What you need to know:
- Dr Katumba Ssentongo, the registrar at the Uganda Medical and Dental Practitioners Council, which authorises foreign researchers that come to do trials in the country, by press time had not yet succeeded checking their records to ascertain when the scientists carried out trials at the hospital.
KAMPALA. Scientists have developed a drug which destroys 99.9 per cent of HIV and Aids in the human body within only four weeks of treatment.
The drug known as Gammora and developed by Zion Medical, an Israel-based biotech company, contains peptides [proteins] derived from the HIV virus, which trigger self-destruction of the infected cell, without affecting the normal ones.
“The peptide, produced by San Diego, California-based PolyPeptide Labs, has the potential to cure HIV-infected patients by destroying all cells carrying the HIV virus-genome. As opposed to the commercially available retroviral treatments, the so-called ‘cocktail,’ which merely suppress the spreading of the virus, but do not cure the infection,” the statement issued by the company, reads in part.
Results of the human clinical trial were announced through a US-based global Cision Public Relations Newswire on Wednesday, last week.
The drug, whose trials were partly carried out in Uganda, has recently concluded Phase 2a of three or four that human drugs in clinical trials go through before being made commercially available.
Capt Jimmy Omara, the spokesperson of Special Forces Command, who run Dr Ronald Bata hospital in Entebbe, confirmed yesterday that they took part in the research, but did not elaborate, neither did he cite the period when the trial was conducted here.
“Yes, we can confirm that such an activity took place. The details of it will be brought when our partners come back here next week,” Capt Omara said in an interview.
But news of the breakthrough was received with caution in Uganda. Dr Stephen Watiti, a medical consultant on HIV/Aids at Mild May-Uganda, applauded the discovery, but warned people living with HIV/Aids to continue adhering to their drugs until the magic drug is on the market.
“If it is a breakthrough, then the world should celebrate, but since it is still under trial, I advise people living with HIV to continue taking their drugs. Otherwise, people will be saved from the daily ARVs,” Dr Watiti told Daily Monitor in a telephone interview yesterday.
Dr Joshua Musinguzi, the head of HIV/Aids programme, said they are yet to receive results of the discovery before he can comment.
If successful, the discovery will be historic following more than three decades of fruitless efforts to find a cure for the pandemic that has claimed millions of lives globally.
As part of the research, nine HIV-infected patients at Dr Ronald Bata Memorial Hospital in Entebbe, Uganda, were randomly assigned to receive either 0.05-0.2 mg/kg, or 0.1- 0.3 mg/kg, or 0.2-0.4 mg/kg of Gammora drug for up to between four and five weeks.
Most patients showed a significant reduction of the viral load of up to 90 per cent from the baseline during the first four weeks. In Part II of the study, conducted two weeks after the first, patients were given Gammora drug with additional retroviral treatment combined for another four to five weeks.
The results found that combined-treated patients demonstrated sustained viral suppression and showed up to 99 per cent reduction in viral load from baseline within four weeks, and patients demonstrated that Gammora is a safe and well-tolerable drug, exhibiting no side effects.
Patients also showed a significant increase of the CD4 cell count which play an important role in the body’s immune system and are an indicator of its overall health, of up to 97 per cent from the baseline.
In about two months, Zion Medical is planning to start a Phase 2b clinical trial to confirm the effects of the drug in the long-term, with effective dosages of Gammora and a higher number of HIV-infected patients.
“These first clinical results were beyond our expectations and promise hope in finding a cure for a disease that has been discovered over 35 years,” Dr Esmira Naftali, head of development at Zion Medical, said.
“Given the limited nature of this study, we are excited to prove the efficiency of our drug in Phase 2b with a greater number of participants over a longer period of time,” she added.
Dr Katumba Ssentongo, the registrar at the Uganda Medical and Dental Practitioners Council, which authorises foreign researchers that come to do trials in the country, by press time had not yet succeeded checking their records to ascertain when the scientists carried out trials at the hospital.
1987: The first HIV vaccine clinical trial opens at the National Institutes of Health Clinical Centre in Bethesda, Maryland. This Phase 1 trial enrolled 138 healthy, HIV-negative volunteers. The gp160 subunit vaccine showed no serious adverse effects.
2012: The World Health Organisation issued guidelines for Pre-exposure prophylaxis which refers to the use of antiviral drugs as a strategy for the prevention of HIV/Aids and made similar recommendations for its use among men and transgender women who have sex with men.
2014: An ongoing study to protect HIV negative women against acquiring the virus is launched and has since shown results of up to 61 per cent effectiveness by using a drug laced vaginal ring. The study is titled; The Ring Study and ‘A study to prevent infection with a ring for extended use’ (ASPIRE).
2017: The first large-scale clinical trial of a long-acting injectable medication for HIV prevention in sexually active women begun. The study in southern and eastern Africa examines whether a long-acting form of the investigational anti-HIV drug cabotegravir injected once every eight weeks can safely protect women at risk for HIV infection.
Scientists have conducted various clinical trials aimed at eliminating HIV/Aids. These include:
•A Phase I clinical trial testing the safety of vaccines that might have the potential to prevent HIV infection began this year at four sites in the United States.
•Another ongoing study to protect HIV negative women against acquiring the virus has since shown results of up to 61 per cent effectiveness by using a drug laced vaginal ring . The study titled The Ring Study and ‘A study to prevent infection with a ring for extended use’ (ASPIRE).
•In South Africa, another study currently in its phase 111 is testing different injectable drugs to see if they can be replaced with oral drugs that are difficult to swallow. A similar trial is also being carried out by the Uganda Virus Research Institute.