A study was conducted in two Australian cities namely Melbourne and Sydney to determine the effectiveness of a new drug for the treatment of HIV. A small sample group of 100 healthy non-HIV infected gay men who were eligible for HIV PEP (Post-exposure Prophylaxis) were part of the study.
Post-exposure Prophylaxis (PEP) is a medical term which refers to the use of anti-HIV drugs that can be consumed immediately after one has been exposed to HIV while Pre-exposure Prophylaxis (PEP) refers to treatment that is given in a situation where HIV infection seems possible and in this instance acts as a preventative measure. PEP drugs help prevent the virus from spreading into the body. People in need of PEP drugs include health care workers, who have been exposed to the virus while taking care of an HIV+ patient and those who have engaged in sexual intercourse with a person with HIV. Efforts are being made to increase access to PEP drugs to prevent the devastating effects of HIV on the global population.
Currently, most PEP regimens involve the use of three drugs that patients are required to take twice or sometimes three times a day. However, the painful side effects make it difficult for patients to complete the course of medication without medical supervision. These regimens are therefore not highly effective in preventing the spread of HIV in the patient’s blood.
Efforts are being made to alter PEP drugs so that people can successfully complete the drug regimen with little or no adverse effects. This will dramatically change the way HIV is perceived by people. It will no longer be a deadly virus, with no hopes for survival, but rather an illness which patients can fight through. The small sample group study proved to be a step closer towards achieving this goal.
The men who participated in the study were given a single tablet daily, consisting of the following drugs: Emtricitabine 200mg; Rilpivirine 25mg; and Tenofovir disoproxil fumarate 300mg.
These drugs are commonly referred to as Reverse Transcriptase Inhibitors (RTI) in medical terms. They are rapidly absorbed into the body before HIV spreads into the patient’s blood. Rapid absorption of a drug also plays a key role in its effectiveness. The fact that these drugs are rapidly absorbed into the body show that the drug regimen is highly effective. The group of men received treatment for 28 days. Over the next 12 weeks the participants were required to return for 7 follow-up study visits. During these study visits their blood samples were taken and the drug dosage re-evaluated. The purpose was to determine if any of the participants discontinued the drug regimen before the trial period of 28 days and also if any of the participants tested positive for HIV by the end of the 12 week trial.
One of the key measures of success of a drug regimen is how easily patients can take the drugs without medical supervision. Most people discontinue taking drugs because of the discomfort caused by the side-effects of the drug. In short the success rate of current PEP regimens is very low as people fail to continue drug intake throughout the course of the prescription.
In this study, 92 out of 100 participants completed the drug regimen. Amongst the 92 participants, 98.5% reported that they followed the drug regimen unsupervised. 78 participants returned their pill bottles at the end of the 28-day period and 98.6% of these had successfully completed the drug regimen. Overall 88 of the 100 men experienced negative side effects which included fatigue and nausea. Four participants experienced severe but not life-threatening effects from the drugs.
To verify the accuracy of the drugs, blood samples of 41 participants were tested within two days of the last dose at the end of the 4th week. All participants were reported to have high levels of drug concentration in their blood thus the drug regimen was successfully followed by the participants.
Although this was a small-scale study which does not provide substantial evidence regarding the effectiveness of the new PEP regimen, a promising sign is that none of the 70 men who attended the final follow-up visit tested positive for HIV by the end of the 12 week drug trial. The results from this small scale study look promote the need for a large-scale study to be conducted, involving core groups and control groups, to obtain statistically significant results. Results from a large-scale study can then be used to change the current PEP drug regimens that are in place.
A study was conducted in two Australian cities namely Melbourne and Sydney to determine the effectiveness of a new drug for the treatment of HIV. A small sample group of 100 healthy non-HIV infected gay men who were eligible for PEP (Pre-exposure Prophylaxis) were part of the study.
Post-exposure Prophylaxis (PEP) is a medical term which refers to the use of anti-HIV drugs that can be consumed immediately after one has been exposed to HIV while Pre-exposure Prophylaxis (PEP) refers to treatment that is given in a situation where HIV infection seems possible and in this instance acts as a preventative measure. PEP drugs help prevent the virus from spreading into the body. People in need of PEP drugs include health care workers, who have been exposed to the virus while taking care of an HIV+ patient and those who have engaged in sexual intercourse with a person with HIV. Efforts are being made to increase access to PEP drugs to prevent the devastating effects of HIV on the global population.
Currently, most PEP regimens involve the use of three drugs that patients are required to take twice or sometimes three times a day. However, the painful side effects make it difficult for patients to complete the course of medication without medical supervision. These regimens are therefore not highly effective in preventing the spread of HIV in the patient’s blood.
Efforts are being made to alter PEP drugs so that people can successfully complete the drug regimen with little or no adverse effects. This will dramatically change the way HIV is perceived by people. It will no longer be a deadly virus, with no hopes for survival, but rather an illness which patients can fight through. The small sample group study proved to be a step closer towards achieving this goal.
The men who participated in the study were given a single tablet daily, consisting of the following drugs: Emtricitabine 200mg; Rilpivirine 25mg; and Tenofovir disoproxil fumarate 300mg.
These drugs are commonly referred to as Reverse Transcriptase Inhibitors (RTI) in medical terms. They are rapidly absorbed into the body before HIV spreads into the patient’s blood. Rapid absorption of a drug also plays a key role in its effectiveness. The fact that these drugs are rapidly absorbed into the body show that the drug regimen is highly effective. The group of men received treatment for 28 days. Over the next 12 weeks the participants were required to return for 7 follow-up study visits. During these study visits their blood samples were taken and the drug dosage re-evaluated. The purpose was to determine if any of the participants discontinued the drug regimen before the trial period of 28 days and also if any of the participants tested positive for HIV by the end of the 12 week trial.
One of the key measures of success of a drug regimen is how easily patients can take the drugs without medical supervision. Most people discontinue taking drugs because of the discomfort caused by the side-effects of the drug. In short the success rate of current PEP regimens is very low as people fail to continue drug intake throughout the course of the prescription.
In this study 92 out of 100 participants completed the drug regimen. Amongst the 92 participants 98.5% reported that they followed the drug regimen unsupervised. 78 participants returned their pill bottles at the end of the 28-day period and 98.6% of these had successfully completed the drug regimen. Overall 88 of the 100 men experienced negative side effects which included fatigue and nausea. Four participants experienced severe but not life-threatening effects from the drugs.
To verify the accuracy of the drugs, blood samples of 41 participants were tested within two days of the last dose at the end of the 4th week. All participants were reported to have high levels of drug concentration in their blood thus the drug regimen was successfully followed by the participants.
Although this was a small scale study which does not provide substantial evidence regarding the effectiveness of the new PEP regimen, a promising sign is that none of the 70 men who attended the final follow up visit tested positive for HIV by the end of the 12 week drug trial. The results from this small scale study look promote the need for a large scale study to be conducted, involving core groups and control groups, to obtain statistically significant results. Results from a large scale study can then be used to change the current PEP drug regimens that are in place.
Original article: http://cid.oxfordjournals.org/content/early/2015/06/28/cid.civ511
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