Treating patients At Risk For HIV
06.03.20

By Dr. Ndira Brar

A simple way to evaluate which patients may be optimal candidates for HIV pre-exposure prophylaxis (PrEP) is to consider anyone who is at high risk for the acquisition of HIV infection. The groups that are commonly considered high risk are men who have sex with men, individuals who have a partner who is HIV positive, people with multiple sexual partners, cross-gender women, and individuals who use intravenous drugs.

There are 2 ways infectious disease specialists commonly offer PrEP. The first is in the case of a patient who comes to your clinic and actively requests PrEP. I think this is an easier conversation because the patient has proactively asked you for PrEP — you can then review risk factors and determine if PrEP is indicated. The other conversation that can happen is when the provider is proactive in identifying people who would benefit from PrEP. But how do you do that? One important factor is knowing if they are in a relationship with someone who is HIV positive. In these cases, I would advise providers of primary care to ask them if this partner is receiving medication and if they are virally suppressed. If the partner with HIV has shown viral suppression, the risk for transmission is very low; it is close to zero. But there are situations where HIV transmission may occur and, to add an additional safety net, I advise clinicians to think about offering PrEP.

Another way to approach the topic is to develop the habit of asking patients who they are having sex with: are they sexually active with men, women, or both? This should be followed by a conversation about their sexual preferences. For example, if a patient reports having sex with men, is this patient the receptive partner? If this is confirmed, the risk for acquisition of any kind of infection, including HIV, is higher, and a clinician should start thinking about prescribing PrEP.

It can be stigmatizing for people to be asked if they have multiple sexual partners. Therefore, when asking patients about a history of multiple sexual partners, I highly advise against asking, “Do you have multiple sexual partners?” In my practice, we always ask, “In the past 6 months, have you been sexually active with more than 1 person?” It is better to ask the numbers, using the framework of the past 3 or 6 months, to get a sense of their sexual experiences. If you find that they have had multiple sexual partners, then discuss PrEP with them.

Regarding specific PrEP regimens, there are 2 US Food and Drug Administration (FDA)-approved medications for PrEP. Both are combinations of 2 anti-HIV drugs: emtricitabine and tenofovir disoproxil fumarate (F/TDF), sold under the brand name Truvada®, and emtricitabine and tenofovir alafenamide (F/TAF), sold under the brand name Descovy®.

Candidates for F/TAF as a PrEP regimen are men and transgender women who have sex with men and who are at risk for HIV-1 infection, because this is the population in which the DISCOVER trial (ClinicalTrials.gov Identifier: NCT02842086) was carried out. This trial showed that F/TAF was not inferior to F/TDF in men and transgender women who have sex with men and who are at risk for sexually acquired HIV infection.1 The FDA later approved F/TAF for PrEP in adults and adolescents who weigh ≥35 kg.2

So, when would I use F/TAF over F/TDF? The DISCOVER trial further evaluated bone mineral density (BMD) and renal outcomes as secondary outcome measures in a subset of patients. There is some evidence from the DISCOVER clinical trial that extended out to 96 weeks that renal function does not decrease and is marginally better preserved with TAF-based PrEP compared with TDF-based PrEP. However, there is no statistically significant difference between the 2 formulations. So, it is not that renal function or glomerular filtration rates (GFRs) are worsened with the use of TDF but rather that kidney function appears to be preserved better with TAF.

A similar finding was demonstrated regarding BMD. Researchers found that in DISCOVER, there were fewer people who lost >3% of BMD at both the spine and the hip in the TAF treatment group. This BMD finding is probably much more concerning than the GFR, because as clinicians we can closely monitor renal function. Further, if monitoring GFR demonstrates complications, cessation of TDF commonly results in full recovery of renal function. Conversely, BMD is not something we can monitor on a regular basis. Some insurance companies do not approve dual energy x-ray absorptiometry (DXA) scans. As such, bone health is a serious concern even in healthy individuals receiving a TDF-containing regimen for a long enough time and in situations where TAF-based regimens may have clinical utility in preserving bone density.

Another significant advantage of a TAF-containing PrEP regimen, like Descovy, is that it can be used in adults with creatinine clearance <15 mL/min who are receiving chronic hemodialysis.3 This is significant because before this approval, there was no PrEP regimen for patients with creatinine clearance <15 mL/min receiving dialysis, which is a sizable population.

Once a patient is started on PrEP, the focus shifts to adherence to the regimen. All studies of PrEP have shown that adherence is important and that the individuals who do go on to develop HIV infection are commonly those who are non-adherent. In the United States, the approved PrEP regimen is a once-daily pill. It is vital for patients to know that if they want this medication to work and prevent HIV infection, they should be taking their medication every day. Like with any other medication that someone has to take daily, there is a possibility that people will simply forget to take it. There may also be the misconception that if one is not sexually active on given days, then it may be unnecessary to take the medication. What we do know is that TDF can take up to 7 days to reach therapeutic levels. If patients stop taking the medication, and the levels drop off — which happens much more rapidly with TDF than with TAF — then they will have to take it again continuously for a few days before the medication can reach therapeutic levels and thus be protective.

To simplify this information for presentation to patients, I like to show them a graph of how the level of the drug decreases in their blood. Visualization is important for patients and it is much easier for them to see how nonadherence for a certain number of days may affect their protection against HIV. I practice this technique in our clinic, and I believe it would be a worthwhile tactic for clinicians who may not frequently work with PrEP. Peaks, troughs, and steady states of drug levels can be a difficult concept to explain to patients, and a graph allows a clinician to say “look how long it takes for the drug to get to a certain level and then when you do not take it, this is what happens.”

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With regard to harms associated with PrEP regimens, most are small and gastrointestinal or renal in nature. We always counsel patients that there are short-term and long-term side effects when starting a medication. With PrEP, in the short term, these are usually gastrointestinal side effects (most commonly nausea). Gastrointestinal symptoms will resolve over approximately 10 days to 2 weeks. Some people may have diarrhea, but this is also likely to resolve. When presented in this way, most patients seem to be fine with the information regarding the short-term side effects. With regard to long-term side effects of PrEP, we advise patients that there is a small percentage of people who demonstrate PrEP-related negative effects on renal function. To this end, we monitor renal function every 3 months, and if we see any decrease in kidney function, the drug is discontinued.

Regarding clinical follow-up after PrEP is initiated, even with TAF-based PrEP regimens, the recommendation is to check renal function every 3 to 6 months. Every clinician should also check creatinine, creatinine clearance, and urine protein before initiation of PrEP. Clinicians should test HIV-1 infection status before PrEP initiation and then check serial HIV-1 infection status during follow-up, in addition to screening for other sexually transmitted infections, including chlamydia, syphilis, and gonorrhea.

Of note, one message I want to emphasize about HIV testing is that if at any time you are seeing a patient who presents with symptoms consistent with a viral syndrome (fever, rash, headache, myalgia), you need to check them for acute HIV infection, which means obtaining an HIV viral load.

References
1. Hare CB, Coll P, Ruane P, et al.The phase 3 Discover studyF/TAF or F/TDF for HIV. Presented at: Annual Conference on Retroviruses and Opportunistic Infections (CROI); March 4-7, 2019; Seattle, WA. Abstract 104.
2.  FDA approves second drug to prevent HIV infection as part of ongoing efforts to end the HIV epidemic [press release]. Silver Spring, MD: US Food and Drug Administration; October 3, 2019. Accessed February 25, 2020.
3. Descovy® [prescribing information]. Foster City, CA: Gilead Sciences, Inc; 2019. https://www.gilead.com/-/media/files/pdfs/medicines/hiv/descovy/descovy_pi.pdf. Revised December 2019. Accessed February 25, 2020.

SOURCE: Infectious Disease Advisor

 

 

Ensuring standards in poultry business

By Ikem Adimorah      

IN his inaugural speech as president, Muhammadu Buhari decried the level of youth unemployment, and likened it to sitting on a gun powder. On that auspicious occasion he promised that agriculture would be one of the major means by which his government would tackle the scourge of unemployment.

All over the world the livestock subsector of Agriculture has been one of the quickest ways of creating jobs especially poultry even in the developed world. Poultry has continued to attract investments due largely to the high returns on investments and the shortness of its gestation period. This is attributable to major improvements in management and control of diseases, especially in climes where regularly and operational frame-works are instituted and enforced to protect investors from unscrupulous gold-diggers.
Nigeria's poultry industry has a long history that predates the introduction of exotic breeds from Europe and America.

However, poultry production has witnessed a lot of growth from the subsistence level to the present commercial level of production.

From indications the country is far from reaching its potential in production. This is evident in the gap between the present actual production and the demand for poultry products in the country. The gap is so wide that even with the inherent health implication of consumption of imported poultry products, and its subsequent ban leading to higher demand for the locally produced products. The production level has remained low; not because Nigerians are not investing in the industry, but due to high mortality and mobility. Each year farms fold up and apparently new farms are opened. The vicious cycle continues. Most times it is blamed on lack of poultry management skills; others times on feed, drugs and technical skills.

Some of these factors include:
1. Lack of poultry hatchery regulation
2. Transportation of Day old chick policy and regulation
3. Regulation on the use of antibiotics in poultry. Etc.

All this is true but a critical look at the quality of day-old chicks available to farmers has persistently continued to be one of the major factors militating against the growth of the industry.

Experts are of the opinion that lack of proper regulatory farm-work in the industry has exposed it to the perennial problem that seemed intractable.

REGULATION OF HATCHERIES
It is evident that most of the day-old chicks which farmers receive into their farms today are infected with various infections like Sallmonellosis, Coccidiosis, Aspergillosis, and Ophallities. Others are prone to Spraddle leg due to fluctuation in temperature and humidity during incubation. Baby chicks overdosed with antibiotic resistant strains are very common. Others have low maternal immunity against diseases. In some hatcheries the parent stocks are not given the necessary vaccinations which can protect the chicks when they are hatched, thereby endangering the lives of the chickens even before the farmers receive them into their farms.


These are some of the problems facing farmers; leading to large mortalities usually witnessed by poultry farmers. Consequently serious financial losses have become synonymous with poultry farming. No wonder banks and other financial institutions find it very difficult to give credit facilities to poultry farmers.


Poultry farming consequently is becoming unattractive as the needed funds are not readily available. More so, poultry is a capital intensive venture if one is to be involved at a commercial level.

It is therefore necessary that a policy frame-work for the production of healthy and viable chicks is put in place. Hatchery business is a highly technical field that requires close monitoring so as to protect the investing public from unnecessary losses due to unprofessional activity of some gold-diggers who by chance find their way into the business only to end-up frustrating the efforts and funds of the investing public.

A great number of day-old birds supplied to the poultry farmers in Nigeria today are produced by the back-yard hatcheries where most unethical practices are common. The activities of these quacks are buoyed by the practice of hatching by major hatcheries at particular days of the week. Buyers gather also at the same time to buy. The rush enhances easy smuggling of the defective baby birds into the market. They sometimes produce cartoons of well established brands, to sell to unsuspecting customers.
The absence of a clear policy frame-work and adequate enforcement of standard have seemingly enshrouded poultry business in the country.

Success is almost unpredictable even from the same source. Majority of the remaining stake-holders are operating under very tight economic conditions such that a little mistake often leads to monumental losses.
It is therefore very important to call on the authorities concerned to ensure strict enforcement of regulations and standards to save the poultry industry. The government should be proactive in sourcing for special intervention funds for the hatcheries and also ensure that the rules are enforced to save poultry farmers and the investing public.

 

TRANSPORTATION OF DAY OLD CHICKS
In the last three decades or more, most of the baby chicks are transported from the hatchery locations to the farm sites across the nation by road in commercial vehicles. Where the farms are collecting long quantities they hire or use their farm vehicles. Over 80 percent of chicks that get to farms are transported by general commercial trucks which also collect from different hatcheries for different farmers or the same farmer.

These chicks hatched from different hatcheries are yoked together in the same vehicle for a number of hours depending on the distance from the hatchery to the farms.

This apparently is aimed at reducing the cost of transportation but the greater harm which the chicks and the farmer eventually encounter is often great, because of cross infections.

The pathogen free chicks from the reputable hatchery are often contaminated before the farmer receives the chicks into the farm. Ophallities, pullorum disease, Coccidiosis, Aspergillosis, collibaccillosis are introduced and in most cases the causative agents are resistant to most common antibiotics available. The farmer in a bid to save his investments often resort to using more antibiotics than usual which eventually find its way into the human food chain according to research.

It is important hatcheries ensure that their chicks are not contaminated in the process of transportation before they are delivered to the farmer as this may be considered as added value to the farmers.

The government on its own should encourage investors to establish more hatcheries to reduce the risk of long distant movements. This may reduce cross infections through mix-up of chicks from different hatcheries. This can be considered a short term measure while the long term measure should involve policies and enforcement of rules and standards.
* Ikem Adimorah is a veterinary medical practitioner in Asaba, Delta State capital.

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