October – November 2018 (Updated September 2024)
Examples of media coverage:
- HIV cure? Major breakthrough made in eradicating deadly virus: ‘Beyond our expectations’ – Daily Star, November 1, 2018
- New drug could cure HIV/Aids – Uganda Daily Monitor, November 7, 2018
- Maker of ‘potential HIV cure’ moves to calm frenzy over new drug – Health24, November 7, 2018
Community-based articles and responses:
- Gammora does not cure HIV – Roger Pebody and Gus Cairns, AIDSMap, November 6, 2018
- Company with false HIV ‘cure’ admits trial was not registered with regulatory body – Sanele Ngcobo, Bhekisisa, November 9, 2018
Original source:
- Press release: Zion Medical Announces Results of First Human Clinical Trial of HIV drug Gammora, Offering Potential Cure – Zion Medical, October 31, 2018
TAG’s commentary:
This announcement relates to a peptide (protein fragment) that was covered on this media monitor page in 2016, when it was claimed to represent a possible HIV cure based just on results in a laboratory dish. But the one published laboratory study did not offer evidence that the approach might cure HIV infection.
The peptide is reported to alter the HIV life cycle in a way that causes more copies of the virus genome to integrate into the genetic code of the cells that it infects. The integration of multiple copies of HIV is said to promote the death of the virus-infected cell by apoptosis (cellular suicide).
On October 31, 2018, Zion Medical, a small biotech company based in Israel, issued a press release claiming once again that the peptide—which they have named Gammora—is a “potential cure.” Again, the evidence does not support the claim.
The press release offers a vague description of results from a 9-person clinical trial conducted at the Dr. Ronald Bata Memorial Hospital in Entebbe, Uganda. According to this description, administration of the peptide led to decreases in HIV viral load compared to baseline levels in individuals who were not receiving antiretroviral therapy.
Subsequent addition of the antiretroviral lopinavir/ritonavir is said to have caused a further reduction in viral load. In some stories this is mistakenly presented as 99% of HIV being eliminated or the peptide being 99% effective – what is being described is a 99% reduction in HIV viral load, which is seen with standard antiretroviral drug combinations. The press release states there was control group of individuals who received lopinavir/ritonavir without the peptide, but does not say if viral load reductions were any different in this group.
The press release claims that the peptide “has the potential to cure HIV infected patients, by destroying all cells carrying the HIV virus-genome.” This is false.
Even if the peptide does kill HIV-infected cells by the mechanism of action that has been ascribed to it, this would not affect the latent HIV reservoir, which is considered the major obstacle to achieving a cure. The latent HIV reservoir is made up of cells carrying the HIV virus genome in an inactive state, and the purported mechanism the peptide would only affect cells in which HIV is actively replicating.
The public relations contact on the Zion Medical press release relayed responses from the company to some questions posed by TAG.
When asked how the peptide would be capable of “destroying all cells carrying the HIV virus-genome,” the company offered a convoluted reply falsely stating “there is a specific known marker” for cells containing latent HIV (no such marker has been discovered) that could allow them to target the cells with a gene therapy approach (a lentiviral vector) that they have not even yet tested against HIV:
“The mechanism can suggest either that latent cells can be destroyed if another [HIV] virus will infect this cell (in naïve patients) or if not, we will need to introduce the latent cells with lentiviral particles which are targeted to those cells (there is a specific known marker) and the LV [lentiviral vector] will ‘replace’ the HIV.”
So, even by the company’s own assessment, the peptide is not capable of “destroying all cells carrying the HIV virus-genome” as claimed in the press release. And their idea for addressing the latent HIV reservoir is based on a misapprehension that a marker of the reservoir exists that would allow it to be targeted by a gene therapy (a gene therapy not tested in the clinical trial, and seemingly not yet tested against HIV at all).
In simple terms, what this means is that the Zion Medical press release stating their peptide is a potential HIV cure is egregiously false. The press release led directly to multiple media stories and social media commentaries that were equally erroneous and misleading.
Another aspect to this announcement that remains unclear is how the clinical trial in Uganda was regulated. The trial is not listed among research authorized by the Uganda National Drug Authority. The company states that the Ugandan Ministry of Health approved the trial, but they are not a regulatory agency charged with assessing whether an experimental candidate is safe to test in people.
The Dr. Ronald Bata Memorial Hospital in Entebbe is operated by the Uganda Special Forces Command (SFC), and an article in the Uganda Daily Monitor contains a quote from spokesperson Jimmy Omara stating that the SFC was involved, but provides no further details.
In an article for Bhekisisa, Sanele Ngcobo reports that the trial was not registered with a regulatory agency. Hopefully further information will emerge about the conduct of the trial.
False claims of HIV cures exploit the hopes people have that an HIV cure will be developed, to generate publicity. Such claims often prove divisive, because a strong desire to believe they might be true can lead people to attack anyone offering evidence-based refutations. The fact that HIV is still so stigmatized can make dangling false hope of eliminating the virus into a form of psychological torture, and there have been reports in the past that claims of cures have caused some people to abandon standard HIV treatment.
No reputable scientist or company should ever engage in this type of hype.
Update 9/16/24: Since this article was posted in 2018 there’s been no verification of the purported results and no credible information about any other research on Gammora for HIV. The subsequent behavior of the company developing the substance (Zion Medical) and its representatives has only further undermined their claims.
An investigation by Bhekisisa in 2018 revealed that the “clinical trial” in Uganda was never approved by local regulatory authorities and Zion Medical representatives initially made false statements in this regard. The company also informed Bhekisisa that future studies would be registered in clinicaltrials.gov but as of today’s date — six years later — no trials of Gammora have ever been entered into the database.
In 2021, company representatives published a “short communication” that just restated the unverified claims about the unapproved clinical trial in Uganda.
In early 2020 the same protagonists also stated that Gammora had shown benefits in people with COVID-19 in the Congo, supposedly after being administered under “compassionate use” protocols. Claiming a given substance can miraculously treat multiple conditions has been a signature of past efforts to promote and sell interventions that don’t work.
The worst aspect of the Gammora story is that products with this name have been – and perhaps still are – being sold online or locally as a cure for HIV. In a case that was prosecuted in Malawi the drug being sold was an antibiotic, gentamicin, which can cause serious side effects including allergic reactions. Zion Medical itself has been quoted as planning to make Gammora “commercially available” in partnership with a “Swiss pharma service provider of unlicensed medicines” named FarmaMondo, despite the absence of any credible research or evidence of safety and efficacy in people.
TAG joins with the many other advocates and organizations (e.g. Africa Check, Medicines Control Authority of Zimbabwe, aidsmap, HIV i-Base) who’ve debunked the false claims about Gammora curing HIV and/or warned against buying or using any products with this name. Anyone selling Gammora should be reported to the appropriate authorities.