ViiV Healthcare Launches New HIV Therapy Cabenuva
… ViiV Healthcare Launches New HIV Therapy Cabenuva …

ViiV Healthcare Unveils New HIV Therapies Cabenuva and Vocabria

GlaxoSmithKline, Pfizer and Shionogi enterprise continues to advance its HIV-focused business mission and develop breakthrough treatments

John G. Baresky

ViiV Healthcare, a company exclusively devoted to the HIV/AIDS marketplace, has announced the FDA has approved its latest new injectable therapy combination Cabenuva (cabotegravir and rilpivirine).

The FDA also approved Vocabria (cabotegravir) which is an oral tablet formulation of Cabenuva. Voacabria should be taken in combination with oral rilpivirine (Edurant) for one month prior to starting treatment with Cabenuva to ensure the medications are well-tolerated before switching to the extended-release injectable formulation.

Cabenuva is indicated as a complete regimen for the treatment of HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA less than 50 copies per milliliter [mL]) on a stable regimen, with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.

Available by prescription only, Cabenuva is administered as two intramuscular injections (cabotegravir and rilpivirine). The complete regimen combines the integrase strand transfer inhibitor (INSTI) cabotegravir, developed by ViiV Healthcare, with rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI) developed by Janssen Sciences Ireland UC, one of the Janssen business units of Johnson & Johnson (NYSE: JNJ).

INSTIs inhibit HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This phase is essential in the HIV replication cycle and is also responsible for establishing chronic infection. Rilpivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI). NNRTIs interfere with an enzyme called reverse transcriptase, which in turn stops the virus from multiplying.

The clinical formulation and therapeutic effect of Cabenuva are further augmented with its convenience attributes that benefit medical professionals and patients. Cabenuva reduces treatment dosing days from 365 days to 12 days per year.

The product is available in two injectable strengths:

  • 400MG/2ML; 600MG/2ML suspension, extended-release (intramuscular)
  • 600MG/3ML; 900MG/3ML suspension, extended-release (intramuscular)

Vocabria is only available by prescription as well and produced as a 30 mg film-coated tablet administered orally.

The FDA issued Cabenuva and Vocabria Fast Track and Priority Review to prioritize and accelerate the evaluation of each product.

Founded in 2009, ViiV was founded by Pfizer (NYSE: PFE) and GlaxoSmithKline (NYSE: GSK) combining their HIV business franchises. Shionogi (OTCMKTS: SGIOY) followed suit and transferred their HIV clinical and commercial assets to the ViiV organization in 2012. The ownership stakes are as follow:

  • 76.5%: GlaxoSmithKline
  • 13.5% Pfizer
  • 10% Shionogi

Since its founding, ViiV has developed and commercialized an impressive array of therapies to treat HIV/AIDS:

  • Cabenuva (cabotegravir and rilpivirine)
  • Combivir (lamivudine and zidovudin)
  • Dovato (dolutegravir and lamivudine)
  • Epivir (lamivudine)
  • Epzicom (abacavir and lamivudine)
  • Juluca (dolutegravir and rilpivirine)
  • Lexiva (fosamprenavir calcium)
  • Retrovir (zidovudine)
  • Rukobia (fostemsavir)
  • Selzentry (maraviroc)
  • Tivicay/ Tivicay PD (dolutegravir)
  • Triumeq (abacavir, dolutegravir, lamivudine)
  • Trizivir (abacavir, lamivudine, zidovudine)
  • Viracept (nelfinavir mesylate)
  • Vocabria (cabotegravir)
  • Ziagen (abacavir)

In addition to creating complex therapies, market access strategy is a built-in element of ViiV’s commercial operations. Prescribing protocols, clinical complexity and cost of HIV/AIDs therapies inhibit the ability of medical professionals to easily prescribe these medications; these also hamper the efforts of patients to receive treatment and pay for it.

The company engages numerous healthcare provider organizations, managed care organizations (MCOs), pharmacy benefit managers (PBMs), specialty pharmacies, governments as well as other payers and supply chain entities to establish and maintain product availability for patients and healthcare professionals on a global basis.

A compact, worldwide organization, ViiV employs over 1,000 associates and is headquartered in Brentford Middlesex, United Kingdom. Their U.S. operations are based in Research Triangle, North Carolina that is accompanied by their research development center exclusively dedicated to HIV/AIDs located in Branford, Connecticut.

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