FDA Approves New Long-Acting HIV Regimen That Could Help Adherence

The FDA recently approved the first long-acting regimen for the treatment of HIV in adults. The dosing schedule could help with adherence in a condition where that is particularly crucial. However, some potential challenges exist with the medication, including whether health plans actually will cover it.

On Jan. 21, the FDA approved ViiV Healthcare’s Cabenuva (cabotegravir and rilpivirine) for the treatment of HIV-1 infection in adults to replace a current antiretroviral regimen in people who are virologically suppressed on it with no history of treatment failure and no known or suspected resistance to either cabotegravir or rilpivirine.

The agency also approved the tablet Vocabria (cabotegravir) to be taken with Johnson & Johnson unit Janssen Therapeutics’ tablet Edurant (rilpivirine) for one month before starting treatment with Cabenuva to ensure the medications are well-tolerated before switching to the extended-release injectable formulation. Cabenuva is the first and only complete long-acting regimen for the treatment of HIV-1 in adults.

Dosing is via two separate single-dose vials, one of cabotegravir and one of rilpivirine. The recommended starting dose is Cabenuva 600 mg/900 mg on the last day of the oral lead-in regimen and then Cabenuva 400 mg/600 mg each subsequent month. Dosing of the intramuscular injectables must be done by a health care professional. Pricing of the initial dose is $5,940, and subsequent monthly doses will be $3,960. According to STAT News, the company is providing the 30-day lead-in regimen at no charge to patients.

“Today’s FDA approval of Cabenuva represents a shift in the way HIV is treated, offering people living with HIV a completely new approach to care,” said Lynn Baxter, head of North America for ViiV Healthcare, in a press release. “Cabenuva reduces the treatment dosing days from 365 days to 12 days per year. At ViiV Healthcare, we are dedicated to ensuring no one living with HIV is left behind, and adding this first-of-its-kind regimen to our industry-leading portfolio of innovative medicines reinforces our mission.”

Company Was Formed to Focus on HIV

ViiV is majority owned by GlaxoSmithKline plc, with Pfizer Inc. and Shionogi Limited as shareholders. It was established in November 2009 to focus specifically on the treatment and care of people with HIV and people at risk of becoming infected with it.

“The approval of Cabenuva allows some HIV-1 infected patients the option of receiving a once-monthly injection instead of a daily oral treatment regimen,” points out Nicole Kjesbo, Pharm.D., clinical program development director at Prime Therapeutics LLC. She tells AIS Health that the drug is “a good option for patients that are nonadherent to an everyday regimen.”

According to ViiV, in clinical trials, nine out of 10 patients preferred Cabenuva over their previous daily oral therapy. In a Jan. 26 Anton Rx Report, Bill Sullivan, executive management consultant and communications editor at Anton Health, wrote that in Europe, where the drug became available last year, “patient feedback has been surprisingly popular in spite of the fact that the therapy requires an office visit for the monthly injections. A patient survey in Europe showed that two-thirds of HIV patients were ‘likely’ to switch to a long-acting injectable regimen.”

Drug Offers ‘Greater Freedom’

In a statement, Brett Andrews, CEO of PRC, a San Francisco-based organization that offers services to people with HIV/AIDS, substance use or mental health issues, said that “for years, many of our clients have struggled to manage their health while working to stabilize key aspects of their lives. Cabenuva will provide some people living with HIV greater freedom to pursue vocational, educational and other opportunities, like travel, without the need for daily oral medication management. A long-acting regimen is an innovation we have been waiting for.”

Early HIV treatment regimens consisted of a variety of pills, but many medications are now available as a once-daily agent. “In recent years, the burden associated with HIV regimens has become less,” observes Kjesbo. “Instead of taking multiple drugs and doses multiple times a day, there are now options to take one combination pill orally once a day.” With these treatments, “adherence is essential. HIV medications taken every day prevent HIV from multiplying and reduce the rate of resistance. Nonadherence can lead to drug resistance and HIV treatment failure.”

In addition to reduced pill burden, Sullivan wrote that another benefit of Cabenuva addresses the fact that “HIV patients are concerned with their privacy. A once a month office injection eliminates having lots of HIV pills in the medicine cabinet.” He also pointed out that people with HIV may visit a clinician approximately every three to six months, so “seeing a clinician monthly facilitates virus level monitoring, promotes disease education, nutrition and psychological counseling, and identification of emergent concomitant medical issues.”

The drug will be available both via specialty pharmacy and buy and bill. ViiV has selected 14 specialty pharmacies to be in its network; for providers buying and billing Cabenuva, there are six specialty distributors available.

In a Zitter Insights survey of 50 physicians conducted between Aug. 30, 2019, and Oct. 2, 2019, 68% of respondents said they were likely to prescribe Cabenuva for patients with a history of adherence issues. Its route of administration and dosing regimen were the main factors influencing their expected prescribing of it. And among 51 commercial payers with 162.7 million covered lives, 39% said they expected to manage the drug at parity with certain HIV therapies.

AIS Health and Zitter Insights are both MMIT companies.

However, challenges could exist around people’s unwillingness to get an injectable medication, Kjesbo says, noting that “injection site reactions occurred in 83% of patients treated with Cabenuva, including 37 with at least a Grade 2 (moderate) reaction.”

According to Kjesbo, “The patient population who will elect to take this will be those that agree to visit their health care professional once per month.…Adherence is crucial with a once-monthly injection. If a patient plans to miss a scheduled injection visit by more than seven days, they will have to take daily oral therapy to replace up to two consecutive monthly injection visits. In addition, if monthly injections are missed or delayed by more than seven days and oral therapy has not been taken in the interim, the patient will have to be reassessed to determine if resumption of injection dosing remains appropriate.”

At Prime, she says, “we anticipate that most health plans will cover the drug in some capacity. Some states also have legislation around HIV requiring coverage.”

Drug Will Fall Under Medical Benefit

Because the drug is administered by a health care professional, “it will largely be adjudicated on the medical benefit and managed through medical policy,” she explains. “Plans may choose not to create a medical policy given this population is generally managed by an HIV specialist. If a plan chooses to manage this drug, potential criteria may include verification the patient has initiated therapy with the oral regimen required and has active HIV infection (to ensure it is not used off-label for HIV prophylaxis). In addition, they may apply a dose check to ensure appropriate dosing and/or documentation of adherence to the regimen.”

The FDA approval comes a little bit more than a year after the FDA issued a complete response letter for the drug in December 2019, citing manufacturing concerns. According to an Endpoints News article, Kimberly Smith, ViiV’s head of research and development, said “that delay was ‘obviously disappointing,’ but was — in hindsight — a blessing as it allowed the drugmaker to add even more long-term safety data to its reworked application.” She told the outlet that the company “worked very closely with our colleagues in CMC [i.e., the FDA’s Chemistry, Manufacturing, and Controls] to make sure we clarified to the FDA…what the questions were and how we addressed them. It was particularly important for us to make sure that we nailed it.”

And while launching a drug that needs to be professionally administered during a pandemic might seem challenging, Endpoints News also reported that “some clinics have established special lines for patients to receive their injections during Covid-19 and others had created designated parking spaces for patients to get the shots without entering the building.”

On Feb. 24, ViiV submitted a supplemental New Drug Application to the FDA for Cabenuva use every two months. A clinical trial showed that dosing was noninferior compared with once-monthly administration. “A big problem with HIV therapy has been missed doses, very often due to loss of insurance coverage,” wrote Sullivan. “A two-month, long-acting injectable regimen would help bridge coverage gaps.”

The company also is studying injectable cabotegravir as a pre-exposure prophylaxis (PrEP) treatment. On Nov. 9, 2020, ViiV said an independent data safety monitoring board recommended early unblinding of a study evaluating the safety and efficacy of the drug for HIV prevention in women after the study showed that cabotegravir was 89% more effective than daily oral emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg, available as Gilead Sciences, Inc.’s Truvada. Earlier last year, another study showed injectable cabotegravir was 69% more effective than Truvada in preventing HIV acquisition in men who have sex with men and transgender women who have sex with men.

However, in July 2020, Arafa Salam, Ph.D., an infectious diseases analyst at GlobalData, wrote that Truvada — for which a generic version is now available — may remain the preferred PrEP treatment due to Cabenuva’s cost and potential adherence issues.

Contact Kjesbo through Jenine Anderson at jenine.anderson@primetherapeutics.com and Sullivan at bsullivan0011@gmail.com.

This story was reprinted from AIS Health’s monthly publication RADAR on Specialty Pharmacy. Visit https://aishealth.com/product/specialty-pharmacy.

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