FDA Approves Symtuza (D/C/F/TAF), the First and Only Complete Darunavir-Based Single-Tablet Regimen for the Treatment of HIV-1 Infection
TITUSVILLE, N.J, JULY 17, 2018 – The Janssen Pharmaceutical Companies of Johnson& Johnson today announced the U.S. Food and Drug Administration (FDA) has approved Symtuza (darunavir, cobicistat, emtricitabine and tenofovir alafenamide -... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 17, 2018 Category: Drugs & Pharmacology Source Type: news

Fixed-Dose Bictegravir-Emtricitabine-Tenofovir Maintains Virologic Suppression in HIV Fixed-Dose Bictegravir-Emtricitabine-Tenofovir Maintains Virologic Suppression in HIV
Fixed-dose bictegravir-emtricitabine-tenofovir (Biktarvy) maintains virologic suppression in adults with HIV-1 who are switched from dolutegravir-abacavir-lamivudine or from boosted protease inhibitor-based regimens, according to results from two noninferiority trials.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - July 13, 2018 Category: Consumer Health News Tags: HIV/AIDS News Source Type: news

Truvada for Teens;'Unrealistic' Ebola Vax;'Safer' HIV Drug Lawsuit
(MedPage Today) -- News and commentary from the world of infectious diseases (Source: MedPage Today Public Health)
Source: MedPage Today Public Health - May 16, 2018 Category: American Health Source Type: news

FDA Approves Expanded Indication for Truvada (emtricitabine and tenofovir disoproxil fumarate) for Reducing the Risk of Acquiring HIV-1 in Adolescents
FOSTER CITY, Calif.--(BUSINESS WIRE)--May 15, 2018-- Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved once-daily oral Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 15, 2018 Category: Drugs & Pharmacology Source Type: news

EMA Panel Recommends Once-Daily HIV-1 Treatment Biktarvy EMA Panel Recommends Once-Daily HIV-1 Treatment Biktarvy
EMA panel recommends marketing authorization for a once-daily HIV-1 combo containing bictegravir, emtricitabine, and tenofovir.International Approvals (Source: Medscape Internal Medicine Headlines)
Source: Medscape Internal Medicine Headlines - April 27, 2018 Category: Internal Medicine Tags: HIV/AIDS News Alert Source Type: news

No Higher Risk for Adverse Birth Outcomes with 3-Drug HIV Tx (CME/CE)
(MedPage Today) -- Tenofovir, emtricitabine, and ritonavir-boosted lopinavir compared with other ART (Source: MedPage Today OB/GYN)
Source: MedPage Today OB/GYN - April 25, 2018 Category: OBGYN Source Type: news

Risk of Adverse Birth Outcomes No Higher With TDF-FTC-LPV/r
WEDNESDAY, April 25, 2018 -- For HIV-infected women and their infants, the risk of adverse birth outcomes is similar with tenofovir, emtricitabine, and ritonavir-boosted lopinavir (TDF-FTC-LPV/r) compared with zidovudine, lamivudine, and... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - April 25, 2018 Category: Pharmaceuticals Source Type: news

Tenofovir Alafenamide Plus Emtricitabine Effective, Safe in HIV Tenofovir Alafenamide Plus Emtricitabine Effective, Safe in HIV
In HIV patients, combination therapy with tenofovir alafenamide and emtricitabine is non-inferior to that of abacavir plus lamivudine, according to a manufacturer-sponsored trial.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - March 13, 2018 Category: Consumer Health News Tags: Medscape Today News Source Type: news

Monthly News Roundup - February 2018
Gilead ’s Biktarvy Cleared for Use in HIV-1 Infection In February, the FDA approved Gilead's Biktarvy (bictegravir, emtricitabine and tenofovir alafenamide, or BIC/FTC/TAF), a combination, once-daily, oral treatment for HIV-1 infection in... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - February 28, 2018 Category: Pharmaceuticals Source Type: news

New York Will Investigate Reports of Gay Men Denied Insurance
Denying men life or disability policies because they take drugs to prevent H.I.V. is discriminatory and may trigger penalties. (Source: NYT Health)
Source: NYT Health - February 15, 2018 Category: Consumer Health News Authors: DONALD G. McNEIL Jr. Tags: Acquired Immune Deficiency Syndrome Discrimination Homosexuality and Bisexuality Truvada (Drug) Insurance GLBTQ Legal Advocates and Defenders (GLAD) New York Times New York State Source Type: news

Biktarvy (Bictegravir, Emtricitabine, and Tenofovir Alafenamide Tablets) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - February 14, 2018 Category: Drugs & Pharmacology Source Type: news

He Took a Drug to Prevent AIDS. Then He Couldn ’ t Get Disability Insurance.
Insurers have denied life and disability coverage to men taking Truvada to prevent H.I.V. infection, say gay rights advocates and medical experts. (Source: NYT Health)
Source: NYT Health - February 12, 2018 Category: Consumer Health News Authors: DONALD G. McNEIL Jr. Tags: Acquired Immune Deficiency Syndrome Truvada (Drug) Discrimination Homosexuality and Bisexuality Life Insurance GLBTQ Legal Advocates and Defenders (GLAD) PrEP (pre-exposure prophylaxis) Mutual of Omaha Source Type: news

New 3-Drug Combo for HIV OK'd
(MedPage Today) -- Gilead's Biktarvy includes bictegravir, emtricitabine, and tenofovir alafenamide (Source: MedPage Today Primary Care)
Source: MedPage Today Primary Care - February 8, 2018 Category: Primary Care Source Type: news

FDA Approves Biktarvy (bictegravir, emtricitabine, tenofovir alafenamide) for Treatment of HIV-1 Infection
FOSTER CITY, Calif.--(BUSINESS WIRE)--Feb. 7, 2018-- Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg,... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 7, 2018 Category: Drugs & Pharmacology Source Type: news

'We dropped the ball': Some Indigenous people had access to HIV drug for years without knowing
Truvada has been free for registered First Nations and Inuit people in B.C. for at least three years. (Source: CBC | Health)
Source: CBC | Health - January 3, 2018 Category: Consumer Health News Tags: News/Canada/British Columbia Source Type: news

Global Health: Six Lessons in Helping African Women Avoid H.I.V.
Countering the bleak history of AIDS prevention in Africa, a nonprofit explains how it helped women hide H.I.V. prevention pills and deflect male anger. (Source: NYT Health)
Source: NYT Health - December 16, 2017 Category: Consumer Health News Authors: DONALD G. McNEIL Jr. Tags: Women and Girls Acquired Immune Deficiency Syndrome Sex Truvada (Drug) Foreign Aid Africa Kenya Source Type: news

HIV Prevention Trials Network (HPTN) announces initiation of HPTN 084
(FHI360) The HIV Prevention Trials Network (HPTN) today announced the initiation of HPTN 084, a Phase 3 double-blind safety and efficacy study of long-acting injectable cabotegravir (CAB) compared to a combination of daily oral tenofovir disoproxil fumarate 300 mg plus emtricitabine 200 mg (TDF/FTC). (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - November 30, 2017 Category: International Medicine & Public Health Source Type: news

Single-tablet Switch Option Effective in Virologically Suppressed HIV Single-tablet Switch Option Effective in Virologically Suppressed HIV
A new single-tablet regimen (STR) that includes the protease inhibitor (PI) darunavir, cobicistat, emtricitabine, and tenofovir alafenamide maintains viral suppression in adults infected with HIV-1, according to results from the EMERALD phase 3 noninferiority trial.Reuters Health Information (Source: Medscape Hiv-Aids Headlines)
Source: Medscape Hiv-Aids Headlines - October 20, 2017 Category: Infectious Diseases Tags: HIV/AIDS News Source Type: news

Janssen Submits New Drug Application to U.S. Food and Drug Administration for the First Darunavir-Based Single Tablet Regimen for the Treatment of HIV-1
Janssen seeks approval for investigational regimen that aims to combine efficacy, durability, and the high genetic barrier to resistance of darunavir with the renal and bone safety profile of emtricitabine/tenofovir alafenamide in a once daily pill (Source: Johnson and Johnson)
Source: Johnson and Johnson - October 19, 2017 Category: Pharmaceuticals Source Type: news

HIV prevention drug could save NHS £1 billion over 80 years
Conclusion Evidence to support the use of Prep is building. Studies have shown that it is very effective at reducing the chances of becoming infected with HIV, for men at risk of infection through unprotected sex with men. The question is more about the cost of treatment – and who should fund it – than whether it works. NHS England previously went to court to say that it should not be responsible for funding Prep, as it is a preventive treatment, and therefore should come under health promotion budgets held by local authorities. The High Court ruled that the NHS was able to fund the drug. NHS England has since ...
Source: NHS News Feed - October 19, 2017 Category: Consumer Health News Tags: Medication Source Type: news

Janssen Announces Pivotal Phase 3 Study Results for Investigational Darunavir-Based Single-Tablet Regimen for the Treatment of HIV-1 Infection in Adults Switching from Boosted Protease Inhibitors Plus Emtricitabine and Tenofovir Disoproxil Fumarate Regimens
EMERALD 48-week safety and efficacy results published in The Lancet HIV and to be presented at IDWeek (Source: Johnson and Johnson)
Source: Johnson and Johnson - October 6, 2017 Category: Pharmaceuticals Source Type: news

Higher-Dose, Once-Daily Raltegravir Regimen for HIV-1 Higher-Dose, Once-Daily Raltegravir Regimen for HIV-1
A 1,200-mg, once-daily regimen of raltegravir, in combination with tenofovir disoproxil fumarate and emtricitabine, is effective in patients with previously untreated HIV-1 infection, according to results from the ONCEMRK trial.Reuters Health Information (Source: Medscape Hiv-Aids Headlines)
Source: Medscape Hiv-Aids Headlines - September 26, 2017 Category: Infectious Diseases Tags: HIV/AIDS News Source Type: news

New Guidelines Issued on HIV Treatment During Pregnancy (FREE)
By Kelly Young Edited by David G. Fairchild, MD, MPH, and Jaye Elizabeth Hefner, MD Tenofovir-emtricitabine should not be a first treatment choice for women with HIV who are pregnant, according to new patient-centered … (Source: Physician's First Watch current issue)
Source: Physician's First Watch current issue - September 12, 2017 Category: Primary Care Source Type: news

Drug Helped Protect Gay Teen Males from HIV
Small study found Truvada worked when taken daily, but some strayed from regimen Source: HealthDay Related MedlinePlus Pages: Gay, Lesbian, Bisexual, and Transgender Health, HIV/AIDS, Teen Health (Source: MedlinePlus Health News)
Source: MedlinePlus Health News - September 6, 2017 Category: Consumer Health News Source Type: news

Drug Helped Protect Gay Teen Males From HIV
Small study found Truvada worked when taken daily, but some strayed from regimen (Source: Fertility News - Doctors Lounge)
Source: Fertility News - Doctors Lounge - September 5, 2017 Category: Reproduction Medicine Tags: Infections, AIDS, Nursing, Pediatrics, Pharmacy, Reproductive Medicine, Research, News, Source Type: news

Drug Helped Protect Gay Teen Males From HIV
Small study found Truvada worked when taken daily, but some strayed from regimen (Source: WebMD Health)
Source: WebMD Health - September 5, 2017 Category: Consumer Health News Source Type: news

Truvada Helped Protect Gay Teen Males From HIV
TUESDAY, Sept. 5, 2017 -- A group of gay and bisexual teenage males safely used a medication that prevents HIV infection, though some failed to follow the drug regimen fully and became infected, researchers report. People at risk for becoming... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - September 5, 2017 Category: General Medicine Source Type: news

Maraviroc-containing Regimens Appear Safe for HIV PrEP in Women Maraviroc-containing Regimens Appear Safe for HIV PrEP in Women
Maraviroc-containing regimens appear to be safe and well tolerated, compared with tenofovir-emtricitabine (TDF-FTC), for preventing HIV infection in women, according to results from a phase 2 trial.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - August 22, 2017 Category: Consumer Health News Tags: Medscape Today News Source Type: news

PrEP use in US exceeds 100,000 in Gilead pharmacy survey
An estimated 120,000 people in the US have started Truvada for pre-exposure prophylaxis (PrEP) since 2012, according to the latest findings from a survey of retail and mail-order pharmacies by Gilead Sciences. (Source: PHPartners.org)
Source: PHPartners.org - August 16, 2017 Category: International Medicine & Public Health Source Type: news

Mylan rolls out HIV treatment medicine in Canada
Mylan launched three generic medications to treat HIV in Canada. The pharmaceutical company, which is based in the Netherlands but run out of its corporate offices in Canonsburg, said it had received Health Canada approval for these generic drugs: emtricitabine/tenofovir disoproxil fumarate 200 mg/300 mg, a generic alternative to Truvada efavirenz/emtricitabin e/tenofovir disoproxil fumarate 600 mg, 200 mg, and 300 mg, a generic alternative to Atripla tenofovir disoproxil 300 mg, a generic alternative… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - August 10, 2017 Category: American Health Authors: Paul J. Gough Source Type: news

Mylan Advances Access in the Fight Against HIV with the Launch of Three Generic Antiretroviral Medicines in Canada
Mylan now offers generic alternatives to Truvada®, Atripla® and Viread® to patients in Canada1 HERTFORDSHIRE, England and PITTSBURGH and TORONTO, Aug. 10, 2017 -- (Healthcare Sales & Marketing Network) -- Mylan Pharmaceuticals ULC, a subsid... Biopharmaceuticals, Generics, Product Launch Mylan, Truvada, Atripla, Viread (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - August 10, 2017 Category: Pharmaceuticals Source Type: news

Gilead Announces U.S. FDA Priority Review Designation for Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide for Treatment of HIV
FOSTER CITY, Calif.--(BUSINESS WIRE)--Aug. 10, 2017-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted priority review for the company ’s New Drug Application (NDA) for an... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 10, 2017 Category: Drugs & Pharmacology Source Type: news

Lower Risk of Adverse Birth Outcomes With Tenofovir-emtricitabine-efavirenz Lower Risk of Adverse Birth Outcomes With Tenofovir-emtricitabine-efavirenz
Exposure of infants, from conception, to the antiretroviral combination of tenofovir disoproxil fumarate, emtricitabine, and efavirenz (TFC-FTC-EFV) is associated with a lower risk of adverse birth outcomes, compared with exposure to other antiretroviral regimens, according to data from Botswana.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - August 8, 2017 Category: Consumer Health News Tags: Medscape Today News Source Type: news

NY gay man was refused HIV drug 'because he has gay sex'
The man, who lives in New York, applied for Truvada's PrEP in July to protect himself from the life-threatening disease. But he received a denial letter from United, citing his sexuality as a reason. (Source: the Mail online | Health)
Source: the Mail online | Health - August 4, 2017 Category: Consumer Health News Source Type: news

Truvada, vaginal ring safe for HIV prevention in adolescents
New research has shown that the use of a monthly vaginal ring and a daily oral Truvada are safe and effective at preventing HIV in adolescent girls. (Source: Health News - UPI.com)
Source: Health News - UPI.com - July 25, 2017 Category: Consumer Health News Source Type: news

In adolescents, oral Truvada and vaginal ring for HIV prevention are safe, acceptable
NIH-funded clinical trials are first of their kind to include younger adolescent girls. (Source: National Institutes of Health (NIH) News Releases)
Source: National Institutes of Health (NIH) News Releases - July 25, 2017 Category: American Health Source Type: news

Janssen Receives Positive CHMP Opinion for SYMTUZA ™ The First Darunavir-Based Single-Tablet Regimen for the Treatment of HIV
- Proven efficacy and durability of darunavir combined with the improved renal laboratory and bone mineral density profile of emtricitabine/tenofovir alafenamide as compared to emtricitabine/tenofovir disoproxil fumarate into one single tablet (Source: Johnson and Johnson)
Source: Johnson and Johnson - July 21, 2017 Category: Pharmaceuticals Source Type: news

Gilead Submits New Drug Application to U.S. Food and Drug Administration for Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide for HIV Treatment
FOSTER CITY, Calif.--(BUSINESS WIRE)--Jun. 12, 2017-- Gilead Sciences, Inc. (NASDAQ: GILD) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for an investigational, once-daily single... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 12, 2017 Category: Drugs & Pharmacology Source Type: news

How approval of a low-price generic HIV prevention drug could hit Gilead
Foster City's Gilead Sciences won approval in 2012 of Truvada as the first drug to prevent the spread of the AIDS virus. What does it mean now that Teva Pharmaceutical Industries has won the OK to introduce a supposedly low-cost version of the drug? (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - June 10, 2017 Category: Biotechnology Authors: Ron Leuty Source Type: news

How approval of a low-price generic HIV prevention drug could hit Gilead
Foster City's Gilead Sciences won approval in 2012 of Truvada as the first drug to prevent the spread of the AIDS virus. What does it mean now that Teva Pharmaceutical Industries has won the OK to introduce a supposedly low-cost version of the drug? (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - June 9, 2017 Category: Pharmaceuticals Authors: Ron Leuty Source Type: news

FDA Approves First Generic Truvada in US FDA Approves First Generic Truvada in US
Generic versions of emtricitabine/tenofovir disoproxil, which can both treat and prevent HIV infections, are already available in other countries.FDA Approvals (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - June 9, 2017 Category: Consumer Health News Tags: HIV/AIDS News Alert Source Type: news

Health Highlights: June 9, 2017
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: Generic Version of HIV Drug Truvada Approved by FDA The first generic version of the HIV drug Truvada (emtricitabine and tenofovir disoproxil... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - June 9, 2017 Category: General Medicine Source Type: news

FDA Approves First Generic Truvada for HIV Infection and Pre-Exposure Prophylaxis (PrEP)
June 8, 2017 - The U.S. Food and Drug Administration has approved the first generic version of Truvada for the treatment of HIV-1, in combination with other antiretroviral agents, and for pre-exposure prophylaxis (PrEP) in combination with safer sex... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - June 8, 2017 Category: Pharmaceuticals Source Type: news

Gilead reports positive data from four Phase III combination trials for HIV-1
US-based biopharmaceutical firm Gilead Sciences has reported positive results from four Phase III clinical trials investigating the combination of bictegravir (BIC), emtricitabine (FTC) and tenofovir alafenamide (TAF) to treat patients with HIV-1. (Source: Drug Development Technology)
Source: Drug Development Technology - May 30, 2017 Category: Pharmaceuticals Source Type: news

A GOP Health Care Plan May Ruin Our Best Chance At Ending HIV And AIDS
Before the pharmacist retrieves my prescription, she leans in and whispers: “Just so you know, it’s $1,300.” This happens almost every time, so I already have at the ready my coupon card from the drug’s manufacturer. The card provides me with $3,600 in co-pays, or about three months worth of medicine, but now I’ve run out. I’m only on the hook for $80, after which I’ll hit my $7,150 health insurance deductible for the year. Then, until January, each monthly prescription will be free for me. I swipe my credit card. Between the manufacturer-provided discounts and my private health i...
Source: Healthy Living - The Huffington Post - May 16, 2017 Category: Consumer Health News Source Type: news

Truvada (Emtricitabine and Tenofovir Disoproxil Fumarate) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - May 8, 2017 Category: Drugs & Pharmacology Source Type: news

Atripla (Efavirenz, Emtricitabine, and Tenofovir Disoproxil Fumarate) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - April 24, 2017 Category: Drugs & Pharmacology Source Type: news

Odefsey (Emtricitabine, Rilpivirine, and Tenofovir Alafenamide Fixed-dose Combination Tablets) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - April 20, 2017 Category: Drugs & Pharmacology Source Type: news

Scotland approves a controversial anti-HIV drug  
The Scottish Medicines Consortium (SMC) has approved the pre-exposure prophylaxis (PrEP) treatment, which has the brand name Truvada.A trial of the drug in England will start in 2017-18. (Source: the Mail online | Health)
Source: the Mail online | Health - April 11, 2017 Category: Consumer Health News Source Type: news

NHS' anti-HIV drug PrEP approved in Scotland, UK
The Scottish Medicines Consortium (SMC), UK, has approved the supply of Emtricitabine / tenofovir disoproxil (Truvada) by the National Health Service (NHS) to prevent HIV in the nation. (Source: Drug Development Technology)
Source: Drug Development Technology - April 10, 2017 Category: Pharmaceuticals Source Type: news