The End of HIV is Near – If Governments and Patients Use the Tools We Have


CME NUGGETS

Ed Susman

Mr. Susman is a freelance medical writer based in Florida, USA. He travels worldwide to report from medical conferences, writing regularly for wire services, internet websites, and medical journals such as the Journal of the National Cancer Institute and AIDS.

For comments, edwardsusman@cs.com


MEXICO CITY – All we really need to do to end the HIV/AIDS epidemic is to use the tools we have now – because those tools, especially treatment as prevention and pre-exposure prophylaxis– can stop spread of the disease, researchers reported here at the 10th International AIDS Society Conference on HIV Science.

“Translating Progress into Success to End the AIDS Epidemic” outlines work that has been done worldwide – in Thailand; in Rakai, Uganda; in Malawi; in New South Wales, Australia; in London, England and in San Francisco – that has worked to reduce the epidemic in those area.

“This is something we can say now that we could not have said with a great deal of certitude a decade or more ago,” Anthony Fauci, MD, director of the United States National Institutes of Allergy and Infectious Diseases, said at a press conference which introduced the report.

“And that is,” Dr. Fauci said, “We do have the tools we need both in the arena of treatment and of prevention. It is now very clear that treatment really does equal prevention. We know very clearly by a number of studies that if you treat a person who is infected with HIV and bring down the level of virus to below detectable that not only do you save the life of that person but you make it essentially impossible for that person to transmit the virus to another individual.”

The reported was put together by amfAR (Foundation for AIDS Research), AVAC (Global Advocacy for HIV Prevention), and Friends of the Global Fight Against AIDS, Tuberculosis and Malaria.

“So the idea is to get people on therapy and make sure they stay on therapy because not only is this an individual issue it is a public health issue,” Dr. Fauci said. “And then you go on to pre-exposure prophylaxis (PrEP). We know that if you have a person at high risk and you give this person a pill a day or on demand that you decrease by greater than 95 percent the likelihood that person will not acquire infection.

“So theoretically, we now have the tools that we can use to end the epidemic as it exists right now,” he said. “The implementation of these tools is going to be the gateways to achieving our aspirational goals to everybody in every region of the world and that is to control HIV all over the world and by controlling it we decrease incidence and by decreasing incidence to actually end the epidemic.”

Chris Collins, MPP, president of Friends of the Global Fight, based in Washington, D.C.. said, “This report provides a new narrative. Ending the epidemic isn’t an insurmountable challenge but a question of putting the evidence to work and scaling access, particularly for those most at risk. It won’t be easy anywhere, but it is possible everywhere.”

What needs to be done, Collins said, is enrollment of African girls into schools, eliminate laws that target gay, lesbian and transgender people, provide health care benefits to sex workers, and reduce the number of children living with HIV.

“We need progress in all these areas,” he said at the press conference. “To end the AIDS epidemic, we need innovation and we need to scale up innovation rapidly. Today, only 300,000 people worldwide are on PrEP. This lack of scale represents a huge opportunity.

“We must be ready to rapidly scale up innovations of the future whether it be injectable PrEP or a protective vaccine,” Collins said. {link to Molly Walker’s stories on both topics}

He predicted that the curves of AID incidence and mortality can be curved dramatically toward ending the epidemic “but it will take specific actions by policy makers, communities and providers. We are not saying that ending the AIDS epidemic will be easy anywhere. We are saying that it is not a mystery of what we have to do. We don’t need a miracle, what we need is leadership.”

He cited common contributors to lowering HIV incidence and mortality across the six locations include:

• Campaigns to encourage HIV testing, particularly among groups that are most affected
• Free and easy access to treatment at the time of diagnosis with HIV
• Scale up of evidence-based HIV prevention, such as voluntary medical male circumcision, pre-exposure prophylaxis and harm reduction
• Concerted efforts to provide human rights-based services and social supports alongside programs to fight stigma and discrimination.

“We have great tools but they are meaningless unless people can access them without fear,” Collins said. “Ending AIDS and universal health care are complementary goals.” He also said that ending the epidemic means reaching out especially to the most marginalized members of society.

Dr. Fauci said that in the United States he thinks the political will is there as announced recently by President Donald Trump and with Health and Human Services Secretary Alex Azar. “This more than a pipedream,” Fauci said. “I wouldn’t be involved with it if it was.”

Two drugs do the job

In one of the key studies at the meeting, researchers suggested that a potent 2-drug combination was at least as good as combinations of 3 and 4 drugs.

After 48 weeks, no confirmed virologic withdrawal was observed among the 369 patients assigned to treatment with dolutegravir/lamivudine and none of those patients had observed resistance mutation, reported Jean van Wyk, MD, the global medical lead for dolutegravir at ViiV Healthcare, Brentford, United Kingdom, the sponsor of the trial.

Among the 372 patients who were assigned to receive a 3-drug or 4-drug regimen that included treatment with tenofovir alafenamide fumarate (TAF) there was one patient who had a confirmed virologic withdrawal; but there was no observed resistance mutation at failure, Dr. van Wyk said at the 10th International AIDS Society Conference on HIV Science.

“Switching to dolutegravir/lamivudine was non-inferior to continuing a TAF-based 3-drug regimen in maintaining virologic suppression in HIV infected antiretroviral experienced adults,” Dr. van Wyk said. “The 2-drug regimen offer a new robust switch option with reduced antiretroviral exposure without increase risk of virologic failure or resistance.”

Overall, he noted, virologic failure occurred in less than 1 percent of patients in either arm of the so-called TANGO trial. The primary endpoint of the trial was percentage of patients experiencing virologic failure; the secondary endpoint was patients ability to achieve virological success – and in that analysis the dolutegravir combination was also noninferior.

The average age of the participants in the TANGO trial was about 40, about 8 percent were women; about 79 percent were white, and about 15 percent were African-American; 19 percent identified as Hispanic or Latino.

In commenting on the TANGO study, press conference moderator Anton Pozniak, MD , IAS President and International Scientific Chair, and an infectious disease consultant at Chelsea and Westminster Hospital, London, said, “Being able to switch people from a 3-drug regiment to 2 drugs should costless money, the pill will be smaller, there will be less drug to take and therefore less chance to develop toxicity because you have one less drug on board. And dolutegravir is a drug with a high resistance barrier.

“We still need longer-term trials to see how this combination can maintain suppression over time,” Pozniak said.

TANGO patients were recruited from among individuals who were on TAF based 3-drug or 4-drug regimens and had been virally suppressed for at least 6 months. Patients were excluded if they had Hepatitis B Virus infection. They enrolled 369 patients who were assigned to receive dolutegravir and lamivudine and371 patients who remained on their multidrug regimens.

Patients switched to dolutegravir/lamivudine did report more adverse events, but Dr. van Wyk suggested that was to be expected as the other patients were continued on regimens, they had been on for months to years. He said there were no new adverse event signals.

The single pill (Dovato) that combines the agents is already available in the West and it is being evaluated for use in resource limited settings and other areas worldwide, Dr. van Wyk said.

He said that clinicians should be careful who they switched from their stable regimen to the 2-drug combination. “It is really about the patient characteristics,” he said. “If a patient has resistance to either dolutegravir or to lamivudine, this combination would not be appropriate.”

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