Showing posts with label Injected. Show all posts
Showing posts with label Injected. Show all posts

May 21, 2020

A PREP Injection Every Other Month Offers More Protection Than Pills


Injecting people with a new, experimental drug every eight weeks provides better protection against HIV than daily pills that have revolutionized the fight against AIDS, US government researchers reported Monday.

The National Institutes of Health released the preliminary results of a major clinical trial involving a drug called cabotegravir. The testing began more than three years ago in seven countries -- including the United States, Brazil, Thailand and South Africa -- and looked at men who have sex with men (MSM) and transgender women, most of them under age 30.

Those are the two groups at highest risk of contracting the human immunodeficiency virus (HIV), which causes AIDS. Another clinical trial focusing on women is under way. 

For now, the only medication approved for HIV prevention is a drug cocktail called PrEP, which stands for pre-exposure prophylaxis. In the US, it has been marketed under the brand names Truvada and Descovy.

HIV-free people who take PrEP daily see their risk of infection from unprotected sex reduced by 99 percent, according to the US Centers for Disease Control and Prevention.

But the fact that these pills must be taken every day is seen as an obstacle, so researchers are looking for less unwieldy alternatives. 

The results released Monday stem from a trial involving more than 4,500 people. Half were injected with cabotegravir and took PrEP placebos, while the other half received a placebo injection and real PrEP pills. So everybody taking part in the trial was treated with either cabotegravir or PrEP.

Fifty contracted the AIDS virus, but the breakdown was lopsided: only 12 among those who received shots of cabotegravir and 38 among those who took Truvada became infected.

This means the injections were 69 percent more effective than the Truvada pills, which are already at the heart of the US strategy to end the HIV epidemic. In the US, at least 200,000 at-risk people take Truvada, according to the drug's maker Gilead.

Since the injection test results were so good, the people running the clinical trial halted the blind phase prematurely to allow all participants to benefit from the injections.

“We are thrilled with the results not only because of the high efficacy of cabotegravir but also because we have demonstrated high efficacy in a study that adequately represents some of the populations most disproportionately impacted by HIV," said Kimberly Smith, head of research and development at ViiV Healthcare, a unit of the GSK group.

These population groups are black men having sex with men in the US, young MSM globally and transgender women, she said


November 4, 2015

Next on HIV: Long Acting Injectable HIV Treatment to Replace Pills


A future of HIV treatment that doesn't depend on daily dosing seemed to move a little closer today with an announcement that early findings show an injected combination of two antiretroviral medicines given monthly or every two months effective in controlling HIV among people whose virus was already suppressed. The findings come from the first 32 weeks of a study that involved more than 300 adults in the U.S., Europe and Canada, but potentially offer the hope of simplified treatment for patients worldwide in resource-limited settings where obstacles to daily treatment remain greatest.

The LATTE 2 study, which compared the outcomes of receiving injections of long-acting formulations of the antiretroviral medicines ripilvirine, from Janssen Sciences pharmaceutical company and cabotegravir, from ViiV Healthcare, to the outcomes of taking a combination three-drug daily pill, is a 96-week randomized trial to determine the potential effectiveness of long-acting HIV treatment. Of 309 adults enrolled in the study in the study, 286 were sorted into three groups after their viruses were suppressed with a daily pill -- 56 participants continuing the daily pill, 115 receiving injections of ripilvirine and cabotegravir every four weeks, and 115 receiving the injections every eight weeks. Patients in all three groups achieved comparable rates of viral suppression, according to the announcement today. Of nine participants who experienced adverse reactions to treatment that caused them to withdrew from the study, six were in the group receiving monthly injections, two were in the group receiving injections every two months, and just one was in the group of participants receiving the daily pill. The most common undesirable side effect was pain at the injection site, which 93 percent of participants receiving injections reported and which caused two participants in the monthly injection group to withdraw from the study. With continued signs of efficacy the study will be followed by a larger late phase trial, to gather more data on the safety and effectiveness of long-acting injectable HIV treatment.

"Reaching resource limited settings is very much on top of the list for Janssen," said Peter Williams, the company's team leader for the ripilvirine side of the study. That will mean addressing some challenges, he added. Currently both drugs used in the injectable regimen need to be kept refrigerated, a challenge in both transport and storage, he noted. Further development could change that, according to the company. In addition, ensuring that vials of both drugs are available at the same time could pose a supply chain challenge, he said, "that we have to be realistic about." The regimen, which is injected intramuscularly, will not be self-administered.
This excerpt was cross-posted with  Science Speaks.   Read the full article.
Peter Williams of Janssen
Peter Williams of Janssen

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