GILD's Investigational Regimen for HIV Treatment Meets Primary Goal

Gilead Sciences, Inc. GILD announced that its investigational single-tablet regimen (STR) of bictegravir and lenacapavir for HIV-1 Treatment met the primary endpoint in the late-stage ARTISTRY-1 study.

This study is a multicenter phase II/III study comparing the investigational once-daily combination of bictegravir, a global guidelines-recommended integrase strand transfer inhibitor, and lenacapavir, a first-in-class capsid inhibitor, versus current therapy in HIV patients who are virologically suppressed on complex regimens.

The positive results of this study have appeased investors. Shares are up in after-market trading.

Gilead’s shares have surged 35.6% year to date compared with the industry's growth of 15.4%.

More on GILD’s ARTISTRY-1 Study

Participants in the ARTISTRY-1 study were randomized in the ratio of 2:1 to receive a fixed-dose combination of bictegravir 75 mg/lenacapavir 50 mg or continue their stable baseline complex regimen.

Results from the ARTISTRY-1 study showed that the once-daily STR of bictegravir and lenacapavir met the primary success criterion for non-inferiority to baseline multi-tablet antiretroviral therapy regimens. The primary efficacy endpoint was the percentage of participants with HIV-1 RNA levels ≥50 copies/mL at week 48, defined by the FDA snapshot algorithm.

Results showed that combination was generally well tolerated, with no significant or new safety concerns identified.

Gilead plans to file the late-stage data from the ARTISTRY trials with regulatory authorities.

Per GILD, HIV-1 patients on complex regimens are unable to benefit from guideline-recommended STRs due to reasons of pre-existing resistance, tolerability and drug-drug interactions. Consequently, these patients may face challenges such as high pill burden, complicated adherence, and reduced quality of life.

Hence, an STR combining bictegravir and lenacapavir could offer a new medication option with convenient dosing for these patients.

GILD is also conducting the double-blind, phase III ARTISTRY-2 trial, which is evaluating the safety and efficacy of switching from Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) to a fixed-dose combination of bictegravir 75 mg/lenacapavir 50 mg in virologically suppressed people with HIV-1. A top-line data readout for the primary endpoint is anticipated before 2025 end.

GILD’s Strong HIV Franchise Maintains Momentum

Gilead has a market-leading HIV franchise, led by flagship HIV therapies — Biktarvy and Descovy. Biktarvy sales and Descovy for pre-exposure prophylaxis (PrEP) have fueled GILD’s top-line growth over the past several quarters.

Flagship HIV therapy Biktarvy is the top revenue generator for GILD. Per GILD, Biktarvy accounts for more than 52% share of the treatment market in the United States, and continues to be the leader in major markets around the world.

Roughly 75% of Descovy sales are for HIV prevention. Descovy currently accounts for more than 45% of the U.S. market share in PrEP market.

GILD’s HIV portfolio received a boost with the FDA approval for its twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir, for the prevention of HIV. This groundbreaking injectable therapy marks the first and only twice-yearly PrEP option available in the United States.

The FDA approval of lenacapavir under the brand name Yeztugo solidifies GILD’s HIV portfolio as its other prevention drug, Truvada, faces generic competition.

The initial uptake of Yeztugo looks good. Yeztugo has a competitive advantage as it needs to be taken only twice a year, unlike daily oral pills, and addresses a broad population. Yeztugo for PrEP raked in sales of $39 million in the third quarter. GILD stated that it achieved its 75% coverage goal for Yeztugo, nearly three months ahead of its target. Gilead continues to target achieving 90% coverage by the end of the first half of 2026.

Positive data from the phase III ARTISTRY-1 and ARTISTRY-2 studies will be a significant boost for the company.

Approval of better HIV treatments should strengthen the HIV franchise in the wake of increasing competition from the likes of GSK plc GSK.

GSK continues to grow its HIV business, driven by strong patient demand for long-acting injectable medicines (Cabenuva and Apretude) and Dovato.

GILD’s Zacks Rank and Stocks to Consider

GILD currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Alkermes ALKS and Amicus Therapeutics FOLD, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Alkermes’ EPS estimates for 2025 have increased to $1.96 from $1.83, while those for 2026 have risen from $1.70 to $1.77 in the past 30 days. The stock has gained nearly 7.9% year to date.

Alkermes’ earnings beat estimates in three of the trailing four quarters and missed the mark in one, delivering an average surprise of 4.58%.

In the past 60 days, estimates for Amicus Therapeutics’ 2025 EPS have increased to 34 cents from 31 cents. During the same time, EPS estimates for 2026 have decreased to 67 cents from 69 cents. Year to date, shares of FOLD have lost 0.4%.
 







 

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