Volume 1 - Issue 1, April 2018

Beyond undetectable: considerations for nurses and pharmacists who care for people with HIV Back

Fiona Marple-Clark,a Bruce Hamish Bowden,b Jayne Howard,c Ngaire Latch,d John McAllister,e Maggie Smith,b Leah Williamsf

Introduction

Modern antiretroviral therapy (ART) now means that the life expectancy of people with HIV is approaching that of the general population.1,2 Slowing the epidemic has now become a key focus, with an emphasis on identifying undiagnosed people with HIV,3 engaging and retaining them in care,4 initiating ART early,5 and using treatment-as-prevention (TasP) and preexposure prophylaxis (PrEP) to reduce the risk of HIV acquisition in HIVnegative men and women.6

In Australia, it is estimated that over 26,000 people live with HIV, and 75% of those people are gay and bisexual men.7 The proportion of HIV-infected people in Australia who are older is increasing, with 43% of people over 50 years of age in 2016 compared with only 5% in 1986 (Figure 1).7 Modelling projections indicate that the percentage of people with HIV over 50 years old will continue to increase for at least the next decade in Western countries.8

Figure 1. Number and proportion of people living with HIV and diagnosed from 1986 to 2016. Adapted from The Kirby Institute. HIV, viral hepatitis and sexually transmissible infections in Australia. Annual Surveillance Report 2017. The Kirby Institute, UNSW Sydney, Sydney NSW 2052. Reproduced with permission.

 

As the population ages, HIV care has moved beyond achieving and sustaining an undetectable viral load to achieving and sustaining quality of life. Increasingly the focus of HIV management is on retaining people in care over their lifetime and the detection, management, and prevention of age-, HIV- and treatment-driven comorbidities, multimorbidity and frailty.9,10 Multimorbidity is of particular concern as it may be associated with polypharmacy, multiple prescribers, potential adherence difficulties and pharmacokinetic and pharmacodynamic drug-drug interactions (DDIs).

In people with stable HIV infection (virologic suppression with immune competence), medical review only twice per year is becoming increasingly common (albeit sexually transmitted infection [STI] testing may be performed more frequently), which may foster disengagement in care and limit comprehensive in-depth review. This creates an opportunity for nurses and pharmacists to augment and support medical care in several ways, including the following:

  • Using validated tools to identify, assess and manage patients who are at risk of disengaging from care, or who are at risk of or experiencing treatment and age-related comorbidities and their precursors (ART toxicity, cigarette smoking, obesity, alcohol and other recreational drug use).
  • Addressing patients’ sexual and reproductive health.
  • Contributing to the use of comprehensive HIV prevention including PrEP.

This article discusses the key issues associated with the management of HIV beyond viral suppression, including specific considerations for nurses and pharmacists.

An undetectable viral load, but challenges remain

Adam says he is privileged to live in Australia and have access to antiretroviral therapy (ART). However, he received little information about ART when he was diagnosed, and inflexible clinic times restricted his access to care. He is thankful that he was able to achieve better access to care when he eventually changed to a different clinic, including the support of exceptional nurses and pharmacists. He is now on ART and has an undetectable viral load. His positive status has meant that he cannot work in some other countries,11 which is one of his greatest passions, and access to ART is often difficult overseas. However, he is confident that since he has been stably virologically suppressed for over six months and is fully adherent to his ART his risk of sexually transmitting the virus to others is negligible to non-existent, as recognised by the Undetectable=Untransmittable (U=U) campaign.12

Engagement in Care

In order to help people with HIV age well, they must first be engaged and retained in care, or found and returned to care if lost along the way. Nurses and pharmacists can play key roles in maintaining life-long engagement in care. These roles include engaging newly diagnosed people in care at point of entry, providing support as they begin treatment, retaining them in care (usually for decades), promoting adherence to medication, promoting their sexual and reproductive health, and identifying and managing comorbidities, as well as DDIs.

Achieving and sustaining life-long engagement can be a major task, in particular with clients with recreational drug use or mental health challenges. All HIV services operate differently, consequently nurses and pharmacists should think about contemporary models of care and how they can best use their services to offer support to patients in complex social situations within their specific setting. The HIV continuum of care comprises multiple phases (Figure 2). People with HIV can withdraw from care at any time without notice or explanation, which presents an ongoing clinical challenge, especially given the current expectation that a lifetime of care is needed. There is currently no gold standard for measuring engagement and retention, although studies have investigated a number of different measurements, including the number of missed appointments,13 the number of CD4 or viral load measurements per year14 and gaps between visits.15

Figure 2. HIV continuum of care. Adapted from Apea V and Nixon E, Third Joint Conference of BHIVA and BASHH, 2014. Reproduced with permission.

 

It is common for a relatively small number of complex clients to require much of a clinic’s time and resources to keep them retained. There is currently no agreed upon approach to identifying clients in complex social situations, and nurses and pharmacists often rely on their knowledge of an individual to identify those at risk of disengagement from care. Consequently, it is difficult to justify the resources required to care for these clients. Nonetheless, there are several approaches to measuring complexity in other healthcare settings that may potentially be adapted to people with HIV. For instance, the Clinical Complexity Rating Scale (CCRS) is one example of a tool that has been developed to assess complexity associated with drug and alcohol use and used to identify issues associated with poorer outcomes, including mental health and housing.16 An adaptation of the CCRS using additional HIV-specific items was able to identify complexity in people with HIV, and ongoing studies are now validating this tool.17

Retention, Engagement and Access to Care for patients with HIV (REACH) is a programme developed at the Royal Perth Hospital to identify clients who are at risk of being, or have become, disengaged with clinic services, or who are  engaged only through sustained team effort. The programme also aims to develop pathways to promote medication adherence and minimise the risk of loss to follow-up, as well as to promote links with services inside and outside the hospital. In REACH, a variety of categories were used to identify clients who were hard to reach, including a detectable HIV viral load, missing two consecutive appointments in the past year, attending at least six allied health appointments but no medical appointments, and attending clinics unscheduled. Data from REACH showed that in a cohort of 108 complex clients with HIV, 40% had ongoing and regular recreational drug use, 35% had mental health issues including anxiety and depression, 35% had unstable or unsafe housing and 25% were currently or had a previous history of incarceration. These clients also had a range of other challenges including comorbidities, beliefs or faith issues, or they suffered discrimination and/or poverty. These findings highlight the challenges of managing clients in complex social situations and reinforce the difficulties of engaging and retaining these people in care.

The Enhanced HIV Care Project at St. Vincent’s Hospital, Sydney, is an intensive nursing support program aimed specifically at maintaining retention in care and viral suppression in patients with complex needs.18 A review of the 26 men and women in this program in 2016 demonstrated that:

  • 88% were male, 8% female and 4% transgender.
  • All were unemployed and subsisting on Newstart Allowance or Disability Support Pension.
  • 7% were living on the streets and homeless.
  • 23% were receiving daily directly observed ART and the remainder weekly to fortnightly supervised ART.
  • 60% had a mental health diagnosis (major psychotic illness of which 20%were untreated).
  • 73% abused illicit substances predominantly crystal methamphetamine (60% intravenous drug use).
  • All (100%) were engaged in care, all (100%) were on HIV treatment, and 73% had fully suppressed HIV virus.
  • No patient required inpatient care throughout 2017.

The relationship between a client and a service can be the most valuable resource in promoting engagement and retention. Good relationships begin at the first visit and, when working with people with HIV, nurses and pharmacists (as well as physicians and social workers) are in the position of being able to continue developing relationships over time. Given the value of relationships, particularly for clients in complex social situations, it is important to look objectively at how services and working practices can facilitate relationship building, as well as what kind of barriers exist in systems and how these barriers can be overcome.

Good surveillance can prevent loss to follow-up and help healthcare providers understand the needs of complex clients and how they use services to maximize opportunities. Working closely with other medical sub-specialities may assist with surveillance. Surveillance also helps with advocacy for the needs of clients in complex social situations, as well as support from hospital management and/or health departments to provide adequate support and staff services.

There are many small changes that nurses and pharmacists can make to their services to support people with HIV, in particular for clients in complex social situations. Nurses and pharmacists often have the most touch points with these people and come to know them better than other members of the health care team. Many of these small quality initiatives can be nurse- or pharmacist-led, and require creativity, collaboration and relationship building. The challenge is to motivate individual healthcare providers to start looking at how they work, and identifying areas that can be improved.

No easy answers – clients with HIV in complex social situations

Clint is a 28-year-old Australian man who was diagnosed with HIV in 2016 and acquired hepatitis C one year later. At the time of his HIV diagnosis, his CD4 count was 768 cells/μL and his viral load was 12,345 copies/mL. He is not adherent with his antiretroviral therapy (ART). Today he presents to the clinic without an appointment, intoxicated on methamphetamine, urgently requesting a letter for Centrelink as his benefits are going to be cut off tomorrow. He has been ejected from his short-term lodgings for dealing drugs and is homeless. He is threatening and aggressive.

Mary is also visiting the clinic today. She is a 32-year-old refugee from Burundi who is adherent with ART and is pregnant with her third child. She usually avoids the clinic at all costs and has evidence on her body of recent violence, but denies she is a victim of violence. She does not speak English and requires an interpreter, but the only interpreter available today is male.

How might these issues impact the future care of these people?
As a nurse or pharmacist, what systems can you implement or actions can you take to ensure these patients are not lost to care?

In these situations, what can you do (if anything) to promote adherence to medication, promote sexual and reproductive health, and identify and manage co-morbidities and drug interactions?

 

Comorbidities and HIV

Many comorbidities associated with aging, such as cardiovascular disease, osteoporosis, metabolic disorders, cognitive impairment, renal disease and some cancers, in particular anal cancer, are observed more frequently and/or occur at an earlier age among people with HIV compared with uninfected people9,19,20 (Figure 3). In the APPLES study of self-reported comorbidities in Australian men, HIV-positive men were found to have significantly increased odds of diabetes, thrombosis and neuropathy, as well as non-significantly increased odds for heart-disease, compared to HIV-negative men.21 Multimorbidity (the coexistence of two or more clinically manifest chronic diseases) and frailty among people with HIV add to the complexity of clinical management and present an ongoing clinical challenge in the aging HIV population.22

Figure 3. Age-related comorbidities with an earlier onset and/or increased incidence in people with HIV. 1Kooij KW, et al. J Infect Dis 2015; 211: 539-548; 2Brown TT, et al. AIDS 2006; 20: 2165-2174; 3Rodger AJ, et al. AIDS 2013; 27: 973-979; 4Clifford DB. Curr Opin Infect Dis 2017; 30: 117-122; 5Siverberg MJ, et al. Ann Intern Med 2015; 163: 507-518; 6Althoff KN, et al. Clin Infect Dis 2015; 60: 627-638; 7Butt AA, et al. AIDS 2009; 23: 1227-1234. Abbreviations: BMD, bone mineral density; BMI, body mass index; HCV, hepatitis C virus.

 

Multiple factors may influence the development of comorbidities in people with HIV, including genetics, HIV-driven inflammation and immune activation, aging, coinfections (with hepatitis B virus, hepatitis C virus [HCV], and/or human papillomavirus), ART, and lifestyle factors such as smoking and the use of alcohol and other drugs.23 While ART suppresses plasma viraemia, preserves or improves CD4 cell count, and confers considerable benefits in morbidity and mortality, some ART medications can also exacerbate age-related comorbidities. For instance, tenofovir disoproxil fumarate (TDF) has been associated with chronic kidney disease, as well as low bone mineral density and osteoporotic fracture,24,25 and abacavir (ABC) has been associated with an increased risk of myocardial infarction.26 Furthermore, some older ART medicines are associated with other toxicities, including efavirenz, which has been associated with central nervous system side effects and impaired neurocognitive functioning,27 and atazanavir, which has been associated with kidney stones.28

As a consequence of the potential toxicities associated with ART, it is important to employ a proactive approach to ART management. For instance, tenofovir alafenamide (TAF) 25 mg results in >90% lower tenofovir plasma levels than TDF 300 mg, and has not been associated with bone or renal toxicity.29,30 Switching from a regimen containing TDF to a regimen containing TAF results in improved bone mineral density and urine protein or albumin to creatinine ratios.31-33 Depending on the setting, nurses and pharmacists may be able to play a key role in proactively identifying people at risk of developing age-related comorbidities at an earlier age, in part due to ART toxicity, for example with TDF or ABC. The Amsterdam tool can be used by pharmacists for clinical medication review, which may also help to detect drug-related problems and optimise treatment.34

HIV, barriers to engagement in care and multiple comorbidities – a case study:
John is a 37-year-old gay Australian man diagnosed with HIV. At the time of his diagnosis, his CD4 count was 414 cells/μL and his viral load was 86,000 copies/mL. He is socially isolated, largely as a result of having been sent abroad by his parents when they discovered his sexuality in his teens. Although he returned to complete high school, he left home in his late teens and hasn’t spoken to his family since. In addition to his HIV diagnosis, he has also has type 2 diabetes and HCV. He experienced 10 years of challenges, including crystal methamphetamine use and failure to engage in alcohol and drug services, as well as poor glycaemic control. He disengaged from care for many years but then reengaged after being hospitalised with myocarditis and other illnesses. As a result of his reengagement in care, he has now achieved an undetectable HIV viral load and is adherent to medications but has deteriorating vision.
John has many challenges ahead.
In your role as a nurse or pharmacist, what can you do to at this point to help care for John?

HIV Prevention and Sexual Health

Prevention strategies
Prevention of HIV transmission is a critical aspect of HIV care.6 Various strategies to reduce HIV transmission are available in Australia. The efficacy of prevention strategies varies from approximately 30% to 96%.35 Of note is that consistent condom use results in only 70% efficacy, whereas PrEP exceeds 90% depending on the degree of adherence.36

Pre-exposure prophylaxis with a registered coformulated product containing emtricitabine (FTC) and tenofovir is recommended for individuals who are at elevated risk of HIV acquisition. The currently licensed products subsidised by the Pharmaceutical Benefits Scheme from 1 April 2018 are: FTC/TDF, FTC/ tenofovir  disoproxil maleate and FTC/tenofovir disoproxil phosphate. The Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine (ASHM) has developed guidelines for PrEP, which recommend that individuals on PrEP be regularly monitored and tested and provided prevention and adherence support.37 The efficacy of PrEP has been shown to be dependent on adherence38,39 and, depending on the setting, nurses and pharmacists can play a key role in encouraging adherence and providing support.

The iPrEX open label study showed that, while 39% of participants reported potentially PrEP-related symptoms compared to 22% at baseline, these symptoms largely resolved to pre-PrEP levels by 3 months and only astrointestinal symptoms were inversely associated with adherence at 4 weeks.40 Furthermore, a meta-analysis of ten randomised studies showed that the proportions of adverse events were similar for PrEP versus placebo, and that no differences were seen in adverse events across subgroups based on mode of acquisition, adherence, gender, drug regimen, dosing or age.2

Over 7000 gay men in Australia were taking PrEP to prevent HIV by the end of 2016, which corresponds to 6% of the estimated sexually active HIV‑negative gay men, and 23% of the estimated gay men at high risk of HIV.7 An increased incidence of STIs, including syphilis, gonorrhoea, and chlamydia, has been reported in some, but not all, studies of PrEP in men who have sex with men (MSM).39,41 This increase may be due to an increased frequency of testing and detection, and more research is needed to understand this trend. Infection with TDF- and/or FTC-resistant virus as a result of PrEP is very uncommon, and usually occurs when a person initiates PrEP with undiagnosed HIV infection or continues to take PrEP in acute HIV infection.42

PrEP has been shown to be efficacious and its provision is straightforward. Nurses and pharmacists can play a key role in reinforcing the continued use of condoms to prevent acquisition of other STIs, which may be increased in MSM using PrEP, as well as regular monitoring and testing, and prevention and adherence support.

Chemsex
ChemSex refers to the use of specific drugs in a sexual context.43 The drugs most commonly used include crystal methamphetamine, gamma hydroxybutyrate (GBH)/gammabutyrolactone (GBL) and mephedrone, alone or in combination. The reasons why people might engage in ChemSex are complex and may be associated with a variety of factors, including fears that lead to a lack of emotional intimacy with others, low self-esteem, a relatively poor sex education, or simply because it makes them feel good. These drugs can offer a false sense of intimacy and many MSM experience their first sexual encounter under their influence.

Studies from 56 Dean Street Clinic in London show that many MSM who engage in ChemSex do not use condoms and many are at high risk of HIV transmission.44 Of ChemSex injecting drug users, approximately one quarter reported sharing needles and a further one quarter reported never having injected themselves,44 showing that many people who engage in ChemSex are inexperienced at injecting. Compounding matters is that apps such as GRINDR and SCRUFF are likely to have made it easy to meet people and be introduced to ChemSex.

The Novel Psychoactive Treatment UK Network (NEPTUNE) provides guidance based on available evidence and clinical consensus for the clinical management of harms of club drugs and novel psychoactive substances. More research is needed to understand ChemSex in Australia and to determine the extent and the consequences of the problem in our community and how healthcare professionals, including nurses and pharmacists, can support these individuals.

Other sexual health initiatives
Many clinics are looking for innovative solutions to increase access to health services and address resource limitations. GeneXpert is a system that can be used by trained lay providers to test for chlamydia and gonorrhoea. Asymptomatic screening by lay providers can alleviate demand on clinical services and enable physicians to focus on care for people with HIV.45 In addition, the use of lay providers to perform diagnostic tests can enhance trust and reduce stigma and cultural barriers within marginalised populations.45 Studies are ongoing with the Kirby Institute, as well as a partnership between QLD Positive People’s RAPID peer-based testing service, the University of Queensland and the Metro North Hospital & Health Service, to test this technology in Australia.

The Test And Go (TAG) service at the Melbourne Sexual Health Clinic (MSHC) is one example of an express walk-in service for STI testing of asymptomatic individuals, which is nurse-led and can therefore alleviate demand on physicians. The TAG service is offered to gay MSM who have had a sexual health screen at MSHC previously, no other sexual health concerns and willing to self-collect an anal swab. Each appointment lasts 15 minutes and asymptomatic screening for HIV, syphilis, chlamydia and gonorrhoea  is performed. One week later, with prior client consent, a text message is sent to the client if the HIV result is negative. Alternatively, a follow-up appointment is made if any of the tests are positive or need to be repeated. The TAG service has been underway at the MSHC since 2015 and has created additional clinical capacity at the general clinic for physicians to see clients at higher risk.

Reproductive and Women’s Health and HIV

When working with female clients, there are many additional concerns that need to be considered, including:

  1. Their relationships with their partners, including contraceptive advice, TasP, access to nonoccupational post-exposure prophylaxis (NPEP), access to PrEP, STI screening, cervical screening and pregnancy.
  2. ART, including their choice of therapy, adherence to medication, adverse effects, DDIs and drugs in pregnancy.
  3. Engagement and retention in care issues, including their need to care for children or extended family, which may interfere with clinic access, and possible lack of social support.

The number of women with HIV in Australia was estimated to be 3162 in 2016.7 The most common age range of diagnosis is currently 30 to 39 years and many are born in high HIV prevalence countries.7

Mother to child transmission is rare, despite an increase in the number of women with HIV becoming pregnant.7 The proportion of Australian-born perinatally exposed infants with HIV has fluctuated7 and may reflect a variety of circumstances, including mothers not being tested for HIV or not using strategies to avoid transmission. Compared with heterosexual men, women have approximately a 10-fold higher risk of HIV infection per sex act.46

Like men with HIV, women with HIV are aging, and the proportion aged over 50 years in 2016 has increased to 26% compared with 17% in 1986.7 Furthermore, older women with HIV are at increased risk and/or earlier onset of the same comorbidities as men with HIV, albeit they also have potential issues with menopause.

Despite women being more likely than men to be HIV-positive globally, they have been underrepresented in clinical studies of ART. However, this is changing and several studies focusing on women with HIV have recently been conducted, including GRACE, WAVES and ARIA.47-49 These studies found that overall treatment outcomes were similar for women. Nonetheless, ART in women requires many unique considerations, such as avoidance of DDIs between ART medicines and hormonal contraception. Choice of ART during pregnancy requires particular care. The Antiretroviral Pregnancy Registry is a useful resource for selecting ART with sufficient safety data in pregnancy.50

Pregnancy in women with HIV also requires many special considerations, including pre-conception advice, reproductive choices, vertical HIV acquisition, breast feeding and conception for serodiscordant couples. Routine reproductive counselling is often poorly done, with one study reporting that in a cohort of 700 women with HIV, 22% became pregnant and more than half of these pregnant women (57%) had not had pre-pregnancy discussions with their healthcare provider about their ART.51 Nurses and pharmacists therefore have an important opportunity to counsel this particularly vulnerable group of women.

Antiretroviral therapy and pharmacological management

Achieving an undetectable viral load is now relatively simple due to the development of safe and effective ART. In fact, a recent randomised controlled study found that >99% of participants who were adherent achieved an undetectable HIV viral load with FTC/TAF plus dolutegravir.52

When to start ART is no longer debated; all patients should start ART as soon as possible.5 All firstline regimens recommended in US Department of Health and Human Services (DHHS) Guidelines for the use of Antiretroviral Agents in Adults and Adolescents Living with HIV now contain integrase inhibitors. Protease inhibitors have been removed for a variety of reasons, including their toxicity.53 Nonetheless, there are still many patients on old regimens, and nurses and pharmacists should encourage clients to have regular discussions with their doctors to ensure they are still receiving optimal evidence-based treatment.

Polypharmacy is particularly common in older people with HIV, which can contribute to a greater risk of DDIs between ART medicines and concomitant medications.53 Prescribers, nurses and pharmacists need to be aware of potential interactions between supplements and ART medicines, and can play a role in identifying issues that may affect the efficacy of ART.

Periodic medication reviews by pharmacists are recommended to assess for the potential for DDIs with ART, as well as with other prescribed, over-the-counter, and complementary and alternative medicines. Polypharmacy is also one  of the main risks for poor adherence, and pharmacists can both monitor for and encourage adherence. Pharmacists can also review barriers to adherence, such as the complexity of the regimen, adverse effects, financial issues including the cost of medications, access to medications, social barriers, lack of understanding of medications and comorbidities associated with active substance use, and troubleshoot ways of overcoming these barriers.

A recent Australian study investigated whether medication reviews by an HIV specialist pharmacist within the general practice setting would lead to effective identification and management of medication-related problems such as DIs.54 This intervention found a higher number of significant medication-related problems per patient than that found in HIV-negative settings,54 and suggests that medication management reviews conducted by HIV specialist pharmacists may help identify, prevent and/or resolve DDIs and other medication-related problems in older people with HIV.

Summary

Long-term health is becoming increasingly important as people with HIV live longer and the proportion of older people with HIV increases. HIV infection, aging and ART can have long-term effects on numerous aspects of health. People with HIV are more susceptible to comorbidities such as neurological impairments, cancer, cardiovascular disease, and bone, liver and kidney disease. The prevalence of risk factors including smoking and recreational drug use also tend to be higher in people with HIV, which can cause complexity in managing HIV and increase mortality rates. Nurses and pharmacists face a variety of challenges when providing care for people with HIV, including limited resources and increasing workloads. Nonetheless, their care is essential to the health and well-being of people with HIV. Continued research into HIV care will likely result in the roles of nurses and pharmacists continuing to evolve beyond helping people achieve an undetectable HIV viral load.

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aGold Coast Sexual Health Service, Gold Coast Hospital and Health Service, Southport, QLD, Australia; bThe Albion Centre, Surry Hills, NSW, Australia; c Melbourne Sexual Health Centre, Carlton, VIC, Australia; d Sexual Health and HIV Service, MNHHS, Brisbane, QLD, Australia; eSt Vincent’s Hospital, Darlinghurst, NSW, Australia; f Royal Perth Hospital, Perth, WA, Australia

Disclosures

Fiona Marple-Clark has received honoraria from Gilead and obtained compassionate medications supplied by Gilead Sciences, Janssen, Merck Sharp & Dohme and ViiV Healthcare. Bruce Hamish Bowden has received honoraria and travel sponsorship from Gilead Sciences and a research grant and travel sponsorship from ViiV Healthcare. John McAllister has received lecture fees and travel sponsorships from Gilead Sciences, Merck Sharp & Dohme and ViiV
Healthcare. The remaining authors have reported nothing to disclose.

The content in this publication is based on the Beyond Undetectable medical education event, held 23 – 24 February 2018 in Melbourne, VIC, Australia. This publication is sponsored by Gilead Sciences Pty Ltd, Level 6, 417 St Kilda Road, Melbourne VIC 3004 Australia. The Beyond Undetectable Meeting was a medical education event sponsored by Gilead. This company education event, and associated hospitality, is subject to the Medicines Australia Code of Conduct. No part of this publication may be reproduced by any process, in any language, without written permission and consent of Gilead. Disclaimer: The opinions of the presenting faculty in this publication are not necessarily those of Gilead. Gilead assumes no responsibility for any errors or omissions in the material published herein. © Gilead 2018. All rights reserved internationally. 001/AU/18-04/MM/1160.