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choice for treatment-na ve patients without significant drug resistance b Nevirapine The target dose of nevirapine is 200 mg orally twice daily, but it is initiated at a dose of 200 mg once a day to decrease the incidence of rash, which is as high as 40% when full doses are begun immediately If rash develops while the patient is taking 200 mg a day, liver enzymes should be checked and the dose should not be increased until the rash resolves Patients with mild rash and no evidence of hepatotoxicity can continue to be treated with nevirapine The hepatotoxicity of the drug can be fatal, particularly in women and those patients with high CD4 counts (> 250/mcL), which limits its role as a first-line agent In light of potential fatal hepatotoxicity, nevirapine should be considered a second-line choice after efavirenz in most clinical settings c Delavirdine Of the three available NNRTIs, delavirdine is least used largely as a result of its less convenient dosing and pill burden compared with the other available NNRTIs Unlike nevirapine and efavirenz, delavirdine inhibits P450 cytochromes rather than inducing these enzymes This means that delavirdine can act like ritonavir and boost other antiretrovirals, although delavirdine is not as potent as ritonavir in this capacity The dosage is 400 mg orally three times a day The major side effect is rash 4 Novel agents a Entry inhibitors Peptide T-20 (enfuvirtide) is the first drug in the new class of fusion inhibitors, which block the entry of HIV into cells The addition of enfuvirtide to an optimized antiretroviral regimen improved CD4 counts and lowered viral loads in heavily pretreated patients with multidrug-resistant HIV The dose is 90 mg by subcutaneous injection twice daily b CCR5 antagonists There are currently two CCR5 inhibitors in development Although the exact role and level of activity of this new class of drugs have not been fully defined, it is clear that there is good antiviral activity and when combined with other active drugs can result in excellent virologic responses This class of entry inhibitors is only active against R5 tropic virus This form of the HIV-1 virus tends to predominate early in infection, while so called dual/mixed tropic virus (which utilizes either R5 or CXCR4 co-receptors) emerges later as infection progresses This selectivity will limit the role of this class of drugs compared with the other classes of antiretrovirals available c Integrase inhibitors HIV integrase inhibitors are currently in phase II/III clinical trials and early reports suggest excellent antiviral activity Because these drugs target a different enzyme of the HIV virus, there is great optimism that they will be helpful for patients who are resistant to other classes of medications and that they might help prevent resistance by use with available medications that target the reverse transcriptase and protease enzymes The first of these drugs, MK0518, is expected to be approved by the FDA in 2007 d Maturation inhibitors Recently, a drug has been tested in humans that appears to interfere with the matura-
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tion of HIV virions This represents a promising new potential target for HIV drug development 5 Constructing regimens There is now little debate about the necessity for combining drugs to achieve long-term suppression of HIV and its associated clinical benefit Only combinations of three or more drugs have been able to decrease HIV viral load by 2 3 logs and allow suppression of HIV RNA to below the threshold of detection for longer than 10 years in some individuals Current evidence supports the use of Truvada (tenofovir and emtricitabine) as the nucleoside/nucleotide backbone combined with efavirenz as the initial regimen This regimen has been shown to be more effective and better tolerated than Combivir (zidovudine and lamivudine) It has the advantages of once daily dosing and is available as a single pill (Atripla) Because 8 10% of newly infected persons in some urban areas of the United States have NNRTI resistance, resistance testing should be performed before initiating efavirenz in this population There are increasing data to suggest the virologic and clinical inferiority of regimens that include only nucleoside and nucleotide analogs without nonnucleoside agents or PIs Thus, triple nucleoside/nucleotide regimens should be avoided when other options exist In the absence of head-tohead comparisons of different regimens in different situations, several general principles should guide the choice of combinations The most important determinant of treatment efficacy is adherence to the regimen Therefore, it is vitally important that the regimen chosen be one to which the patient can easily adhere In general, patients are more compliant with medication regimens that are once or twice a day only, do not require special timing with regard to meals, can be taken at the same time as other medications, do not require refrigeration or special preparation, and do not have bothersome side effects To the extent possible, agents to which the patient has not been exposed are preferable to drugs for which resistance mutations may have already occurred Toxicities should ideally be nonoverlapping An individual s relative contraindications to a given drug or drugs should be considered The regimen should not include agents that are either virologically antagonistic or incompatible in terms of drug drug interactions Compatible dosing schedules prescribing medications that can be taken at the same time improve adherence to treatment Finally, highly complex therapeutic regimens should be reserved for individuals who are capable of adhering to the rigorous demands of taking multiple medications and having this therapy closely monitored Conversely, simplified regimens that deliver the lowest number of pills given at the longest possible dosing intervals are desirable for patients who have difficulty taking multiple medications Possible ways of incorporating nonnucleoside agents and PIs into combinations are displayed in Figure 31 2 A number of points about the nucleoside/nucleotide backbone of regimens have become clearer The combination of stavudine plus didanosine should be avoided, since there is increased risk of toxicities, in particular in pregnant women because of the increased risk of lactic acidosis, which can be fatal Moreover, the nucleoside pair of zidovudine and stavudine should be avoided because of increased toxicity and
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