Revisiting Immunity

NAPWA helps to promote immune-based therapies
by Chael Needle

At the International AIDS Conference last June, the AIDS Institute and the National Association of People with AIDS (NAPWA) hosted a Community Treatment Research Forum entitled, “Research Advances from Therapeutic HIV Vaccines and Other Immune-Based Therapies.” Presented by researchers and experts in the field, the symposium covered the latest in potential candidates for the AIDS armamentarium.

When it comes to AIDS treatments, most are familiar with antiretrovirals—agents that inhibit or interrupt the HIV replication process. While antiretrovirals have seen success in suppressing the virus and improving T-cell counts, treatment issues remain. According to NIAID, some of the most pressing issues include latent reservoirs of HIV that keep the virus a persistent presence in the body; drug resistance that creates a need to switch regimens; and health problems such as end-organ failure, among others. Importantly, AIDS science needs to figure out how to restore the immune function damaged by HIV.

Immune-based therapies (IBTs), currently in the research and development phase, find ways to help an individual’s own immune system fight the virus and/or help the immune system rebound after the damage wreaked by HIV infection and replication.

NAPWA chose to focus on immune-based therapies as part of its general mission to advocate for people living with HIV/AIDS. Representing the 1.3 million living with HIV/AIDS, the nonprofit champions civil and human rights, strives to expand federal healthcare funding, particularly Medicaid expansion and ADAP, and promotes awareness with National HIV Testing Day. But NAPWA also seeks to fill specific gaps in treatment education and funding, marshalling public and private resources toward that end.

“The conference had [scheduled] a lot of great content, but we realized that immune-based therapy was one [area] that had not received the visibility that it really needed,” says Stephen Bailous, vice president for community affairs at NAPWA. “The biotech companies [researching these new candidates] are fragile and under-resourced. They need someone to champion their cause so they can continue to do this work.” Not merely as a business, but as a lifesaving venture, he says.

As someone currently enrolled in a clinical trial, executive director of NAPWA Frank J. Oldham, Jr., attests: “On this [trial] medication, my viral load went down to zero. Though I’m only taking two pills a day, it would be great to be able to have a vaccine that would allow someone to maintain this state of zero viral load for months and months. These therapies offer a lot of hope and promise.”

NAPWA has been emboldened by the Presidential administration’s sustained support of people living with HIV/AIDS and the LGBT community, as well as its concerted efforts to address HIV/AIDS. It’s a golden opportunity, says Oldham, for us to call for increased funding of candidate therapies and increased support of friendly partners like President Obama, director of the Office of National AIDS Policy Jeffrey Crowley, and the CDC, whose ideas need more funding and bipartisan follow-through to be put into action. Because of Obama detractors, notes Oldham, “the agenda is being delayed. If the agenda is delayed, we lose lives.”

The nonprofit has also been heartened by NIH’s renewed interest in immune-based therapies. NAPWA continues to work with these governmental entities and other partners, and recently were happy to share with them successes presented at the conference forum.

Says Bailous, some of the successes derive from a “two-pronged approach”: The candidates in Phase II studies demonstrated an ability to suppress the virus, but they have also shown a capacity to rebuild the immune system. “None of the pharmaceuticals [on the market] can rebuild your immune system,” he reminds. “For folks who are running out of pharmaceutical options, and are just not tolerating them very well, this is a whole new ray of hope.

“Much more than prevention vaccines, these are much closer to coming to market. If we’re fortunate to have some of these companies attract some more development dollars, and conduct the awfully expensive Phase III clinical trials that need to be done, there actually could be something on the market in the next four to five years. With prevention vaccines, it may be twenty years.”

Results from studies of four therapeutic vaccines were presented at the forum:

• Vacc-4x: Bionor Immuno’s therapeutic HIV-1 vaccine based on modified peptides, currently in Phase II trials, showed that about half of the study volunteers retained memory to Vacc-4x seven years after initial immunization. (After the conference, Bionor researchers reported that this memory can be safely reactivated when participants in the study were revaccinated, with enhanced immune response and activation of killer T-cells as part of the potential benefit.)

• AGS-004: Argos Therapeutics’ candidate showed large decreases in viral loads allowing extended strategic antiretroviral treatment interruptions for treatment-experienced patients.

• DermaVir: An HIV therapeutic vaccine from Genetic Immunity was found to safely boost HIV-specific immune response and reduce viral load within six months in treatment-naïve individuals in a Phase II study.

• FIT-06: Finland’s FIT Biotech two-year Phase II results showed that its DNA vaccine reduces viral load and increases CD4 cell count in treatment naïve individuals.

A novel class also generated excitement from its Phase II results:

• VS411: ViroStatics’ class of therapeutics, AV-HALTs (Antiviral-HyperActivation Limiting Therapeutics), were shown to safely reduce both excessive immune system activation and viral load within twenty-eight days in treatment-naïve individuals.

Other candidates presented at the conference forum included TBR-652, IQP-0410 and IQP-0528, VIRxSYS, and PEPTERON.

NAPWA’s vote of confidence is steadfastly practical. For those of us who remember a time when the treatment cupboard was completely empty and people with AIDS were dying often, says Oldham, the promise that antiretrovirals brought with them then echoes the promise of immune-based therapies now. “That is why NAPWA wants to be forefront,” he says. “At NAPWA, we have great partners in industy—BMS, Gilead, Tibotec, among others—and as people living with HIV and AIDS and people who have experienced the worst part of this epidemic, we are grateful for the medications that we have today. However, we also want to improve beyond that, and so do our partners in industry.”

HAART will most likely be used in tandem with immune-based therapies. Says Bailous, “This isn’t going to replace anything. It will just give us more weapons in the war. And we need every available weapon.”

Bailous adds that immune-based therapeutic vaccines might bode well for addressing the pandemic in resource-limited countries and communities where antiretrovirals may be available but do not reach patients because of poor infrastructure. Adds Oldham: “It might also be a treatment-as-prevention tool by reducing the community’s viral load.”

Oldham’s caveat is that we need to address oppression-related and other health disparities as we move forward. “Poverty is the main one, but civil rights, social justice issues for gay people, stigma—all of those things are surrounding HIV/AIDS. So while NAPWA is strongly focused on and appreciative of the new medications and vaccine therapies that are being researched, we also know that these structural interventions—the social issues—are also paramount. We’re never going to have a day when you’re going to give someone a pill or a vaccine and it’s going to cure homelessness, homophobia, racism, and all those issues that we’ve all grown up and lived with.”

Building on the partnerships forged in Vienna, NAPWA plans to move forward with its treatment education efforts at future conferences and within communities. It will also stay on top of treatment access, especially in the most affected communities and communities with the least resources (usually it is the same community).

Though we live in a free-market, profit-driven society, says Oldham, “[w]e have to ask: How much is a human life worth? How much investment is a person’s life worth? It may cost a lot of dollars to save a life from poverty, from all of these other things that surround people, and also it may take a lot of dollars in terms of research to get medications that will save the lives of people.” The anniversary of Katrina, he notes, reminds us of the “devastation caused when we as a society neglect our citizens, our valued people.”

Chael Needle wrote about other treatment advances at the International AIDS Conference in the August issue.

September 2010