- A long-acting HIV therapy from Johnson & Johnson and ViiV Healthcare has shown similar efficacy to a standard of care regimen, according to topline Phase 3 data announced Wednesday.
- The ATLAS study tested whether an injectable therapy that combined ViiV's cabotegravir, an investigational analog of the blockbuster HIV drug dolutegravir, with rilpivirine, the active ingredient in J&J's Edurant, would help patients maintain the same viral load as a daily oral regimen of two nucleoside reverse transcriptase inhibitors plus a third antiretroviral agent.
- Following 48 weeks of treatment, the proportion of patients with 50 or more plasma HIV-1 RNA copies per milliliter was non-inferior when comparing the three-drug and two-drug regimens.
The HIV market has become quite crowded over the last decade. Since 2010 alone, the Food and Drug Administration has approved 20 new treatments.
Edurant, for example, received a thumbs up back in 2011 and has achieved annual sales growth ever since. In 2017, the drug raked in $714 million, an increase of 25% from the year prior. On the big pharma's second quarter earnings call, CEO Alex Gorsky highlighted the "continued solid performance in long-acting injectables in neuroscience, Xarelto, and our HIV portfolio."
Yet that solid performance isn't guaranteed to last. Rival drugmakers Gilead Sciences and GlaxoSmithKline are heavyweights in the HIV space, and have doubled down in the therapeutic area as other pieces of their portfolios suffer.
On Gilead's end, its once awe-inspiring hepatitis C business is crumbling due to ultra-effective drugs like Sovaldi (sofosbuvir) effectively curing more of the available patient population. GSK's in a somewhat similar pinch, as its flagship respiratory drug Advair (fluticasone propionate/salmeterol) experiences lower sales and looming generic competition.
GSK acknowledged that revenue from Triumeq (abacavir/dolutegravir/lamivudine) and Tivicay (dolutegravir) really helped offset declines elsewhere during the second quarter. The British pharma is looking to add more marketed HIV treatments to its arsenal — and has shown a particular interest in two-drug regimens.
ViiV, which is majority-owned by GSK, last month reported results from two late-stage studies that showed a two-drug regimen of dolutegravir and lamivudine was as effective as a triplet consisting of Dolutegravir, emtricitabine and tenofovir disoproxil fumarate. GSK expects to submit the doublet to U.S. regulators for approval later this year.
Now, the ATLAS results provide even more evidence to back up the two-drug approach.
"The data from ATLAS suggest a long-acting, injectable [two-drug regimen] of cabotegravir and rilpivirine may offer an alternative to daily, oral three-drug therapy for people who have previously achieved viral suppression," John Pottage, Jr., Chief Scientific and Medical Officer at ViiV said in an Aug. 15 statement. "If approved, this regimen would give people living with HIV one month between each dose of antiretroviral therapy, changing HIV treatment from 365 dosing days per year, to just 12."
The cabotegravir and rilpivirine combo may run into trouble because of its administration, however. While a once-monthly dose may appeal to some, research also indicates that patients prefer drugs taken orally versus a needle — an advantage held by drugs like Gilead's Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide).