"Antiretroviral therapy (ART) for the treatment of [HIV] infection has improved steadily since the advent of potent combination therapy in 1996," the guidelines authors write. "New drugs have been approved that offer new mechanisms of action, improvements in potency and activity even against multidrug-resistant viruses, dosing convenience, and tolerability."
Topics covered in the updated and in previous guidelines have included baseline evaluation, treatment goals, indications for starting ART, choosing initial therapy in ART-naive patients, drugs or combinations to be avoided, managing adverse effects and drug interactions, managing treatment failure, and ART-related considerations directed to specific patient populations.
A new section in the updated guidelines addresses HIV diagnosis and treatment considerations in older patients with HIV infection, who often have more comorbid conditions, which complicates treatment. A new table lists the monthly average wholesale price for US Food and Drug Administration–approved brand and generic antiretroviral (ARV) drugs, including fixed-dose combination products.
Key updates to existing sections of the guidelines include the following:
- Starting ART in treatment-naive patients:
- ART is recommended for all HIV-infected individuals, but the strength of this recommendation varies according to CD4 cell count before treatment.
- Regardless of CD4 count, starting ART is strongly recommended for patients who are pregnant or who have a history of an AIDS-defining illness, HIV-associated nephropathy, or coinfection with hepatitis B virus.
- ART should be offered to infected patients, particularly heterosexuals, who are at risk of transmitting HIV to sexual partners.
- Patients starting ART should understand the benefits and risks and be willing and able to adhere to treatment. On a case-by-case basis, clinicians may decide to defer therapy because of specific clinical and/or psychosocial factors.
- HIV-infected women: The update explains the use of hormonal contraception in HIV-infected women, including interactions between combined oral contraceptives and ARV drugs and a possible association between hormonal contraceptive use and HIV acquisition or transmission.
- HIV/hepatitis C virus (HCV) coinfection: The update highlights the newly approved HCV NS3/4A protease inhibitors boceprevir and telaprevir, their interactions with ART, available evidence regarding ongoing research in HIV/HCV coinfected patients, and preliminary recommendations on administering these drugs with ART.
- Mycobacterium tuberculosis disease with HIV coinfection: The update includes recommendations about when to start ART in HIV-infected patients diagnosed with tuberculosis but not yet receiving ART. Specific recommendations are based on CD4 counts and severity of major clinical disease.
- Drug interaction tables: Based on recent pharmacokinetic data, key updates include:
- a change in the recommendation on rifabutin dosing with HIV protease inhibitors;
- a new recommendation not to use HIV protease inhibitors and nonnucleoside reverse transcriptase inhibitors with rifapentine;
- additional information and recommendations on interactions of boceprevir and telaprevir with different ARV drugs; and
- updated interactions between different ritonavir-boosted protease inhibitors and HMG-CoA reductase inhibitors.
- Prevention of secondary HIV transmission: The update describes the role of effective ART in preventing HIV transmission and evidence-based interventions to facilitate identifying and counseling patients with high-risk behaviors.
Some of the study authors report various financial relationships with Bristol-Myers Squibb, Genentech/Roche, Janssen Therapeutics (formerly Tibotec Therapeutics), Merck, Abbott, Gilead, ViiV, GlaxoSmithKline, Hoffmann-La Roche, Tobira, Sanofi Pasteur, Abbott, RAPID Pharmaceuticals, Sangamo Biosciences, MedImmune, ViroStatics, Tai-Med, Medicines Dev Ltd, Pfizer, Virionyx Corp Ltd, Avexa, Human Genome Sciences, Oncolys, Roche, Vertex, VIRxSYS, Ardea Biosciences Avexa, Monogram Biosciences, Pain Therapeutics, Serono, Teva, Argos, BMS, and/or Boehringer Ingelheim.