Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • Resources
    • Voices
  • Advertise
  • SUBSCRIBE

Data Reinforce Long-Term Safety, Efficacy, and Tolerability Profile of Symtuza

By Janssen Pharmaceutical Companies of Johnson & Johnson | October 30, 2018

The Janssen Pharmaceutical Companies of Johnson & Johnson has announced new 96-week data from the pivotal Phase 3 AMBER study of Symtuza (darunavir, cobicistat, emtricitabine, and tenofovir alafenamide), a single-tablet regimen (STR) for treatment-naïve and certain virologically suppressed adults living with human immunodeficiency virus type 1 (HIV-1).

The 96-week data, which is the continuation of the 48-week results, reinforce the long-term safety, efficacy and tolerability profile of Symtuza as a treatment for people new to HIV antiretroviral treatment.

According to Janssen, the results, presented at HIV Glasgow, further build on the growing clinical data set, which includes the EMERALD, AMBER, and DIAMOND studies, demonstrating that Symtuza, the first and only complete darunavir-based STR, gives healthcare providers a new treatment option to bring clinically appropriate patients the protective barrier to resistance of darunavir in a formulation designed for tolerability and the convenience of an STR.   

Based on the U.S. Department of Health and Human Services (DHHS) guidelines, darunavir-based regimens are a recommended option in situations where clinicians may not have all genotypic resistance test results, when patients may be at risk for sub-optimal adherence, or in rapid initiation scenarios. The International Antiviral Society (IAS)-USA guidelines also recommend darunavir-based regimens in rapid initiation scenarios.

The 96-week data were presented at HIV Glasgow on Tuesday, October 30.

(Source: Janssen Pharmaceutical Companies of Johnson & Johnson)

Related Articles Read More >

Sandoz Logo 2025
Sandoz breaks ground on biosimilar plant in Slovenia
Nymi Logo_2022 (1)
Nymi, Caliber partner on passwordless authentication for pharma manufacturing
Moving toward the autonomous lab and what’s possible today
Antheia_Logo (1)
Pharma ingredient manufacturer Antheia raises $56M Series C
“ppw
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news, technologies, and developments in Pharmaceutical Processing.

DeviceTalks Tuesdays

DeviceTalks Tuesdays

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Pharmaceutical Processing World
  • Subscribe to our E-Newsletter
  • Contact Us
  • About Us
  • R&D World
  • Drug Delivery Business News
  • Drug Discovery & Development
  • DeviceTalks
  • MassDevice
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • Medical Design Sourcing
  • Medtech100 Index
  • R&D 100 Awards

Copyright © 2025 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • Resources
    • Voices
  • Advertise
  • SUBSCRIBE