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Gilead (GILD) Announces Data on Combination Therapy for HIV

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Gilead Sciences, Inc.GILD recently announced data from a phase II study. The study evaluated the efficacy, safety and tolerability of bictegravir (75 mg) (BIC) in combination of emtricitabine/tenofovir alafenamide (200/25 mg) (FTC/TAF) versus dolutegravir (50 mg) (DTG) and emtricitabine/tenofovir alafenamide (200/25 mg) (FTC/TAF) in treating naïve, HIV-1 infected adults.

We note that GlaxoSmithKline's GSK markets dolutegravir as Tivicay.

Shares of Gilead underperformed the Zacks classified industry in the last one year with the stock losing 24.6% during this period, compared with the industry's decline of 2.8%.

Shares of Gilead underperformed the Zacks classified Medical-Biomedical and Genetics industry in the last one year with the stock losing 24.6% during this period, compared with the industry's decline of 2.8%.

Coming back to the latest news, the results from the study showed that both the BIC+FTC/TAF and DTG+FTC/TAF regimens had high virologic response rates at week 24 and week 48.

The results of the study showed that 98 subjects were randomly selected in a 2:1 ratio to receive either BIC+FTC/TAF (n=65) or DTG+FTC/TAF (n=33). At week 24, 97% of patients taking BIC+FTC/TAF and 94%of patients taking DTG+FTC/TAF achieved HIV-1 RNA levels less than 50 copies/mL. The results show that bictegravir in combination with the FTC/TAF can be a new alternative treatment option for HIV patients.

The company has advanced the combination of bictegravir and FTC/TAF into four phase III clinical trials.Gilead Sciences expects to release additional data by the end of 2017.

Gilead Sciences also released data from a preclinical study evaluating HIV capsid inhibitors for potential use as a long-acting antiretroviral (ARV) treatment. This study identified novel HIV-1 capsid inhibitors with highly potent antiviral activity and a favorable resistance profile to existing ARVs in vitro.

We remind investors that Gilead is a dominant player in the HIV market with a strong portfolio. Gilead is currently looking to introduce drugs with improved long-term safety profiles in the HIV market. The newly launched TAF-based products - Genvoya, Odefsey and Descovy are performing well in both the U.S. and EU.

By the end of 2016, TAF-based regimens are expected to make up 37% of Gilead's HIV prescription volume in the treatment market. The company expects that the use of Truvada for pre-exposure prophylaxis (PrEP) will continue to boost sales of HIV franchise going forward, particularly in the U.S. At the end of 2016, approximately 110,000 people in the U.S. were using Truvada for this indication.

However, the company's HCV franchise continues to be under competitive and pricing pressure leading to a massive decline in Harvoni and Sovaldi sales. We note that Harvoni, Sovaldi and Epclusa, are facing competition from AbbVie's ABBV Viekira Pak and Viekira XR among others.

Gilead Sciences, Inc. Price and Consensus

Gilead Sciences, Inc. Price and Consensus | Gilead Sciences, Inc. Quote

Zacks Rank & Key Pick

Gilead currently carries Zacks Rank #5 (Strong Sell).

A better-ranked stock in the health care sector is Sucampo Pharmaceuticals SCMP which currently carries a Zacks Rank #2 (Buy).

You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here .

Sucampo's earnings estimates were stable at $1.22 for 2016 but have increased from $1.69 to $1.74 for 2017 over the last 60 days. The company posted a positive earnings surprise in all of the four trailing quarters with an average beat of 35.5%.

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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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