- HIV-positive women can switch from several other treatments for the disease to Gilead Sciences Inc.'s recently approved Biktarvy and still experience the same amount of benefit, according to fresh clinical data announced Tuesday.
- The data came from Study 1961, a Phase 3 trial that enrolled 470 virologcially suppressed adult women with HIV who are taking Genvoya, Stribild, or a mixture of atazanavir, ritonavir and Truvada to manage their disease. Investigators had half of the participants replace those therapies with Biktarvy. After 48 weeks, both groups showed the same amount — 1.7% — of patients with viral loads equal to or above 50 copies per milliliter.
- The Food and Drug Administration OK'd Biktarvy in early February to treat adults with HIV who either never received antiretroviral medication or are looking to replace their existing regimen. To switch, patients must be virologically suppressed on a stable antiretroviral regimen for at least three months and not be resistant to Biktarvy's composite active ingredients.
Gilead's in a tight spot. It's once-glorious hepatitis C business is dwindling at a feverish rate. Company executives are predicting sales from Sovaldi (sofosbuvir), Harvoni (ledipasvir/sofosbuvir) and the rest of the franchise will reach around $3.8 billion in 2018, down from the more than $19 billion they fetched just three years ago.
The big biotech's late-stage pipeline also isn't earth-shattering. There's selonsertib, a potential treatment for non-alcoholic steatohepatitis that failed before as a treatment for pulmonary arterial hypertension and diabetic kidney disease. There's also Zydelig (idelalisib), a phosphoinositide 3-kinase delta inhibitor approved for chronic lymphocytic leukemia (CLL) and lymphoma. The drug is in Phase 3 testing for relapsed refractory CLL, but has suffered from safety concerns and weak returns.
On the portfolio side, the acquisition of Kite Pharma Inc. added some highly anticipated assets to Gilead's belt, most notably the recently approved Yescarta (axicabtagene ciloleucel). It's unclear, however, when the innovative therapy will start to meaningfully contribute to the company's bottom lines.
In the meantime, Gilead is finding solace in HIV drugs.
Revenues from the company's HIV unit rose 10% in 2017 to $14.2 billion. Strong performances from Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide), Descovy (emtricitabine/tenofovir alafenamide) and Odefsey (emtricitabine/rilpivirine/tenofovir alafenamide) contributed to the boost, and its a surefire bet that Biktarvy will as well. Jefferies analyst Michael Yee wrote in an investor note last month that Gilead's newest offering could fetch at least $850 million this year and, at some point, annual sales of $3 billion.
"By removing most of the overhang of declining [hep C] revenues going forward, we can focus on the positive financial trends driven by the continued uptake of [tenofovir alafenamide]-containing regimens and short-term and long-term growth through Yescarta, selonsertib and filgotinib," Gilead CEO John Milligan said during a Feb. 6 call.
Biktarvy combines three active ingredients, including a novel integrase strand transfer inhibitor, and is administered as a once-daily tablet cleared for adults.
In Study 1961, the drug demonstrated non-inferiority to select boosted protease inhibitor (bPI) or boosted elvitegravir-containing regimens. Overall, 95.7% of the group receiving Biktarvy had viral loads less than 50 copies per milliliter, while 95.3% of the patients who didn't switch therapies had the same experience.
"Gilead is committed to researching and developing treatments that have the potential to be used in a broad range of patients, including women who have traditionally been underrepresented in HIV clinical trials," said Norbert Bischofberger, EVP of R&D and chief scientific officer at Gilead Sciences. "This study demonstrates that Biktarvy offers a safety and efficacy profile that may help to care for women living with HIV."