Systemic lupus (SL) is a rare chronic autoimmune disease characterized by the production of autoantibodies directed against nuclear antigens, particularly native double-stranded deoxyribonucleic acid (DNA), and excessive production of antiviral cytokines: type I interferons, particularly interferon alpha (IFN-α). IFN-α production results from the excessive detection of nucleic acids (DNA or Ribonucleic Acid (RNA)) by endosomal or intracytoplasmic receptors that are capable of inducing interferon production. The precise mechanisms of cytoplasmic sensor activation remain unknown; however, recent work in the field of interferonopathies suggests a role for human endogenous retroviruses (HERVs). HERVs are remnants of ancient infections caused by exogenous retroviruses integrated into the genome during evolution and represent 8% of the human genome.Several studies have suggested a role for HERVs in the development and maintenance of an excessive immune response in lupus patients and other autoimmune diseases by affecting the type I interferons (I IFN) signalling pathway.
To date, none of the approved immunosuppressive drugs for Systemic Lupus Erythematosus (SLE) have been shown to be effective in the background treatment of SL or in preventing relapse. Consequently, there is an urgent need to identify new molecules and therapeutic avenues for disease-modifying therapies.
In this study, an innovative therapeutic strategy using a combination of nucleoside reverse transcriptase inhibitors (NRTIs), abacavir/lamivudine, is proposed to treat SLE. Thus, we propose a pilot Phase II, randomized, open-label study using NRTIs in patients with SL in remission or with low clinical activity, and evaluating a biological endpoint (IFN signature), which is a direct proxy for the drug's expected effect.
The main objective is to compare the addition of Abacavir/Lamivudine (Add-on) to standard care for 6 months, on the value of the interferon (IFN) transcriptomic signature of patients with systemic lupus with low activity as defined by the Lupus Low Disease Activity State (LLDAS).

Start Date01 Sep 2024

Sponsor / Collaborator

Hospices Civils de Lyon

NCT04493216

/ TerminatedPhase 2

A Phase IIb, Randomized, Partially Blind, Active Controlled, Dose-range Finding Study of GSK3640254 Compared to a Reference Arm of Dolutegravir, Each in Combination With Nucleoside Reverse Transcriptase Inhibitors, in HIV-1 Infected Antiretroviral Treatment-naive Adults

This is a phase 2b, randomized, multicenter, parallel group, partially blind (to GSK3640254 doses [100, 150 and 200 milligrams {mg}]), active controlled clinical trial. It aims to investigate the safety, efficacy and dose-response of GSK3640254 compared to dolutegravir (DTG), each given in combination with 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs) (abacavir/lamivudine [ABC/3TC] or emtricitabine/tenofovir alafenamide [FTC/TAF]).

Start Date18 Nov 2020

Sponsor / Collaborator

ViiV Healthcare Ltd.

NCT04301661

/ CompletedNot ApplicableIIT

Cellular Pharmacology and Platelet Effects of Abacavir and Lamivudine Anabolites

This study will evaluate the intracellular pharmacokinetics and platelet effects of abacavir (ABC), lamivudine (3TC), tenofovir alafenamide (TAF), and emtricitabine (FTC) in persons living with HIV that are receiving these medications as part of standard HIV care.
Participants remaining on ABC/3TC- or TAF/FTC-containing therapy will be on study for 4 weeks, and will have two visits: a screening visit and one short PK visit consisting of a single blood draw at week 4.
Participants switching from their ABC/3TC-containing therapy will be on study for 3 weeks, and will have nine visits: a screening visit and 8 short PK visits consisting of a single blood draw at Day 0, 1, 3, 7, 10, 14, 18, and 21.

Start Date06 Mar 2020

Sponsor / Collaborator

University of Colorado Denver

100 Clinical Results associated with Abacavir Sulfate/Lamivudine

100 Translational Medicine associated with Abacavir Sulfate/Lamivudine

100 Patents (Medical) associated with Abacavir Sulfate/Lamivudine

Literatures (Medical) associated with Abacavir Sulfate/Lamivudine

01 Jan 2019·Infection & chemotherapy

Safety and Effectiveness Analysis of Kivexa^®(lamivudine/abacavir sulfate) in Human Immunodeficiency Virus Infected Korean Patients

Article

Author: Kim, Shin-Woo ; Lee, Yil-Seob ; Ann, Heawon ; Choi, Young Hwa ; Kim, Yeon-Sook ; Lee, Chang-Seop ; Choi, Won Suk ; Lee, Jin-Soo ; Lee, Sun-Hee ; Jung, Sook-In

BACKGROUND:

Lamivudine and abacavir sulfate are widely used nucleoside/tide reverse transcriptase inhibitors (NRTI) backbone agents, which are recommended in major international treatment guidelines. The fixed-dose combination of lamivudine and abacavir sulfate has been developed to contribute to low pill burden of antiretroviral therapy (ART) regimen and patient adherence. A mandatory post-marketing surveillance was conducted in Korea to monitor the safety of Kivexa (lamivudine 300 mg/abacavir 600 mg).

MATERIALS AND METHODS:

An open label, multi-center, non-interventional post-marketing surveillance was conducted to monitor the safety of Kivexa from July 2011 to July 2017 in 23 hospitals in Korea. Subjects over 12 years old taking Kivexa per prescribing information were enrolled. The primary outcome was defined as the occurrence of any adverse events during the study period. Secondary outcomes included the occurrence of adverse drug reaction, the occurrence of serious adverse events and the effectiveness of Kivexa.

RESULTS:

A total of 600 patients from 23 hospitals were enrolled within the 6 years of study. The total observation period was 1,004 person-years. Three hundred and ten patients reported 674 adverse events. The incidence of upper respiratory infection (65 cases, 10.9%) was the highest, followed by diarrhea (20 cases, 3.3%), and nausea (18 cases, 3.0%). 109 subjects reported 71 events of adverse drug reactions, and the most common reaction was nausea in 2.33% of the subjects. Thirty-one subjects reported serious adverse events, none of them were considered drug related. From the total of 600 subjects, excluding 48 subjects who were 'effectiveness unassessable' by investigators, 552 patients were eligible for the subjective effectiveness analysis. 459 (83.2%) were evaluated as 'improved'. Proportion of subjects whose human immunodeficiency virus-RNA is <50 copies/ml was 61.2% (309/505) at the beginning of observation and increased to 91.9% (464/505) at the end of study period.

CONCLUSIONS:

The post-marketing surveillance showed the safety of Kivexa in HIV-1 patients in Korea. Ischemic cardiovascular events and hypersensitivity associated with Kivexa were few. There was no significant new safety information. This data may be helpful in implementing Kivexa and lamivudine/abacavir sulfate containing drugs in Korea.

01 Feb 2018·Open forum infectious diseasesQ3 · MEDICINE

HIV-1 Drug Resistance and Third-Line Therapy Outcomes in Patients Failing Second-Line Therapy in Zimbabwe

Q3 · MEDICINE

ArticleOA

Author: Keiser, Olivia ; Spoerri, Adrian ; Estill, Janne ; Chimbetete, Cleophas ; Shamu, Tinei ; Katzenstein, David ; Egger, Matthias

Abstract:

Objectives:

To analyze the patterns and risk factors of HIV drug resistance mutations among patients failing second-line treatment and to describe early treatment responses to recommended third-line antiretroviral therapy (ART) in a national referral HIV clinic in Zimbabwe.

Methods:

Patients on boosted protease inhibitor (PI) regimens for more than 6 months with treatment failure confirmed by 2 viral load (VL) tests >1000 copies/mL were genotyped, and susceptibility to available antiretroviral drugs was estimated by the Stanford HIVdb program. Risk factors for major PI resistance were assessed by logistic regression. Third-line treatment was provided as Darunavir/r, Raltegravir, or Dolutegravir and Zidovudine, Abacavir Lamivudine, or Tenofovir.

Results:

Genotypes were performed on 86 patients who had good adherence to treatment. The median duration of first- and second-line ART was 3.8 years (interquartile range [IQR], 2.3–5.1) and 2.6 years (IQR, 1.6–4.9), respectively. The median HIV viral load and CD4 cell count were 65 210 copies/mL (IQR, 8728–208 920 copies/mL) and 201 cells/mm3 (IQR, 49–333 cells/mm3). Major PI resistance-associated mutations (RAMs) were demonstrated in 44 (51%) non-nucleoside reverse transcriptase inhibitor RAMs in 72 patients (83%) and nucleoside reverse transcriptase inhibitors RAMs in 62 patients (72%). PI resistance was associated with age >24 years (P = .003) and CD4 cell count <200 cells/mm3 (P = .007). In multivariable analysis, only age >24 years was significantly associated (adjusted odds ratio, 4.75; 95% confidence interval, 1.69–13.38; P = .003) with major PI mutations. Third-line DRV/r- and InSTI-based therapy achieved virologic suppression in 29/36 patients (81%) after 6 months.

Conclusions:

The prevelance of PI mutations was high. Adolescents and young adults had a lower risk of acquiring major PI resistance mutations, possibly due to poor adherence to ART. Third-line treatment with a regimen of Darunavir/r, Raltegravir/Dolutegravir, and optimized nucleoside reverse transcriptase inhibitors was effective.

28 Oct 2017·Endocrinology, diabetes & metabolism case reports

Acute development of Cushing syndrome in an HIV-infected child on atazanavir/ritonavir based antiretroviral therapy

Article

Author: Kelly, Shannon ; Dubrocq, Gueorgui ; Rakhmanina, Natella ; Estrada, Andrea

Summary:

An 11-year-old male with perinatally acquired human immune deficiency virus (HIV) infection on antiretroviral regimen, which included abacavir plus lamivudine (Epzicom), didanosine, ritonavir and atazanavir presented with bilateral axillary striae, increased appetite, fatigue, facial swelling and acute weight gain. Two months prior to presentation, the patient had received a diagnostic and therapeutic intra-articular triamcinolone injection in the knee for pain relief and subsequently became progressively swollen in the face, developed striae bilaterally at the axillae, experienced increased appetite, fatigue and an 8 pound weight gain. During the endocrine workup, suspicion for adrenal insufficiency prompted 24-h urine collection for free cortisol, which was found to be undetectable (below LLQ of 1.0 µg/L). This prompted further evaluation of the hypothalamic–pituitary axis (HPA) by standard dose adrenocorticotropic hormone (ACTH) stimulation test. A 250 µg cosyntropin stimulation test was performed and confirmed HPA axis suppression. Baseline cortisol level was <1 µg/dL and stimulated cortisol level at 30 min was 3.8 µg/dL. The patient was diagnosed with iatrogenic Cushing syndrome and suppression of HPA axis secondary to the drug interaction between ritonavir (RTV) and intra-articular triamcinolone injection. Following endocrine evaluation and workup, the patient was admitted for planned orthopaedic procedure including elective left hamstring lengthening, distal femoral osteotomy and patellar tendon advancement. Taking into consideration the diagnosis of iatrogenic Cushing syndrome, at the start of the surgical procedure, 100 mg IV stress dose of hydrocortisone followed by 50 mg hydrocortisone every 8 h for 24 h was administered. Stress dosing was discontinued 24 h after the procedure. Throughout the hospitalization and upon discharge, the patient continued his ART. From initial presentation, patient has remained clinically stable throughout surgery and postoperative period.

Learning points::

Drug–drug interaction between ritonavir and triamcinolone can cause Cushing syndrome.Although triamcinolone has a half-life of 3 h, an intra-articular injection may be systematically absorbed for 3 weeks after injection, and adrenal suppression may last as long as 30 days.Co-administration of ritonavir and corticosteroids may result in an increase of plasma levels of corticosteroids levels, as they are both eliminated by CYP3A metabolism, and this interaction has the potential to prolong the half-life of triamcinolone several fold.No specific guidelines are available for the management of iatrogenic Cushing syndrome secondary to ritonavir and corticosteroids.One treatment option includes replacing ritonavir with a non-protease inhibitor-based regimen.Initiating hydrocortisone replacement therapy to prevent an adrenal crisis is also an alternate option.

News (Medical) associated with Abacavir Sulfate/Lamivudine

07 Nov 2024

·www.businesswire.com

Late-Breaking Clinical Data and Real-World Evidence Presented at HIV Glasgow as Gilead Extends Leadership Efforts Toward Ending the Epidemic

FOSTER CITY, Calif.--( BUSINESS WIRE )--Gilead Sciences, Inc. (Nasdaq: GILD) today announced the upcoming presentation of HIV research findings at the International Congress on Drug Therapy in HIV Infection ( HIV Glasgow 2024 ), taking place from November 10-13. The results from more than 40 studies across HIV treatment and prevention include late-breaking data and seven oral presentations. These findings reflect a robust portfolio and future-looking pipeline focused on person-centered drug development strategies to address unmet needs in HIV and help end the epidemic. “ We look forward to presenting new research from our broad and innovative HIV portfolio and pipeline as we strive to help end the epidemic through continuous scientific discovery,” said Jared Baeten, MD, PhD, Senior Vice President, Virology Therapeutic Area Head, Gilead Sciences. “ Our contributions to HIV Glasgow 2024 demonstrate that people are at the center of all we do at Gilead. The breadth and depth of Gilead’s work underscore our commitment to driving the next wave of transformational innovations in HIV research.” HIV Prevention Research A late-breaking oral presentation at HIV Glasgow will be the first in-depth look at the full results from the PURPOSE 2 trial ( NCT04925752 ), including data not presented last month at the HIV Research for Prevention Conference in Lima, Peru. PURPOSE 2 is a pivotal Phase 3 trial evaluating twice-yearly lenacapavir, Gilead’s injectable HIV-1 capsid inhibitor for the investigational use of HIV prevention, among a broad and geographically diverse range of cisgender men and gender-diverse people. The trial is part of a comprehensive program assessing lenacapavir in a variety of populations who need or want pre-exposure prophylaxis (PrEP) and, if approved, would be the first and only twice-yearly HIV prevention choice. Prevention research presented at HIV Glasgow will also include a systematic review and meta-analysis of real-world data mapping HIV prevalence against PrEP uptake, health economic data on the impact of PrEP in France and the return on investment that HIV prevention has yielded for the French healthcare system. Data will also be presented from a study examining same-day PrEP initiation and its effect on PrEP uptake at a Canadian clinic. HIV Treatment Research Continuous scientific discovery in HIV treatment is a pillar of Gilead’s commitment to help end the epidemic. At HIV Glasgow, presented study results and analyses will include further evaluation of Biktarvy ® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) as a long-term treatment option for a broad range of people with HIV who may also have common comorbidities and other specific health needs. Outcomes from pipeline research studies will provide insights into investigational treatment candidates, including the novel combination regimen of lenacapavir plus bictegravir. Additionally, late-breaking data from the Phase 2 study ( NCT05052996 ) evaluating an investigational once-weekly oral combination regimen of lenacapavir and islatravir will be presented during an oral session. Specifically, Biktarvy presentations will include four-year outcomes from BICSTaR, ( NCT03580668 ) an ongoing global, observational, real-world study evaluating the effectiveness, safety, and tolerability of Biktarvy in treatment-naïve and treatment-experienced people with HIV who have a high burden of co-morbidities. As the average age of people with HIV increases, the management of comorbid conditions is an important consideration in HIV clinical care. BICSTaR helps to inform what the future of coordinated person-centered HIV care could look like. Additional research studies evaluating Biktarvy include three-year outcomes from ALLIANCE, an ongoing Phase III study ( NCT03547908 ) evaluating the efficacy and safety of the single-tablet regimen versus dolutegravir 50 mg (DTG) + emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg, F/TDF, DTG+F/TDF, in adults with HIV/hepatitis B (HBV) coinfection who were initiating therapy. Gilead will also present outcomes from the Phase 2 portion of the ARTISTRY-1 study ( NCT05502341 ) investigating the efficacy and safety of switching from a complex stable baseline regimen to an investigational once-daily regimen of lenacapavir and bictegravir. Additional lenacapavir data to be presented at HIV Glasgow will evaluate the efficacy and safety of the novel antiviral agent in combination with broadly neutralizing antibodies teropavimab (GS-5423) and zinlirvimab (GS-2872) as a potential long-acting treatment regimen with twice-yearly dosing. HIV treatment research pipeline findings also include a presentation of new pharmacokinetic and resistance data on GS-1720, a selective integrase strand transfer inhibitor (INSTI). The agent is being evaluated as a component of a novel, investigational, once-weekly oral INSTI/capsid-inhibitor combination regimen with GS-4182 aimed at providing new long-acting treatment options for people with HIV. A late-breaker presentation will compare the rate of treatment emergent resistance associate mutations (TE-RAMs) in people with HIV taking three-drug single tablet regimens and cabotegravir+rilpivirine. A separate late-breaker oral presentation will explore clinical features and resistance patterns during second-generation INSTI failure from the ROSETTA-registry. Overview of Scientific Presentations HIV TREATMENT RESEARCH (B/F/TAF) Oral Presentation Randomized, multicenter, double-blind clinical trial designed to evaluate the safety and convenience of switching from dolutegravir/lamivudine to bictegravir/emtricitabine/tenofovir alafenamide in people with HIV, good virologic control and neuropsychiatric comorbidities: Week 24 results from the MIND Study. Poster Four-year outcomes from the BICSTaR study: Observational analysis of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in treatment-naïve (TN) and treatment-experienced (TE) people with HIV in Canada, France and Germany Poster Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in treatment-naïve people with both HIV-1 and hepatitis B: 3-year outcomes from ALLIANCE Poster Global survey to evaluate engagement in care and treatment experiences of people with HIV Poster Rapid Start (RS) with bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) as initial treatment in people with HIV-1 (PWH): A systematic literature review (SLR) of clinical and patient-reported outcomes (PROs) Poster Persistence, safety, and virologic outcomes of B/F/TAF as a baseline or switch regimen in HIV-infected people living with advanced HIV disease in the real world: the BIC-CD4 study. Poster Real-world effectiveness in treatment-experienced (TE) people with HIV (PWH) switching to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) with distinct patterns of self-reported adherence Poster Multicentre, prospective cohort study of same-day initiation of antiretroviral therapy with BIC/FTC/TAF among antiretroviral-naïve people with HIV Poster Real-World Persistence of Bictegravir- versus Dolutegravir-based Single Tablet Regimens in a Large Urban Canadian HIV Centre Poster Incidence of comorbidities over 18 months with BIC/FTC/TAF, DTG/ABC/3TC or DTG/3TC in real life settings in the ANRS-CO3 - AquiVIH-NA cohort. Poster Effectiveness of switching to B/F/TAF in virologically suppressed people with HIV and with preexisting resistance-associated mutations in Italy: the BIC-BARRIER Study Poster Evaluation of T-cell immunosenescence in +60 years PLWH virologically suppressed on 3DR with BIC/FTC/TAF or 2DR with DTG/3TC: the Collateral-2 study. LONG-ACTING HIV TREATMENT & PREVENTION RESEARCH (LENACAPAVIR) Oral Presentation (late breaker) Once-Weekly Islatravir Plus Lenacapavir in Virologically Suppressed PWH: Week 48 Safety, Efficacy, and Metabolic Changes Oral Presentation (late breaker) Persistence in use of twice-yearly lenacapavir versus daily oral PrEP in the PURPOSE 1 Phase 3 trial Oral Presentation (late breaker) Twice-yearly lenacapavir PrEP in cisgender gay men, transgender women and men, and gender-diverse people (PURPOSE 2) Poster Pharmacokinetic/Pharmacodynamic and Resistance Analyses of GS-1720, a Once-Weekly Oral Integrase Strand Transfer Inhibitor Poster Pharmacokinetics of oral islatravir (ISL) plus lenacapavir (LEN) given once weekly in an open-label, active-controlled, phase 2 study of virologically suppressed people with HIV HIV TREATMENT PIPELINE RESEARCH Oral Presentation Efficacy and safety analysis of lenacapavir with broadly neutralising antibodies, teropavimab and zinlirvimab, in people with HIV-1 highly sensitive to one or both broadly neutralising antibodies Poster Pharmacokinetic (PK) analysis of oral once-daily bictegravir (BIC) plus lenacapavir (LEN) administered separately (BIC 75mg + LEN 25mg; BIC 75mg + LEN 50mg) and as a single-tablet BIC/LEN 75/50mg fixed-dose combination (FDC) to support Phase 3 dose selection Poster Effect of acid reducing agents on the pharmacokinetics of oral GS-4182 Poster Safety and immunogenicity of GS-1966+GS-1144 vaccines in virally suppressed adults living with HIV-1: a phase 1b, randomised, placebo-controlled study Poster Metabolic changes at 48 weeks in virologically suppressed people with HIV switching from complex antiretroviral regimens to bictegravir plus lenacapavir: ARTISTRY-1 trial HIV PREVENTION RESEARCH Poster Estimating return on investment (ROI) with increased utilisation of HIV pre-exposure prophylaxis (PrEP) among key populations in France from a national health payer perspective Poster PrEP cascade improvement through same-day PrEP initiation Poster Prevalence of HIV drug resistance in people newly diagnosed with HIV who have used Pre-exposure Prophylaxis in Europe; the PrEPaRe study. Poster HIV-1 prevalence and pre-exposure prophylaxis uptake among key populations in high-income economies (2017-2023): a systematic review and meta-analysis of real-world studies ADDITIONAL HIV RESEARCH Oral Presentation (late breaker) Clinical features and resistance patterns during second-generation INSTI failure: The ROSETTA-registry Oral Presentation (late breaker) Mortality using raltegravir versus other integrase inhibitors in people with HIV in Europe and Australia Poster (late breaker) Comparison of treatment-emergent resistance associated mutations among three-drug single tablet regimens and cabotegravir+rilpivirine for the treatment of virologically suppressed people with HIV: A Systematic Literature Review and Network Meta-Analysis Poster (late breaker) The prevalence and factors associated with polypharmacy in participants with HIV in the Pharmacokinetic and clinical Observations in PeoPle over fiftY (POPPY) study over a 3-5 year period Poster Replication-competent HIV-1 harbouring resistance-associated mutations is present in the viral reservoir Poster Treatment Patterns in Virologically Suppressed, Treatment-Experienced People with HIV; a US Real-World Database Study Poster Demographic and clinical characteristics of treatment naïve people with HIV, and their healthcare professionals’ reasons for treatment choice: findings from a real-world survey in five European countries Poster Understanding knowledge and attitudes regarding HIV amongst secondary care healthcare professionals in the United Kingdom: A national survey Poster The association between anticholinergic medication use and cognitive function in older people with HIV in the Pharmacokinetic and clinical Observations in PeoPle over fifty (POPPY) Study For more information about Gilead at HIV Glasgow 2024, including a complete list of abstracts and their corresponding oral and poster sessions, please visit https://hivglasgow.org/programme/ . The use of lenacapavir for the prevention of HIV is investigational and has not been determined to be safe or efficacious and is not approved anywhere globally. Islatravir in combination with lenacapavir is investigational and not approved anywhere globally. The safety and efficacy of the combination of islatravir and lenacapavir have not been established. Islatravir is Merck’s investigational nucleoside reverse transcriptase translocation inhibitor under evaluation in multiple ongoing early and late-stage clinical studies in combination with other antiretrovirals for the treatment of HIV-1. Bictegravir and lenacapavir in combination are investigational and not approved anywhere globally. Their safety and efficacy have not been established. The use of Biktarvy in individuals with HIV/HBV co-infection is investigational and the safety and efficacy of this use have not been established. GS-5423, GS-2872, GS-1720 are investigational compounds, and alone or in combination with lenacapavir, are not approved by the U.S. Food and Drug Administration or any other regulatory authority for any use. Their safety and efficacy are unknown. Please see below for U.S. Indication and Important Safety Information, including Boxed Warning , for Biktarvy. There is currently no cure for HIV or AIDS. About Lenacapavir Lenacapavir is approved in multiple countries for the treatment of adults with multi-drug resistant HIV in combination with other antiretrovirals. The use of lenacapavir for HIV prevention is investigational and the safety and efficacy of lenacapavir for this use have not been established. The multi-stage mechanism of action of lenacapavir is distinguishable from other currently approved classes of antiviral agents. While most antivirals act on just one stage of viral replication, lenacapavir is designed to inhibit HIV at multiple stages of its lifecycle and has no known cross resistance exhibited in vitro to other existing drug classes. Lenacapavir is being evaluated as a long-acting option in multiple ongoing and planned early and late-stage clinical studies in Gilead’s HIV prevention and treatment research program. Lenacapavir is being developed as a foundation for potential future HIV therapies with the goal of offering both long-acting oral and injectable options with several dosing frequencies, in combination or as a mono agent, that help address individual needs and preferences of people and communities affected by HIV. About Biktarvy ® Biktarvy is a complete HIV treatment that combines three powerful medicines to form the smallest 3-drug, integrase strand transfer inhibitor (INSTI)-based single-tablet regimen (STR) available, offering simple once-daily dosing with or without food, with a limited drug interaction potential and a high barrier to resistance. Biktarvy combines the novel, unboosted INSTI bictegravir, with the F/TAF backbone. Biktarvy is a complete STR and should not be taken with other HIV medicines. U.S. Indication for Biktarvy Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg) is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 14 kg who have no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically-suppressed (HIV-1 RNA <50 copies per mL) on a stable ARV regimen with no known or suspected substitutions associated with resistance to bictegravir or tenofovir. U.S. Important Safety Information for Biktarvy BOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of BIKTARVY. Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue BIKTARVY. If appropriate, anti-hepatitis B therapy may be warranted. Contraindications Coadministration : Do not use BIKTARVY with dofetilide or rifampin. Warnings and precautions Drug interactions : See Contraindications and Drug Interactions sections. Consider the potential for drug interactions prior to and during BIKTARVY therapy and monitor for adverse reactions. Immune reconstitution syndrome , including the occurrence of autoimmune disorders with variable time to onset, has been reported. New onset or worsening renal impairment : Postmarketing cases of renal impairment, including acute renal failure, proximal renal tubulopathy (PRT), and Fanconi syndrome have been reported with tenofovir alafenamide (TAF)–containing products. Do not initiate BIKTARVY in patients with estimated creatinine clearance (CrCl) <30 mL/min except in virologically suppressed adults <15 mL/min who are receiving chronic hemodialysis. Patients with impaired renal function and/or taking nephrotoxic agents (including NSAIDs) are at increased risk of renal-related adverse reactions. Discontinue BIKTARVY in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome. Renal monitoring: Prior to or when initiating BIKTARVY and during therapy, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients as clinically appropriate. In patients with chronic kidney disease, assess serum phosphorus. Lactic acidosis and severe hepatomegaly with steatosis : Fatal cases have been reported with the use of nucleoside analogs, including FTC and TDF. Discontinue BIKTARVY if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations. Adverse reactions Most common adverse reactions (incidence ≥5%; all grades) in clinical studies through week 144 were diarrhea (6%), nausea (6%), and headache (5%). Drug interactions Prescribing information : Consult the full prescribing information for BIKTARVY for more information on Contraindications, Warnings, and potentially significant drug interactions, including clinical comments. Enzymes/transporters : Drugs that induce P-gp or induce both CYP3A and UGT1A1 can substantially decrease the concentration of components of BIKTARVY. Drugs that inhibit P-gp, BCRP, or inhibit both CYP3A and UGT1A1 may significantly increase the concentrations of components of BIKTARVY. BIKTARVY can increase the concentration of drugs that are substrates of OCT2 or MATE1. Drugs affecting renal function : Coadministration of BIKTARVY with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of FTC and tenofovir and the risk of adverse reactions. Dosage and administration Dosage : Adult and pediatric patients weighing ≥25 kg: 1 tablet containing 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), and 25 mg tenofovir alafenamide (TAF) taken once daily with or without food. Pediatric patients weighing ≥14 kg to <25 kg: 1 tablet containing 30 mg BIC, 120 mg FTC, and 15 mg TAF taken once daily with or without food. For children unable to swallow a whole tablet, the tablet can be split and each part taken separately as long as all parts are ingested within approximately 10 minutes. Renal impairment : For patients weighing ≥25 kg, not recommended in patients with CrCl 15 to <30 mL/min, or <15 mL/min who are not receiving chronic hemodialysis, or <15 mL/min who are receiving chronic hemodialysis and have no antiretroviral treatment history. For patients weighing ≥14 kg to <25 kg, not recommended in patients with CrCl <30 mL/min. Hepatic impairment : Not recommended in patients with severe hepatic impairment. Prior to or when initiating : Test patients for HBV infection. Prior to or when initiating, and during treatment : As clinically appropriate, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, assess serum phosphorus. Pregnancy and lactation Pregnancy : BIKTARVY is recommended in pregnant individuals who are virologically suppressed on a stable ARV regimen with no known substitutions associated with resistance to any of the individual components of BIKTARVY. Lower plasma exposures of BIKTARVY were observed during pregnancy; therefore, viral load should be monitored closely during pregnancy. Lactation : Individuals infected with HIV-1 should be informed of the potential risks of breastfeeding. About Gilead Sciences in HIV Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, Calif. For more than 35 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Gilead researchers have developed 12 HIV medications , including the first single-tablet regimen to treat HIV, the first antiretroviral for pre-exposure prophylaxis (PrEP) to help reduce new HIV infections, and the first long-acting injectable HIV treatment medication administered twice-yearly. Our advances in medical research have helped to transform HIV into a treatable, preventable, chronic condition for millions of people. Gilead is committed to continued scientific innovation to provide solutions for the evolving needs of people affected by HIV around the world. Through partnerships , collaborations and charitable giving, the company also aims to improve education, expand access and address barriers to care, with the goal of ending the HIV epidemic worldwide. Gilead is recognized as one of the leading funders of HIV-related programs in a report released by Funders Concerned About AIDS. Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical trials, including those involving Biktarvy, bictegravir, lenacapavir, teropavimab, zinlirvimab and GS-1720 (such as the ALLIANCE, ARTISTRY, BICSTaR, PURPOSE 2 and NCT05052996 studies); uncertainties relating to regulatory applications and related filing and approval timelines, including potential applications for indications currently under evaluation, such as regulatory applications for lenacapavir for PrEP, and the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; the possibility that Gilead may make a strategic decision to discontinue development of programs for indications that are currently under evaluation, including bictegravir, lenacapavir and GS-1720, and, as a result, these programs may never be successfully commercialized for such indications; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements. Biktarvy, Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies. All other trademarks are the property of their respective owner(s). U.S. full Prescribing Information for Biktarvy, including BOXED WARNING , and U.S. full Prescribing Information for lenacapavir are available at www.gilead.com . For more information about Gilead, please visit the company’s website at www.gilead.com , follow Gilead on X/Twitter ( @Gilead Sciences ) and LinkedIn , or contact Gilead Public Affairs at public_affairs@gilead.com , 1-800-GILEAD-5 or 1-650-574-3000.

Phase 2Phase 3Clinical ResultPhase 1Drug Approval

18 Oct 2022

·www.biospace.com

Gilead Presents Real-World and Long-Term Data From HIV Research Programs at HIV Glasgow 2022

– New Clinical and Patient-Reported Outcomes in People with HIV on Biktarvy® in Observational BICSTaR Study Demonstrate Consistent Efficacy Pro Real-World Setting – – Long-Term Switch Data Further Establish the Robust and Durable Efficacy Pro Biktarvy – – Clinical Data Reinforces the Sustained Efficacy of Twice-Yearly Lenacapavir in People with Multi-Drug Resistant HIV – FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced the company’s upcoming new data from its HIV research and development programs to be presented at the 30th International Congress on Drug Therapy in HIV Infection (HIV Glasgow 2022) in Glasgow, Scotland and virtually from October 23-26, 2022. Gilead will present data supporting its current and pipeline innovations in HIV treatment and the latest research from its ongoing cure development program, reflecting the company’s innovative approach to continuous scientific discovery. “Continued scientific innovation and inclusive approaches are essential in the discovery and development of person-centred options that address the evolving needs of a broad range of individuals and communities affected by HIV,” said Jared Baeten, MD, PhD, Vice President, HIV Clinical Development, Gilead Sciences. “The data presented at HIV Glasgow reflect the latest progress in our research and development programs and underscore Gilead’s commitment to driving transformational innovation in HIV research. Our goal, together with the broader HIV community, is to end the HIV epidemic for everyone, everywhere. We look forward to connecting in person in Scotland at this year’s meeting and sharing these data with the scientific community as we work towards this important goal.” Driving Transformational Innovation in HIV Research Gilead will present new data on Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) evaluating the safety, efficacy and resistance pro the once-daily single-tablet regimen in a broad range of people with HIV. The latest findings from the BICSTaR study, a global, observational, real-world study evaluating the effectiveness, safety, and tolerability of Biktarvy in treatment-naïve and treatment-experienced people with HIV with a high burden of co-morbidities, will be presented. As the average age of persons living with HIV increases, the evaluation and management of comorbid conditions that may occur in an individual’s life takes on a larger role in HIV clinical care. These latest findings may help inform the future of coordinated, person-centred HIV care and the role of Biktarvy in long-term treatment. Gilead will also present long-term safety and efficacy data from two Phase 3 studies (Study 1489 and Study 1490) evaluating outcomes in adults with HIV who switched to treatment with Biktarvy following 144 weeks of initial treatment with a dolutegravir-based regimen. Following previous presentation of the primary endpoint findings at Week 48, at HIV Glasgow 2022 results of the open-label extension phase through a maximum of Week 240 will be presented. These data provide additional long-term evidence of the safety and efficacy of Biktarvy in those who switch from a DTG-containing regimen. Long-term clinical outcomes following a regimen switch are often lacking for modern antiretroviral therapy. Additionally, Gilead will share new findings on long-acting HIV treatment strategies. Data will include a subgroup analysis from the ongoing Phase 3 CAPELLA trial evaluating lenacapavir, recently approved in the EU and UK and marketed as Sunlenca®, in people with HIV who are heavily-treatment experienced with poor outcome measures at baseline, including high HIV-1 RNA, low CD4+ T cell counts and resistance to some or all the active agents in their optimized background regimen. Summary of Presentations Accepted abstracts at HIV Glasgow 2022 include: HIV Treatment Research Poster number Abstract title P088 Outcomes after switching from 144 weeks of blinded DTG/ABC/3TC or DTG+F/TAF to 96 weeks of open-label TAF P067 B/F/TAF for the treatment of people living with HIV: 24-month analyses by age, race, sex, adherence and late presentation in a multi-country cohort study P156 Risk factors associated with ≥±10% weight change in treatment-naïve and treatment-experienced PLW HIV initiating or switching to an NNRTI- or INSTI-based antiretroviral therapy in four large cohort studies P103 ART regimen persistence among treatment-experienced patients with HIV switching to a multi-tablet regimen or single-tablet regimen since 2018 P026 Week 52 subgroup efficacy analyses of long-acting subcutaneous lenacapavir in Phase 2/3 in heavily treatment-experienced people with multi-drug resistant HIV (CAPELLA study) P027 Common adverse events in clinical studies of people using lenacapavir for HIV treatment P224 Phenotypic analyses of clinical isolates with capsid substitutions observed in people living with HIV treated with lenacapavir HIV Cure Research Poster number Abstract title P112 A pooled analysis of eight clinical studies suggests a link between influenza-like adverse events and pharmacodynamics of the TLR7 agonist vesatolimod For more information about Gilead at HIV Glasgow 2022, including a complete list of abstracts, please visit: Please see below for U.S. Indications and Important Safety Information, including Boxed Warnings, for Biktarvy®. The use of Biktarvy in individuals with a history of treatment failure or known resistance to the components of Biktarvy is investigational, and the safety and efficacy of Biktarvy for this use have not been established. Lenacapavir is a first-in-class, long-acting HIV capsid inhibitor approved in the EU and UK for the treatment of HIV infection, in combination with other antiretroviral(s), in adults with multi-drug resistant HIV infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen. Lenacapavir, alone or in combination, is not approved by any regulatory authority outside of the EU or the UK for any use. The European Marketing Authorization applies to all 27 member states of the European Union, as well as Norway, Iceland and Liechtenstein. For important safety information for lenacapavir, including dosing and method of administration, special warnings, drug interactions and adverse drug reactions, please see the Summary of Product Characteristics (SmPC) for lenacapavir, available from the European Medicines Agency website at . There is currently no cure for HIV or AIDS. U.S. Indication for Biktarvy Biktarvy is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 14 kg who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy. U.S. Important Safety Information for Biktarvy BOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of BIKTARVY. Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue BIKTARVY. If appropriate, anti-hepatitis B therapy may be warranted. Contraindications Coadministration: Do not use BIKTARVY with dofetilide or rifampin. Warnings and precautions Drug interactions: See Contraindications and Drug Interactions sections. Consider the potential for drug interactions prior to and during BIKTARVY therapy and monitor for adverse reactions. Immune reconstitution syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported. New onset or worsening renal impairment: Postmarketing cases of renal impairment, including acute renal failure, proximal renal tubulopathy (PRT), and Fanconi syndrome have been reported with tenofovir alafenamide (TAF)–containing products. Do not initiate BIKTARVY in patients with estimated creatinine clearance (CrCl) <30 mL/min except in virologically suppressed adults <15 mL/min who are receiving chronic hemodialysis. Patients with impaired renal function and/or taking nephrotoxic agents (including NSAIDs) are at increased risk of renal-related adverse reactions. Discontinue BIKTARVY in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome. Renal monitoring: Prior to or when initiating BIKTARVY and during therapy, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients as clinically appropriate. In patients with chronic kidney disease, assess serum phosphorus. Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including FTC and TDF. Discontinue BIKTARVY if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations. Adverse reactions Most common adverse reactions (incidence ≥5%; all grades) in clinical studies through week 144 were diarrhea (6%), nausea (6%), and headache (5%). Drug interactions Prescribing information: Consult the full prescribing information for BIKTARVY for more information on Contraindications, Warnings, and potentially significant drug interactions, including clinical comments. Enzymes/transporters: Drugs that induce P-gp or induce both CYP3A and UGT1A1 can substantially decrease the concentration of components of BIKTARVY. Drugs that inhibit P-gp, BCRP, or inhibit both CYP3A and UGT1A1 may significantly increase the concentrations of components of BIKTARVY. BIKTARVY can increase the concentration of drugs that are substrates of OCT2 or MATE1. Drugs affecting renal function: Coadministration of BIKTARVY with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of FTC and tenofovir and the risk of adverse reactions. Dosage and administration Dosage: Adult and pediatric patients weighing ≥25 kg: 1 tablet containing 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), and 25 mg tenofovir alafenamide (TAF) taken once daily with or without food. Pediatric patients weighing ≥14 kg to <25 kg: 1 tablet containing 30 mg BIC, 120 mg FTC, and 15 mg TAF taken once daily with or without food. For children unable to swallow a whole tablet, the tablet can be split and each part taken separately as long as all parts are ingested within approximately 10 minutes. Renal impairment: For patients weighing ≥25 kg, not recommended in patients with CrCl 15 to <30 mL/min, or <15 mL/min who are not receiving chronic hemodialysis, or <15 mL/min who are receiving chronic hemodialysis and have no antiretroviral treatment history. For patients weighing ≥14 kg to <25 kg, not recommended in patients with CrCl <30 mL/min. Hepatic impairment: Not recommended in patients with severe hepatic impairment. Prior to or when initiating: Test patients for HBV infection. Prior to or when initiating, and during treatment: As clinically appropriate, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, assess serum phosphorus. Pregnancy and lactation Pregnancy: There is insufficient human data on the use of BIKTARVY during pregnancy. Dolutegravir, another integrase inhibitor, has been associated with neural tube defects. Discuss the benefit-risk of using BIKTARVY during pregnancy and conception. An Antiretroviral Pregnancy Registry (APR) has been established. Available data from the APR for FTC shows no difference in the rates of birth defects compared with a US reference population. Lactation: Women infected with HIV-1 should be instructed not to breastfeed, due to the potential for HIV-1 transmission. About Biktarvy Biktarvy is a complete HIV treatment that combines three powerful medicines to form the smallest 3-drug, integrase strand transfer inhibitor (INSTI)-based single-tablet regimen (STR) available, offering simple once-daily dosing with or without food, with a limited drug interaction potential and a high barrier to resistance. Biktarvy combines the novel, unboosted INSTI bictegravir, with the Descovy® (emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, F/TAF) backbone. Biktarvy is a complete STR and should not be taken with other HIV medicines. About Sunlenca Sunlenca is a first-in-class, long-acting HIV capsid inhibitor approved in the European Union for the treatment of HIV infection, in combination with other antiretroviral(s), in people with multi-drug resistant HIV who are heavily-treatment experienced. Sunlenca’s multi-stage mechanism of action is distinguishable from other currently approved classes of antiviral agents and is designed to provide a new avenue for the development of a long-acting treatment option for individuals with multi-drug resistant HIV whose virus was no longer effectively responding to therapy. While most antivirals act on just one stage of viral replication, Sunlenca is designed to inhibit HIV at multiple stages of its lifecycle and has no known cross resistance to other existing drug classes. Sunlenca is the only HIV treatment option administered twice-yearly. About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. For 35 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Gilead researchers have developed 12 HIV medications, including the first single-tablet regimen to treat HIV, the first antiretroviral for pre-exposure prophylaxis (PrEP) to reduce the risk of acquiring HIV infection, and the first, long-acting injectable HIV treatment medication administered twice-yearly. Our advances in medical research have helped to transform HIV into a preventable, chronic condition for millions of people. Gilead is committed to continued scientific innovation to provide solutions for the evolving needs of people affected by HIV around the world. Through partnerships and collaborations, the company also aims to improve education, expand access and address barriers to care, with the goal of ending the HIV epidemic for everyone, everywhere. Gilead was recognized as the number one philanthropic funder of HIV-related programs in a report released by Funders Concerned About AIDS. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to initiate, progress and complete clinical trials in the anticipated timelines or at all, and the possibility of unfavorable results from ongoing and additional clinical trials, including those involving Biktarvy and Sunlenca (lenacapavir); uncertainties relating to regulatory applications and related filing and approval timelines, including the risk that additional regulatory authorities may not approve lenacapavir for the treatment of HIV in a timely manner or at all; the risk that any regulatory approvals, if granted, may be subject to significant limitations on use; the risk that physicians in the EU and UK may not see the benefits of prescribing Sunlenca; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2022, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements. Full Summary of Product Characteristics for Sunlenca are available from the EMA website at . U.S. full Prescribing Information for Biktarvy, including BOXED WARNINGS, are available at . Biktarvy, Sunlenca, Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies. For more information about Gilead, please visit the company’s website at , follow Gilead on Twitter (@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

First in ClassCollaborate

21 Oct 2021

·www.biospace.com

Gilead Presents Long-Term Switch Data Reinforcing Biktarvy® as a Treatment Option for a Broad Range of People Living With HIV

Oct. 21, 2021 11:37 UTC Gilead Presents Long-Term Switch Data Reinforcing Biktarvy® as a Treatment Option for a Broad Range of People Living With HIV – Analysis of Real-World Data in People Living With HIV in the International BICSTaR Study to be Presented at EACS 2021 Also Confirm the Long-Term Efficacy and Safety Pro Biktarvy – FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced the company’s upcoming contributions to the 18th European AIDS Conference (EACS 2021), taking place virtually and onsite in London from October 27-30. Forty-four studies from Gilead’s HIV research and development programs will be presented, including data from the global, observational, real-world BICSTaR study, which along with Gilead’s community-focused programs, reflect the company’s ongoing focus and commitment to advancing scientific discovery and supporting the development and delivery of practical solutions that can help improve care for all people affected by HIV. “We look forward to presenting research at EACS 2021 that could help inform clinical outcomes and support clinicians in the collective endeavor to help end the HIV epidemic,” said Frank Duff, MD, Senior Vice President, Virology Therapeutic Area Head, Gilead Sciences. “In addition to helping create a world with no new HIV infections, we also strive to ensure the people living with HIV can realize long-term treatment success. This includes extending treatment success markers, which can lead to more holistic and patient-centered HIV care, in turn helping us better assess and address the evolving and unmet needs of people affected by the HIV epidemic.” Gilead will present long-term safety and efficacy data evaluating outcomes in adults living with HIV who switched to Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) from boosted protease inhibitor-based regimens including in those with pre-existing resistance. The primary endpoint was at week 48; results of the open-label extension phase through a maximum of week 181 are slated for presentation at EACS 2021. The data further establish the robust and durable efficacy pro Biktarvy as a treatment option for virologically suppressed people living with HIV with known resistance. The use of Biktarvy in individuals with known resistance to the components of Biktarvy is investigational. Twelve-month data and a descriptive analysis of patient-reported outcomes from the ongoing BICSTaR Study, a global, observational, real-world study evaluating the effectiveness, safety, and tolerability of Biktarvy in treatment-naïve and treatment-experienced people living with HIV, will be presented at the conference. As the population of persons living with HIV increases, the evaluation and management of comorbid conditions that may occur in an individual’s life takes on a larger role in HIV clinical care. These findings may help inform a future paradigm of coordinated, patient-centered HIV care. Additionally, at EACS 2021, Gilead will share new findings on long-acting HIV treatment strategies, as well as updates from the company’s continued pursuit of a cure for HIV. Data will include subgroup and resistance analyses from the ongoing Phase 3 CAPELLA trial evaluating the antiviral activity of investigational lenacapavir administered subcutaneously every six months in combination with an optimized antiretroviral background regimen in people living with HIV who are heavily treatment-experienced with multi-drug resistant HIV-1 infection. To further aid the development of a functional HIV cure, Gilead conducted a study using mathematical modelling and machine learning in a Phase 1b study to identify predictive immune biomarkers of HIV post-treatment controllers. HIV post-treatment controllers, a rare group of people who manage to sustain their viral load suppression after stopping antiretroviral therapy, have the potential to help us further research and understand possible ways to induce a similar response to treatment in a broader group of people living with HIV. Beyond presenting new scientific data from the company’s HIV research and development programs, Gilead will convene a symposium featuring community, clinical and health systems experts to discuss the ongoing impact of COVID-19 on the HIV cascade of care and lessons learned that can be applied in the future as we seek to accelerate the end of the HIV epidemic, work towards increased health equity, and prepare for future emerging viruses. Select Gilead accepted abstracts are as follows: HIV Treatment Research Poster PE2/57 B/F/TAF for the treatment of people living with HIV (PLWH): 12-Month (12M) effectiveness, persistence, and safety in a multi-country cohort study Poster PE2/50 Patient-reported outcome (PRO) measures at 12 months (12M) in a real-world cohort of people living with HIV (PLWH) with a high prevalence of comorbidities receiving B/F/TAF in Europe, Canada, and Israel Poster PE1/6 Prevalence and risk factors of preexisting thymidine analogue mutations (TAMS) in clinical trial participants and sustained viral suppression after switching to B/F/TAF Poster PE1/19 Long-term efficacy of B/F/TAF after switch from boosted protease inhibitor-based regimens including in those with preexisting resistance and viral blips Poster PE1/10 In vitro forgiveness of oral and long-acting INSTI-containing regimens at drug concentrations simulating variable adherence Poster PE2/68 Outcomes 48 weeks after switching from DTG/ABC/3TC or DTG+F/TAF to B/F/TAF Poster PE7/28 Persistence on guideline-recommended HIV treatment: Comparison among US Medicaid beneficiaries newly initiating treatment with single-versus multiple-tablet regimens Investigational Long-Acting HIV Treatment Research (Lenacapavir) Oral Abstract OS1/1 Resistance analysis of long-acting lenacapavir in highly treatment-experienced people with HIV after 26 weeks of treatment Poster PE2/69 Subgroup efficacy analyses of long-acting subcutaneous lenacapavir in phase 2/3 in heavily treatment-experienced people with HIV (CAPELLA study) HIV Cure Research Poster PE2/1 Mathematical modeling identifies predictive immune biomarkers of post-treatment HIV controllers HIV Prevention Research Poster PE6/19 Context-specific performance of recency assays in South Africa and Uganda: An in silico simulation approach Poster BPD2/1 Investigating zero transmission of HIV in the MSM population: A UK modelling study COVID-19 Research Poster PE1/2 Nucleotide reverse transcriptase inhibitors (NRTIS) tenofovir, TAF, TDF, and FTC are inactive against SARS-COV-2 Poster PE4/17 Clinical outcomes of hospitalized COVID-19 patients by disease severity treated with remdesivir- NEAT ID 909REM Study Poster PE4/51 Use of the NEWS2 score in clinical outcomes of hospitalized COVID-19 patients by disease severity treated with remdesivir For more information, including a complete list of abstracts, please visit: Please see below for the U.S. Indication and Important Safety Information, including Boxed Warnings, for Biktarvy and Descovy for PrEP®. Lenacapavir and vesatolimod are investigational compounds and are not approved anywhere globally. Their safety and efficacy have not been established. The use of Biktarvy in individuals with a history of treatment failure or known resistance to the components of Biktarvy is investigational, and the safety and efficacy of Biktarvy for this use have not been established. There is currently no cure for HIV or AIDS. U.S. Indication for Biktarvy Biktarvy is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 14 kg who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy. U.S. Important Safety Information for Biktarvy BOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of BIKTARVY. Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue BIKTARVY. If appropriate, anti-hepatitis B therapy may be warranted. Contraindications Coadministration: Do not use BIKTARVY with dofetilide or rifampin. Warnings and precautions Drug interactions: See Contraindications and Drug Interactions sections. Consider the potential for drug interactions prior to and during BIKTARVY therapy and monitor for adverse reactions. Immune reconstitution syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported. New onset or worsening renal impairment: Postmarketing cases of renal impairment, including acute renal failure, proximal renal tubulopathy (PRT), and Fanconi syndrome have been reported with tenofovir alafenamide (TAF)–containing products. Do not initiate BIKTARVY in patients with estimated creatinine clearance (CrCl) <30 mL/min except in virologically suppressed adults <15 mL/min who are receiving chronic hemodialysis. Patients with impaired renal function and/or taking nephrotoxic agents (including NSAIDs) are at increased risk of renal-related adverse reactions. Discontinue BIKTARVY in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome. Renal monitoring: Prior to or when initiating BIKTARVY and during therapy, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients as clinically appropriate. In patients with chronic kidney disease, assess serum phosphorus. Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including FTC and TDF. Discontinue BIKTARVY if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations. Adverse reactions Most common adverse reactions (incidence ≥5%; all grades) in clinical studies through week 144 were diarrhea (6%), nausea (6%), and headache (5%). Drug interactions Prescribing information: Consult the full prescribing information for BIKTARVY for more information on Contraindications, Warnings, and potentially significant drug interactions, including clinical comments. Enzymes/transporters: Drugs that induce P-gp or induce both CYP3A and UGT1A1 can substantially decrease the concentration of components of BIKTARVY. Drugs that inhibit P-gp, BCRP, or inhibit both CYP3A and UGT1A1 may significantly increase the concentrations of components of BIKTARVY. BIKTARVY can increase the concentration of drugs that are substrates of OCT2 or MATE1. Drugs affecting renal function: Coadministration of BIKTARVY with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of FTC and tenofovir and the risk of adverse reactions. Dosage and administration Dosage: Adult and pediatric patients weighing ≥25 kg: 1 tablet containing 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), and 25 mg tenofovir alafenamide (TAF) taken once daily with or without food. Pediatric patients weighing ≥14 kg to <25 kg: 1 tablet containing 30 mg BIC, 120 mg FTC, and 15 mg TAF taken once daily with or without food. For children unable to swallow a whole tablet, the tablet can be split and each part taken separately as long as all parts are ingested within approximately 10 minutes. Renal impairment: For patients weighing ≥25 kg, not recommended in patients with CrCl 15 to <30 mL/min, or <15 mL/min who are not receiving chronic hemodialysis, or <15 mL/min who are receiving chronic hemodialysis and have no antiretroviral treatment history. For patients weighing ≥14 kg to <25 kg, not recommended in patients with CrCl <30 mL/min. Hepatic impairment: Not recommended in patients with severe hepatic impairment. Prior to or when initiating: Test patients for HBV infection. Prior to or when initiating, and during treatment: As clinically appropriate, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, assess serum phosphorus. Pregnancy and lactation Pregnancy: There is insufficient human data on the use of BIKTARVY during pregnancy. Dolutegravir, another integrase inhibitor, has been associated with neural tube defects. Discuss the benefit-risk of using BIKTARVY during pregnancy and conception. An Antiretroviral Pregnancy Registry (APR) has been established. Available data from the APR for FTC shows no difference in the rates of birth defects compared with a US reference population. Lactation: Women infected with HIV-1 should be instructed not to breastfeed, due to the potential for HIV-1 transmission. U.S. Indication for Descovy for PrEP Descovy for PrEP is indicated in at-risk adults and adolescents (≥35 kg) to reduce the risk of sexually acquired HIV-1 infection, excluding individuals at risk from receptive vaginal sex. HIV-1–negative status must be confirmed immediately prior to initiation. Limitation of Use: Descovy for PrEP is not indicated in individuals at risk of HIV-1 from receptive vaginal sex because effectiveness in this population has not been evaluated. U.S. Important Safety Information and Indication for Descovy for PrEP BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF DESCOVY FOR PrEP IN UNDIAGNOSED EARLY HIV-1 INFECTION and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B Descovy for PrEP must be prescribed only to patients confirmed to be HIV negative immediately prior to initiation and at least every 3 months during use. Drug-resistant HIV-1 variants have been identified with use of emtricitabine/tenofovir disoproxil fumarate. (FTC/TDF) for HIV-1 PrEP following undetected acute HIV-1 infection. Do not initiate if signs or symptoms of acute HIV-1 infection are present unless HIV-negative status is confirmed. Severe acute exacerbations of hepatitis B have been reported in patients infected with hepatitis B virus (HBV) who discontinued products containing FTC and/or TDF and may occur with discontinuation of Descovy. Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients with HBV who discontinue Descovy. If appropriate, anti-hepatitis B therapy may be warranted. Contraindication Descovy for PrEP is contraindicated in patients with unknown or positive HIV status. Comprehensive management to reduce risks Use Descovy for PrEP to reduce the risk of HIV-1 infection as part of a comprehensive strategy that includes adherence to daily dosing and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections (STIs). HIV-1 risk factors: Behavioral, biological, or epidemiologic HIV-1 risk factors may include, but are not limited to: condomless sex, past or current STIs, self-identified HIV risk, having sexual partners of unknown HIV-1 viremic status, or sexual activity in a high-prevalence area or network. Reduce STI risk: Counsel on the use of STI prevention measures (e.g., consistent and correct condom use, knowledge of partner's HIV-1 viremic status, regular testing for STIs). Reduce potential for drug resistance: Only prescribe Descovy for PrEP to patients confirmed to be HIV negative immediately prior to initiation, at least every 3 months while taking Descovy, and upon an STI diagnosis. HIV-1 resistance substitutions may emerge in patients with undetected HIV-1 infection who are taking only Descovy because Descovy alone is not a complete regimen for treating HIV-1. Some HIV tests may not detect acute HIV infection. Prior to initiating Descovy for PrEP, ask patients about potential recent exposure events. If recent (<1 month) exposures are reported or suspected, or symptoms of acute HIV infection (e.g., fever, fatigue, myalgia, skin rash) are present, confirm HIV-negative status with a test approved by the FDA for use in the diagnosis of acute HIV infection. If HIV-1 infection is suspected or if symptoms of acute infection are present while taking Descovy for PrEP, convert the Descovy for PrEP regimen to a complete HIV treatment regimen until HIV-negative status is confirmed by a test approved by the FDA for use in the diagnosis of acute HIV infection. Counsel on adherence: Counsel patients to strictly adhere to daily dosing, as efficacy is strongly correlated with adherence. Some patients, such as adolescents, may benefit from more frequent visits and counseling. Warnings and precautions New onset or worsening renal impairment: Postmarketing cases of renal impairment, including acute renal failure, proximal renal tubulopathy (PRT), and Fanconi syndrome have been reported with tenofovir alafenamide (TAF)-containing products. Do not initiate Descovy in patients with estimated creatinine clearance (CrCl) <30 mL/min. Patients with impaired renal function and/or taking nephrotoxic agents (including NSAIDs) are at increased risk of renal-related adverse reactions. Discontinue Descovy in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome. Monitor renal function in all patients (see Dosage and Administration section). Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including FTC and TDF. Discontinue use if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations. Adverse reactions: Most common adverse reactions (≥2%) in the Descovy for PrEP clinical trial were diarrhea, nausea, headache, fatigue, and abdominal pain. Drug interactions: Prescribing information: Consult the full Prescribing Information for Descovy for more information, warnings, and potentially significant drug interactions, including clinical comments. Metabolism: Drugs that inhibit P-gp can increase the concentrations of TAF, a component of Descovy. Drugs that induce P-gp can decrease the concentrations of TAF, which may lead to loss of efficacy. Drugs affecting renal function: Coadministration of Descovy with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of FTC and tenofovir and the risk of adverse reactions. Dosage and administration: Dosage: One tablet taken once daily with or without food. HIV screening: Test for HIV-1 infection immediately prior to initiating, at least every 3 months during use, and upon diagnosis of an STI (see Warnings and Precautions section). HBV screening: Test for HBV infection prior to or when initiating Descovy. Renal impairment and monitoring: Not recommended in patients with creatinine clearance (CrCl) <30 mL/min. Prior to or when initiating Descovy, and during use on a clinically appropriate schedule, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, assess serum phosphorus. About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. For more than 30 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Gilead researchers have developed eleven HIV medications, including the first single-tablet regimen to treat HIV and the first once-daily oral antiretroviral tablet for pre-exposure prophylaxis (PrEP) to reduce the risk of acquiring HIV infection. These advances in medical research have helped to transform HIV into a preventable, chronic condition for millions of people. Gilead is committed to continued scientific innovation to provide solutions for the evolving needs of people affected by HIV around the world. Through partnerships and collaborations, the company also aims to improve education, expand access and address barriers to care, with the goal of ending the HIV epidemic for everyone, everywhere. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to initiate, progress or complete clinical trials or studies within currently anticipated timelines or at all, including those involving Biktarvy, Descovy for PrEP, lenacapavir and vesatolimod; the possibility of unfavorable results from such ongoing and additional clinical trials, including those involving Biktarvy, Descovy for PrEP, lenacapavir and vesatolimod; the possibility that Gilead may make a strategic decision to discontinue development of lenacapavir and vesatolimod and as a result, these compounds may never be successfully commercialized; Gilead’s ability to receive regulatory approvals in a timely manner or at all, including marketing approvals of lenacapavir and vesatolimod, and the risk that any such approvals, if granted, may have significant limitations on its use; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2021, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements. U.S. full Prescribing Information for Biktarvy and Descovy, including BOXED WARNINGS, are available at . Biktarvy, Descovy, Descovy for PrEP, Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies. All other trademarks are the property of their respective owner(s). For more information about Gilead, please visit the company’s website at , follow Gilead on Twitter (@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

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10 top approved records.

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Indication	Country/Location	Organization	Date
HIV Infections	US	ViiV Healthcare Co.	02 Aug 2004

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00084149 (CTgov)	Phase 2	HIV Infections	54	Cyclosporine (Cyclosporine)	hqoveljlnq(dfejeewglk) = aaczfauvos qyhoysveup (ejrhfojjpl, nkplqvojfe - tnovdvxwup) View more	-	13 Sep 2018
				Cyclosporine (No Cyclosporine)	hqoveljlnq(dfejeewglk) = ezcechebxm qyhoysveup (ejrhfojjpl, praqexhyik - wrrxrcmoai) View more
NCT02469246 (CTgov)	Phase 3	HIV Infections	567	placebo+ABC/3TC+F/TAF (F/TAF)	lemozrjvzm(qdycmjlohe) = lfkcqcmqqf enwoisswqr (oyexmiuktl, tlvsxelqja - gfrzfzigtb) View more	-	11 Jun 2018
				ABC (ABC/3TC)	lemozrjvzm(qdycmjlohe) = hdebkbcyte enwoisswqr (oyexmiuktl, xkrmhjxgvk - xfkeznileu) View more
NCT02246998 (CTgov)	Phase 4	HIV Infections	72	STB+iohexol (STB + Iohexol)	tytneohzhu(cbrncyzsgv) = rzhywnoyzv sqxqxnxkbn (pdmesynjjx, flvydlvsev - bhgeoawyhq) View more	-	03 Jan 2018
				ATV+iohexol+TVD+RTV (TVD + ATV/r + Iohexol)	tytneohzhu(cbrncyzsgv) = wydcvbetxg sqxqxnxkbn (pdmesynjjx, thycwgafds - acfmhhnrll) View more
NCT01352715 (A5273 \| SELECT, CTgov)	Phase 3	HIV Infections	515	Lopinavir/ritonavir+raltegravir (Arm A: LPV/r Plus RAL)	mggefufces(fapvtpauhk) = hgszzbgvcw nsczdoqdzz (ovkcppplfj, ggjrvndryz - giocwsndux) View more	-	06 Jan 2016
				Abacavir/lamivudine+Zidovudine+Abacavir+Lamivudine/zidovudine+Abacavir/lamivudine/zidovudine+Emtricitabine/tenofovir disoproxil fumarate+Lamivudine+Lopinavir/ritonavir (Arm B: LPV/r Plus Best Available NRTIs)	mggefufces(fapvtpauhk) = sefwyeuvrp nsczdoqdzz (ovkcppplfj, jrbltocgvj - fafbtfnoil) View more
NCT00192634 (STEAL, Pubmed \| PLoS One)	Phase 4	HIV Infections	254	Tenofovir-emtricitabine	tewjfimxmq(vyiypvqzrk) = zurkdujmyw ncyxrwcido (xyayaolpit ) View more	-	01 Jan 2014
NCT00865007 (KRETA, Pubmed \| J Antimicrob Chemother)	Phase 4	-	95	Lopinavir/ritonavir plus abacavir/lamivudine	dwellamzpv(oxvgsgkdph) = dhxppucvns nyupyewatc (ubsjsbpqml, 1.6 - 3.7) View more	-	01 Jun 2013
				Lopinavir/ritonavir monotherapy	dwellamzpv(oxvgsgkdph) = fzmumccyxl nyupyewatc (ubsjsbpqml, 2.0 - 5.4) View more
NCT00118898 (A5224s, Pubmed \| J Infect Dis)	Phase 3	-	1,864	Abacavir-Lamivudine (ABC/3TC)	aidptxmsca(htoyzcazqj) = arivmhlmho tauczcftov (hujillekxl )	-	15 Feb 2013
				Tenofovir DF-Emtricitabine (TDF/FTC)	oqpuegkkqf(fvmqwpzdlg) = tufdfadgay wkapndpvti (fwbmfyvrjq, -24.70 to 2.90) View more
SPIRAL trial (Pubmed \| AIDS Res Hum Retroviruses)	Not Applicable	-	-	Abacavir/Lamivudine	psjxioldbx(rtdxdxiors) = Triglycerides decreased and HDL cholesterol increased through the study more pronouncedly with abacavir/lamivudine than with tenofovir/emtricitabine sgkwvtvpht (lqzvdqyaoh ) View more	-	01 Feb 2013
				Tenofovir/Emtricitabine
NCT00544128 (Pubmed \| Intern Med)	Phase 4	HIV Infections	109	Abacavir/lamivudine	gligsrqeki(qsngjzledv) = Clinically suspected abacavir-associated hypersensitivity reactions occurred in only one (1.9%) patient in the ABC/3TC arm. dgfowvesgb (smoldrzxqe ) View more	-	01 Jan 2013
				Tenofovir/emtricitabine with atazanavir/ritonavir
NCT01102972 (ASSURE, CTgov)	Phase 4	HIV Infections	297	ATV+3TC+ABC (ABC/3TC + ATV)	jbdyvofneu(ucaffuhxwc) = mkzkquaphn nsympctwol (ahajdujwcn, lzgqnjsdnb - mlkpwwgffj) View more	-	31 Dec 2012
				TDF+ATV+FTC+RTV (TDF/FTC + ATV/RTV)	jbdyvofneu(ucaffuhxwc) = lhxhyoailc nsympctwol (ahajdujwcn, zvttidcfpy - kylnzrijsf) View more

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