Human Immunodeficiency Virus • Infectious Disease

Digital Health Feedback System for Longitudinal Measurement of Medication Adherence During Anti-Retroviral (ARV)Therapy (clinicaltrials.gov) - P4 | N=100 | Active, not recruiting | Sponsor: University of California, San Diego | Trial completion date: Dec 2021 ➔ Dec 2023

Adherence • Trial completion date • Human Immunodeficiency Virus • Infectious Disease

Estimated changes in price discounts for tenofovir-inclusive HIV treatments following introduction of tenofovir alafenamide. (PubMed, AIDS) - "We estimated list and net prices for tenofovir disoproxil fumarate (TDF) products Truvada, Complera, and Stribild, and their tenofovir alafenamide (TAF) versions Descovy, Odefsey, and Genvoya. This strategy encouraged patients switching from Truvada to Descovy before the availability of generic Truvada. Conversely, Gilead offered lower discounts for Odefsey and Genvoya, which resulted into higher net prices compared to Complera and Stribild."

Journal • Human Immunodeficiency Virus • Infectious Disease

High Prevalence of Doravirine Resistance in HIV-1-Infected Patients with Virological Failure to an NNRTI-Based Single-Tablet Regimen. (PubMed, Infect Drug Resist) - "Seventy-four patients failed treatment with TDF/FTC/EFV (Atripla), 30 with TDF/FTC/RPV (Complera) and 3 with TAF/FTC/RPV (Odefsey). Our findings showed a high rate of doravirine cross-resistance in patients with NNRTI-based STR treatment failure. Doravirine should be used cautiously as a salvage regimen in patients who fail NNRTI treatment."

Journal • Human Immunodeficiency Virus • Infectious Disease

Safety and efficacy of switching to BIC/FTC/TAF plus DOR in HIV-infected patients with multiclass-resistant virus (AIDS 2022) - "With approval of the single-tablet regimen bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) and the nonnucleoside reverse transcriptase inhibitor (NNRTI) doravirine (DOR), switching patients with multiclass-resistant virus to BIC/FTC/TAF plus DOR may be beneficial as both BIC/FTC/TAF and DOR have a high barrier to resistance, no food restrictions, and low potential for DDIs and AEs. This study evaluated the safety and efficacy of switching from rilpivirine/emtricitabine/tenofovir alafenamide (RPV/FTC/TAF) plus dolutegravir (DTG), to BIC/FTC/TAF plus DOR in multiclass-resistant patients... Switching from RPV/FTC/TAF plus DTG to BIC/FTC/TAF plus DOR in HIV-infected males with multiclass-resistant virus was well tolerated and efficacious with an advantageous AE profile and no food restrictions."

Clinical • Human Immunodeficiency Virus • Infectious Disease • CD4

"I use Complera and Odefsey sometimes to avoid INSTIs if I am super concerned about it. Personally I think the jury is still out on TAF and weight gain." (@Weavofloxacin)

"👇 great 🧵about #RAFTAF study The main question is why it was stopped early by DSMB due to the futility if the number of events was fewer in the AF ablation group (HF 0.71 95% CI 0.49-1.03) @FudimMarat @FH_Verbrugge @VKutyifa @AndreasGevaert @pmyhre @SolovevaAnzhel @Mdmetzl" (@YMareev)

DSMB

"Odefsey & Pifeltro are pretty bad too..." (@LizHighleyman)

The difficulty to diagnose HIV infection in a person on pre-exposure prophylaxis: a case report (EACS 2021) - "We started the antiretroviral treatment with emtricitabine, tenofovir alafenamide, rilpivirine and dolutegravir. Also, there is no consensus about the antiretroviral selection in patients who have seroconverted while on PrEP, or specific recommendations on how to proceed in ambiguous HIV test results. Further studies of the immunovirological characteristics of this type of infections as well as the design of protocols/guidelines are warranted."

Clinical • Human Immunodeficiency Virus • Infectious Disease

Effectiveness, persistence and safety of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) and rilpivirine/emtricitabine/tenofovir alafenamide (R/F/TAF) in treatment-naïve and treatment-experienced people living with HIV (PLWH) - 24-month results of the French TARANIS cohort (EACS 2021) - "Purpose: Based on findings from clinical studies, F/TAF-based therapies are among the recommended regimens in the EACS guidelines for HIV treatment initiation since 2016.  In this French cohort, virologic effectiveness and safety of E/C/F/TAF and R/F/TAF were confirmed after 2-year follow-up with only 1% discontinuing due to lack of efficacy and 8% due to drug-related adverse events. Discontinuations were mainly attributed to non-treatment-related reasons. Emergence of resistance was rare (100,000 cp/mL, n (%) HIV-1-RNA 5%, n (%)hypertension: 52 (16.0)hyperlipidemia: 39 (12.0)neuropsychiatric disorder: 38 (11.7)cardiovascular: 21 (6.5)chronic hepatitis C: 20 (6.2)diabetes mellitus: 18 (5.5)hypertension: 4 (5.7)hyperlipidemia: 2 (2.9)neuropsychiatric disorder: 3 (4.3)cardiovascular: 3 (4.3)chronic hepatitis C: 1 (1.4)diabetes mellitus: 2 (2.9)hypertension: 48 (18.8)hyperlipidemia: 37 (14.5)neuropsychiatric disorder: 35 (13.7)cardiovascular: 18 (7.1)chronic..."

Clinical • Cardiovascular • CNS Disorders • Diabetes • Dyslipidemia • Hepatitis C • Hepatology • Human Immunodeficiency Virus • Hypertension • Infectious Disease • Inflammation • Mental Retardation • Metabolic Disorders • Psychiatry • CD4

Effectiveness, persistence and safety of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) and rilpivirine/emtricitabine/tenofovir alafenamide (R/F/TAF) in treatment-naïve and treatment-experienced people living with HIV (PLWH) - 24-month results of the French TARANIS cohort (EACS 2021) - "Purpose: Based on findings from clinical studies, F/TAF-based therapies are among the recommended regimens in the EACS guidelines for HIV treatment initiation since 2016.  In this French cohort, virologic effectiveness and safety of E/C/F/TAF and R/F/TAF were confirmed after 2-year follow-up with only 1% discontinuing due to lack of efficacy and 8% due to drug-related adverse events. Discontinuations were mainly attributed to non-treatment-related reasons. Emergence of resistance was rare (100,000 cp/mL, n (%) HIV-1-RNA 5%, n (%)hypertension: 52 (16.0)hyperlipidemia: 39 (12.0)neuropsychiatric disorder: 38 (11.7)cardiovascular: 21 (6.5)chronic hepatitis C: 20 (6.2)diabetes mellitus: 18 (5.5)hypertension: 4 (5.7)hyperlipidemia: 2 (2.9)neuropsychiatric disorder: 3 (4.3)cardiovascular: 3 (4.3)chronic hepatitis C: 1 (1.4)diabetes mellitus: 2 (2.9)hypertension: 48 (18.8)hyperlipidemia: 37 (14.5)neuropsychiatric disorder: 35 (13.7)cardiovascular: 18 (7.1)chronic..."

Clinical • Cardiovascular • CNS Disorders • Diabetes • Dyslipidemia • Hepatitis C • Hepatology • Human Immunodeficiency Virus • Hypertension • Infectious Disease • Inflammation • Mental Retardation • Metabolic Disorders • Psychiatry • CD4

Digital Health Feedback System for Longitudinal Measurement of Medication Adherence During Anti-Retroviral (ARV)Therapy (clinicaltrials.gov) - P4; N=100; Active, not recruiting; Sponsor: University of California, San Diego; Recruiting ➔ Active, not recruiting; Trial completion date: Jun 2021 ➔ Dec 2021; Trial primary completion date: Jun 2021 ➔ Dec 2021

Clinical • Enrollment closed • Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease

Impact of switching to TAF/FTC/RPV, TAF/FTC/EVG/cobi and ABC/3TC/DTG on cardiovascular risk and lipid profile in people living with HIV: a retrospective cohort study. (PubMed, BMC Infect Dis) - "No difference in the cardiovascular risk after 1 year from the switch to these STRs were observed. PLWH switched to TAF/FTC/EVG/cobi and TAF/FTC/RPV showed an increase in total cholesterol levels and body weight 12 months after the switch."

Journal • Retrospective data • Cardiovascular • Human Immunodeficiency Virus • Infectious Disease

"@CardioNerds Tardy 2🐦 #RAFTAF -Futility concerns, early termination & low events esp in EF <45%. Would use caution in drawing any conclusion wrt to primary endpoints. HF class, Biomarker, 6 min walk all improved along w EF. (CASTLE-AF & EAST AF Net 4) Rhythm control is 🔑" (@KTamirisaMD)

Biomarker

Digital Health Feedback System for Longitudinal Measurement of Medication Adherence During Anti-Retroviral (ARV)Therapy (clinicaltrials.gov) - P4; N=100; Recruiting; Sponsor: University of California, San Diego; Trial completion date: Jun 2020 ➔ Jun 2021; Trial primary completion date: Jun 2020 ➔ Jun 2021

Clinical • Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease

"I was thinking Odefsey because you already try the patient on rilpivirine." (@IdVilchez)

Clinical

Clinical outcomes of HIV-1 infected patients switched from complex multi-tablet regimens to tenofovir alafenamide based single-tablet regimens plus a boosted protease inhibitor in a real-world setting. (PubMed, J Virus Erad) - "This retrospective analysis included all HIV-1 infected patients seen at a single center from March 2016 to December 2017 who were switched from twice-daily (BID) regimens or regimens containing ​≥ ​3 pills daily to elvitegravir/cobicistat/emtricitabine/tenofovir-alafenamide (E/C/F/TAF) plus darunavir (DRV) or rilpivirine/emtricitabine/tenofovir-alafenamide (RPV/F/TAF) plus DRV boosted with ritonavir or cobicistat (DRV/r-c). Adverse drug reactions (ADRs) occurred in 3/61 (5%) (all Grade 2) leading to 3/61 (5%) ADR-related discontinuations. In this real-world cohort of MTR-treated patients, switching to a TAF-based STR plus boosted PI maintained virologic control in 97% and was well-tolerated, supporting potential use of this strategy for regimen simplification."

Clinical • Clinical data • Journal • Real-World Evidence • Human Immunodeficiency Virus • Infectious Disease

[VIRTUAL] Evaluating the IMPACT on Pharmaceutical Expenditure of HIV in the USA between 2017-2020 (ISPOR-EU 2020) - "These were Stribild, Complera, Genvoya, Odefsey & Trizivir. Over the 2.5-year period, the treatment population stayed relatively flat, but price changes rose significantly. Price rises in ARVs are, therefore, the majority driver of HIV pharmaceutical expenditure surges. This is also reflected in Medicaid expenditure increases, in which ARVs are consistently amongst the costliest drug classes.Unwarranted price increases may cause further patient access barriers and expand the population of HIV+ individuals who do not receive regular treatment."

Human Immunodeficiency Virus • Infectious Disease