You may have seen a handy little graphic on what to use when starting HIV therapy. It appears in every issue of Positively Aware's Annual HIV Drug Guide, among other places. That graphic is taken from U.S. HIV treatment guidelines, but there is so much more to the guidelines than just that one table.
There are dozens of tables, in fact: advantages and disadvantages of every HIV drug; drug interactions between medications for HIV and those for opioid dependence; HIV drug combinations never to take; and so on and so forth. All basically handy-dandy little lists of good things to know.
Then there is the text, in mostly understandable language, though not fun to read. This 166-page manual can put you to sleep with just one paragraph. (To wit, its very title is "Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents." Simple, yes. Exciting? No.)
Some of the many topics covered include co-infection with hepatitis B and C; lab tests and how often to take them; HIV drug resistance; and adherence (how to take the medications correctly).
So you can think of the guidelines as a useful manual to race through, looking for what you need to know, when you need to know it. Just remember that the guidelines are just that -- a guide, not rules set in stone. And furthermore, that they are updated on a regular basis. Recommendations are rated according to the strength of the evidence behind them.
One of the best things about the guidelines is that they follow the ups and downs of treatment knowledge and controversy, although not necessarily instantaneously.
The guidelines are issued by the U.S. Department of Health and Human Services (DHHS), and produced by a panel of experts, including people living with HIV. The panel looks at the latest and most important data. For example, the consensus on when to start treatment has changed over the years from beginning at a low CD4+ T-cell count to starting at higher levels, and will continue to change. That question has not yet been absolutely answered!
In cases where the best scientific data has yet to be produced, the DHHS panel "attempted to reflect reasonable options in its conclusions." The manual also notes that, "Guidelines are only a starting point for medical decision-making. They can identify some of the boundaries of high-quality care but cannot substitute for sound judgment."
Another important use for the guidelines is to guide health care workers (the reason for its existence, actually), especially those providers with less experience in treating HIV. So, pointing out some information to your providers, as you see fit, might be helpful. It's also good to see what your providers might be thinking.
In addition to this most often referenced set of guidelines (for adults and adolescents), the DHHS also produces HIV treatment guidelines for opportunistic infections, pediatrics, pregnant women, and post-exposure prevention (both health care-related and non-medical). Moreover, the International AIDS Society-USA also produces a set of HIV treatment guidelines, as well as HIV drug resistance testing guidelines; go to www.iasusa.org. Go to www.aidsinfo.gov to view all the government guidelines. Note: DHHS no longer mails out copies.
Highlights From the Guidelines
The following are taken directly from the guidelines for HIV treatment from the U.S. Department of Health and Human Services, with minor editing:
- Patients living with HIV infection must often cope with multiple social, psychiatric, and medical issues that are best addressed through a patient-centered, multidisciplinary approach to the disease. The evaluation also must include assessment of high-risk behaviors, substance abuse, social support, mental illness, co-morbidities, economic factors (e.g., unstable housing), medical insurance status and adequacy of coverage, and other factors that are known to impair adherence to treatment and to increase the risk of HIV transmission. Once evaluated, these factors should be managed accordingly.
- It is critical that all newly diagnosed patients be educated about HIV disease and linked to care for full evaluation, follow-up, and management. Once in care, focused effort is required to retain patients in the health care system.
Initial evaluation should include:
- CD4 T-cell count;
- Plasma HIV RNA (viral load);
- Complete blood count, chemistry profile, transaminase levels, blood urea nitrogen (BUN) and creatinine, urinalysis, and serologies for hepatitis A, B, and C viruses;
- Fasting blood glucose and serum lipids; and
- Genotypic resistance testing at entry into care, regardless of whether [HIV treatment] will be initiated immediately.
- In addition, screening tests for sexually transmitted infections and tests for determining risk for opportunistic infections and need for prophylaxis [prevention], should be performed as recommended by HIV primary care and opportunistic infections guidelines.
- When ascertained in a simple, nonjudgmental, routine, and structured format that normalizes less-than-perfect adherence and minimizes socially desirable responses [providers should be neutral -- not showing disapproval when behavior is undesirable; patients may feel pressured to lie to avoid disapproval], patient self-report remains the most useful method for the assessment and longitudinal [long-term] monitoring of a patient's adherence in the clinical setting.
- More recent data suggest that most virologic failure on first-line regimens occurred due to either pre-existing (transmitted) drug resistance or suboptimal adherence.
- For incomplete adherence, identify and address the underlying cause(s) (e.g., difficulties accessing or tolerating medications, depression, active substance abuse) and simplify the regimen if possible (e.g., decrease pill count or dosing frequency).
- Assess the patient's tolerance of the current regimen and the severity and duration of side effects, keeping in mind that even minor side effects can impact adherence. Management strategies for intolerance in the absence of drug resistance may include:
- using symptomatic treatment (e.g., anti-emetics and anti-diarrheals)
- changing one ARV to another within the same drug class, if needed (e.g., change to [Viread] or [Ziagen] for [zidovudine]-related toxicities; change to [Viramune] or [Intelence] for [Sustiva]-related toxicities)
- changing from one drug class to another (e.g., from a non-nucleoside reverse transcriptase inhibitor [NNRTI] to a protease inhibitor [PI], from [fusion inhibitor Fuzeon] to [integrase inhibitor Isentress]) if necessary and no prior drug resistance is suspected
- Review food/fasting requirements for each medication. Review recent history of gastrointestinal symptoms (such as vomiting or diarrhea) to assess the likelihood of short-term malabsorption. Review concomitant [taken at the same time] medications and dietary supplements for possible adverse drug-drug interactions (consult Drug Interactions section and tables for common interactions) and make appropriate substitutions for ARV agents and/or concomitant medications, if possible. [There is also a section on how to simplify treatment.]
- Viremia "blips" (e.g., viral suppression followed by a detectable HIV RNA level [viral load] and then subsequent return to undetectable levels) usually are not associated with subsequent virologic failure.
- For some highly ART-experienced patients, maximal virologic [viral load] suppression is not possible. In this case, ART should be continued with regimens designed to minimize toxicity, preserve CD4 cell counts, and avoid clinical progression [disease]. [See much more information on this topic in the guidelines.]
- Education about HIV risk behaviors and effective strategies to prevent HIV transmission should be provided at each patient visit. ... Each patient encounter provides opportunities to reinforce HIV prevention messages -- messages that patients often look to their providers to deliver but may fail to receive. [See the guidelines for more on prevention.]
- The guidelines cannot always keep pace with the rapid evolution of new data in this field, and they cannot provide guidance for all patients. Clinicians should exercise clinical judgment in management decisions tailored to unique patient circumstances.