Gilead Announces Positive Data on New HIV Therapy Biktarvy

Gilead Sciences, Inc.GILD announced encouraging 48-weeks results from a phase III study (Study 1961) among 470 virologically suppressed adult women with HIV infection at the International Workshop on HIV and Women and at the 2018 Conference on Retroviruses and Opportunistic Infections ("CROI") in Boston (Poster 2539).

The study evaluated the efficacy and safety of switching from a boosted protease inhibitor (bPI) or boosted elvitegravir-containing regimen to Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg), a once-daily single tablet regimen ("STR").

Biktarvy was found to be statistically non-inferior to regimens containing a bPI or boosted elvitegravir and demonstrated no treatment-emergent resistance at 48 weeks in the ongoing study.

The study data showed that women who switched to Biktarvy maintained high levels of viral suppression, comparable to those who remained on a baseline regimen of either Genvoya, Stribild or ATV+RTV+FTC/TDF. Moreover, none of the participants on Biktarvy developed treatment-emergent resistance.

Biktarvy, Gilead's latest triple therapy, was approved by the FDA in February 2018 as a complete regimen for the treatment of HIV-1 infection in adults who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA

Meanwhile, the HIV franchise continues to gain traction on the back of rapid adoption of TAF-based regimens in the United States and EU. The TAF-based regimens now represent 62% of total Gilead HIV prescription volume following the launch of Genvoya along with Odefsey and Descovy in 2016.

A marketing authorization application for Biktarvy is under review in the European Union. Meanwhile, additional clinical trials of Biktarvy are ongoing, including a study in adolescents and children with HIV. The approval of this new HIV therapy will pose stiff competition to GlaxoSmith's GSK existing therapies, Tivicay and Triumeq.

Gilead's stock has lost 4.8% in the last six months compared with the industry's decline of 9.8%.

Gilead is banking on its HIV franchise which has been under tremendous pressure for a while due to lower patient starts and increased competition from AbbVie's ABBV therapies.

Zacks Rank & Key Pick

Gilead currently carries a Zacks Rank #3 (Hold).

A better-ranked stock in the health care sector is Regeneron Pharmaceuticals, Inc. REGN which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today's Zacks #1 Rank stocks here .

Regeneron's earnings per share estimates have moved up from $17.13 to $18.65 and from $20.37 to $21.56 for 2018 and 2019, respectively in the last 30 days. The company delivered a positive earnings surprise in three of the last four quarters, with an average beat of 9.15%.

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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