2-Drug HIV Regimens Expected to Boost GlaxoSmithKline’s Revenues


Jan. 31 2018, Updated 10:34 a.m. ET

Jucala FDA approval

On November 21, 2017, the U.S. Food and Drug Administration (or FDA) approved Jucala, a two-drug oral regimen comprising of dolutegravir and rilpivirine for patients suffering with HIV-1 infections who have not demonstrated treatment failure or history of drug resistance to the individual components of the new therapy. These patients also need to demonstrate suppressed virus levels due to a previous stable regimen at least for a period of six months. Juluca is commercialized by ViiV Healthcare, a joint venture of GlaxoSmithKline (GSK), Pfizer (PFE), and Shinogi.

Article continues below advertisement

Since the current standard of care includes three or more drugs, the two drug regimen could help reduce toxicity levels for treated patients. Further, according to a Patient Pathways survey presented at IAS 2017, approximately 66% of HIV patients opt for regimens with fewer drugs. Additionally, the latest Department of Health and Human Services’ guidelines as updated on October 17, 2017, have mentioned dolutegravir plus rilpivirine as a reasonable switch option for HIV-1 patients with suppressed viral response, with no resistance to dolutegravir or rilpivirine, and for whom the use of Nucleoside reverse transcriptase inhibitors (or NRTIs) is not advisable. GlaxoSmithKline makes up about 0.83% of the Vanguard FTSE Developed Markets ETF’s (VEA) total portfolio holdings.

Two-drug HIV regimens

Besides Jucala, ViiV Healthcare is also involved in studying two other drug regimens: dolutegravir plus lamivudine and cabotegravir plus rilpivirine. GlaxoSmithKline expects ViiV Healthcare to release data from the phase three program, GEMINI, comparing dolutegravir plus lamivudine regimen with doultegravir plus Truvada’s three-drug regimen in treatment-naïve HIV-1 patients in 2018. Based on this data, the company expects that the new drug application for this therapy will be filed with the FDA in 2018.

GlaxoSmithKline expects ViiV Healthcare to release data from the phase three study, ATLAS-2M, which will study whether the two-month dosing of long-acting cabotegravir plus rilpivirine is as effective in its antiviral activity as the monthly dosing of this regimen in HIV-1 patients with suppressed virus levels.

These innovative two drug regimens are expected to enable GlaxoSmithKline to compete effectively with other HIV players such as Gilead Sciences (GILD) and Bristol-Myers Squibb (BMY).

In the next article, we’ll discuss growth prospects for GlaxoSmithKline’s vaccines business in greater detail.


More From Market Realist

  • Businesswoman looking out a window
    Company & Industry Overviews
    Shifting Focus: Three Women Investing Funds in 2021
  • Aol logo on office building,
    Company & Industry Overviews
    What We Know About Apollo Global Management, New Owners of AOL and Yahoo
  • Chick-fil-A sign
    Company & Industry Overviews
    Why It Only Costs $10K to Own a Chick-fil-A Location
  • Beyond Meat Burger 3.0
    Company & Industry Overviews
    How Is Beyond Burger 3.0 Different and Will It Bring BYND Stock Up?
  • CONNECT with Market Realist
  • Link to Facebook
  • Link to Twitter
  • Link to Instagram
  • Link to Email Subscribe
Market Realist Logo
Do Not Sell My Personal Information

© Copyright 2021 Market Realist. Market Realist is a registered trademark. All Rights Reserved. People may receive compensation for some links to products and services on this website. Offers may be subject to change without notice.