Antiviral Group: 'Biomedical' Tx Could Slow HIV (original) (raw)

MELBOURNE, Australia -- Nearly all people living with HIV could be rendered noninfectious by a suite of "biomedical interventions," according to new recommendations for HIV prevention.

Similarly, people at risk for HIV now have biomedical options that can reduce their risk of acquiring the disease, according to the International Antiviral Society-USA (IAS-USA).

It's the first time the IAS-USA has issued recommendations for HIV prevention in clinical care settings. The new guidelines are twinned with its usual recommendations -- updated every 2 years -- for the treatment of HIV.

Both documents are to be presented here at the International AIDS Conference, along with simultaneous publication in the the July 23/30 issue of the_ Journal of the American Medical Association._

"After more than 30 years, we are at a potential turning point in the control of the global HIV epidemic," the recommendations concluded.

That's largely because control of HIV transmission no longer has to rely solely on changes in human behavior, such as using condoms or refraining from sexual activity.

Instead, tools such as antiretroviral treatment (ART) and pre-exposure prophylaxis (PrEP) can help bolster individual efforts to prevent the disease, the guidelines panel argued.

Clinicians, using evidence-based HIV prevention tools, are crucial in implementing these new interventions, the guidelines panel said.

Details of the Guidelines

Both guidelines are based on a systematic review of HIV literature, either published or presented at scientific conferences, with recommendations arrived at by consensus among panel members.

The preventions panel broke its recommendations into four categories:

In line with current recommendations from the CDC, the panel urged that all adults and adolescents should be offered HIV testing at least once.

People at higher than average risk of HIV -- either because of risky behavior or residence in a region with a high prevalence of the virus -- should be tested more often "at intervals appropriate to the individual's situation," the panel recommended.

To direct that need for additional testing, clinicians from time to time should assess risk, such as sexual and drug-use activities, the panel urged.

Patients must be informed of the testing, the panel noted, and the right to refuse must be honored, but through pretest counseling "clinicians should ensure that refusals are informed decisions."

For people with HIV, the first step is to offer antiretroviral therapy as soon as the virus is diagnosed -- a recommendation that is echoed by the treatment guidelines.

Both guidelines panels urge therapy for all patients with HIV, for its individual medical benefits and because accumulating evidence shows that people with fully suppressed virus are almost completely noninfectious.

The prevention panel said that clinicians should educate patients about both the personal and the public benefits of therapy and should assess patients' "readiness to initiate and adhere" to long-term treatment.

They should also develop strategies to support adherence, tailored to the individual patient.

In addition, clinicians should be aware that acute HIV infection has a nonspecific presentation and "urgently pursue" specific diagnostics, such as a plasma HIV viral load, if there's a suspicion of infection.

HIV-positive injection drug users need access, simultaneously, to ART, needle and syringe exchange programs, supervised injection sites, medicalized heroin, and medically assisted therapy, including opioid-substitution therapy, the panel said.

The panel also urged physicians to "actively" link patients to care as soon as possible after a diagnosis. It also urged a range of supports to keep people in care, including such things as "patient health navigation, community and peer outreach, (and) provision of culturally appropriate print media."

For people not infected with HIV, the panel recommendations noted that there are medical interventions that can reduce the risk of acquiring the virus, including ART and PrEP.

Physicians should perform a risk assessment to decide the focus of risk reduction counseling and services, the panel recommended. Also, for those at high risk of catching HIV, risk reduction interventions and services are "warranted, especially for individuals and couples who seek repeat HIV testing to monitor seroconversion."

Daily PrEP, with the single pill combination emtricitabine/tenofovir (Truvada), should be offered to those at high risk based either on a background HIV incidence of greater than 2% or a recent diagnosis of a sexually transmitted infection.

It should also be offered to people who have used post-exposure prophylaxis more than twice in the previous year and some injection drug users, the guidelines say.

The panel noted that PrEP should be part of an integrated approach to risk reduction and might become unnecessary if a person's behavior changes, so that a regular assessment of risk is needed.

Some Modification

Aside from its recommendation to offer ART to all newly diagnosed patients, the prevention panel also modified its recommendations on which initial treatments to offer, how often to monitor treatment, and how to care for treatment-experienced patients.

The therapy should be started as soon as possible and preferably within 2 weeks of diagnosis for those with opportunistic infections, the panel recommended.

The recommendation is not new -- it was first made in the 2012 guidelines -- but the evidence for it has strengthened. The 2014 guidelines emphasized that clinical trials have shown that successful therapy prevents transmission of the virus.

The initial regimen for treatment-naive patients continues to be based on a backbone of two nucleoside or nucleotide reverse transcriptase inhibitors, in combination with a potent third agent, the panel said.

The potent third agents recommended by the panel include efavirenz (Sustiva), ritonavir-boosted atazanavir (Reyataz), ritonavir-boosted darunavir (Prezista), and raltegravir (Isentress).

But new regimens have been added, including:

The panel also added several regimens as alternative first-line treatment options that can be used if none of the recommended regimens is appropriate.

The recommendations for monitoring had not changed since 2010, but this year's guidelines say plasma HIV RNA levels should be monitored approximately 4 weeks after treatment is initiated or changed and repeated every 3 months to confirm suppression of viremia.

The earlier guidelines suggested such testing should continue for at least a year, but that restriction has been removed.

If the virus has been suppressed consistently for more than 2 years and CD4-positive T-cell counts are consistently greater than 500 per microliter, monitoring CD4s can be optional, the panel said, except in circumstances such as virologic failure.

The panel now recommends laboratory monitoring for treatment toxicity, but said if the situation is stable after 16 weeks of therapy, the frequency can be guided by comorbidities and by the components of the regimen.

For treated patients with multidrug resistance, physicians can consider including a boosted protease inhibitor or agents from newer drug classes, depending on resistance, viral tropism, and available options, the panel recommended.

Switching a drug regimen to improve tolerability, reduce toxicity, and improve convenience should not reduce the level of virologic suppression, whose maintenance is "paramount," the panel said.

But switching or regimen simplification in patients whose HIV is fully suppressed is generally safe, although earlier treatment and resistance must be taken into account.

Disclosures

Both reports were supported and funded by the IAS-USA; no private sector or government funding was used.

The IAS-USA disclosed relevant relationships with Abbott Laboratories, AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, Janssen Therapeutics, Merck, Mylan, Pfizer, Salix Pharmaceuticals, Tibotec Therapeutics, Vertex Pharmaceuticals, and ViiV Healthcare.

Jeanne M. Marrazzo, MD, MPH, lead author of the clinical are guidelines, disclosed relevant relationships with Merck and AstraZeneca.

Huldrych F. Günthard, MD, lead author of the 2014 recommendations, disclosed relevant relationships with Gilead Sciences, Merck, ViiV, Bristol-Myers Squibb, and Janssen.

Primary Source

Journal of the American Medical Association

Source Reference: Marrazzo JM, et al "HIV prevention in clinical care settings: 2014 recommendations of the International Antiviral Society-USA panel" JAMA 2014; 312: 390-409.

Secondary Source

Journal of the American Medical Association

Source Reference: Günthard HF, et al "Antiretroviral treatment of adult HIV Infection: 2014 recommendations of the International Antiviral Society-USA panel" JAMA 2014; 312: 410-425.