Florida: HIV / AIDS, 3 unitsPage 7 of 13

6. Clinical Management of HIV

Florida’s plan to decrease HIV transmission and reduce HIV-related deaths has four components:

  1. Implementing routine HIV and STI screening in healthcare settings
  2. Providing rapid access to treatment
  3. Improving access to antiretroviral pre-exposure prophylaxis (PReP)
  4. Increasing HIV awareness through community outreach, engagement, and messaging (FDOH, 2021, October 22).

Every patient with HIV entering into care should have a complete medical history, physical examination, laboratory evaluation, and counseling. The purpose is to confirm the presence of HIV infection, obtain appropriate baseline historical and laboratory data, ensure patient understanding about HIV infection and its transmission, and initiate treatment and care (HIV.gov, 2021, August 16).

The initial evaluation should also include an introductory discussion on the benefits of antiretroviral therapy (ART) for the patient’s health and prevention of HIV transmission. The baseline information should be used to define management goals and plans with the patient (HIV.gov, 2021, August 16).

The CD4+ T-cell count, known as the CD4 count, serves as the major clinical indicator of immune function in patients who have HIV-infection. It is one of the key factors in determining the urgency of antiretroviral therapy (ART) initiation and the need for opportunistic infection prophylaxis. It is also the strongest predictor of subsequent disease progression and survival according to clinical trials and cohort studies (Thompson et al., 2020).


Several studies have demonstrated that overall outcomes in patients with HIV are better when care is delivered by clinicians with HIV expertise, reflecting the complexity of HIV transmission and its treatment. Appropriate training, continuing education, and clinical experience are all components of optimal care. Providers who do not have this requisite training and experience should consult HIV experts when needed (HIV.gov, August 16, 2021).

Antiretroviral Therapy (ART)

In 1996, researchers discovered that taking combinations of antiviral medications (the cocktail) dramatically reduced the amount of HIV viral load in the bloodstream of a person infected with HIV. Clients with HIV/AIDS consumed a bulky regimen of multiple pills several times per day. The reduction of deaths from AIDS in the U.S. has been primarily attributed to this combination therapy, known as antiretroviral therapy (ART).

Antiretroviral therapy for the treatment of HIV infection has improved steadily since 1996. ART has dramatically reduced HIV-associated morbidity and mortality and has transformed HIV infection into a manageable chronic condition, with life expectancy approaching that for people without HIV (HIV.gov, August 16, 2021).

ART is highly effective at preventing sexual transmission of HIV in patients who have adequately suppressed viral loads. Unfortunately, in 2016, only 51% of people with HIV in the U.S. had maximally suppressed viral loads; the lack of suppression is mostly due to undiagnosed HIV infection and failure to link or retain patients with HIV in care (HIV.gov, August 16, 2021).

Antiretroviral therapy has reduced HIV-related morbidity and mortality at all stages of HIV infection and has reduced HIV transmission. Suppression of the virus delays or prevents the development of drug-resistance mutations, preserves or improves CD4 T lymphocyte (CD4) cell numbers, and provides substantial clinical benefits, all of which are important treatment goals (HIV.gov, August 16, 2021).

HIV suppression with ART may also decrease inflammation and immune activation thought to contribute to higher rates of cardiovascular and other end-organ damage reported in cohorts with HIV. Despite these benefits, eradication of HIV infection cannot be achieved with available antiretrovirals. Treatment interruption has been associated with rebound viremia, worsening of immune function, and increased morbidity and mortality (HIV.gov, August 16, 2021).

Once initiated, ART should be continued, with the following key treatment goals:

  • Maximally and durably suppress plasma HIV RNA;
  • Restore and preserve immunologic function;
  • Reduce HIV-associated morbidity and prolong the duration and quality of survival; and
  • Prevent HIV transmission. (HIV.gov, August 16, 2021).

Achieving viral suppression requires the use of combination ARV regimens that generally include three active drugs from two or more drug classes. Patient characteristics and results from drug resistance testing guide design of the specific regimen. When initial HIV suppression is not achieved or not maintained, changing to a new regimen with at least two active drugs is often required. The increasing number of antiretroviral drugs and drug classes makes viral suppression below detection limits an achievable goal in most patients (HIV.gov, August 16, 2021).

After initiation of effective ART, viral load reduction to below detection usually occurs within the first 12 to 24 weeks of therapy. Predictors of virologic success include the following:

  • Low baseline viremia;
  • High potency of the antiretroviral regimen;
  • Tolerability of the regimen;
  • Convenience of the regimen; and
  • Excellent adherence to the regimen. (HIV.gov, August 16, 2021)

Proper patient education is essential for adherence to the prescribed schedule and monitoring of side effects. Regular testing after initial diagnosis for CD4 response guides medical personnel to the effectiveness of treatment, which reduces the chance of transmission, and calls attention to any opportunistic infections or drug resistance. Lab work to monitor CD4 should be done at 2 and 4 weeks after initiating drug therapy and then every 3 to 6 months.

Regular appointments to monitor kidney and liver function is recommended. Other complications from pharmacologic treatment should also be closely followed:

  • Nausea, vomiting
  • Poor appetite and weight loss
  • Osteopenia or osteoporosis
  • Hyperlipidemia
  • Hyperglycemia
  • Cognitive and emotional problems
  • Sleep disorders

Identifying what is due to the disease and what is due to medication side effects can be confusing. Regular physical exams will check for skin sores; swollen lymph node in the mouth, throat and neck, abdomen and groin; nervous system disorders; and respiratory complications.

Many studies have demonstrated that better outcomes are achieved when a clinician with HIV expertise cares for HIV-infected people as outpatients. Appropriate training and experience, as well as ongoing continuing education, are important components for optimal care.

Access to HIV Medications

In the early 2000s, lack of access to HIV/AIDS treatment was declared a global health emergency, and world leaders set a goal of universal access to antiretroviral therapy by 2010. By the end of 2020, more than 27 million people with HIV were getting ART treatment, representing about 73% of all people with HIV (HIV.gov, 2021, June 25).

The addition of new drugs and combination therapy has contributed to a decline in mortality for people infected with HIV but has placed the cost of treatment beyond the means of many people. Even the lowest price—U.S. $1800 to $4500 per person per month—for the first-line ART regimen remains out of reach for many patients in resource-limited settings (Nazario, 2020).

Name brand medications are beyond the means of many patients: Truvada costs $2,000/month and Epivir is $400 for a 30-day supply in the United States. The newer Biktarvy and Cabenuva are even more expensive.

Commercial and private insurance, Medicare, Medicaid, and other federal government programs such as Ryan White HIV/AIDS Program are available for drug assistance programs. Unfortunately, private insurance companies may charge high copayments. For more information see HIV.gov, which has an HIV Testing and Care Services Locator.

Second-line antiretrovirals have emerged, offering therapeutic improvements with fewer pills. Although the prices of some new second-line antiretrovirals have also declined in some countries, second-line treatment is nearly always more expensive than first-line treatment.

As treatment scales up globally, many HIV/AIDS patients receiving first-line therapies will need therapeutic alternatives. The cost of second- and third-line HIV/AIDS treatment and access to the latest ARV therapies is a problem of public health concern globally.

Rural and Underserved Areas

Primary care providers without HIV experience, such as those who provide service in rural or underserved areas, should identify experts in the region who will provide consultation when needed (DHHS, 2020, May 12).

Peer Support Increase Medication Adherence

Peer Support is an individual- and group-level intervention that aims to increase medication adherence among HIV-positive patients. Patients who are HIV-positive, taking antiretroviral therapy (ART), and adherent to their treatment are trained to serve as “peers” for patients who are either ART-experienced or ART-naïve and need additional support (CDC, 2021, August 2).

Patients who serve as peers provide medication-related social support through group meetings and weekly individual telephone calls. Group meetings are led by peers, who are supervised by agency or clinic program staff. The group meetings are designed to give patients an opportunity to engage face-to-face with their assigned peer, meet other peers and patients who are taking ART and share experiences with the group (CDC, 2021, August 2).

The Power of HIV-Positive Peers to Change Lives [5:27]

Two medical clinicians, at Highland Hospital, Oakland, CA and Kansas City Free Health Clinic, MO, talk about how HIV-positive peers have helped their patients link to care and adhere to treatment. From ThePEERCenter, 2009.


The weekly individual peer phone calls provide in-depth personal attention and feedback to answer any questions the patient may have felt uncomfortable asking during group meetings. Group discussions focus on identifying barriers to ART adherence and problem-solving strategies to overcome barriers (CDC, 2021, August 2).

Group meetings may also focus on life issues that may affect adherence, including disclosure, romantic relationships, substance use, and mental health issues. Based on issues identified by group members, peers may work with program staff to schedule speakers (e.g., nutritionist) to present during group sessions (CDC, 2021, August 2).

HIV and Viral Hepatitis Co-Infection

People infected with HIV are at risk for contracting viral hepatitis. About one-third of HIV-infected people are co-infected with either HBV or HCV.

Viral hepatitis progresses faster and causes more liver-related health problems among people with HIV due to their impaired immune response. Although drug therapy has extended the life expectancy of people with HIV, liver disease related to HBV and HCV has become the leading cause of non-AIDS-related deaths in this population (Lewis & Sifri, 2015).

To prevent co-infection with HBV, the Advisory Committee on Immunization Practices recommends universal HBV vaccination for high-risk patients with HIV. High-risk people are considered people who have multiple sex partners; gay, bisexual, and other men who have sex with men; injection drug users; and those who are exposed to blood at their jobs.

Co-infection with viral hepatitis can complicate the treatment and management of HIV. Because hepatitis infection combined with HIV may lead more quickly to liver damage, it is recommended that all people with HIV be tested for HBV and HCV (AASLD, 2020).

HIV/HBV and HIV/HCV co-infections can be effectively treated in many people, but treatment is complex and people with co-infection should look for healthcare providers with expertise in the management of both HIV infection and viral hepatitis.

Aging with HIV

As a result of improvements in effectiveness of antiretroviral therapy and initiation of HIV “treatment without delay”, people with HIV are surviving to older ages in the United States. Despite a concentration of new infections among younger ages, the proportion of people living with HIV over 60 years of age increased from 6% to 10% from 2014–2018 (Kasaie et al, 2022).

People who are aging with HIV have an increased burden of age-related chronic conditions, including renal impairment, cardiovascular disease, cancer, end-stage liver disease, hypertension, and diabetes. This is due to both chronic immune activation from the viral infection as well as metabolic outcomes linked to some earlier versions of antiretroviral medications. In addition, persons with HIV have a higher prevalence of traditional risk factors for age-related conditions, the most prominent being a higher prevalence of smoking (Althoff, 2021).

HIV and COVID-19 (SARS-CoV-2)

A fuller picture is emerging of the interplay between HIV infection and SARS-CoV-2 infection, and of COVID-19 vaccine response in people living with HIV. Evidence indicates that people living with HIV who acquire SARS-CoV-2 infection are at heightened risk of serious illness and death. The risk is especially high for people who are not controlling their HIV infection with antiretroviral therapy (UNAIDS, December 1, 2021).

A recent study involving 5.8 million people at 54 clinical sites in the U.S. found that living with HIV was associated with a 20% higher risk of being hospitalized for COVID-19 infection and a 29% higher risk of COVID-19 mortality. The risk of adverse outcomes among people living with HIV is highest among those who have low CD4 cell counts or detectable HIV viral loads. This highlights the importance and multiple benefits of successful HIV treatment (UNAIDS, December 1, 2021).

People living with HIV and with low CD4 cell counts may be at higher risk of poor COVID-19 outcomes even if they are virally suppressed. This suggests that people who have recently started HIV treatment or those who have experienced low CD4 cell counts for long periods may need closer observation if they acquire COVID-19. The CDC recommends a COVID-19 vaccine booster for people with advanced or untreated HIV (UNAIDS, December 1, 2021).

There is no evidence that HIV infection is associated with adverse reactions to current COVID-19 vaccines. There is conflicting evidence on whether people living with HIV may have weaker vaccine-induced antibody responses. A recent study in the U.S. reported a lower vaccine-induced antibody response in people living with HIV than in HIV-negative people, with the effect seeming to differ depending on the vaccine. The response was poorest in people with unsuppressed HIV infections. Antibodies, though, are not the only determinant of vaccine response, and this study did not measure T-cell responses (UNAIDS, December 1, 2021).