Treatment is a life-long commitment for people afflicted with HIV. Once treatment has commenced, patients should continue taking their meds as strictly advised. It sounds simple enough, but it’s easier said than done.
The standard treatment for HIV, highly active antiretroviral therapy or HAART, involves the combination of three or more drugs (a “drug cocktail”), according to the World Health Organization (WHO). HAART prevents the virus from replicating and developing resistance thus helping improve patients’ quality of life. It has been found to have effectively lower death rates among HIV patients by as much as 70 percent, according to an independent report on Investing.com.
However, there are instances when patients and their healthcare providers may decide to pause or modify HAART. AIDS.gov stated two of the reasons for stopping HAART: drug toxicity and regimen failure. Drug toxicity occurs when HIV meds cause side effects that prevent patients from going on with the treatment. Regimen failure means the prescribed drugs failed to keep the patient’s HIV virus under wraps.
When HAART is stopped, the period is often referred to as a “drug holiday” or structured treatment interruption. But it comes at a price–pausing treatment could make patients more ill as they lose their body’s ability to contain the HIV virus.
In the United States, Cytodyn Inc. (OTC: CYDY), a Washington-based biotechnology company engaged in developing new therapies for the treatment of immune deficiency viruses-caused infections, is currently working on a drug that prolongs this so-called drug holiday while preventing viral rebound in patients. Called PRO 140, the drug is based on a new class of humanized cell-specific monoclonal antibodies (mAbs) which binds with CCR5, a chemokine receptor that the virus uses as an entry point to healthy cells.
PRO 140 belongs to a new class of HIV/AIDS therapeutics called viral-entry inhibitors. Unlike other drugs, it is cost-effective because it can be administered less frequently (weekly or bi-monthly). It also has fewer side effects, according to the company.
So far, the company has been successful with its trials, and is ready to move on to Phase 3. For the trial, participants took their HAART meds plus PRO 140 during the first week and continued with only the weekly PRO 140 monotherapy for the next 12 weeks.
The company found that none of the participants had any viral breakouts within four weeks of monotherapy. Also, 50 percent of the patients did not have any virologic failures within 8 weeks.
Dr. Nader Pourhassan, Cytodyn President and CEO, said there are currently over 30 drugs approved for HIV/AIDS treatment in the market but most of these drugs present ill side effects and drug resistance, not to mention that they require patients to take the drug indefinitely.
“We believe this [the preliminary result] is a very strong indication that PRO 140 is effective to allow 4 weeks of drug holiday with weekly injections. PRO 140’s safety has been well documented in previous studies, as well as our current study,” Pourhassan said of the positive outcome of the PRO 140 trials.
“We believe PRO 140 may prove to be a potential new therapy for HIV patients who need to cycle off conventional treatment regimens.”
Cytodyn, Inc. is awaiting FDA’s clearance to enter the third phase (licensing trial) of its clinical trial to further prove the effectiveness of PRO 140.
The company disclosed that PRO 140 works only with patients who are HIV positive with the R5 strain of the virus, which has uses the CCR5 receptor as a molecular gateway to infect health cells. Patients with the HIV strain X4 will not respond well to PRO 140 as the strain uses the other coreceptor, CXCR4.
The Centers for Disease Control and Prevention (CDC) has estimated that there are 1,144,500 people aged 13 and older living with HIV, including 180,900 or some 15.8 percent of the population who have no knowledge of their infection.
CDC noted that while the number of new HIV infections has “remained relatively stable” the past decade, the pace that new infections has grown is staggering.