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Janssen and ViiV to Develop NRTI-free Single-tablet Regimen


Janssen R&D and ViiV Healthcare announced last week that they will collaborate on the development of a dual single-tablet regimen containing the non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine and the new integrase inhibitor dolutegravir, to be used as maintenance therapy for people who achieve viral suppression using a traditional regimen.

The approval of more agents in novel classes allows for combination regimens that omit the oldest class of HIV drugs, the nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs). While NRTIs are an effective part of combination antiretroviral therapy, they can cause toxicities ranging from anemia and neuropathy to kidney and bone problems.

Studies have shown that various NRTI-free regimens can provide good HIV suppression with minimal side effects. As reported at this year's Retrovirus Conference, a dual combination of rilpivirine and a long-acting version of dolutegravir (GSK1265744) maintained undetectable viral load in the LATTE study.

A few one-pill-once-daily regimens are currently on the market (Gilead Science's Atripla, Complera, and Stribild), all of which contain the NRTIs tenofovir and emtricitabine. ViiV's dolutegravir (Tivicay), the newest integrase inhibitor, is a component of a single-tablet regimen with abacavir/lamivudine that is awaiting FDA approval. There are currently no NRTI-free single-tablet regimens.

Below is an edited excerpt from a Janssen press release describing the collaboration.

Janssen Collaborates With ViiV Healthcare to Develop Two-Drug Single Tablet Regimen for the Maintenance Treatment of People Living With HIV

Cork, Ireland -- June 12, 2014 -- Janssen R&D Ireland Ltd announced today that they have entered into a collaboration with ViiV Healthcare to develop and commercialize a new single tablet regimen containing Janssen's non-nucleoside reverse transcriptase inhibitor rilpivirine (marketed as Edurant) and ViiV's integrase inhibitor dolutegravir (marketed as Tivicay) as the sole active ingredients for the maintenance treatment of people living with human immunodeficiency virus (HIV). The companies will further investigate development of this drug combination for pediatric use.
If successfully developed and approved by regulatory authorities, this treatment could offer people living with HIV who are virologically suppressed an option to switch from a standard three-drug therapy to a two-drug, nucleoside reverse transcriptase inhibitor (NRTI)-sparing antiviral regimen. 
"HIV remains a significant medical challenge, and our goal is to find new treatment regimens for patients," says Paul Stoffels, Chief Scientific Officer, Johnson & Johnson and Worldwide Chairman, Janssen. "We are pleased to collaborate with ViiV Healthcare in pursuing this shift in the HIV treatment paradigm and reaffirm our commitment to collaborate and develop new HIV treatments and fixed-dose regimens." 
Formulation and clinical development for the single tablet regimen will begin in the coming months.
Since the beginning of the HIV epidemic, almost 75 million people have been infected with the HIV virus. It is estimated that 35 million people are currently living with HIV globally, with 2.5 million people becoming newly infected each year.[1],[2],[3]
Standard HIV-drug therapy contains three active components: a backbone of two NRTIs, plus either a non-nucleoside reverse transcriptase inhibitor (NNRTI), protease inhibitor (PI) or integrase inhibitor (INI).



Janssen R&D. Janssen Collaborates With ViiV Healthcare to Develop Two-Drug Single Tablet Regimen for the Maintenance Treatment of People Living With HIV. Press release. June 12, 2014.