Biktarvy, launched by Gilead Sciences in 2018, quickly became a mainstay in HIV treatment. Biktarvy is a fixed-dose combination tablet containing bictegravir (50 mg), emtricitabine (200 mg), and tenofovir alafenamide (25 mg). In 2022, the drug generated an impressive $10.39 billion in sales, making it the world’s best-selling HIV treatment.

1. Introduction

Biktarvy, launched by Gilead Sciences in 2018, quickly became a mainstay in HIV treatment. The launch of Biktarvy marks a major milestone in Gilead’s HIV research history, building on the success of previous therapies such as Truvada and Genvoya.

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2. Composition and dosage form

Biktarvy is a fixed-dose combination tablet containing bictegravir (50 mg), emtricitabine (200 mg) and tenofovir alafenamide (25 mg). The three ingredients work together to inhibit viral replication by targeting different stages of the viral life cycle. Bictegravir is an integrase strand transfer inhibitor (INSTI) – which prevents the HIV virus from integrating its DNA into the body’s cells. Emtricitabine and tenofovir alafenamide are nucleoside reverse transcriptase inhibitors (NRTIs) – which block the replication of the HIV virus by interfering with the reverse transcriptase enzyme. This combination blocks the virus’s ability to replicate, providing effective viral suppression in a single daily pill, which helps improve patient adherence to treatment.

3. Indications

Biktarvy is indicated for the treatment of HIV-1 infection in adults and children 2 years of age and older, (weighing at least 14 kg). It is used in treatment-naive individuals or those who are virologically suppressed (without a history of treatment failure). The drug’s effectiveness lies in its ability to maintain viral suppression, allowing patients to achieve and maintain an undetectable viral load. This is important in preventing progression to AIDS and reducing the risk of transmission.

A daily dose combined with a low side effect profile makes Biktarvy a preferred choice for both patients and healthcare providers. Biktarvy is particularly appreciated for its minimal drug-drug interactions, making it suitable for patients taking other medications.

4. Approvals and Patent

Biktarvy was approved by the US Food and Drug Administration (FDA) in February 2018 and has since received approval in several other regions, including the European Union, Japan, and Canada. The patent protection is expected to last until the early 2030s, ensuring Gilead’s market dominance. This long patent protection period will be critical to maintaining Gilead’s leadership in the HIV treatment market, especially as competitors develop alternative therapies, including long-acting injectables such as Cabenuva from GlaxoSmithKline.

5. Market Dominance and Impressive Sales

Gilead Sciences and GlaxoSmithKline (GSK), along with the Viiv Healthcare joint venture formed by GSK and Pfizer, have been key players in the HIV treatment space for more than two decades. In August 2004, two fixed-dose dual NRTI combinations, Gilead’s Truvada and GSK’s Epzicom, were approved in the United States, starting the competition for market share. Atripla, Gilead’s triple NRTI/NNRTI combination, launched in July 2006, marking a major step forward. Gilead continues to favor triple combination regimens, a strategy that has proven effective and contributed to Biktarvy’s early success.
Biktarvy has emerged as one of the top-selling drugs globally since its approval. In 2022, the drug generated an impressive $10.39 billion in sales, making it the top-selling HIV drug in the world. The drug continues to drive Gilead’s growth, contributing significantly to the company’s financial success. According to Gilead’s 2023 financial report, Biktarvy is expected to maintain strong sales growth, driven by its efficacy and convenience. Its market share continues to grow, especially as it remains a major first-line option for HIV management.

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The drug’s success is also driven by patient adherence benefits, as the single-pill regimen significantly simplifies treatment compared to multi-pill options. Furthermore, with ongoing patent protection, Biktarvy is expected to generate billions of dollars in revenue over the next decade, cementing its position as a cornerstone of HIV care.

Conclusion

Biktarvy has become a game changer in the HIV space. Its combination of efficacy, safety, and convenience has made it the preferred treatment for HIV patients. Gilead’s strategy of creating a comprehensive, daily pill that provides long-lasting viral suppression has redefined patient care, improving quality of life and outcomes. With strong patent protection and strong market performance, Biktarvy is expected to remain a leading force in HIV treatment for many years to come..

In just over two years since 2012, the market has seen the introduction of three new products:

- Stribild: Gilead’s (a quadruple fixed-dose combination: dual NRTI + boosted integrase inhibitor) in August 2012.
- Tivicay: an integrase inhibitor by Viiv in August 2013.
- Triumeq: a triple fixed-dose combination: dual NRTI + integrase inhibitor) by Viiv in September 2014. Triumeq achieved impressive sales of $1.115 billion in its first year of launch and reached $3.535 billion in 2018, affirming Viiv’s strong competitive position in the HIV treatment race.
- Genova: Gilead continued to consolidate its leadership with Genvoya (a quadruple fixed-dose combination: dual NRTI + boosted integrase inhibitor), which launched in December 2015 and generated $1.5 billion in sales in its first year. By 2018, with Genvoya sales reaching $4.624 billion, Gilead held 53% of the HIV market, compared to GSK’s 23%.