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ViiV's 2-drug HIV pill beats Gilead to market, but may not win on long-term use

The Nov. 21 approval of a daily HIV treatment that combines two medicines in one pill makes ViiV Healthcare Ltd., majority-owned by GlaxoSmithKline plc, first to market with a reduced-drug regimen — yet safety concerns could give an opening to an incoming Gilead Sciences Inc. competitor.

ViiV's pill, Juluca, brings together dolutegravir, known in single-tablet form as Tivicay, with rilpivirine, sold individually as Edurant by Johnson & Johnson's Janssen unit, to treat HIV-1 patients on a long-term basis. Similarly, Gilead's pipeline therapy combines experimental bictegravir with elvitegravir, an enzyme inhibitor that Gilead has previously used in four-drug combination pill Stribild.

Juluca will enter a market filled with three- and four-drug regimens, drug cocktails that have successfully suppressed HIV and transformed its survival expectations. While life-saving, such therapies are not without risk: Decades of daily use have led to long-term toxicity concerns.

The new reduced-drug regimens have the potential to lower toxicity a chief selling point. However, on the day of Juluca's approval, the U.S. Food and Drug Administration attached a new liver toxicity warning and monitoring requirement to the drug and other cocktails containing dolutegravir.

That came after a recently published study described a case of liver failure on a dolutegravir regimen, RBC Capital Markets analyst Brian Abrahams pointed out in a note after the approval. Two weeks earlier, Abrahams and his team had analyzed FDA-reported adverse events and suggested this could actually be the second dolutegravir-related liver failure.

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While drug-induced liver problems are not uncommon with HIV antiretroviral therapy, RBC's analysis suggested that such incidents are four times more likely with dolutegravir than with regimens containing Gilead's elvitegravir, such as the single bictegravir and elvitegravir pill in the pipeline.

This could give Gilead a competitive advantage in long-term therapy, Abrahams said. RBC already forecast that the company will make $19.5 billion on HIV therapy in 2025, largely due to demographics and price increases — yet if it can take a share of ViiV's HIV market, this potential could grow significantly.

ViiV Healthcare, which also counts Pfizer Inc. and Shionogi & Co. Ltd. among its shareholders, is entirely focused on HIV; yet the virus is also a critical disease area for Gilead. Its medicines for HIV and hepatitis B virus collectively made $3.6 billion in the latest quarter, supporting revenue as sales for its blockbuster hepatitis C virus drugs continued to slip and foundations are laid for its new blood cancer therapy, Yescarta.

Importantly for Gilead, HIV regimens based around its newer tenofovir alafenamide fumarate drugs such as Genovya and Descovy made up 56% of total prescription volumes in the third quarter. Older HIV medicines Truvada and Atripla previously accounted for much of this volume but are now facing generic competition.

ViiV's decision to price Juluca at $31,000 — in step with another of its combination therapies, Triumeq — leaves some breathing room for Gilead's own pricing strategy, which Evercore ISI analyst Umer Raffat said in a note is crucial to the company's longer-term forecasts.