HIVdent.org | Drug News

*Featured Articles*
	TAG’s 2019 Pipeline Report: The Latest in HIV and HCV R&D Treatment Action Group \| July 2019
	Changes in drug interaction profiles for first-line HIV therapy over the 20 years of the Liverpool Drug Interaction website Department of Pharmacology & Therapeutics, University of Liverpool
	Proportion of serious drug interactions dropping on Liverpool antiretroviral website 20th International Workshop on Clinical Pharmacology of HIV, Hepatitis & Other Antiviral Drugs. May 14-16, 2019. Noordwijk, the Netherlands
	Recommendations for the Use of Antiretroviral Drugs in Pregnant Women with HIV Infection and Interventions to Reduce Perinatal HIV Transmission in the United States aidsinfo \| December 2018
	Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV AIDSinfo \| October 25, 2018
	Meta-analysis of the risk of Grade 3/4 or serious clinical adverse events in 12 randomised trials of PrEP HIV Drug Therapy, Glasgow 2018, October 28-31, 2018, Glasgow
	Department of Health and Human Services Adults and Adolescents Antiretroviral Guidelines Panel* Classifies a Fixed-Dose Combination Product of Bictegravir/Tenofovir Alafenamide/Emtricitabine as One of the Recommended Initial Regimens for Most People with HIV AIDSinfo \| March 27, 2018
	Hepatitis C Treatments Viekira Pak and Technivie: Drug Safety Communication - Risk of Serious Liver Injury
	NASTAD Release: ADAP Formulary Database
	HIV/AIDS Update- Prezista (darunavir) labeling changes
	The 17th Annual HIV Drug Guide Positively Aware, Test Positive Aware Network

*News Updates*
	ViiV Healthcare submits regulatory application to the European Medicines Agency for fostemsavir, an investigational, first-in-class attachment inhibitor for the treatment of HIV in adults with few treatment options available ViiV Healthcare \| London, 10 January 2020
	Gilead Sciences Licenses Portfolio of HIV Antibodies From The Rockefeller University FOSTER CITY, Calif.--(BUSINESS WIRE)--Jan. 9, 2020
	FDA Programs to Register HIV Drugs for Use in Resource-Constrained Settings Infectious Disease Advisor \| January 3, 2020
	Following backlash, Facebook disables misleading HIV medication ads Dec. 30, 2019, 3:44 PM EST
	Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in a Rapid Initiation Model of Care for HIV-1 Infection: Primary Analysis of the DIAMOND Study Clinical Infectious Diseases 27 December 2019
	What's New in the Guidelines? aidsinfo \| December 2019
	ViiV Healthcare receives complete response letter from US FDA for use of investigational cabotegravir and rilpivirine long-acting regimen in the treatment of HIV ViiV Healthcare \| December 21, 2019
	Prescribing practices for pregnant women with HIV not aligned with guidelines Healio \| December 18, 2019
	Facebook ads are spreading lies about anti-HIV drug PrEP. The company won't act The Guardian \| December 14, 2019
	Cost prevents 7% of people will HIV from adhering to medication Healio \| December 12, 2019
	ViiV Healthcare submits New Drug Application to the FDA for fostemsavir, an investigational, first-in-class attachment inhibitor for the treatment of HIV in adults with few treatment options available Viiv \| December 5, 2019
	HARVONI, EPCLUSA, and VOSEVI Labeling updates: HCV-infected adults with severe renal impairment FDA \| November 18, 2019
	CDC Antibiotic Resistance: New Threats Report
	Understanding the Medicaid Prescription Drug Rebate Program – Kaiser Family Foundation KFF \| November 12, 2019
	Untangling the Trump administration's lawsuit over an HIV prevention drug Science Magazine \| November 8, 2019
	Facts About Gilead’s PrEP Medications Donation to Help Support Ending the HIV Epidemic Efforts NATAP \| November 4, 2019 at 12:01:02 PM EST
	Gilead Perspective on HHS Lawsuit
	The ADVANCE clinical trial: changes from baseline to week 96 in DXA-assessed body composition in TAF/FTC+DTG compared to TDF/FTC+DTG, and TDF/FTC/EFV 17th European AIDS Conference, November 6-9, 2019, Basel
	Integrase Inhibitors Tied to Weight Gain, Hepatic Steatosis in Longitudinal Cohort 17th European AIDS Conference, November 6-9, 2019, Basel
	INI Resistance Remains Rare in INI-Naive--Initial CD4, Viral Load Predict Failure 17th European AIDS Conference, November 6-9, 2019, Basel
	Switch From TDF to TAF in HIV/HBV+ Maintains Viral Control, Helps Kidneys 17th European AIDS Conference, November 6-9, 2019, Basel
	DTG Easily Most Popular INI Across Europe, With Lowest Quitting Rate 17th European AIDS Conference, November 6-9, 2019, Basel
	Gilead Presents Data on Investigational HIV-1 Capsid Inhibitor GS-6207 as a Potential Component of Long-Acting HIV Therapy Gilead \| November 8, 2019
	BARACLUDE: Updates to Adverse Reactions from Long-Term Observational Study FDA \| November 8, 2019
	Label updates to efavirenz containing products FDA \| October 30, 2019
	Hepatitis C Treatments Are Safe and Effective for Seniors POZ \| October 28, 2019
	Dolutegravir and risk of neural tube defects: Labeling Updates FDA \| October 25, 2019
	Gilead Announced It Will Donate 2.4 Million Bottles of Truvada for PrEP. Here's How It Will Work The Body Pro \| October 16, 2019
	Rapid ART Initiation: A New Model Presents Unique Opportunities and Challenges Contagionlive.com \| October 11, 2019
	The 8th World Workshop on Oral Health and Disease in AIDS BRITISH DENTAL JOURNAL \| VOLUME 227 NO. 7 \| October 11 2019 Photos courtesy of Dr. David Croser
	IDWeek 2019: ViiV Healthcare to present 20 abstracts from its innovative R&D portfolio with focus on 2-drug and long-acting regimens and mental health impact of HIV ViiV Healthcare \| October 2, 2019
	MAVYRET: new dosage regimen and labeling updates FDA \| October 1, 2019
	FDA approves new HIV treatment (Long-Acting Ibalizumab) for patients who have limited treatment options NATAP \| September 26, 2019
	Merck’s PIFELTRO™ (doravirine) and DELSTRIGO™ (doravirine/lamivudine/tenofovir disoproxil fumarate) Receive US FDA Approval for Use in Appropriate Adults Living with HIV-1 Who Are Virologically Suppressed Business Wire \| September 20, 2019
	Theratechnologies Reaches Agreement With AIDS Drug Assistance Program (ADAP) for New EGRIFTA SV Yahoo Finance \| September 19, 2019
	FDA warns patients and health care professionals about rare instances of serious liver injury or failure with certain hepatitis C treatments in some patients with advanced liver disease FDA \| August 28, 2019
	ViiV Healthcare reports positive phase III study results of investigational, long-acting, injectable HIV-treatment regimen administered every two months GSK \| August 22, 2019
	Extensive Drug Resistance Has Become Rare Among People With HIV POZ \| August 19, 2019
	FDA panel backs Gilead's HIV prevention drug for certain population Reuters \| August 7, 2019
	BIKTARVY: recent changes to labeling FDA \| August 6, 2019
	ViiV Healthcare Submits Regulatory Application to European Medicines Agency for Investigational ... Yahoo Finance \| July 29, 2019
	WHO Recommends Antiretroviral Drug Dolutegravir As Preferred HIV Treatment, Including For ... Kaiser Family Foundation \| July 23, 2019
	Folic acid reduces risk of neural tube defects linked to HIV drug dolutegravir EurekAlert \| July 23, 2019
	Efficacy and safety of dolutegravir–rilpivirine for maintenance of virological suppression in adults with HIV-1: 100-week data from the randomised, open-label, phase 3 SWORD-1 and SWORD-2 studies The Lancet \| July 12, 2019
	Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV aidsinfo \| July 10, 2019
	Merck Highlights Commitment to HIV Research with Presentations for Investigational Anti-HIV Agent MK-8591 at IAS 2019 BioSpace \| July 10, 2019
	ViiV Healthcare announces phase III study meets primary endpoint, demonstrating the ability to control HIV-1 with a 2-drug regimen of dolutegravir plus lamivudine in virally suppressed patients switching from a TAF-containing, 3-drug regimen ViiV Healthcare \| July 10, 2019
	GSK's Dovato suppresses AIDS virus at same levels of three-drug regimen Reuters \| July 10, 2019
	Gilead and Lyndra Team Up to Develop Long-Acting HIV Therapies BioSpace \| July 9, 2019
	ViiV Healthcare announces start of first-ever study to identify and evaluate approaches to implementing its once-monthly injectable HIV treatment in clinical practice ViiV Healthcare \| July 8, 2019
	TRUVADA: Important Updates to the REMS FDA: HIV Email Updates \| July 1, 2019
	Long-Acting Antiretrovirals for Treatment NASTAD \| June 26, 2019
	HIV Updates: BIKTARVY label revisions
	HIV drug cabotegravir not associated with weight gain Healio \| June 8, 2019
	AIDS groups criticize Express Scripts for excluding several HIV medicines STAT \| June 6, 2019
	National Ryan White HIV/AIDS Program (RWHAP) Part B and AIDS Drug Assistance Program (ADAP) Monitoring Project: 2019 Annual Report NASTAD \| June 6, 2019
	Other than dolutegravir, no antiretroviral interactions with valproic acid in 134 people 20th International Workshop on Clinical Pharmacology of HIV, Hepatitis & Other Antiviral Drugs. May 14-16, 2019. Noordwijk, the Netherlands
	Phase 1 results show safety and once-daily potential of new HIV maturation inhibitor 20th International Workshop on Clinical Pharmacology of HIV, Hepatitis & Other Antiviral Drugs. May 14-16, 2019. Noordwijk, the Netherlands
	Management of antiretrovirals in Seniors - The importance of assisted treatment for adherence to treatment 20th International Workshop on Clinical Pharmacology of HIV, Hepatitis & Other Antiviral Drugs. May 14-16, 2019. Noordwijk, the Netherlands
	One third of French HIV group uses illicit drugs, often risking antiretroviral interactions 20th International Workshop on Clinical Pharmacology of HIV, Hepatitis & Other Antiviral Drugs. May 14-16, 2019. Noordwijk, the Netherlands
	Baseline genotype testing at HIV diagnosis not cost-effective Healio \| May 13, 2019
	Gilead to Donate Up to 2.4M Bottles of HIV Prevention Pills Each Year in the U.S. POZ \| May 10, 2019
	NIH Trial Evaluates Long-acting HIV Medication Unable to Adhere to Strict Daily Regimens NIH \| May 9, 2019
	Co-formulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, phase 3, non-inferiority trial The Lancet \| May 5, 2019
	ViiV Healthcare seeks FDA approval for long-term injectable HIV treatment WRAL Tech Wire \| April 29, 2019
	MSM at Highest Risk for HIV Acquisition Express Greatest Interest and Preference for Injectable Antiretroviral PrEP Compared to Daily, Oral Medication AIDS Behav. 2018 Apr;22(4):1158-1164. doi: 10.1007/s10461-017-1972-6
	Updates New ARTs/ New ART Data - CROI including Bictegravir, Dolutegravir+Rilpivirine, Dolutegravir+3TC, Doravirine; Fostemsavir & MK-8591 NATAP \| April 10, 2019
	NATAP: HIV-Drug Resistance Testing/DHHS Guidelines Last Updated: October 25, 2018
	ViiV Healthcare Announces CHMP Positive Opinion for DOVATO® (DOLUTEGRAVIR/LAMIVUDINE) as a Once-Daily, Single-Pill, Two-Drug Reimen for the Treatment of HIV Infection ViiV \| April 26, 2019
	New Rule at Centers for Medicare and Medicaid Helps Lower Costs of Meds POZ \| April 23, 2019 Special thanks to The AIDS Institute for leading the charge on this important issue
	Expanded Access - Pre-Approval Access to Rilpivirine Long Acting (RPV LA) Injectable Suspension for the Treatment of a Participant With Human Immunodeficiency Virus (HIV)-1 Infection NATAP \| April 18, 2019
	FDA Has Approved New Two-Drug Regimen to Treat People with HIV Healthline \| April 15, 2019
	Janssen Presents New Data from First Phase 3 Trial of a Single-Tablet Regimen in a Rapid Initiation Model of Care Demonstrating Safety and Efficacy with SYMTUZA® through 48 Weeks Janssen \| April 11, 2019
	FDA approves first two-drug complete regimen for HIV-infected patients who have never received antiretroviral treatment FDA \| April 8, 2019
	Gilead Announces New Grant Programs Supporting Investigator-Sponsored Research in Liver Diseases Market Watch \| Apr 9, 2019
	Pharma giant profits from HIV treatment funded by taxpayers and patented by the government Washington Post \| March 26, 2019
	Gilead's Asegua Therapeutics selected to partner with health department for hepatitis C drug subscription model Gilead \| March 26, 2019
	Long-acting injectable treatment maintains viral suppression aidsmap \| March 8, 2019
	Factors associated with therapeutic failure of 2-drug regimens, DAT’AIDS cohort: Two-antiretroviral maintenance failure--raltegravir regimens seem most vulnerable Conference on Retroviruses and Opportunistic Infections (CROI), March 4-7, 2019, Seattle
	Integrase inhibitor treatment leads to greater weight gain aidsmap \| March 7, 2019
	ViiV Healthcare Presents Positive, 48-Week Data from Two Pivotal Phase III Studies Showing Long-Acting, Injectable Two-Drug Regimen of Cabotegravir and Rilpivirine Has Similar Efficacy to Daily, Three-Drug Oral Treatment in Adults Living with HIV-1 Infection ViiV \| March 7, 2019
	HIV-1 escape in the central nervous system on elvitegravir-based antiretroviral therapy AIDS: March 1, 2019
	Gilead Announces Topline Data From Phase 3 STELLAR-4 Study of Selonsertib in Compensated Cirrhosis (F4) Due to Nonalcoholic Steatohepatitis (NASH) Gilead \| February 11, 2019
	Acyclovir labeling now includes details for treating premature infants infected with herpes virus NIH \| February 8, 2019
	FDA Hepatitis Update- VEMLIDY labeling revised (renal information) FDA \| February 6, 2019
	U.S. FDA Accepts sNDAs for PIFELTRO™ (doravirine) and DELSTRIGO™ (doravirine / lamivudine / tenofovir disoproxil fumarate) Merck \| January 22, 2019
	Pharm To Exam Table – Candida glabrata Urinary Tract Infections University of Nebraska Medical Center \| December 21, 2018 Note from Dr. Reznik – This information is valuable for oral infections with Candida glabrata
	HIV EMAIL UPDATES FDA \| December 11, 2018
	Dolutegravir plus lamivudine versus dolutegravir plus tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naive adults with HIV-1 infection (GEMINI-1 and GEMINI-2): week 48 results from two multicentre, double-blind, randomised, non-inferiority, phase 3 trials The Lancet \| November 9, 2018
	Safety, tolerability, and pharmacokinetics of long-acting injectable cabotegravir in low-risk HIV-uninfected individuals: HPTN 077, a phase 2a randomized controlled trial PLoS Med. 2018 Nov 8;15(11):e1002690. doi: 10.1371/journal.pmed.1002690. eCollection 2018 Nov
	FDA HIV Update: GENVOYA, STRIBILD, and TYBOST Pregnancy Label FDA \| November 7, 2018
	Novel antibiotic shows promise in treatment of uncomplicated gonorrhea NIH \| November 7, 2018
	NASTAD Announces the Release of PrEPcost.org NASTAD \| November 6, 2018
	Development of an End-user Informed Tenofovir Alafenamide (TAF) Implant for Long-acting (LA)-HIV Pre-exposure Prophylaxis (PrEP) NATAP \| November 6, 2018
	Transgender women taking PrEP have lower levels of PrEP drugs, especially in rectal tissues, than ... aidsmap \| November 2018
	Prolonged HIV suppression is possible using ibalizumab, analysis of highly drug-resistant patients ... aidsmap \| November 2, 2018
	Dolutegravir or lower-dose efavirenz equally effective, but less resistance with dolutegravir aidsmap \| November 1, 2018
	FDA HIV Update- ODEFSEY/COMPLERA: Pregnancy Label Updates FDA \| October 31, 2018
	ViiV Healthcare reports positive 48-week results for second phase III study for novel, long-acting, injectable HIV-treatment regimen HIV Drug Therapy, Glasgow 2018, October 28-31, 2018, Glasgow
	Two Thirds Reach Sub-50 Viral Load Through 48 Weeks With Ibalizumab HIV Drug Therapy, Glasgow 2018, October 28-31, 2018, Glasgow
	Polypharmacy in One Third of Big HIV Cohort vs One Fifth of Non-HIV Group HIV Drug Therapy, Glasgow 2018, October 28-31, 2018, Glasgow
	Good HIV Response Rate, Sustained Safety Through 96 Weeks With D/C/F/TAF HIV Drug Therapy, Glasgow 2018, October 28-31, 2018, Glasgow
	Outcomes of Patients Not Achieving Primary Endpoint From an Ibalizumba Phase 3 Trial HIV Drug Therapy, Glasgow 2018, October 28-31, 2018, Glasgow
	Bictegravir/F/TAF Noninferior to DTG Plus F/TAF at 96 Weeks: No Resistance HIV Drug Therapy, Glasgow 2018, October 28-31, 2018, Glasgow

TRUVADA: Important Updates to the REMS

Co-formulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, phase 3, non-inferiority trial

Janssen Presents New Data from First Phase 3 Trial of a Single-Tablet Regimen in a Rapid Initiation Model of Care Demonstrating Safety and Efficacy with SYMTUZA® through 48 Weeks

FDA approves first two-drug complete regimen for HIV-infected patients who have never received antiretroviral treatment

Gilead Announces New Grant Programs Supporting Investigator-Sponsored Research in Liver Diseases

Gilead Announces Topline Data From Phase 3 STELLAR-4 Study of Selonsertib in Compensated Cirrhosis (F4) Due to Nonalcoholic Steatohepatitis (NASH)