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Selected Highlights from the New EACS Guidelines for Treatment of HIV-infected Adults

• Complete medical history.

• Physical examination (including body mass index, blood pressure).

• Laboratory evaluation:

- HIV antibody status;

- Plasma HIV RNA;

- Genotypic resistance testing, determination of HIV subtype;

- HLA-B*5701 testing (for abacavir hypersensitivity);

- Absolute CD4 cell count and percentage (CD8 optional);

- Complete blood count;

- ALT and AST;

- Testing for other infections: toxoplasma; CMV; hepatitis A, B, C; syphilis and other sexually transmitted infections;

- Fasting blood glucose and lipid levels;

- Urine protein and sugar.

- Other tests (e.g., alkaline phosphatase, creatinine clearance, amylase, lipase) that may provide further useful information.

• Cervical Pap smear for women (anal Pap smears for at-risk men and women were not recommended, but some experts think they should be).

• Assessment of social and psychological condition.

• Hepatitis A and B and pneumococcal vaccines if appropriate.

• Patients not on treatment:

- At least every 6 months: CD4 cell count and percentage, complete blood count, HIV viral load.

- Every year: physical examination, evaluation of social and psychological support, smoking cessation, other infections (including hepatitis B and C), cervical Pap smear, fasting blood lipids, alpha-fetoprotein and ultrasound for patients with liver cirrhosis.

• Patients on antiretroviral therapy: HIV RNA, CD4 cell count and percentage (CD8 optional), complete blood count, creatinine, ALT and AST, bilirubin, fasting blood glucose and lipids, and other tests for side effects related to specific drugs.

• Participation in a clinical trial.

• Treatment indicated if patient has an AIDS-defining illness or CD4 count below 350 cells/mm3 after 3 months.

• Treatment should be considered if patient has severe illness or prolonged symptoms (especially central nervous system symptoms).

• In most cases, wait 6 months, then follow guidelines for treatment of chronic HIV infection.

• Resistance testing is advised as soon as possible during acute infection.

• Counsel patients about risk of other sexually transmitted diseases and prevention of HIV transmission to others.

• Treatment is recommended for patients with advanced HIV disease (CDC stage B or C), and as soon as possible for those with opportunistic illnesses.

• Treatment is recommended without delay for patients with a CD4 count below 200 cells/mm3.

• Treatment is recommended if CD4 count is 201-350 cells/mm3.

• Treatment may be offered if CD4 count is 350-500 cells/mm3 depending on factors such as HIV viral load, speed of CD4 cell decline, HCV coinfection, and older age.

• Treatment should be deferred if CD4 count > 500 cells/mm3.

• Genotypic resistance testing is recommended before starting treatment (ideally at the time of diagnosis).

• Efavirenz (Sustiva, Stocrin); not recommended for pregnant women.

• Nevirapine (Viramune); should be used cautiously in people with relatively high CD4 cell counts (> 250 cells/mm3 for women or > 400 cells/mm3 for men).

• Recommended:

-Ritonavir-boosted fosamprenavir (Lexiva, Telzir).

- Lopinavir/ritonavir (Kaletra).

- Ritonavir-boosted saquinavir (Invirase).

• Alternative:

- Ritonavir-boosted atazanavir (Reyataz); although it offers once-daily convenience, it is not approved by the European Medicines Agency for treatment-naive people.

• Recommended:

- Abacavir (Ziagen) + 3TC (Epivir); upgraded since the new HLA-B*5701 genetic test helps determine which people are at risk of abacavir hypersensitivity reactions.

- Tenofovir (Viread) + emtricitabine (Emtriva).

• Alternative:

- AZT (Retrovir) + 3TC; downgraded from a recommended backbone in the previous guidelines, as AZT has raised increasing toxicity concerns.

- ddI (Videx) + 3TC or emtricitabine (only if recommended options are unavailable or cannot be tolerated).

• Try to determine the reasons for treatment failure, evaluating adherence, drug tolerance, interactions, psychosocial issues.

• Use resistance testing to assess which drugs still work (most reliable after viral load has risen to 500-1000 copies/mL).

• Consider therapeutic drug level monitoring to assess whether concentrations are adequate.

• If HIV RNA is between 50 and 500-1000 copies/mL, recheck in 1-2 months (this could be an isolated viral load "blip" that does not indicate treatment failure).

• If viral load is confirmed > 500-1000 copies/mL, change the regimen as soon as possible, guided by resistance testing.

• On the new regimen, viral load should fall to < 400 copies/mL after 3 months and < 50 copies/mL after 6 months.

• If HIV has demonstrated resistance mutations, switch to 2 (and preferably 3) new active drugs.

• Regimens after treatment failure should include at least 1 drug from a previously unused class (which now may include fusion inhibitors, CCR5 inhibitors, or integrase inhibitors).

• If a patient does not have 2 new active drugs available, defer switching unless the person has a very low CD4 cell count (< 100 cells/mm3) or high risk of disease progression.

• The entire regimen should be optimized based on treatment history and resistance testing.

• If multiple options are available, take into account convenience, toxicity, drug interactions, and future treatment.

• The goal is full suppression of HIV RNA by the time of delivery, and preferably by the third trimester.

• Monitor women every month as the delivery date approaches.

• Criteria for starting antiretroviral therapy are the same as for non-pregnant adults.

• If a woman becomes pregnant while on HAART, she should stay on therapy but switch drugs that are potentially harmful to the developing fetus (e.g., efavirenz).

• If a woman is treatment-naive and needs HAART based on CD4 cell count, ideally start therapy after the first trimester.

• If a woman is treatment-naive and does not yet need treatment, start antiretroviral therapy at week 28 of pregnancy, or earlier if viral load is high.

• Start treatment immediately if a woman is first seen after week 28 of pregnancy.

• Regimen choices are the same as for adults in general except:

- Avoid efavirenz, which can cause birth defects.

- Avoid tenofovir; U.S. perinatal guidelines list tenofovir as non-preferred due to insufficient data in pregnant women, but do not say it is contraindicated).

- Avoid the ddI + d4T combination;

• Abacavir and nevirapine should not be newly started, but a woman already taking them can continue.

• Preferred protease inhibitors are lopinavir/ritonavir and ritonavir-boosted saquinavir.

• AZT should be included in the regimen if possible, due to its ability to prevent mother-to-child HIV transmission.

• The benefits of intravenous AZT (as recommended in the U.S. perinatal guidelines) is unclear if the woman has a viral load below 50 copies/mL.

• Single-dose nevirapine during labor is not recommended.

• Cesarean section is recommended unless viral load is undetectable near the end of pregnancy (weeks 34-36).