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J&J's Phase III Data Shows Switch to its HIV Drug Beneficial

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Johnson & Johnson (JNJ - Free Report) announced long-term data from a late-stage study on Symtuza in HIV-1 patients who are virologically suppressed. Switching to J&J’s HIV treatment helped to maintain high rates of virologic suppression in such patients. Symtuza is J&J’s darunavir-based once-daily single-tablet regimen (STR) approved for the treatment of HIV in treatment-naïve and certain virologically suppressed adults.

New 96-week data from the phase III EMERALD study showed that switching to Symtuza maintained high virologic suppression in 91% of patients and also led to low rates of virologic failure (1% of the patient population) at the end of the study period. The data was presented at IDWeek 2018 in San Francisco, CA. The patient population studied in EMERALD comprised HIV patients who experienced prior virologic failure and/or who may have resistance to emtricitabine.

The stock has dipped 0.5% this year so far against an increase of 7.8% recorded by the industry.



Symtuza (darunavir, cobicistat, emtricitabine, tenofovir alafenamide) was approved in the United States in July this year and in the EU in September last year. The U.S. label, however, comes with a boxed warning regarding the risk of post-treatment acute exacerbation of hepatitis B.

Another new HIV STR in J&J’s portfolio is Juluca, which was developed in partnership with Glaxo (GSK - Free Report) . Juluca is the first two-drug regimen to gain FDA approval that reduces the number of medicines HIV patients take without compromising on the efficacy of a conventional three-drug regimen.

Juluca combines two approved HIV drugs — ViiV Healthcare’s Tivicay (50 mg) and J&J’s  Edurant (25 mg) — into a single, once-daily pill for the treatment of virologically suppressed HIV-1 infection. ViiV Healthcare is an HIV company majorly owned by Glaxo and Pfizer (PFE - Free Report) .

Gilead (GILD - Free Report) also gained FDA approval for a single tablet HIV regimen (triple therapy) named Biktarvy in February.

J&J currently has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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