Ongoing And Planned Clinical Trials
The INSIGHT network is planning a large clinical trial that will randomize subjects, on a global basis, who have CD4 cell counts > 500 cells/µL to have immediate initiation of ART or deferral of ART until the CD4 cell count is < 350 cells/µL . A pilot phase of the study will initially enroll 1200 subjects, with sample size for the remainder of the study to be determined, at the initial Data and Safety Monitoring Board review, on the basis of the event rate. The primary end points will be fatal and nonfatal AIDS-defining events, nonfatal serious non-AIDSdefining events, and fatal non-AIDS events.
Two randomized clinical trials are evaluating the timing of initial ART in developing countries. The HIV Prevention Trials Network will address the issue of when to initiate ART as a secondary objective. The primary objective of the study is to evaluate whether ART reduces the risk of HIV transmission in 1500 heterosexual couples with discordant HIV status. Eligible couples comprised an HIV-infected partner with a CD4 cell count of 350550 cells/µL and an HIV-uninfected partner. The HIV-infected partners are randomized to immediate versus deferred therapy until they develop an AIDS-defining illness or a CD4 cell count < 250 cells/µL. Although the primary end point is HIV transmission to the HIV-uninfected partner, the study will have a unique opportunity for evaluating the effect of early ART.
How Should I Take My Antiretroviral Treatment
When and how you take your ART will vary depending on the specific antiretroviral drugs you take. Most antiretroviral drugs are taken once a day, with or without food. However, some drugs are taken twice a day. If this might be something you find difficult, talk to your doctor about your options.
Once you start ART its very important that you take it properly and dont miss or skip doses, as this can lead to something called HIV drug resistance, and may mean that your drugs dont work as well for you in the future. If youre finding it hard to take your treatment at the right times and in the right way, speak to your healthcare worker. They can offer you support and give you advice on how to make taking your treatment easier.
Fda Approves New Hiv Prevention Drug Taken By Injection Every Two Months To Replace Daily Pill Cocktail
- The FDA has approved a new preventative drug for HIV that may be easier to take for patients compared to past options
- The new drug, Apretude, is taken by injection every two months, and could replace a daily pill regimen that’s challenging for patients to maintain
- One clinical trial of Apretude found that patients who took the drug had a 69% lower risk of HIV infection compared to those who took daily pills
- A second trial found that patients who took Apretude had a 90% lower risk
- The new drug may be a great option for people at high risk of HIV, but potential patients could face access barriers to the drug
- Existing preventative HIV drugs are used more by white people, though black and Hispanic/Latino Americans are a greater share of the high-risk population
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Choosing A Regimen For Rapid Art Initiation
The preferred medications for rapid ART initiation are based on the established regimens for individuals who are ART-naive and are restricted to those that can be safely initiated in the absence of readily available baseline laboratory testing results, such as viral load, CD4 count, and HLA-B*5701. The preferred regimens have a high barrier to resistance, are well tolerated, and limit the potential for drug-drug interactions. Initial regimens should be selected on the basis of patient preferences and clinical characteristics, and a preferred regimen should be used whenever possible .
The 2-drug ART regimen of dolutegravir/lamivudine cannot be used for rapid ART because a baseline HIV genotypic resistance profile and hepatitis B virus status are required prior to prescription of this regimen
One alternative regimen has been studied formally in the setting of rapid ART initiation, in a phase 3, open-label, single-arm, prospective, multicenter study without the benefit of resistance testing, and produced high rates of viral suppression at 48 weeks .
When following a rapid ART initiation protocol, care providers should avoid regimens containing abacavir because results of HLA-B*5701 testing are not likely to be available. Similarly, rilpivirine should be avoided in any patient who has a viral load > 100,000 copies/mL and in any patient whose viral load is unknown.
- See the NYSDOH AI guideline Selecting an Initial ART Regimen for more information.
Fda Approves First Injectable Treatment For Hiv Pre
Drug Given Every Two Months Rather Than Daily Pill is Important Tool in Effort to End the HIV Epidemic
SILVER SPRING, Md., Dec. 20, 2021 /PRNewswire/ — Today, the U.S. Food and Drug Administration approved Apretude for use in at-risk adults and adolescents weighing at least 35 kilograms for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV. Apretude is given first as two initiation injections administered one month apart, and then every two months thereafter. Patients can either start their treatment with Apretude or take oral cabotegravir for four weeks to assess how well they tolerate the drug.
“Today’s approval adds an important tool in the effort to end the HIV epidemic by providing the first option to prevent HIV that does not involve taking a daily pill,” said Debra Birnkrant, M.D., director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research. “This injection, given every two months, will be critical to addressing the HIV epidemic in the U.S., including helping high-risk individuals and certain groups where adherence to daily medication has been a major challenge or not a realistic option.”
Participants who took Apretude started the trial with cabotegravir and a placebo daily for up to five weeks, followed by Apretude 600mg injection at months one and two, then every two months thereafter and a daily placebo tablet.
Additional Resources:
Media Contact: , 202-384-2219 Consumer Inquiries: or 888-INFO-FDA
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Which Drugs Should You Take
Now that you have learned a little about the types of drugs that are available and how they work, you may be wondering how your provider will know which treatment you should take.
HIV drugs are used in combination with one another in order to get the best results. The goal is to get the viral load as low as possible for as long as possible.
HIV drugs do different things to the virus–they attack it in different ways–so using combinations works better than using just one by itself. Combinations usually include three antiretroviral drugs. Except in very special circumstances, anti-HIV drugs should never be used one or two at a time. Using only one or two drugs at a time can fail to control the viral load and let the virus adapt to the drug. Once the virus adapts to a drug, the drug won’t work as well against the virus, and maybe it won’t work at all.
There is no one combination of HIV drugs that works best for everyone. Each combination has its pluses and minuses.
So, how will your provider know which combination to choose? You and your provider can consider the options, keeping certain things in mind, such as possible side effects, the number of pills you’ll need to take, and how the drugs interact with each other and with other medications you may take.
Print out these questions to ask your health care provider so that you will be ready to discuss combination therapy.
Rapid Art Initiation Is Safe
In the San Francisco study discussed above , 89.7% of patients used integrase strand transfer inhibitor -containing regimens and 12.8% used protease inhibitor-containing regimens. The predominant INSTI-based regimen was dolutegravir plus emtricitabine/tenofovir disoproxil fumarate. The clinic did not have any cases of major resistance mutations to the prescribed ART regimen, and no regimen switches were made because of resistance. Two patients had their regimens changed because of rash, and in 10 cases, the regimen was simplified to a single-tablet regimen.
Of 149 patients initiating ART through a program in New York City, only 1 required a regimen change because of subsequently detected resistance .
Rapid ART initiation is safe. Most designated regimens for rapid ART initiation are the same regimens that are recommended as initial treatment in the existing NYSDOH, International Antiviral SocietyUSA, and DHHS guidelines. These regimens are well-tolerated and effective, and the likelihood of drug resistance is low based on the current prevalence of drug resistance .
References
Amanyire G, Semitala FC, Namusobya J, et al. Effects of a multicomponent intervention to streamline initiation of antiretroviral therapy in Africa: a stepped-wedge cluster-randomised trial. Lancet HIV 2016 3:e539-e548.
CDC. Understanding the HIV care continuum. 2018
NYCDHMH. HIV surveillance annual report, 2017. 2018
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Preferred And Alternative Regimens For Rapid Art Initiation
Table 1: Preferred and Alternative Regimens for Rapid ART Initiation in Nonpregnant Adults, below, includes initial preferred and alternative regimens for rapid ART initiation in nonpregnant adults. The regimens are listed alphabetically. For specific details on choosing a regimen, see the discussions in other sections of this guideline and the package inserts for the drugs listed below.
Providing ART: Some clinics provide patients with the first dose of ART and a 30-day prescription when a rapid ART initiation protocol is being followed . Others may provide a 7-day ART starter pack or a 30-day prescription.
| Table 1: Preferred and Alternative Regimens for Rapid ART Initiation in Nonpregnant Adults |
What Factors Are Considered When Choosing An Hiv Treatment Regimen
When choosing an HIV treatment regimen, people with HIV and their health care providers consider the following factors:
- Other diseases or conditions that the person with HIV may have, such as heart disease or pregnancy.
- Possible side effects of HIV medicines.
- Potential interactions between HIV medicines or between HIV medicines and other medicines the person with HIV is taking.
- Results of drug-resistance testing . Drug-resistance testing identifies which, if any, HIV medicines will not be effective against a persons HIV.
- Convenience of the treatment regimen. For example, a regimen that includes two or more HIV medicines combined in one pill is convenient to follow.
- Any issues that can make it difficult to follow an HIV treatment regimen. For example, a lack of health insurance or an inability to pay for HIV medicines can make it hard to take HIV medicines consistently every day.
The best HIV treatment regimen for a person depends on their individual needs.
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Us And Global Guidelines Recommend Starting Art As Soon As Possible After Diagnosis
DHHS1
- ART should be initiated as soon as possible in all patients living with HIV, regardless of CD4 count
- In persons with acute or recent HIV infection, in pregnant people with HIV, or in people who will initiate ART on the day of or soon after HIV diagnosis, ART initiation should not be delayed while awaiting resistance testing results the regimen can be modified once results are reported
When initiating treatment, it is important to educate patients on the benefits and considerations of ART and adherence. Treatment may be deferred on a case-by-case basis, as clinically appropriate.
WHO9
- Rapid antiretroviral therapy initiation, defined as within seven days of diagnosis, should be offered to all patients with HIV*
Consider the overarching principles of providing people-centered care with a focus on the health needs and preferences of patients. People should be supported in making informed decisions regarding when to start treatment.
IASUSA10
- ART should be initiated as soon as possible after diagnosis, including immediately after diagnosis, unless patient is not ready to commit to starting therapy
- Immediate initiation , if clinically appropriate, requires improving linkage to care, adequate staffing, specialized services, and careful selection of medical therapy
*Rapid initiation is defined as within seven days from the day of HIV diagnosis people with advanced HIV disease should be given priority for assessment and initiation.
What Conditions Make It Especially Important To Start Hiv Medicines Right Away
The following conditions make it especially important to start HIV medicines right away:
- Pregnancy
- AIDS-defining conditions
Pregnancy
All pregnant women with HIV should take HIV medicines to protect their health and prevent perinatal transmission of HIV. Women with HIV who become pregnant and are not already taking HIV medicines should start taking HIV medicines as soon as possible and throughout pregnancy. In most cases, women who are already on an effective HIV treatment regimen when they become pregnant should continue using the same regimen throughout their pregnancies.
The risk of perinatal transmission of HIV during pregnancy and childbirth is lowest when a woman with HIV has an undetectable viral load. Maintaining an undetectable viral load also helps keep the mother-to-be healthy.
Early HIV infection
Early HIV infection, also known as acute HIV infection, is the period up to 6 months after infection with HIV. During early HIV infection, a persons viral load is often very high.
Studies suggest that even at this early stage of HIV infection, HIV medicines can begin to protect a persons health. In addition, starting HIV medicines during early HIV infection reduces the risk of HIV transmission.
AIDS-defining conditions
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When Should I Start Antiretroviral Treatment
Its now recommended that people diagnosed with HIV start antiretroviral treatment straight away. This is because the sooner you start treatment, the sooner you can benefit from it. Starting treatment as soon as possible protects your immune system from damage and gives you the best chance of staying strong and healthy in the future.
I immediately started my treatment, and boy I have to tell you, I never experienced any sort of setback and have never been sick – and now I am even undetectable.
– Mpho, South Africa
Rationale For Rapid Art Initiation
Lead authors: Asa Radix, MD, MPH, and Noga Shalev, MD, with the Medical Care Criteria Committee, updated October 2021
The New York State Department of Health HIV Clinical Guidelines Program and the U.S. Department of Health and Human Services recommend initiation of ART for all patients with a confirmed HIV diagnosis regardless of their CD4 cell count or viral load, for the benefit of the individual with HIV and to reduce the risk of transmission to others . Initiating ART during early HIV infection may improve immunologic recovery and reduce the size of the HIV reservoir there is also evidence that initiating ART at the time of diagnosis reduces treatment delays and improves retention in care and viral suppression at 12 months .
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When Is It Time To Start Taking Hiv Medicines
Treatment with HIV medicines is recommended for everyone with HIV. People with HIV should start taking HIV medicines as soon as possible after HIV is diagnosed.
A main goal of HIV treatment is to reduce a persons viral load to an undetectable level. An undetectable viral load means that the level of HIV in the blood is too low to be detected by a viral load test. Maintaining an undetectable viral load helps a person with HIV live a longer, healthier life. People with HIV who maintain an undetectable viral load have effectively no risk of transmitting HIV to their HIV-negative partners through sex.
To reduce their viral load, it is important for people with HIV to start taking HIV medicines as soon as possible. Starting HIV medicines right away is especially important for people with HIV who have certain conditions.
How Are Hiv And Aids Treated
The most effective treatment for HIV is antiretroviral therapy . This is a combination of several medicines that aims to control the amount of virus in your body. Antiretroviral medicines slow the rate at which the virus grows. Taking these medicines can reduce the amount of virus in your body and help you stay healthy.
After you start treatment, it’s important to take your medicines exactly as your doctor tells you. When treatment doesn’t work, it is often because HIV has become resistant to the medicine. This can happen if you don’t take your medicines correctly.
Other steps you can take include the following:
- Keep your immune system strong by eating right, quitting smoking, and learning how to avoid infection.
- Monitor your CD4+ counts to check the effect of the virus on your immune system.
- See a counselor to help you handle the strong emotions and stress that can follow an HIV diagnosis.
- Reduce stress so that you can better manage the HIV illness.
Starting treatment
Medical experts recommend that people begin treatment for HIV as soon as they know that they are infected. Treatment is especially important for pregnant women, people who have other infections , and people who have symptoms of AIDS.
Research suggests that treatment of early HIV with antiretroviral medicines has long-term benefits, such as a stronger immune system.
Treatment to prevent HIV infection
Other treatments for HIV
Treatment for AIDS
Living with HIV
If your partner has HIV:
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