January 9, 2020

FDA Defers its Decision on the First Long-Acting Injectable ARV

On December 23, the US Food and Drug Administration (FDA) deferred its decision on approving Cabenuva, a long-acting, injectable ARV developed by ViiV Healthcare. Reuters reported that ViiV received a “complete response letter (CRL) from the FDA in which the regulator questioned the treatment’s chemistry, manufacturing and controls process, but not its safety.”

Cabenuva, a combination of long-acting rilpivirine and cabotegravir, is designed to be administered intra-muscularly once a month by a health care provider. It is designed as an alternative for people with HIV who prefer monthly injection to taking a daily pill. ViiV has been asked to further explain their data related to product testing and manufacture. No timeline has yet been announced.

To date, 40,000 Cabenuva injections have been administered in clinical trials and people currently getting the regimen are being assured that it is safe to continue their normal dosing.

POZ reports that over 1,100 people with HIV in 16 countries participated in two large-scale clinical trials of Cabanuva. The results showed viral suppression equivalent to those achieved with daily oral triple-ARV treatment. POZ notes that “the trial participants reported high levels of satisfaction with the regimen, greatly preferring it to taking daily pills.” Only 1% of participants withdrew from the trials, most of them due to discomfort/pain at the injection site. The manufacturer’s press release includes more details.

Congress Appropriators Increase Allocations in New Federal HIV Budget

Racing against the risk of another federal government shut-down (as occurred last January), a “minibus” of four appropriation bills was passed by Congress shortly before it adjourned for the December holidays. After the House of Representatives passed the minibus on December 17, it swept through the Senate on December 19 and was signed by the President the next day. In the package were funding bills critical to our national HIV response.

They approved a $300 million allocation for the “Ending the HIV Epidemic” initiative proposed by the Administration last February that includes $140 million for the CDC’s HIV prevention strategy, $70 million for the Ryan White Health Care Act and $50 million for the Health Resources and Services Administration (HRSA) initiative to expand PrEP promotion and delivery through community health centers.

Jennifer Kates of the Kaiser Family Foundation observed that, while encouraging, these funding levels will need still need future expansion. “As a first year installment, it represents a significant increase for these programs and should help to jump start the effort. But it will be important to see what future funding requests are made, to fully reach targets,” she added.

The House and Senate also rejected some major budget cuts proposed by the administration, including its efforts to cut NIH’s HIV research funding by $424 million. Instead, the appropriators increased NIH’s current funding by $2.6 million overall, with $25 million of that increase earmarked for HIV research. Similarly, Congress and the Senate rejected the Administration’s proposal to cut $1 billion from the President’s Emergency Plan for AIDS Relief (PEPFAR), a State Department initiative that has been active globally since 2003. Instead, Congress not only maintained PEPFAR funding at its FY2019 levels, but also authorized a $1.56 billion commitment to support the Global Fund over the next three years.