Key positive data on monthly HIV regimen offer hope for patients saddled with standard daily pills

HIV patients have much to cheer about this week. After reports that a second HIV patient has experienced sustained remission following a bone marrow transplant, a pair of drugmakers on Thursday posted pivotal data that showed their monthly injectable treatments worked as well as the standard daily three-drug cocktail in suppressing the virus that causes AIDS.

The injectable regimen comprising two drugs — Johnson & Johnson’s $JNJ rilpivirine (sold as Edurant) and ViiV Healthcare’s experimental treatment cabotegravir — was tested in a two late-stage studies in more than 1180 patients altogether. The total dataset will be used to submit applications to market the injectable formulation to regulators later this year, ViiV said.

The best way to thwart the spread of HIV is to use condoms. But for those already afflicted with the virus, antiretroviral therapy must be taken every single day to suppress the virus or unbridled replication can overwhelm the immune system and eventually cause AIDS.

Apart from drastically reducing the number of times treatment must be administered to 12 from 365, the injectable regimen — if approved — could in certain parts of the world reduce the stigma of picking up HIV prescriptions at pharmacies.

Daily pills also rack up expensive bills in the United States, with monthly expenditure on treatment hitting thousands per month — depending on the regimen, insurance provider and rebates/discounts. Endpoints News has asked the manufacturers about their pricing plans for the injectable monthly regimen, and is awaiting comment.

According to the WHO estimates, 36.9 million people were living with HIV globally in 2017.

Injected every four weeks, 48-week data on the two-drug formulation from both studies — FLAIR and ATLAS — were positive, with about 1% of patients from either study developing drug resistance, similar to those who take standard daily therapy, ViiV said.

Positive ATLAS data was published last August. On Thursday, the two drugmakers broke out the detailed numbers for both ATLAS and FLAIR.

The ATLAS study found virologic suppression rates at week 48 were similar between treatment arms — (cabotegravir + rilpivirine: 285/308 [92.5%]) versus current antiretroviral therapy  (294/308 [95.5%]). In the FLAIR study virologic suppression rates at week 48 were also similar between treatment arms — (cabotegravir + rilpivirine: 265/283 [93.6%]) versus the standard Triumeq regimen: (264/283 [93.3%]).

ViiV — which was established in 2009 by British drugmaker GSK $GSK in partnership with Pfizer $PFE — is also testing the two-drug injectable version administered every two months in the ATLAS-2M study. It already has an arsenal of 13 approved antiretroviral medicines.

GSK’s approach to grabbing market share from Gilead $GILD  — which currently dominates the HIV market that is estimated to hit $22.5 billion by 2025 — is to convince regulators, doctors and patients to adopt its two-drug regimens, versus Gilead’s triple-drug cocktails, that could potentially result in fewer toxic side-effects, reduce dosing frequency, and be more cost-effective — although critics suggest this may not be the most effective strategy because the virus will only have to fight against two drugs which could culminate in drug resistance. But if the injectable monthly regimen makes it to the market, Gilead’s crown may be more vulnerable than ever.

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Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT
Director of Operations
Atlas Venture Cambridge, MA

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