What to do when a patient is not ready to stop smoking

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Thu, 09/24/2020 - 14:10

Recommendations from the American Thoracic Society

Below is a case involving a patient who is not yet ready to quit smoking. We later provide treatment recommendations for this patient based on a new guideline from the American Thoracic Society.

Case

Dr. Anne Sprogell and Dr. Neil Skolnik of Abington (Pa.) Hospital-Jefferson Health
Dr. Anne Sprogell and Dr. Neil Skolnik

A 58-year-old female comes into the office for a physical exam. She has been smoking two packs a day since she was 23 years of age. You have tried at previous visits to get her to quit, but she hasn’t been interested. The patient says she has a lot of stress, and that it is still not the right time for her to stop smoking. You tell her she needs to quit and, though the patient understands that quitting would be beneficial for her health, she just isn’t ready to try to kick the habit. How do you proceed?

The Guideline in context

Even though this patient stated that she is not ready to stop smoking, she is still a candidate for pharmacological treatment for her tobacco dependence and can be offered varenicline, according to the ATS guideline.1

It is imperative that tobacco cessation is addressed with patients in the most effective and comprehensive ways possible. In a previously published column, we have discussed the ATS’ recommended approaches for treating patients who are ready to stop smoking cigarettes. The reality is that many patients, if not most, are not ready to quit when we speak to them during any given office visit. The ATS guideline addresses this critical issue by recommending treatment with varenicline in patients who are not ready to stop smoking. It also states that this is a better strategy than waiting to start treatment until patients say they are ready for it.

This recommendation – to prescribe varenicline to smokers even when they are not ready to quit smoking – is based on solid clinical trial evidence. Research has shown that behavior change is dynamic and that the decision to stop smoking is not always a planned one.1 Patients often make quit attempts between office visits, and are often successful in those attempts. Because the decision to try to stop smoking is influenced by the satisfaction and physical addiction that comes from smoking, a medication such as varenicline that is a partial agonist/antagonist at the alpha4-beta2 nicotinic receptor might increase the likelihood that a patient would decide to try to stop smoking. This is because taking this type of a drug would lead the patient to no longer experience the reinforcing effects of nicotine.2 This hypothesis was examined in five randomized trials.1

In these studies, regular smokers who were not ready to make a quit attempt were randomized to varenicline versus placebo. Twice as many individuals who took varenicline stopped smoking 6 months after starting treatment.1

Suggested treatment

This patient should be offered varenicline. This individual meets the criteria for this treatment according to the ATS guideline in that the patient is a regular smoker who doesn’t think she is ready to stop smoking but understands she needs to stop and is open to taking medication to assist her with quitting.

Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Hospital–Jefferson Health. Dr. Sprogell is a third-year resident in the family medicine residency program at Abington Jefferson Health. They have no conflicts related to the content of this piece. For questions or comments, feel free to contact Dr. Skolnik on Twitter @NeilSkolnik.

References

1. Leone F T et al. Initiating pharmacologic treatment in tobacco-dependent adults: An official American Thoracic Society Clinical Practice Guideline. Am J Respir Crit Care Med. 2020 Jul 15;202(2):e5–e31.

2. Ebbert JO et al. Varenicline for smoking cessation: Efficacy, safety, and treatment recommendations. Patient Prefer Adherence. 2010;4:355-62.
 

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Recommendations from the American Thoracic Society

Below is a case involving a patient who is not yet ready to quit smoking. We later provide treatment recommendations for this patient based on a new guideline from the American Thoracic Society.

Case

Dr. Anne Sprogell and Dr. Neil Skolnik of Abington (Pa.) Hospital-Jefferson Health
Dr. Anne Sprogell and Dr. Neil Skolnik

A 58-year-old female comes into the office for a physical exam. She has been smoking two packs a day since she was 23 years of age. You have tried at previous visits to get her to quit, but she hasn’t been interested. The patient says she has a lot of stress, and that it is still not the right time for her to stop smoking. You tell her she needs to quit and, though the patient understands that quitting would be beneficial for her health, she just isn’t ready to try to kick the habit. How do you proceed?

The Guideline in context

Even though this patient stated that she is not ready to stop smoking, she is still a candidate for pharmacological treatment for her tobacco dependence and can be offered varenicline, according to the ATS guideline.1

It is imperative that tobacco cessation is addressed with patients in the most effective and comprehensive ways possible. In a previously published column, we have discussed the ATS’ recommended approaches for treating patients who are ready to stop smoking cigarettes. The reality is that many patients, if not most, are not ready to quit when we speak to them during any given office visit. The ATS guideline addresses this critical issue by recommending treatment with varenicline in patients who are not ready to stop smoking. It also states that this is a better strategy than waiting to start treatment until patients say they are ready for it.

This recommendation – to prescribe varenicline to smokers even when they are not ready to quit smoking – is based on solid clinical trial evidence. Research has shown that behavior change is dynamic and that the decision to stop smoking is not always a planned one.1 Patients often make quit attempts between office visits, and are often successful in those attempts. Because the decision to try to stop smoking is influenced by the satisfaction and physical addiction that comes from smoking, a medication such as varenicline that is a partial agonist/antagonist at the alpha4-beta2 nicotinic receptor might increase the likelihood that a patient would decide to try to stop smoking. This is because taking this type of a drug would lead the patient to no longer experience the reinforcing effects of nicotine.2 This hypothesis was examined in five randomized trials.1

In these studies, regular smokers who were not ready to make a quit attempt were randomized to varenicline versus placebo. Twice as many individuals who took varenicline stopped smoking 6 months after starting treatment.1

Suggested treatment

This patient should be offered varenicline. This individual meets the criteria for this treatment according to the ATS guideline in that the patient is a regular smoker who doesn’t think she is ready to stop smoking but understands she needs to stop and is open to taking medication to assist her with quitting.

Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Hospital–Jefferson Health. Dr. Sprogell is a third-year resident in the family medicine residency program at Abington Jefferson Health. They have no conflicts related to the content of this piece. For questions or comments, feel free to contact Dr. Skolnik on Twitter @NeilSkolnik.

References

1. Leone F T et al. Initiating pharmacologic treatment in tobacco-dependent adults: An official American Thoracic Society Clinical Practice Guideline. Am J Respir Crit Care Med. 2020 Jul 15;202(2):e5–e31.

2. Ebbert JO et al. Varenicline for smoking cessation: Efficacy, safety, and treatment recommendations. Patient Prefer Adherence. 2010;4:355-62.
 

Below is a case involving a patient who is not yet ready to quit smoking. We later provide treatment recommendations for this patient based on a new guideline from the American Thoracic Society.

Case

Dr. Anne Sprogell and Dr. Neil Skolnik of Abington (Pa.) Hospital-Jefferson Health
Dr. Anne Sprogell and Dr. Neil Skolnik

A 58-year-old female comes into the office for a physical exam. She has been smoking two packs a day since she was 23 years of age. You have tried at previous visits to get her to quit, but she hasn’t been interested. The patient says she has a lot of stress, and that it is still not the right time for her to stop smoking. You tell her she needs to quit and, though the patient understands that quitting would be beneficial for her health, she just isn’t ready to try to kick the habit. How do you proceed?

The Guideline in context

Even though this patient stated that she is not ready to stop smoking, she is still a candidate for pharmacological treatment for her tobacco dependence and can be offered varenicline, according to the ATS guideline.1

It is imperative that tobacco cessation is addressed with patients in the most effective and comprehensive ways possible. In a previously published column, we have discussed the ATS’ recommended approaches for treating patients who are ready to stop smoking cigarettes. The reality is that many patients, if not most, are not ready to quit when we speak to them during any given office visit. The ATS guideline addresses this critical issue by recommending treatment with varenicline in patients who are not ready to stop smoking. It also states that this is a better strategy than waiting to start treatment until patients say they are ready for it.

This recommendation – to prescribe varenicline to smokers even when they are not ready to quit smoking – is based on solid clinical trial evidence. Research has shown that behavior change is dynamic and that the decision to stop smoking is not always a planned one.1 Patients often make quit attempts between office visits, and are often successful in those attempts. Because the decision to try to stop smoking is influenced by the satisfaction and physical addiction that comes from smoking, a medication such as varenicline that is a partial agonist/antagonist at the alpha4-beta2 nicotinic receptor might increase the likelihood that a patient would decide to try to stop smoking. This is because taking this type of a drug would lead the patient to no longer experience the reinforcing effects of nicotine.2 This hypothesis was examined in five randomized trials.1

In these studies, regular smokers who were not ready to make a quit attempt were randomized to varenicline versus placebo. Twice as many individuals who took varenicline stopped smoking 6 months after starting treatment.1

Suggested treatment

This patient should be offered varenicline. This individual meets the criteria for this treatment according to the ATS guideline in that the patient is a regular smoker who doesn’t think she is ready to stop smoking but understands she needs to stop and is open to taking medication to assist her with quitting.

Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Hospital–Jefferson Health. Dr. Sprogell is a third-year resident in the family medicine residency program at Abington Jefferson Health. They have no conflicts related to the content of this piece. For questions or comments, feel free to contact Dr. Skolnik on Twitter @NeilSkolnik.

References

1. Leone F T et al. Initiating pharmacologic treatment in tobacco-dependent adults: An official American Thoracic Society Clinical Practice Guideline. Am J Respir Crit Care Med. 2020 Jul 15;202(2):e5–e31.

2. Ebbert JO et al. Varenicline for smoking cessation: Efficacy, safety, and treatment recommendations. Patient Prefer Adherence. 2010;4:355-62.
 

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Treatment for a tobacco-dependent adult

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Changed
Thu, 08/20/2020 - 15:48

Applying American Thoracic Society’s new clinical practice guideline

Complications from tobacco use are the most common preventable cause of death, disability, and disease in the United States. Tobacco use causes 480,000 premature deaths every year. In pregnancy, tobacco use causes complications such as premature birth, intrauterine growth restriction, and placental abruption. In the perinatal period, it is associated with sudden infant death syndrome. While cigarette smoking is decreasing in adolescents, e-cigarette use in on the rise. Approximately 1,600 children aged 12-17 smoke their first cigarette every day and it is estimated that 5.6 million children and adolescents will die of a tobacco use–related death.1 For these reasons it is important to address tobacco use and cessation with patients whenever it is possible. Below is a case and recommendations related to a new American Thoracic Society guideline on initiating pharmacologic treatment in tobacco-dependent adults.

Dr. Anne Sprogell and Dr. Neil Skolnik of Abington (Pa.) Hospital-Jefferson Health
Dr. Anne Sprogell and Dr. Neil Skolnik


Case

A forty-five-year-old male who rarely comes to the office is here today for a physical exam at the urging of his partner. He has been smoking a pack a day since age 17. You have tried at past visits to discuss quitting, but he had been in the precontemplative stage and had been unwilling to consider any change. This visit, however, he is ready to try to quit. What can you offer him?

Core recommendations from ATS guidelines

This patient can be offered varenicline plus nicotine replacement therapy rather than nicotine replacement therapy, bupropion, e-cigarettes, or varenicline alone. His course of therapy should extend beyond 12 weeks instead of the standard 6- to 12-week therapy. Alternatively, he could be offered varenicline alone, rather than nicotine replacement.2


A change from previous guidelines

What makes this recommendation so interesting and new is the emphasis it places on varenicline. The United States Preventive Services Task Force released a recommendation statement in 2015 that stressed a combination of pharmacological and behavioral interventions. It discussed nicotine replacement therapy, bupropion, and varenicline, but did not recommend any one over any of the others.3 The new recommendation from the American Thoracic Society favors varenicline over other pharmacologic interventions. It is based on an independent systematic review of the literature that showed higher rates of tobacco use abstinence at the 6-month follow-up with varenicline alone versus nicotine replacement therapy alone, bupropion alone, or e-cigarette use only.

A review of 14 randomized controlled trials showed that varenicline improves abstinence rates during treatment by approximately 40% compared with nicotine replacement, and by 20% at the end of 6 months of treatment. The review found that varenicline plus nicotine replacement therapy is more effective than varenicline alone. In this comparison, based on three trials, there was a 36% higher abstinence rate at 6 months using varenicline plus nicotine replacement. When varenicline use was compared with use of a nicotine patch, bupropion, or e-cigarettes, there was a reduction in serious adverse events – changes in mood, suicidal ideation, and neurological side effects such as seizures.2 Clinicians may remember a black box warning on the varenicline label citing neuropsychiatric effects and it is important to note that the Food and Drug Administration removed this boxed warning in 2016.4

 

 



Opinion

This recommendation represents an important, evidence-based change from previous guidelines. It presents the opportunity for better outcomes, but will likely take a while to filter into practice, as clinicians need to become more comfortable with the use of varenicline and insurance supports the cost of varenicline.

The average cost of varenicline for 12 weeks is between $1,220 and $1,584. For comparison, nicotine replacement therapy costs $170 to $240 for the same number of weeks. To put those costs in perspective, the 12-week cost of cigarettes for a two-pack-a-day smoker is approximately $1,000.

For some patients, the motivation to quit smoking comes from the realization of how much they are spending on cigarettes each month. That said, if a patient does not have insurance or their insurance does not cover the cost of varenicline, nicotine replacement therapy might be more appealing. It should be noted that better abstinence rates have been seen in patients taking varenicline plus nicotine replacement therapy versus varenicline alone.



Suggested treatment

Based on a systematic review of randomized controlled trials, the American Thoracic Society’s guideline on pharmacological treatment in tobacco-dependent adults concludes that varenicline plus nicotine patch is the preferred pharmacological treatment for tobacco cessation when compared with varenicline alone, bupropion alone, nicotine replacement therapy alone, and e-cigarettes alone. If the patient does not want to start two medicines at once, then varenicline alone would be the preferred choice.

Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Hospital–Jefferson Health. Dr. Sprogell is a third-year resident in the family medicine residency program at Abington Jefferson Health. They have no conflicts related to the content of this piece. For questions or comments, feel free to contact Dr. Skolnik on Twitter @NeilSkolnik.

References

1. U.S. Preventive Services Task Force. Primary care interventions for prevention and cessation of tobacco use in children and adolescents: U.S. Preventive Services Task Force Recommendation Statement. JAMA.2020;323(16):1590-8. doi: 10.1001/jama.2020.4679.

2. Leone FT et al. Initiating pharmacologic treatment in tobacco-dependent adults: An official American Thoracic Society Clinical Practice Guideline. Am J Respir Crit Care Med. 2020;202(2):e5–e31.

3. Tobacco smoking cessation in adults, including pregnant women: Behavioral and pharmacotherapy interventions. U.S. Preventive Services Task Force 2015 Sep 21.

4. FDA Drug Safety Communication: FDA revises description of mental health side effects of the stop-smoking medicines Chantix (varenicline) and Zyban (bupropion) to reflect clinical trial findings. 2016 Dec. 16.

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Applying American Thoracic Society’s new clinical practice guideline

Applying American Thoracic Society’s new clinical practice guideline

Complications from tobacco use are the most common preventable cause of death, disability, and disease in the United States. Tobacco use causes 480,000 premature deaths every year. In pregnancy, tobacco use causes complications such as premature birth, intrauterine growth restriction, and placental abruption. In the perinatal period, it is associated with sudden infant death syndrome. While cigarette smoking is decreasing in adolescents, e-cigarette use in on the rise. Approximately 1,600 children aged 12-17 smoke their first cigarette every day and it is estimated that 5.6 million children and adolescents will die of a tobacco use–related death.1 For these reasons it is important to address tobacco use and cessation with patients whenever it is possible. Below is a case and recommendations related to a new American Thoracic Society guideline on initiating pharmacologic treatment in tobacco-dependent adults.

Dr. Anne Sprogell and Dr. Neil Skolnik of Abington (Pa.) Hospital-Jefferson Health
Dr. Anne Sprogell and Dr. Neil Skolnik


Case

A forty-five-year-old male who rarely comes to the office is here today for a physical exam at the urging of his partner. He has been smoking a pack a day since age 17. You have tried at past visits to discuss quitting, but he had been in the precontemplative stage and had been unwilling to consider any change. This visit, however, he is ready to try to quit. What can you offer him?

Core recommendations from ATS guidelines

This patient can be offered varenicline plus nicotine replacement therapy rather than nicotine replacement therapy, bupropion, e-cigarettes, or varenicline alone. His course of therapy should extend beyond 12 weeks instead of the standard 6- to 12-week therapy. Alternatively, he could be offered varenicline alone, rather than nicotine replacement.2


A change from previous guidelines

What makes this recommendation so interesting and new is the emphasis it places on varenicline. The United States Preventive Services Task Force released a recommendation statement in 2015 that stressed a combination of pharmacological and behavioral interventions. It discussed nicotine replacement therapy, bupropion, and varenicline, but did not recommend any one over any of the others.3 The new recommendation from the American Thoracic Society favors varenicline over other pharmacologic interventions. It is based on an independent systematic review of the literature that showed higher rates of tobacco use abstinence at the 6-month follow-up with varenicline alone versus nicotine replacement therapy alone, bupropion alone, or e-cigarette use only.

A review of 14 randomized controlled trials showed that varenicline improves abstinence rates during treatment by approximately 40% compared with nicotine replacement, and by 20% at the end of 6 months of treatment. The review found that varenicline plus nicotine replacement therapy is more effective than varenicline alone. In this comparison, based on three trials, there was a 36% higher abstinence rate at 6 months using varenicline plus nicotine replacement. When varenicline use was compared with use of a nicotine patch, bupropion, or e-cigarettes, there was a reduction in serious adverse events – changes in mood, suicidal ideation, and neurological side effects such as seizures.2 Clinicians may remember a black box warning on the varenicline label citing neuropsychiatric effects and it is important to note that the Food and Drug Administration removed this boxed warning in 2016.4

 

 



Opinion

This recommendation represents an important, evidence-based change from previous guidelines. It presents the opportunity for better outcomes, but will likely take a while to filter into practice, as clinicians need to become more comfortable with the use of varenicline and insurance supports the cost of varenicline.

The average cost of varenicline for 12 weeks is between $1,220 and $1,584. For comparison, nicotine replacement therapy costs $170 to $240 for the same number of weeks. To put those costs in perspective, the 12-week cost of cigarettes for a two-pack-a-day smoker is approximately $1,000.

For some patients, the motivation to quit smoking comes from the realization of how much they are spending on cigarettes each month. That said, if a patient does not have insurance or their insurance does not cover the cost of varenicline, nicotine replacement therapy might be more appealing. It should be noted that better abstinence rates have been seen in patients taking varenicline plus nicotine replacement therapy versus varenicline alone.



Suggested treatment

Based on a systematic review of randomized controlled trials, the American Thoracic Society’s guideline on pharmacological treatment in tobacco-dependent adults concludes that varenicline plus nicotine patch is the preferred pharmacological treatment for tobacco cessation when compared with varenicline alone, bupropion alone, nicotine replacement therapy alone, and e-cigarettes alone. If the patient does not want to start two medicines at once, then varenicline alone would be the preferred choice.

Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Hospital–Jefferson Health. Dr. Sprogell is a third-year resident in the family medicine residency program at Abington Jefferson Health. They have no conflicts related to the content of this piece. For questions or comments, feel free to contact Dr. Skolnik on Twitter @NeilSkolnik.

References

1. U.S. Preventive Services Task Force. Primary care interventions for prevention and cessation of tobacco use in children and adolescents: U.S. Preventive Services Task Force Recommendation Statement. JAMA.2020;323(16):1590-8. doi: 10.1001/jama.2020.4679.

2. Leone FT et al. Initiating pharmacologic treatment in tobacco-dependent adults: An official American Thoracic Society Clinical Practice Guideline. Am J Respir Crit Care Med. 2020;202(2):e5–e31.

3. Tobacco smoking cessation in adults, including pregnant women: Behavioral and pharmacotherapy interventions. U.S. Preventive Services Task Force 2015 Sep 21.

4. FDA Drug Safety Communication: FDA revises description of mental health side effects of the stop-smoking medicines Chantix (varenicline) and Zyban (bupropion) to reflect clinical trial findings. 2016 Dec. 16.

Complications from tobacco use are the most common preventable cause of death, disability, and disease in the United States. Tobacco use causes 480,000 premature deaths every year. In pregnancy, tobacco use causes complications such as premature birth, intrauterine growth restriction, and placental abruption. In the perinatal period, it is associated with sudden infant death syndrome. While cigarette smoking is decreasing in adolescents, e-cigarette use in on the rise. Approximately 1,600 children aged 12-17 smoke their first cigarette every day and it is estimated that 5.6 million children and adolescents will die of a tobacco use–related death.1 For these reasons it is important to address tobacco use and cessation with patients whenever it is possible. Below is a case and recommendations related to a new American Thoracic Society guideline on initiating pharmacologic treatment in tobacco-dependent adults.

Dr. Anne Sprogell and Dr. Neil Skolnik of Abington (Pa.) Hospital-Jefferson Health
Dr. Anne Sprogell and Dr. Neil Skolnik


Case

A forty-five-year-old male who rarely comes to the office is here today for a physical exam at the urging of his partner. He has been smoking a pack a day since age 17. You have tried at past visits to discuss quitting, but he had been in the precontemplative stage and had been unwilling to consider any change. This visit, however, he is ready to try to quit. What can you offer him?

Core recommendations from ATS guidelines

This patient can be offered varenicline plus nicotine replacement therapy rather than nicotine replacement therapy, bupropion, e-cigarettes, or varenicline alone. His course of therapy should extend beyond 12 weeks instead of the standard 6- to 12-week therapy. Alternatively, he could be offered varenicline alone, rather than nicotine replacement.2


A change from previous guidelines

What makes this recommendation so interesting and new is the emphasis it places on varenicline. The United States Preventive Services Task Force released a recommendation statement in 2015 that stressed a combination of pharmacological and behavioral interventions. It discussed nicotine replacement therapy, bupropion, and varenicline, but did not recommend any one over any of the others.3 The new recommendation from the American Thoracic Society favors varenicline over other pharmacologic interventions. It is based on an independent systematic review of the literature that showed higher rates of tobacco use abstinence at the 6-month follow-up with varenicline alone versus nicotine replacement therapy alone, bupropion alone, or e-cigarette use only.

A review of 14 randomized controlled trials showed that varenicline improves abstinence rates during treatment by approximately 40% compared with nicotine replacement, and by 20% at the end of 6 months of treatment. The review found that varenicline plus nicotine replacement therapy is more effective than varenicline alone. In this comparison, based on three trials, there was a 36% higher abstinence rate at 6 months using varenicline plus nicotine replacement. When varenicline use was compared with use of a nicotine patch, bupropion, or e-cigarettes, there was a reduction in serious adverse events – changes in mood, suicidal ideation, and neurological side effects such as seizures.2 Clinicians may remember a black box warning on the varenicline label citing neuropsychiatric effects and it is important to note that the Food and Drug Administration removed this boxed warning in 2016.4

 

 



Opinion

This recommendation represents an important, evidence-based change from previous guidelines. It presents the opportunity for better outcomes, but will likely take a while to filter into practice, as clinicians need to become more comfortable with the use of varenicline and insurance supports the cost of varenicline.

The average cost of varenicline for 12 weeks is between $1,220 and $1,584. For comparison, nicotine replacement therapy costs $170 to $240 for the same number of weeks. To put those costs in perspective, the 12-week cost of cigarettes for a two-pack-a-day smoker is approximately $1,000.

For some patients, the motivation to quit smoking comes from the realization of how much they are spending on cigarettes each month. That said, if a patient does not have insurance or their insurance does not cover the cost of varenicline, nicotine replacement therapy might be more appealing. It should be noted that better abstinence rates have been seen in patients taking varenicline plus nicotine replacement therapy versus varenicline alone.



Suggested treatment

Based on a systematic review of randomized controlled trials, the American Thoracic Society’s guideline on pharmacological treatment in tobacco-dependent adults concludes that varenicline plus nicotine patch is the preferred pharmacological treatment for tobacco cessation when compared with varenicline alone, bupropion alone, nicotine replacement therapy alone, and e-cigarettes alone. If the patient does not want to start two medicines at once, then varenicline alone would be the preferred choice.

Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Hospital–Jefferson Health. Dr. Sprogell is a third-year resident in the family medicine residency program at Abington Jefferson Health. They have no conflicts related to the content of this piece. For questions or comments, feel free to contact Dr. Skolnik on Twitter @NeilSkolnik.

References

1. U.S. Preventive Services Task Force. Primary care interventions for prevention and cessation of tobacco use in children and adolescents: U.S. Preventive Services Task Force Recommendation Statement. JAMA.2020;323(16):1590-8. doi: 10.1001/jama.2020.4679.

2. Leone FT et al. Initiating pharmacologic treatment in tobacco-dependent adults: An official American Thoracic Society Clinical Practice Guideline. Am J Respir Crit Care Med. 2020;202(2):e5–e31.

3. Tobacco smoking cessation in adults, including pregnant women: Behavioral and pharmacotherapy interventions. U.S. Preventive Services Task Force 2015 Sep 21.

4. FDA Drug Safety Communication: FDA revises description of mental health side effects of the stop-smoking medicines Chantix (varenicline) and Zyban (bupropion) to reflect clinical trial findings. 2016 Dec. 16.

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USPSTF recommendations on screening for abdominal aortic aneurysm

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Changed
Wed, 01/22/2020 - 13:24

The prevalence of abdominal aortic aneurysms (AAAs) is decreasing, thought to be caused by a decrease in smoking. But the risk of death if one ruptures is as high as 81%. So, screening is still an important part of preventive medicine.

Dr. Anne Sprogell and Dr. Neil Skolnik of Abington (Pa.) Hospital-Jefferson Health
Dr. Anne Sprogell and Dr. Neil Skolnik

When the abdominal aorta enlarges to greater than 3.0 cm, it is considered an aneurysm. Risk factors that can lead to an enlarged aorta include older age, male sex, smoking, history of AAA in a first-degree relative, hypertension, history of other aneurysms, coronary artery disease, cerebrovascular disease, atherosclerosis, and hypercholesterolemia.

History of AAA in a first-degree relative puts patients at double the risk of developing an abdominal aortic aneurysm. Interestingly, diabetes has been associated with a reduced risk of AAA. People of African American, Asian, and Hispanic descent have a reduced risk of AAA.
 

Screening

Screening is performed using abdominal duplex ultrasound. It has high sensitivity (94%-100%) and specificity (98%-100%), is low cost, and has low risk to the patient. The U.S. Preventive Services Task Force breaks its screening recommendations into four categories:

1. Men aged 65-75 years who have ever smoked (at least 100 cigarettes in their lifetime): One-time screening (grade B, moderate net benefit).

2. Men aged 65-75 years who have never smoked: Selectively offer screening (grade C, small net benefit). “To determine whether this service is appropriate, patients and clinicians should consider the patient’s medical history, family history, other risk factors, and personal values.”

3. Women without a smoking history or family history of AAA: Do not perform screening (grade D, recommendation against the service).

4. Women aged 65-75 years who have a smoking history or family history of AAA: There is insufficient evidence on whether or not to screen for AAA (grade I, insufficient evidence).

To assess screening and treatment of AAAs, the USPSTF looked at four randomized, controlled trials largely focused on men older than 65 years. With the combined data, they found 246 men would need to be screened to prevent 1 AAA rupture, and 305 men would need to be screened to prevent 1 death from AAA.

The USPSTF does note that, while the risk of death is lower for elective AAA repair than ruptured AAA, there is still increased risk with elective surgery. In addition, increased screening and detection increases the rate of elective surgery. Overdiagnosis and overtreatment could represent a harm.
 

Treatment

Surgical repair of AAA in men depends on the size of the aneurysm and rate of growth.

For men, surgical repair is standard when the AAA reaches 5.5 cm or if the AAA is growing faster than 1.0 cm per year and is larger than 4.0 cm. For women, surgical repair is often recommended between 5.0 cm and 5.4 cm in size.

Surgical repair is not recommended for AAAs that are less than 5.0 cm because the annual risk of rupture is 0%-1% below 5.0 cm. The risk increases to 11% for aneurysms that are 5.0-5.9 cm in size.

There are two methods of surgical repair: endovascular aneurysm repair and open repair. Recommendations for the surveillance of AAA between 3.0 cm and 5.5 cm is regular ultrasound surveillance, with the interval becoming shorter as the aneurysm size becomes larger. Exact intervals differ from one guideline group to another.
 

 

 

Screening and treatment in women

While it is true that AAAs in women are more likely to rupture at smaller sizes than AAAs in men, the AAAs that rupture in women are more likely to rupture at an older age than AAAs rupture in men.

The prevalence of AAAs in women is thought to be one-sixth of the prevalence of men. In addition, women had a higher 30-day mortality after surgical repair. They also had higher rates of complications for elective surgical repair of AAAs.

For these reasons, it is unclear that the benefits of AAA screening and treatment in women outweigh the risks, and the USPSTF cannot come to a conclusive recommendation for women who have ever smoked or women who have a family history of AAA.

The USPSTF is able to state definitively that they do not recommend screening in women with no smoking history or family history of AAA.
 

Bottom line

The USPSTF recommends screening men aged 65-75 years who have ever smoked and selectively screening men aged 65-75 years with no smoking history. The USPSTF recommends against screening women aged 65-75 years who have never smoked and have no family history of AAA. There is insufficient evidence to either recommend for or against screening women aged 65-75 years who have smoked or have a family history of AAA.

Reference

Owens DK et al. Screening for abdominal aortic aneurysm: U.S. Preventive Services Task Force Recommendation Statement. JAMA. 2019 Dec 10;322(22):2211-18.

Dr. Sprogell is a second-year resident in the family medicine residency program at Abington (Pa.) Hospital–Jefferson Health. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health.

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The prevalence of abdominal aortic aneurysms (AAAs) is decreasing, thought to be caused by a decrease in smoking. But the risk of death if one ruptures is as high as 81%. So, screening is still an important part of preventive medicine.

Dr. Anne Sprogell and Dr. Neil Skolnik of Abington (Pa.) Hospital-Jefferson Health
Dr. Anne Sprogell and Dr. Neil Skolnik

When the abdominal aorta enlarges to greater than 3.0 cm, it is considered an aneurysm. Risk factors that can lead to an enlarged aorta include older age, male sex, smoking, history of AAA in a first-degree relative, hypertension, history of other aneurysms, coronary artery disease, cerebrovascular disease, atherosclerosis, and hypercholesterolemia.

History of AAA in a first-degree relative puts patients at double the risk of developing an abdominal aortic aneurysm. Interestingly, diabetes has been associated with a reduced risk of AAA. People of African American, Asian, and Hispanic descent have a reduced risk of AAA.
 

Screening

Screening is performed using abdominal duplex ultrasound. It has high sensitivity (94%-100%) and specificity (98%-100%), is low cost, and has low risk to the patient. The U.S. Preventive Services Task Force breaks its screening recommendations into four categories:

1. Men aged 65-75 years who have ever smoked (at least 100 cigarettes in their lifetime): One-time screening (grade B, moderate net benefit).

2. Men aged 65-75 years who have never smoked: Selectively offer screening (grade C, small net benefit). “To determine whether this service is appropriate, patients and clinicians should consider the patient’s medical history, family history, other risk factors, and personal values.”

3. Women without a smoking history or family history of AAA: Do not perform screening (grade D, recommendation against the service).

4. Women aged 65-75 years who have a smoking history or family history of AAA: There is insufficient evidence on whether or not to screen for AAA (grade I, insufficient evidence).

To assess screening and treatment of AAAs, the USPSTF looked at four randomized, controlled trials largely focused on men older than 65 years. With the combined data, they found 246 men would need to be screened to prevent 1 AAA rupture, and 305 men would need to be screened to prevent 1 death from AAA.

The USPSTF does note that, while the risk of death is lower for elective AAA repair than ruptured AAA, there is still increased risk with elective surgery. In addition, increased screening and detection increases the rate of elective surgery. Overdiagnosis and overtreatment could represent a harm.
 

Treatment

Surgical repair of AAA in men depends on the size of the aneurysm and rate of growth.

For men, surgical repair is standard when the AAA reaches 5.5 cm or if the AAA is growing faster than 1.0 cm per year and is larger than 4.0 cm. For women, surgical repair is often recommended between 5.0 cm and 5.4 cm in size.

Surgical repair is not recommended for AAAs that are less than 5.0 cm because the annual risk of rupture is 0%-1% below 5.0 cm. The risk increases to 11% for aneurysms that are 5.0-5.9 cm in size.

There are two methods of surgical repair: endovascular aneurysm repair and open repair. Recommendations for the surveillance of AAA between 3.0 cm and 5.5 cm is regular ultrasound surveillance, with the interval becoming shorter as the aneurysm size becomes larger. Exact intervals differ from one guideline group to another.
 

 

 

Screening and treatment in women

While it is true that AAAs in women are more likely to rupture at smaller sizes than AAAs in men, the AAAs that rupture in women are more likely to rupture at an older age than AAAs rupture in men.

The prevalence of AAAs in women is thought to be one-sixth of the prevalence of men. In addition, women had a higher 30-day mortality after surgical repair. They also had higher rates of complications for elective surgical repair of AAAs.

For these reasons, it is unclear that the benefits of AAA screening and treatment in women outweigh the risks, and the USPSTF cannot come to a conclusive recommendation for women who have ever smoked or women who have a family history of AAA.

The USPSTF is able to state definitively that they do not recommend screening in women with no smoking history or family history of AAA.
 

Bottom line

The USPSTF recommends screening men aged 65-75 years who have ever smoked and selectively screening men aged 65-75 years with no smoking history. The USPSTF recommends against screening women aged 65-75 years who have never smoked and have no family history of AAA. There is insufficient evidence to either recommend for or against screening women aged 65-75 years who have smoked or have a family history of AAA.

Reference

Owens DK et al. Screening for abdominal aortic aneurysm: U.S. Preventive Services Task Force Recommendation Statement. JAMA. 2019 Dec 10;322(22):2211-18.

Dr. Sprogell is a second-year resident in the family medicine residency program at Abington (Pa.) Hospital–Jefferson Health. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health.

The prevalence of abdominal aortic aneurysms (AAAs) is decreasing, thought to be caused by a decrease in smoking. But the risk of death if one ruptures is as high as 81%. So, screening is still an important part of preventive medicine.

Dr. Anne Sprogell and Dr. Neil Skolnik of Abington (Pa.) Hospital-Jefferson Health
Dr. Anne Sprogell and Dr. Neil Skolnik

When the abdominal aorta enlarges to greater than 3.0 cm, it is considered an aneurysm. Risk factors that can lead to an enlarged aorta include older age, male sex, smoking, history of AAA in a first-degree relative, hypertension, history of other aneurysms, coronary artery disease, cerebrovascular disease, atherosclerosis, and hypercholesterolemia.

History of AAA in a first-degree relative puts patients at double the risk of developing an abdominal aortic aneurysm. Interestingly, diabetes has been associated with a reduced risk of AAA. People of African American, Asian, and Hispanic descent have a reduced risk of AAA.
 

Screening

Screening is performed using abdominal duplex ultrasound. It has high sensitivity (94%-100%) and specificity (98%-100%), is low cost, and has low risk to the patient. The U.S. Preventive Services Task Force breaks its screening recommendations into four categories:

1. Men aged 65-75 years who have ever smoked (at least 100 cigarettes in their lifetime): One-time screening (grade B, moderate net benefit).

2. Men aged 65-75 years who have never smoked: Selectively offer screening (grade C, small net benefit). “To determine whether this service is appropriate, patients and clinicians should consider the patient’s medical history, family history, other risk factors, and personal values.”

3. Women without a smoking history or family history of AAA: Do not perform screening (grade D, recommendation against the service).

4. Women aged 65-75 years who have a smoking history or family history of AAA: There is insufficient evidence on whether or not to screen for AAA (grade I, insufficient evidence).

To assess screening and treatment of AAAs, the USPSTF looked at four randomized, controlled trials largely focused on men older than 65 years. With the combined data, they found 246 men would need to be screened to prevent 1 AAA rupture, and 305 men would need to be screened to prevent 1 death from AAA.

The USPSTF does note that, while the risk of death is lower for elective AAA repair than ruptured AAA, there is still increased risk with elective surgery. In addition, increased screening and detection increases the rate of elective surgery. Overdiagnosis and overtreatment could represent a harm.
 

Treatment

Surgical repair of AAA in men depends on the size of the aneurysm and rate of growth.

For men, surgical repair is standard when the AAA reaches 5.5 cm or if the AAA is growing faster than 1.0 cm per year and is larger than 4.0 cm. For women, surgical repair is often recommended between 5.0 cm and 5.4 cm in size.

Surgical repair is not recommended for AAAs that are less than 5.0 cm because the annual risk of rupture is 0%-1% below 5.0 cm. The risk increases to 11% for aneurysms that are 5.0-5.9 cm in size.

There are two methods of surgical repair: endovascular aneurysm repair and open repair. Recommendations for the surveillance of AAA between 3.0 cm and 5.5 cm is regular ultrasound surveillance, with the interval becoming shorter as the aneurysm size becomes larger. Exact intervals differ from one guideline group to another.
 

 

 

Screening and treatment in women

While it is true that AAAs in women are more likely to rupture at smaller sizes than AAAs in men, the AAAs that rupture in women are more likely to rupture at an older age than AAAs rupture in men.

The prevalence of AAAs in women is thought to be one-sixth of the prevalence of men. In addition, women had a higher 30-day mortality after surgical repair. They also had higher rates of complications for elective surgical repair of AAAs.

For these reasons, it is unclear that the benefits of AAA screening and treatment in women outweigh the risks, and the USPSTF cannot come to a conclusive recommendation for women who have ever smoked or women who have a family history of AAA.

The USPSTF is able to state definitively that they do not recommend screening in women with no smoking history or family history of AAA.
 

Bottom line

The USPSTF recommends screening men aged 65-75 years who have ever smoked and selectively screening men aged 65-75 years with no smoking history. The USPSTF recommends against screening women aged 65-75 years who have never smoked and have no family history of AAA. There is insufficient evidence to either recommend for or against screening women aged 65-75 years who have smoked or have a family history of AAA.

Reference

Owens DK et al. Screening for abdominal aortic aneurysm: U.S. Preventive Services Task Force Recommendation Statement. JAMA. 2019 Dec 10;322(22):2211-18.

Dr. Sprogell is a second-year resident in the family medicine residency program at Abington (Pa.) Hospital–Jefferson Health. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health.

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Summary: Preexposure prophylaxis for the prevention of HIV infection USPSTF recommendation statement

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Thu, 09/05/2019 - 13:37

It is estimated that there are 1.1 million people in the United States living with HIV and that 15% of those people do not know they have HIV. Although the number of new cases reported each year is decreasing, there were still 38,281 new diagnoses in 2017. New cases might be decreasing overall, but the incidence of HIV is rising in some groups including people aged 25-29 years old and American Indian/Alaska Native and Asian populations. In addition, HIV disproportionately affects men who have sex with men, black/African American populations, and Hispanic/Latino populations, according to the USPSTF statement.

Dr. Anne Sprogell and Dr. Neil Skolnik of Abington (Pa.) Hospital-Jefferson Health
Dr. Anne Sprogell and Dr. Neil Skolnik

Given the prevalence of HIV and rising new cases in certain groups, it is thought that preexposure prophylaxis (PrEP) is being underutilized. The CDC reported that, in 2015, 1.2 million people were candidates for PrEP, but in 2017, only 100,282 people were using PrEP. The USPSTF performed a meta-analysis of 12 RCTs comparing rates of HIV infection in groups treated with PrEP versus those treated with placebo or no treatment and found a risk ratio of 0.46 (95% confidence interval, 0.33-0.66) and absolute risk reduction of –2% (95% CI, –2.8% to –1.2%) after 4 months and 4 years.

With this epidemiologic data and the meta-analysis, the USPSTF offered the following recommendations.
 

Screening

In order to decrease the rates of transmission and incidence of HIV infection, we must appropriately identify those who would be good candidates for PrEP. That begins with taking a complete and thorough sexual and injection drug use history in a manner that does not make patients feel stigmatized or discriminated against. The USPSTF recommends screening for HIV infection in patients aged 15-65 years old, in younger and older patients who have increased risk factors, and all pregnant patients. PrEP is not an appropriate choice in those who have HIV because it can lead to drug resistance.

When screening for HIV and considering starting PrEP, it is recommended that clinicians also test for kidney function, hepatitis B and C, other STIs, and pregnancy. The USPSTF suggests that the following groups be considered for PrEP given the increased risk of HIV infection:

  • Men who have sex with men, are sexually active, and have one of these additional characteristics: a serodiscordant sex partner, inconsistent use of condoms during receptive or insertive anal sex, or infection with syphilis, gonorrhea, or chlamydia in the past 6 months.
  • Heterosexual men or women who are sexually active with one or more of these additional characteristics: a serodiscordant sex partner, inconsistent use of condoms during sex with a partner whose HIV status is unknown and who is at high risk, and infection with syphilis or gonorrhea in the past 6 months.
  • Patients who inject drugs with one or more of the following characteristics: shared use of drug injection equipment and risk of sexual acquisition (as in the categories above).

The USPSTF also notes that those who engage in transactional sex (for money, drugs, or housing) and transgender patients are at an increased risk of HIV infection.

 

 

Treatment

The only FDA approved treatment for the prevention HIV infection is once daily oral combined tenofovir disoproxil fumarate and emtricitabine; however, some studies have found that tenofovir disproxil fumarate monotherapy is also effective. Considering these trials, the CDC has suggested that tenofovir disoproxil fumarate monotherapy can be used as an alternative for men and women at high risk and those who inject drugs.

Tenofovir disoproxil fumarate/emtricitabine can also be used in pregnant patients, however the USPSTF notes that no PrEP trials included pregnant women. Additionally, tenofovir disoproxil fumarate/emtricitabine can be used in adolescents who weigh more than 35 kg. It is unknown how much time it takes to achieve protection against HIV infection after starting PrEP, and there is no clear timeline for how long patients should be on PrEP. Patients may discontinue medication because of preference, decreased risk of HIV exposure, or side effects.

Side effects include renal adverse events (serum creatinine rise), gastrointestinal adverse events (mostly nausea), and bone loss and increased fracture risk, although none were statistically significant when PrEP and placebo groups were compared. The USPSTF’s recommendations note that the effectiveness of PrEP is dependent on medication adherence.

While PrEP is an important part of preventing HIV, it is always important to counsel patients on other ways to reduce risk. The USPSTF notes that consistent condom use reduces the risk of HIV infection by around 80% in addition to reducing the risk of other STIs. All trials studied by the USPSTF for these recommendations included counseling on behavior, adherence, and condom use.
 

Bottom Line

It is estimated that 1.1 million Americans are living with HIV and 15% are unaware that they are positive for HIV. Overall cases of new HIV diagnoses are down, but they are rising in some groups. PrEP is an effective medication for reducing the risk of HIV infection, but is currently underutilized. Every patient should be screened for high-risk sexual behavior and drug use with a thorough history. Patients aged 15-65 years should be screened for HIV. If patients are negative for HIV, but participate in high-risk sexual behaviors and drug injection, they should be offered PrEP along with counseling on, medication adherence, condom use, and reduction of high-risk behaviors.
 

Dr. Skolnik is professor of family and community medicine at Jefferson Medical College, Philadelphia, and an associate director of the family medicine residency program at Abington (Pa.) Jefferson Health. Dr. Sprogell is a second-year resident in the Family Medicine Residency Program at Abington Jefferson Health

Reference

Owens DK et al. “Preexposure prophylaxis for the prevention of HIV infection: US Preventive Services Task Force recommendation statement.” JAMA. 2019 Jun 11;321(22):2203-13.

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It is estimated that there are 1.1 million people in the United States living with HIV and that 15% of those people do not know they have HIV. Although the number of new cases reported each year is decreasing, there were still 38,281 new diagnoses in 2017. New cases might be decreasing overall, but the incidence of HIV is rising in some groups including people aged 25-29 years old and American Indian/Alaska Native and Asian populations. In addition, HIV disproportionately affects men who have sex with men, black/African American populations, and Hispanic/Latino populations, according to the USPSTF statement.

Dr. Anne Sprogell and Dr. Neil Skolnik of Abington (Pa.) Hospital-Jefferson Health
Dr. Anne Sprogell and Dr. Neil Skolnik

Given the prevalence of HIV and rising new cases in certain groups, it is thought that preexposure prophylaxis (PrEP) is being underutilized. The CDC reported that, in 2015, 1.2 million people were candidates for PrEP, but in 2017, only 100,282 people were using PrEP. The USPSTF performed a meta-analysis of 12 RCTs comparing rates of HIV infection in groups treated with PrEP versus those treated with placebo or no treatment and found a risk ratio of 0.46 (95% confidence interval, 0.33-0.66) and absolute risk reduction of –2% (95% CI, –2.8% to –1.2%) after 4 months and 4 years.

With this epidemiologic data and the meta-analysis, the USPSTF offered the following recommendations.
 

Screening

In order to decrease the rates of transmission and incidence of HIV infection, we must appropriately identify those who would be good candidates for PrEP. That begins with taking a complete and thorough sexual and injection drug use history in a manner that does not make patients feel stigmatized or discriminated against. The USPSTF recommends screening for HIV infection in patients aged 15-65 years old, in younger and older patients who have increased risk factors, and all pregnant patients. PrEP is not an appropriate choice in those who have HIV because it can lead to drug resistance.

When screening for HIV and considering starting PrEP, it is recommended that clinicians also test for kidney function, hepatitis B and C, other STIs, and pregnancy. The USPSTF suggests that the following groups be considered for PrEP given the increased risk of HIV infection:

  • Men who have sex with men, are sexually active, and have one of these additional characteristics: a serodiscordant sex partner, inconsistent use of condoms during receptive or insertive anal sex, or infection with syphilis, gonorrhea, or chlamydia in the past 6 months.
  • Heterosexual men or women who are sexually active with one or more of these additional characteristics: a serodiscordant sex partner, inconsistent use of condoms during sex with a partner whose HIV status is unknown and who is at high risk, and infection with syphilis or gonorrhea in the past 6 months.
  • Patients who inject drugs with one or more of the following characteristics: shared use of drug injection equipment and risk of sexual acquisition (as in the categories above).

The USPSTF also notes that those who engage in transactional sex (for money, drugs, or housing) and transgender patients are at an increased risk of HIV infection.

 

 

Treatment

The only FDA approved treatment for the prevention HIV infection is once daily oral combined tenofovir disoproxil fumarate and emtricitabine; however, some studies have found that tenofovir disproxil fumarate monotherapy is also effective. Considering these trials, the CDC has suggested that tenofovir disoproxil fumarate monotherapy can be used as an alternative for men and women at high risk and those who inject drugs.

Tenofovir disoproxil fumarate/emtricitabine can also be used in pregnant patients, however the USPSTF notes that no PrEP trials included pregnant women. Additionally, tenofovir disoproxil fumarate/emtricitabine can be used in adolescents who weigh more than 35 kg. It is unknown how much time it takes to achieve protection against HIV infection after starting PrEP, and there is no clear timeline for how long patients should be on PrEP. Patients may discontinue medication because of preference, decreased risk of HIV exposure, or side effects.

Side effects include renal adverse events (serum creatinine rise), gastrointestinal adverse events (mostly nausea), and bone loss and increased fracture risk, although none were statistically significant when PrEP and placebo groups were compared. The USPSTF’s recommendations note that the effectiveness of PrEP is dependent on medication adherence.

While PrEP is an important part of preventing HIV, it is always important to counsel patients on other ways to reduce risk. The USPSTF notes that consistent condom use reduces the risk of HIV infection by around 80% in addition to reducing the risk of other STIs. All trials studied by the USPSTF for these recommendations included counseling on behavior, adherence, and condom use.
 

Bottom Line

It is estimated that 1.1 million Americans are living with HIV and 15% are unaware that they are positive for HIV. Overall cases of new HIV diagnoses are down, but they are rising in some groups. PrEP is an effective medication for reducing the risk of HIV infection, but is currently underutilized. Every patient should be screened for high-risk sexual behavior and drug use with a thorough history. Patients aged 15-65 years should be screened for HIV. If patients are negative for HIV, but participate in high-risk sexual behaviors and drug injection, they should be offered PrEP along with counseling on, medication adherence, condom use, and reduction of high-risk behaviors.
 

Dr. Skolnik is professor of family and community medicine at Jefferson Medical College, Philadelphia, and an associate director of the family medicine residency program at Abington (Pa.) Jefferson Health. Dr. Sprogell is a second-year resident in the Family Medicine Residency Program at Abington Jefferson Health

Reference

Owens DK et al. “Preexposure prophylaxis for the prevention of HIV infection: US Preventive Services Task Force recommendation statement.” JAMA. 2019 Jun 11;321(22):2203-13.

It is estimated that there are 1.1 million people in the United States living with HIV and that 15% of those people do not know they have HIV. Although the number of new cases reported each year is decreasing, there were still 38,281 new diagnoses in 2017. New cases might be decreasing overall, but the incidence of HIV is rising in some groups including people aged 25-29 years old and American Indian/Alaska Native and Asian populations. In addition, HIV disproportionately affects men who have sex with men, black/African American populations, and Hispanic/Latino populations, according to the USPSTF statement.

Dr. Anne Sprogell and Dr. Neil Skolnik of Abington (Pa.) Hospital-Jefferson Health
Dr. Anne Sprogell and Dr. Neil Skolnik

Given the prevalence of HIV and rising new cases in certain groups, it is thought that preexposure prophylaxis (PrEP) is being underutilized. The CDC reported that, in 2015, 1.2 million people were candidates for PrEP, but in 2017, only 100,282 people were using PrEP. The USPSTF performed a meta-analysis of 12 RCTs comparing rates of HIV infection in groups treated with PrEP versus those treated with placebo or no treatment and found a risk ratio of 0.46 (95% confidence interval, 0.33-0.66) and absolute risk reduction of –2% (95% CI, –2.8% to –1.2%) after 4 months and 4 years.

With this epidemiologic data and the meta-analysis, the USPSTF offered the following recommendations.
 

Screening

In order to decrease the rates of transmission and incidence of HIV infection, we must appropriately identify those who would be good candidates for PrEP. That begins with taking a complete and thorough sexual and injection drug use history in a manner that does not make patients feel stigmatized or discriminated against. The USPSTF recommends screening for HIV infection in patients aged 15-65 years old, in younger and older patients who have increased risk factors, and all pregnant patients. PrEP is not an appropriate choice in those who have HIV because it can lead to drug resistance.

When screening for HIV and considering starting PrEP, it is recommended that clinicians also test for kidney function, hepatitis B and C, other STIs, and pregnancy. The USPSTF suggests that the following groups be considered for PrEP given the increased risk of HIV infection:

  • Men who have sex with men, are sexually active, and have one of these additional characteristics: a serodiscordant sex partner, inconsistent use of condoms during receptive or insertive anal sex, or infection with syphilis, gonorrhea, or chlamydia in the past 6 months.
  • Heterosexual men or women who are sexually active with one or more of these additional characteristics: a serodiscordant sex partner, inconsistent use of condoms during sex with a partner whose HIV status is unknown and who is at high risk, and infection with syphilis or gonorrhea in the past 6 months.
  • Patients who inject drugs with one or more of the following characteristics: shared use of drug injection equipment and risk of sexual acquisition (as in the categories above).

The USPSTF also notes that those who engage in transactional sex (for money, drugs, or housing) and transgender patients are at an increased risk of HIV infection.

 

 

Treatment

The only FDA approved treatment for the prevention HIV infection is once daily oral combined tenofovir disoproxil fumarate and emtricitabine; however, some studies have found that tenofovir disproxil fumarate monotherapy is also effective. Considering these trials, the CDC has suggested that tenofovir disoproxil fumarate monotherapy can be used as an alternative for men and women at high risk and those who inject drugs.

Tenofovir disoproxil fumarate/emtricitabine can also be used in pregnant patients, however the USPSTF notes that no PrEP trials included pregnant women. Additionally, tenofovir disoproxil fumarate/emtricitabine can be used in adolescents who weigh more than 35 kg. It is unknown how much time it takes to achieve protection against HIV infection after starting PrEP, and there is no clear timeline for how long patients should be on PrEP. Patients may discontinue medication because of preference, decreased risk of HIV exposure, or side effects.

Side effects include renal adverse events (serum creatinine rise), gastrointestinal adverse events (mostly nausea), and bone loss and increased fracture risk, although none were statistically significant when PrEP and placebo groups were compared. The USPSTF’s recommendations note that the effectiveness of PrEP is dependent on medication adherence.

While PrEP is an important part of preventing HIV, it is always important to counsel patients on other ways to reduce risk. The USPSTF notes that consistent condom use reduces the risk of HIV infection by around 80% in addition to reducing the risk of other STIs. All trials studied by the USPSTF for these recommendations included counseling on behavior, adherence, and condom use.
 

Bottom Line

It is estimated that 1.1 million Americans are living with HIV and 15% are unaware that they are positive for HIV. Overall cases of new HIV diagnoses are down, but they are rising in some groups. PrEP is an effective medication for reducing the risk of HIV infection, but is currently underutilized. Every patient should be screened for high-risk sexual behavior and drug use with a thorough history. Patients aged 15-65 years should be screened for HIV. If patients are negative for HIV, but participate in high-risk sexual behaviors and drug injection, they should be offered PrEP along with counseling on, medication adherence, condom use, and reduction of high-risk behaviors.
 

Dr. Skolnik is professor of family and community medicine at Jefferson Medical College, Philadelphia, and an associate director of the family medicine residency program at Abington (Pa.) Jefferson Health. Dr. Sprogell is a second-year resident in the Family Medicine Residency Program at Abington Jefferson Health

Reference

Owens DK et al. “Preexposure prophylaxis for the prevention of HIV infection: US Preventive Services Task Force recommendation statement.” JAMA. 2019 Jun 11;321(22):2203-13.

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