Posts Tagged → #HIVAIDS

Post-exposure Starter Pack versus Full 28 Day Prescription for HIV

HIV PEP medication has been helping to greatly reduce the possibility of infection after exposure to HIV. PEP is prescribed for 28 days as a two or a three-drug regimen. It is recommended that PEP therapy starts within 72 hours after HIV exposure. A recently published report compared the efficacy of the 28 day full prescription of PEP versus the practice in which a 3-5 day PEP Starter Pack course is handed over to patients and they are provided with rest of the PEP course at the next visit.

The Starter Pack

PEP Starter Packs are prescribed by some instead of the whole 28-day PEP to

  • help new users get used to the regimen
  • facilitate and encourage adherence
  • evaluate potential toxicity
  • reduce anxiety for worried patients while providing counseling at the same time

About The Paper

This paper is basically a compilation of data available on PEP practices and the outcomes will help inform future World Health Organization (WHO) PEP guidelines.

Two different authors of the paper simultaneously searched online databases for articles, abstracts and conferences available on PEP practices. In case of any disagreement among the two authors a third author helped. Only randomized trials and prospective observational studies were included in the formulation of the results. The reports which did not report PEP duration and had less than 10 individuals with PEP were not included in the study.

The type of HIV exposure, the study population, the number of drugs for PEP and the use of zidovudine / tenofovir along with attendance in follow-up visits were evaluated in the study.

Results

Although the overall result quality of this systemic review were marked to be very low, the results showed that out of the total 3259 titles which were initially selected only 54 studies passed the inclusive criteria. Out of these, 37 studies were about the Starter pack while 17 studies reported results of the full 28 day PEP prescription.

According to the report, Starter packs were usually given for a period of one to 14 days. 47% of the studies done on the Starter pack showed that most were given a 3-day Starter pack.

It is interesting to note that the prescription of a full 28 day PEP was more common among occupational exposure. It was reported that 22.4% of  individuals who were started on the Starter pack PEP refused to complete treatment as compared to the 11.4% receiving full PEP. 6.8% of the subjects receiving Starter pack stopped the medication due to toxicity while failure was 4.2% in people receiving full PEP.  The overall completion rate of PEP was 70% among the people who were prescribed full PEP versus the Starter Pack which was only 53.2%.

Conclusion

In conclusion, it can be inferred that the Starter packs might have some benefits but the overall compliance and adherence is not ideal. Therefore, an early start of full 28 day PEP is recommended.

Source:

Ford N et al., Starter Packs Versus Full Prescription of Antiretroviral Drugs for Postexposure Prophylaxis: A systemic Review. Clinical Infectious Diseases, 2015.

 

Two-Drug or a Three-Drug Post-exposure Prophylaxis in Occupational Exposure to HIV

Among occupations, Medical professionals are the ones who are most highly exposed to infections and threats of communicable diseases. Human Immunodeficiency Virus (HIV), being an untreatable virus, holds great risk to medical professionals especially those who work with HIV-infected patients and needles. HIV Post-Exposure Prophylaxis (PEP) is something that can greatly reduce the risk of infection during the course of their work. A review article published in a medical scientific journal, “Clinical Infectious Diseases” in 2004 gathered the published data to correlate the efficacy and toxicity of two drug and three-drug PEP regimen for occupational exposure to HIV.

Most of the available literature is on animal models as there are ethical limitations for clinical trials on humans. In a nutshell, these trials show an earlier start and a 4-week use of PEP is the most effective. Only one case-control study, reported and published in 1994, was conducted on health care professionals which showed that the use of a single antiretroviral drug (zidovudine) decreases the risk of HIV transmission to 79%. It also showed that only 33 out of 698 professionals, receiving monotherapy PEP became seropositive. After this study, the Center for Disease Control and Prevention (CDC) developed empirical PEP treatment guidelines for occupational HIV exposure.

These guidelines suggest the use of at least two drugs for PEP. According to the review there is more usage of a three-drug therapy in both the USA and Europe despite more side effects than a two-drug therapy which unfortunately leads to lesser compliance and early discontinuation usually resulting in PEP failure. However, HIV infected patients show better compliance to therapy with three-drug as compared to people receiving PEP for prevention.

For minor pricks and exposure to aberrations, CDC recommends the use of only a 2-drug regimen of PEP. The aim is to prevent virus from developing the infection in the body which can be achieved by a 2 drug therapy for at least 28 days. For more deep exposure like penetrating wounds, a three-drug therapy is recommended. Interestingly, one study showed that those on a three-drug PEP therapy had more side effects than HIV-infected patients on a three-drug treatment as well as an 8-times higher rate of discontinuation.

The review showed that the efficacy of the three-drug PEP was better than the two-drug PEP, but overall adherence to the treatment was better with two-drug PEP therapy. As mentioned previously, the toxicity was found to be higher with three-drug PEP. Although there is  data on the frequency and percentage of the antiretroviral drug resistance, there is almost no data on the extent of drug resistance to the different types on PEP.

Based on the available data, the authors of the publication made a model for the PEP which showed that without HIV PEP, 300 out of 100,000 HIV-exposed health care professionals will become seropositive. This transmission will come down to 108/100,000 with three-drug PEP therapy. A two-drug PEP will result in transmission to only 105, which are only 3 cases less than the three-drug PEP.

The two-drug PEP, as a whole, has better outcome and lesser toxicity than the three-drug PEP. Therefore, with lower antiretroviral resistance a two-drug PEP is recommended by the review.

Source:

Bassett I V et al Two Drugs or Three? Balancing Efficacy, Toxicity, and Resistance in Postexposure Prophylaxis for Occupational Exposure to HIV. Clinical Infectious Diseases, 2004.

HIV/SIV PEP in Non Human Primates: a Meta-analysis

Animals have long been the most faithful friends of humans but what is more interesting to know is that they have been a model for scientific experimentation which helps humans to make better medication and cure. A recently published meta-analysis report by the team of Irvine C. in the journal “Clinical Infectious Diseases”, the authors have admirably gathered the data published since May 2004 on the efficacy of HIV Post-exposure Prophylaxis (PEP).

The efficacy of PEP in humans was first published in 1997 in a case report. As there are ethical limitations in human subjects, animal models play a vital role in the clinical trials and research. Therefore, there are more studies on animal models and this analysis was done one data published on nonhuman primates.

The meta-analysis was done on more than 2000 papers published in medical web portals like Pubmed, Web of Science and Embase on nonhuman primates. Out of the 2517 papers and abstracts searched and found on HIV PEP, 2238 papers were excluded. 247 were duplicates which were also excluded. Out of the 40 remaining full articles, only 25 were finally selected because only these 25 papers had at least one animal which converted from being uninfected to seropositive and was given at least one antiretroviral medication. To have a more accurate analysis, the data was extracted by two different authors of the paper, simultaneously. The selection criteria were:

  • publication which were from peer reviewed journals
  • had controls
  • randomization to treatment
  • sample size was calculated
  • statement of compliance and statement related to conflicts of interests.

This meta-analysis was conducted according to protocol following the requirements set by the Preferred Reporting Items for Systemic Reviews and Meta-analysis (PRISMA).

Most of the animals which were studied in these reports were rhesus macaques or cynomolgus monkeys. Out of the total 408 primates studied, 180 were the infected animals versus 103 controls. The simian immunodeficiency virus (SIV) or Human Immunodeficiency virus (HIV) were administered to animals primarily via an intravenous route while the PEP drug/drugs were given subcutaneously. Interestingly, the animals which were on PEP were at an 89% lower risk of becoming seropositive.

The report also shows that the earlier the PEP is started the lower the rate of seroconversion. While there was no significant difference in the type of the antiretroviral medication given, there was a lower percentage of the seroconversion in the animals treated with tenofovir when compared with other drugs.

Another thing of interest with the figures was that older studies showed less efficacy of the drugs while more recent studies favored PEP.

After the authors collected and reviewed the data from previously reported papers, they emphasized that there is a need for better publications and research on the efficacy of PEP in nonhuman primates.

This meta-analysis, as a final point, emphasizes on the efficaciousness of earlier start in the application of antiretroviral PEP medications after exposure to HIV.

Source:

Irvine C et al. Efficacy of HIV Postexposure Prophylaxis: Systemic Review and Meta-analysis of Nonhuman Primate Studies. Clinical Infectious Diseases. 2015

HIV PEP – A Ray of Hope

The Human Immunodeficiency Virus known as HIV attacks a person’s immune system making them susceptible to infections like tuberculosis, opportunistic infections and even tumours. These are diseases that would normally not affect people with a strong immune system.

Although studies show that there is no cure for HIV, there are drugs available that can slow down the course of the disease and may help extend the life expectancy of a person infected by it.

The HIV pandemic is widespread in regions like Asia and Africa. The last five years have seen a 277% rise in HIV cases in the Philippines alone. Over 400 HIV positive cases were reported in 2007, in the Philippines. This figure rose to a staggering 2,400 cases in the year 2011. Representatives from the United Nation’s Program on HIV-AIDS in Manila, paint a gloomy picture stating that the Philippines is unlikely to meet the sixth Millennium Development Goal i.e. the goal set for reduction of HIV/AIDS.

In Africa, war-ravaged Uganda is also being crushed by the weight of HIV. Northern Uganda reportedly has the highest prevalence of HIV nationwide. A ballpark figure of 100,000 children live with HIV/AIDS in Uganda and at least half of these children reside in the Gulu district of Northern Uganda. Being the economic capital of Northern Uganda, Gulu has its own portfolio of challenges including poverty, child abuse and other health concerns.

Efforts are being made by organizations such as Opportunities Industrialization Centers (OIC) International’s Health, Nutrition & HIV/AIDS programs which educate communities regarding health issues and also provide palliative care to ensure that individuals and communities are equipped with knowledge to lead healthy lives.

Advancements in medical science have yielded two types of drugs that help counter HIV namely Pre-Exposure Prophylaxis (PrEP) and Post Exposure Prophylaxis (PEP). Truvada is a well-known antiretroviral drug. Truvada is a combination therapy because it has 2 medicines in one pill (emtricitabine and tenofovir disoproxil fumarate). Truvada is always used with other anti-HIV medicines to treat HIV-1 infection because Truvada alone is not a complete treatment. Truvada is a Pre-Exposure Prophylaxis (PrEP) drug which must be taken daily to block the transmission of HIV.

Post Exposure Prophylaxis (PEP), on the other hand is a line of HIV medication normally taken within the first 72 hours after a person is possibly exposed to the virus. PEP drugs help prevent the virus from spreading within the body. Health care workers, who have been exposed to the virus while taking care of an HIV+ patient and those that have engaged in sexual intercourse with a person with HIV need to be treated with PEP.

While medical science progresses to counter HIV anti-social elements are in play to further spread the virus and create new challenges for those working to help obliterate the deadly curse. A recent study in the US has found that HIV positive patients, faced with dire economic circumstances, are selling their HIV medications to HIV-negative people, who are using them as a preventative drug against contracting the virus. The motivating factors behind the rise of this new black market and its implications on the current status of HIV are discussed below.

Dr. Steven Kurtz from the Center for Applied Research on Substance Use and Health Disparities in Coral Gables, Florida, recently presented his research at the Conference of the Association for the Social Sciences and Humanities (ASSHH) on HIV in Stellenbosch, South Africa. ASSHH is a well reputed international membership organization geared towards promoting and supporting critically informed and theoretically engaged social science and humanities research on HIV/AIDS.

147 gay men were recruited by Doctor Steven Kurtz. These people were regular drug abusers resorting to drugs like cocaine, crack or heroin. National AIDS Manual AIDSMAP (NAM AIDSMAP) a London-based non-profit geared towards disseminating information pertaining to AIDS. NAM AIDSMAP reported that in order to gain a better understanding of the factors that caused people to trade/sell antiretroviral drugs, Kurtz deliberately over-recruited individuals that were engaged in such activities.

The study conducted by Kurtz found that people faced with dire financial situations were prime perpetrators of the aforementioned activities.

The study also found that the average income of men who sold their antiretroviral drugs, was likely to be under $1000 per month. These men were more likely to have traded sex for money or drugs and were dependent on drugs as well.

Interestingly, the study proved that there was no correlation between the trade of antiretroviral medication and the age, race or level of education of the perpetrators.

Furthermore, it was found that men who had sold their HIV treatment also had low adherence to the antiretroviral treatment. (Adherence in medical terms refers to how easily a patient can take the drugs without medical supervision). Lower adherence means most patients fail to continue/complete a drug regimen.

The study brought to light multiple factors that motivated the trade/sale of HIV medications. It reported that a high proportion of men (74%) sold their medication to purchase recreational drugs or alcohol. While 23% of men wanted to cover their living expenses. A few men had leftover medication or wanted to help someone in need.

Kurtz’s study also brought to light an alarming finding; there was a prevailing misconception amongst the men about the purpose of Pre-Exposure Prophylaxis (PrEP). They confused PrEP with Post Exposure Prophylaxis (PEP). This general misconception regarding has serious implications regarding the prevalence of HIV and its treatment. There is a dire need to carry out a mass public awareness campaign to inform people about the difference between PrEP and PEP.

Despite the challenges, PrEP and PEP are proving to be life saving and have helped counter the negative effects of the deadly virus. Uganda experienced a recent case where PEP medications have actually helped save the life of a 6-year-old boy. This boy was exposed to the disease after being sexually abused by a member of his community. He is in good health but is continuously monitored by medical professionals.

PrEP and PEP have made it possible to stem the tide of rising HIV infections across the globe. With improved education and dissemination of these drugs, the fight against the scourge of HIV is a battle that can be won.

Ground-breaking New Medication for HIV PEP Treatment

HIV PEP NEWS

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

 

New York State Department of Health AIDS Institute recently updated their HIV PEP guidelines

The New York State Department of Health AIDS Institute (NYSDHAI) recently tasked their Medical Care Criteria Committee (MCCC) to update their HIV PEP (Post-exposure Prophylaxis) guidelines. PEP refers to the treatment required and administered after exposure to HIV – a sexually transmitted disease (STD). This exposure is categorised as resulting from sexual assault, occupational exposure, and non-occupational exposure.

In 2012, the recommended medications for post-exposure treatment was the use of tenofovir [Viread®] with emtricitabine [Emtriva®] (or lamivudine [Epivir®]) and raltegravir [Isentress®] – due mainly to the higher rate of completion of the shorter 28-day course of treatment. In 2014, however, dolutegravir [Tivicay®] was added as an alternative to raltegravir [Isentress®]. Dolutegravir is an approved antiretroviral drug designed to block the action of the virus. This change was initiated to further improve the rate of completion of the course of medication based on the side-effects and dosage requirements of dolutegravir [Tivicay®] which have displayed improved tolerability.

The MCCC reported that the efficacy of the above mentioned medications may be compromised when taken alongside aluminium, calcium, iron, or magnesium. Being mindful of the presence of these minerals in food and over the counter antacids was particularly emphasised. As such it was stated that antacids should be taken a minimum of 2 hours before and 6 hours after the medication to receive the maximum benefits of the drugs.

Due to the 6 week window period during which the virus can spread undetected, the committee expressed the need to perform a laboratory blood test (HIV RNA test) even if the patient tests negative during the initial screening test. A newer fourth-generation HIV test was suggested for a more accurate result and the importance of all patients being tested was emphasised.

The recommendations stated that PEP must, as a matter of urgency, begin within 2 hours after exposure while awaiting results of the patient’s baseline tests. Baseline testing refers to the initial tests conducted and includes an immune function test (CD4 count); HIV replication test (viral load); kidney, liver, cholesterol, and blood cell tests; and tests for accompanying viruses or diseases. Baseline testing is required even in cases where PEP treatment is declined.

It was further recommended that patients receive access to psychological counselling and support in order to improve their adherence to guidelines and provide the necessary framework for the completion of treatment.

The committee later updated their recommendations to include further HIV testing at 4 weeks and 12 weeks after exposure and added that routine testing at 6 months is unnecessary in the event that the 12 week test yields a negative result for the presence of HIV. It was clarified that pre-exposure treatment should be explained and made available to individuals who display high-risk sexual activity in the case of non-occupational exposure.

In a public announcement in April 2015, the Governor of New York revealed a detailed plan to reduce new HIV infections. The Blueprint to End the AIDS Epidemic outlines the plan which requires changes to regulation, and a critical look at the state of existing medical infrastructure in order for implementation to be successful.

The uniting feature of similarity between the Governor’s announcement and the Committee’s recommendations was the emphasis on promoting education among both medical personnel and the general public. Numerous campaigns have been launched to this end including the distribution of resources to the relevant clinics and a written inventory of the resources available. The underlying factors for success in reducing HIV infections remains in the availability of resources, education, and expenses.