每年大约有38，000名美国人被诊断患有艾滋病。2012年，美国食品和药物管理局批准了一种被称为PrEP(即暴露前预防)的突破性药物，如果每天服用，可以达到99%的有效降低性传播艾滋病毒的风险。
现在，新的研究表明，每两个月注射一次，而不是每天服用一次，同样有效。这种注射，虽然还没有得到食品和药物管理局的批准，但将为试图保护自己免受艾滋病毒感染的人提供一种新的选择。
“我认为很多人不想服用避孕药，因为它会干扰他们的日常活动，或者因为他们不想让药瓶放在家里让每个人都看到，”布兰登·杰克逊说，他是一项名为HPTN 083的研究的参与者，该研究提供每两个月一次的注射。
如果不每天服用，这种药丸预防艾滋病的效果会显著下降。
杰克逊指出，人们不想每天服用避孕药的原因有很多，包括记得吃药、重新服药的后勤保障，甚至可能与你的药箱里有艾滋病毒药物有关的污名。
许多试图保护自己免受艾滋病毒感染的人都是与男性发生性关系的男性，他们的药箱里有一个抗艾滋病毒的药瓶，这可能会引发一些问题，而这些问题可能是开给他们的人不想回答的。对于一些认为自己身体健康的人来说，每天吃药也是不直观的，而每两个月打一针可以在预定的医生就诊时间内完成。
2010年11月23日，加州圣安塞尔莫的杰克药房展示了几瓶抗逆转录病毒药物特鲁瓦达。
杰克逊参与了一项名为HPTN 083的研究，该研究将一种名为卡波替格雷韦的药物(每八周注射一次)与一种已经批准的名为特鲁瓦达的每日预防艾滋病药物进行了对比。
研究发现，总的来说，在预防艾滋病毒感染方面，注射即使不比药丸更有效，也一样有效。
“注射容易多了，”杰克逊说。“我可能不会每天吃药。我真的很喜欢这些镜头;很难100%坚持服药，并且很容易错过剂量。拍摄要方便得多。”
“我们知道准备工作。合规是真正的动力，”南岸健康中心传染病主任、美国广播公司新闻撰稿人托德·埃勒林博士说。埃勒林博士说:“这项研究的关键在于，它需要一些有效的东西，并因为依从性而使其变得更好。”埃勒林博士因向生产这种药物的公司ViiV和Gilead的其他医生发表演讲而获得报酬。
因此，由于美国死于COVID-19大流行的人数现已超过107，000人，并且正在进行一场寻找一种安全有效的疫苗来对抗导致COVID-19的病毒的竞赛，从事艾滋病毒预防工作的医生对研究结果尤其感到振奋。
埃默里大学医学院传染病副教授、该研究的研究人员之一科琳·凯利博士说:“在困难时期得到这个消息，一切都被COVID和corona所掩盖，这真的令人激动。”。"它给我们的航行增加了动力。"她说。
HPTN 083研究招募了来自七个不同国家的4570名男性，包括美国、南非、越南和阿根廷。
参与者被随机分配到两组中的一组，其中一组每八周接受一次抗艾滋病药物注射卡波替格雷，另一组服用一种非活性药物。另一组接受了非活性形式的注射和名为特鲁瓦达的抗艾滋病药丸。
性的飞行员在首例病例中为留在空军而战
这两种药物都是通过阻止艾滋病毒在体内繁殖来发挥作用的。在研究过程中，50名参与者感染了艾滋病毒。在这50名新感染的参与者中，12名正在接受cabotegravir注射，38名正在服用Truvada药丸。
基于这些结果，国家卫生研究院停止了该项研究的“盲法”部分，因为结果清楚地表明，卡波替格雷与现有的特鲁瓦达药丸效果一样好，甚至更好。积极的结果比预期的更早向公众公布，自愿参与研究的人告诉他们接受了哪种药物。
埃勒林说:“当国家卫生研究院提前停止一项研究时，这是一件大事。"他们正试图发出关于这项研究的信号。"
此外，凯利指出，研究结果也很有说服力，因为所有的参与者都是与男性发生性关系的男性或与男性发生性关系的变性女性。
“看，从历史上看，并没有将这一群体包括在内，他们在临床试验中的代表性通常不足，”她说，并指出来自非白人种族群体的男性感染艾滋病毒/艾滋病的风险更高。
根据联邦政府的统计，非洲裔美国人和拉丁裔男同性恋和双性恋男子在美国新感染的艾滋病毒/艾滋病中所占比例最高。
在这张未标注日期的股票图片中，一个人接受了注射。
重要的是，研究参与者是多样化的，代表了受艾滋病毒影响最大的人群。三分之二的研究参与者年龄在30岁以下，大约12%是变性女性，一半是黑人或非洲裔美国人。
此外，在等待食品和药物管理局批准的同时，艾滋病毒/艾滋病和公共卫生专家仍然保持乐观，但注意到需要更多关于费用的信息。
“在艾滋病毒预防方面，这是一个非常令人兴奋的发现;奥尔巴尼大学公共卫生学院院长大卫·霍尔特格雷夫博士说:“选择总是更好的。“试验中没有提到的是使用注射剂而不是药丸的成本效益——我们不知道每次注射的成本。”
卡巴拉韦已经在临床试验中得到广泛研究。事实上，这种可注射的药物——当与第二种药物——利匹韦林联合使用时——已经在加拿大被批准用于治疗已经感染了艾滋病毒的人。生产卡巴拉韦的公司ViiV说，它预计卡巴拉韦和利匹韦林将于2021年在美国被批准作为艾滋病毒治疗药物。
谈到艾滋病毒预防，欢跃和国家卫生研究院仍在单独研究卡波替格雷，没有第二种附加药物。目前还不清楚这种独立的艾滋病预防药物何时会在美国上市，但是研究人员正在继续研究它在不同人群中的有效性，包括异性恋女性。
在美国食品和药物管理局批准之前，尚不清楚这两种注射方式的成本。目前，大多数保险计划和医疗补助都包括特鲁瓦达和其他艾滋病毒日常预防药物，尽管许多药物需要复杂的预先授权程序，并且相关的自付费用甚至会使被保险人负担不起药物。
莫尼卡·萨克斯纳，医学博士，是美国广播公司新闻医疗组的特约成员。
Injection every 2 months could stop HIV transmission, study shows
Every year almost 38,000 people Americans are diagnosed with HIV. In 2012, the Food and Drug Administration approved groundbreaking medication known as PrEP, or preexposure prophylaxis, that if taken daily is up to 99% effective in lowering the risk of sexually transmitting HIV.
Now, new research shows that an injection given every two months -- rather than a pill you take every day -- can be just as effective. That injection, while not yet FDA-approved, would offer a new option for people trying to protect themselves from HIV.
"I think a lot people don't want to take the pill because it interferes with their daily activities or because they don't want pill bottles laying around the house for everyone to see," says Brandon Jackson, a participant in a study called HPTN 083, that offered the every two month injection.
If not taken daily, the pill's effectiveness at preventing HIV decreases significantly.
Jackson notes that people have many reasons for not wanting to take a daily pill including remembering to take the pill, the logistics of getting refills and even the possible stigma associated with having an HIV medication in your medicine cabinet.
Many of the people trying to protect themselves from HIV are men who have sex with men, and it's possible the presence of an anti-HIV pill bottle in their medicine cabinet might raise questions the person they are prescribed to may not want to answer. It's also not intuitive for some people who feel otherwise healthy to take a pill every day, whereas getting a shot every 2 months can be accomplished during a scheduled doctor visit.
Bottles of antiretroviral drug Truvada are displayed at Jack's Pharmacy on November 23, 2010 in San Anselmo, California.
Jackson participated in a study called HPTN 083, which compared a medication called cabotegravir, given as a shot every eight weeks, against an already-approved daily HIV prevention pill called Truvada.
The study found that, overall, the injection was as effective, if not more effective, than the pill in preventing HIV infections.
"The injection is so much easier," says Jackson. "I probably wouldn't take a daily pill. I am really a fan of the shots; it's difficult to be 100% adherent to the pills and easy to miss a dosage. The shots are much more convenient."
"We know PrEP works. Compliance is the real kicker," said Dr. Todd Ellerin, director of infectious diseases at South Shore Health and an ABC News Contributor. "The crux of this study is that it takes something that works and makes it better because of compliance," said Dr. Ellerin, who is compensated for making speeches to other doctors for the companies ViiV and Gilead that make the drugs.
So as the U.S. death toll from the COVID-19 pandemic now stands at more than 107,000 people and a race is on to find a safe and effective vaccine against the virus that causes COVID-19 -- doctors who work on HIV prevention are especially heartened by the study results.
"Everything overshadowed by COVID and corona -- to get this news during tough times, is thrilling, really," said Dr. Colleen Kelley, Associate Professor of Infectious Diseases at Emory University School of Medicine and one of the study's researchers. "It puts a boost in our sails." she stated.
The HPTN 083 study enrolled 4,570 men in seven different countries including the United States, South Africa, Vietnam and Argentina.
Participants were randomly assigned to one of two groups, with one group receiving an anti-HIV medication injection, cabotegravir, every eight weeks and an inactive form of pills. The other group received an inactive form of the injection and the anti-HIV pill called Truvada.
IV-positive airmen fighting to stay in the Air Force in 1st-of-its kind case
Both medications work by blocking the HIV virus from multiplying in the body. During the study, 50 participants became infected with HIV. Of those 50 newly infected participants, 12 were receiving the cabotegravir injection and 38 were taking the Truvada pill.
Based on these results, the NIH stopped the 'blinded' part of the study because the results clearly showed that cabotegravir works just as well -- if not better than -- the existing Truvada pill. The positive results were announced to the public earlier than expected, and the people who volunteered for the study told which type of medication they had received.
"When the NIH stops a study early it's a big deal," said Ellerin. "They are trying to send a signal about the study."
Moreover, Kelley notes the results were also compelling because all of the participants were men who have sex with men or transgender women who have sex with men.
"Look, historically it has not been the case to include this group, they are often underrepresented in clinical trials," she said noting that men from non-white racial groups have an elevated risk of contracting HIV/AIDS.
According to statistics from the federal government African American and Latino gay and bisexual men represent the highest proportions of new HIV/AIDS infections in the United States.
A person receives an injection in this undated stock image.
Importantly, the study participants were diverse and represented populations that are most affected by HIV. Two-thirds of the study participants were under 30, about 12% were transgender women, and half identified as Black or African American.
Also, while waiting for FDA approval, HIV/AIDS and public health specialists remain optimistic, but note more information is needed with regards to cost.
"This is a very exciting finding with regards to HIV prevention; choice is always better" states Dr. David Holtgrave, Dean of the School of Public Health at University of Albany. "What wasn't addressed in the trial was the cost effectiveness of using an injectable instead of a pill -- we don't know the cost per injection."
Cabotegravir has already been studied extensively in clinical trials. In fact, the injectable drug -- when combined with a second medication called rilpivirine -- is already approved in Canada as a treatment for people who are already infected with HIV. ViiV, the company that makes cabotegravir, says it expects cabotegravir and rilpivirine to be approved as an HIV treatment by 2021 in the United States.
When it comes to HIV prevention, ViiV and the NIH are still studying cabotegravir alone, without the second add-on drug. It's not clear exactly when this stand-alone HIV prevention medication will be available in the United States, but researchers are continuing to study its effectiveness in different groups of people, including heterosexual women.
Pending FDA approval, it remains unclear how much either injection will cost. Currently, Truvada and other HIV daily prevention pills are covered by most insurance plans and Medicaid, although many require a complex pre-authorization process and have associated out of pocket costs that can make the medication unaffordable even for the insured.
Monica Saxena, M.D., J.D., is a contributing member of the ABC News Medical Unit.
