Breakthrough HIV reported in the injectable PrEP trial.Experts say the drug is still very effective

In a large clinical trial evaluating Apretude, a recently approved injection by ViiV Healthcare, as a form of HIV prophylaxis, seven participants were infected with the virus despite being injected on time. ..

New findings indicate that breakthrough infections can occur among people taking Apretude, as well as those taking tablets daily to prevent HIV.

Dr. Rafael J. LandbitzLeading the Apretude clinical trial in question, he is rare in such cases of PrEP failure, regardless of what form of prophylactic antiretroviral drug people at risk of HIV are taking. He told NBC News that he hopes it will remain what he has characterized.

Nonetheless, Appletude is very effective, Landbitz said. The drug “may end the HIV epidemic, especially for those who are trying to take oral PrEP.”

Landbitz, an infectious disease specialist at the University of California, Los Angeles, said it could always be unclear why breakthrough infections occurred among people who received Appletude. He and his colleagues already know that the blood levels of the first four drugs that experienced such an infection were not unexpectedly low.

Food and Drug Administration approved Apretude for use as known as Pre-Exposure Prophylaxis (PrEP) for HIV on December 20th. A long-acting drug intended for healthcare professionals to inject every two months has been added to the two daily tablets — Gilead Sciences’ Torubada When Descobi — Approved as PrEP in 2012 and 2019, respectively.

Oral PrEP when taken daily Reduces the risk of getting HIV by 99 More than a percentage of men having sex with men, or MSM — The majority of PrEP users..

However, many people at risk of HIV are reluctant to remain loyal to such daily pill regimens — especially studies. Shown, Black MSM..In this demographic Highest HIV infection rate in JapanBut both have long been behind that white counterpart Start and continue PrEP..

HIV advocates use Apretude Potential solution To this permanent compliance issue. Still, to receive Apretude, you need to visit the clinic every two months, compared to every three months to maintain your Descovy or Truvada prescription as PrEP.

Men who have sex with men Estimated 70 percent According to the Centers for Disease Control and Prevention, there are about 35,000 HIV infections in the United States each year.

Appletude vs. Torubada

One of two double-blind Clinical trials As a result, the FDA now approves the use of Apretude because it contains PrEP. 4,566 cisgender MSM and transgender women In the United States and six other countries in Latin America, Asia and Africa. (A Second trial Includes African cisgender females. ) Half of the 1,698 US research members were black.

All participants were considered at high risk of becoming infected with HIV and received a randomized Truvada or Apretude, with each group receiving a corresponding placebo.

In 2020, Landovitz and his colleagues found that patients who received Apretude had a median follow-up of about 17 months in the blind phase of the study. Two-thirds lower HIV acquisition rate Compared to the person who got Torubada. This obvious difference was caused by poor daily adherence to the torbada regimen and, by comparison, a large amount of sexual coverage of participants.

On Tuesday, Landovitz announced the latest test results at virtually the venue. Conference on retroviruses and opportunistic infections He reviewed 12 months of unblinded data from the study in mid-2020.

During that period, new HIV prevalence increased in both the Apretude and Truvada groups. This phenomenon suggested by Landovitz may have been caused by two factors. First, participants’ compliance with both injection schedules and pill regimens was low after open-label. Moreover, in this latter trial stage, the majority of participants lived in Latin America and the background HIV prevalence was relatively high.

Nonetheless, Apretude injection maintained about the same percentage of superior overall protection against HIV compared to oral PrEP, as was seen during the blind period of the study.

During the combined study period, 25 people in the Apretude group and 72 people in the Truvada group were infected with HIV during approximately the same amount of cumulative follow-up.

Breakthrough case

Seven breakthrough infections among people who received scheduled injections occurred during a cumulative 4,660-year follow-up period among all people in the Apretude arm of the study. (In the meantime, an additional 18 people were infected with HIV who did not receive Apretude on time.) This is about 15 of them once when a group of 10,000 people was given Apretude in a similar situation. This means that you are expected to experience these groundbreaking HIV infections. Year.

The First case of PrEP failure In 2016, it was reported among individuals who adhered to the daily pill regimen. Have been Only a handful of additional cases reportedIt is clear that this is mainly the result of people’s contracts Relatively rare HIV strain It is resistant to the antiretroviral pair of tenofovir and emtricitabine contained in both Truvada and Descovy.

According to Landbitz, HIV infections that are resistant to Appletude’s antiretroviral class are “very rare.” So he said drug resistance could not explain the breakthrough infection among people receiving injections as PrEP.

Breakthrough infections also occurred in at least one, and in some cases, two, transgender women and the Truvada group of the Apretude trial, including MSM.Add one such Breakthrough case Occurred in a corresponding trial of a cisgender female. After unblinding each trial, further analysis is needed to determine if additional people have been infected with HIV while adhering to the torubada regimen.

Studies show that Concentration of applete in blood, Drug levels are about 90% to 92% lower in rectal tissue, but about 80% lower in vaginal and cervical tissue. Landovitz told NBC News that these disparities could help explain the emergence of seven breakthrough infections among transgender women and people in the Apretude department of PrEP studies, including MSMs. So far, ViiV can report that there were no cases of Appletude failure during the blind phase in PrEP trials involving cisgender females. Further analysis is needed to determine if such a breakthrough infection occurred after the study was unblinded.

Cost and availability

Apretude is not yet widely available in the United States. ViiV is campaigning for insurers to add injectable preventatives to their list of eligible medicines.

Pharmaceutical companies Multiple generic versions Tolvada was on the market last year and is now only $ 26 a month. Apretude costs $ 1,850 in 30 days. This is similar to the price of Gilead’s Descovy and the brand name Truvada. CDC reported At this week’s Retrovirus Conference, in the first three quarters of 2021, about 42% of US PrEP prescriptions were for generic Truvada.

and paper Landovitz is Anne M of Harvard Medical School. Co-authored with Dr. Neilan and others and published in the Annual Internal Medicine Report on February 1, Apretude concludes that it should be less than $ 308 per month, above the price of a typical Truvada. Cost-effective.

According to the United States Preventive Services Task Force Give an “A” rating in 2019, Oral PrEP should now be covered by almost all private insurance companies at no cost.That means both dosing and quarterly clinic visits are required Free for those with private health insurance.. Medicaid and Medicare are also targeted for tableted PrEP, but may require prescription out-of-pocket costs.

Carl Schmitt, Executive Director HIV + Hepatitis Policy Institute In Washington, supporters like himself reported that they were pushing the task force quickly. Include Apretude in PrEP “A” grade..

In the meantime, ViiV will provide private insurance holders with an out-of-pocket card that covers up to $ 7,500 in injection-related out-of-pocket costs and $ 350 in injection management costs each year.

Dr. Rupa R. Patel, PrEP Clinic Lead Whitman Walker Health in Washington told NBC News that the bi-monthly dosing schedule for the drug was “not yet ideal,” despite the considerable effectiveness of Appletude.

“Of course, you should take it every 6 or 12 months,” he said.

Multiple additional forms of long-acting PrEP, administered about twice a year, are actually In the pharmaceutical pipeline.. However, Merck announced in December that it has withheld all of its clinical development. Experimental drug islatravir After long-acting anti-retroviral drugs were associated with a decline in CD4 immune cells (white blood cells, which provide an important indicator of immune health) in some study participants. This tendency occurred in both those who received the drug as an HIV treatment and those who received it as PrEP.

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