Page 156 - HIV/AIDS Guidelines

coinfected patients have received HIV PIs and boceprevir during HCV treatment. Patients who are
currently receiving these drug combinations should be advised not to stop any medication until
contacting their health care providers. If therapy with HIV PIs and boceprevir is continued, patients
should be closely monitored for HIV and HCV responses and consideration should be given to switching
the HIV PI or EFV to RAL during boceprevir therapy. Additional clinical trial data are needed to
determine if other ARVs may be coadministered with boceprevir.
• Telaprevir is approved for the treatment of HCV genotype 1 infection in patients without HIV infection.
Telaprevir is administered in combination with PegIFN/RBV for the initial 12 weeks of HCV therapy
followed by 12 or 36 weeks of additional treatment with PegIFN/RBV. Data on the use of this regimen in
HIV/HCV-coinfected individuals are limited. In 1 small study of coinfected patients, higher HCV
response was observed with telaprevir plus PegIFN/RBV (38 patients) than with PegIFN/RBV alone (22
patients). In this study, patients received ART containing EFV or ATV/r plus tenofovir/emtricitabine
(TDF/FTC) or no ART during the HCV therapy. 44
Because telaprevir is a substrate and an inhibitor of CYP3A4 and p-gp enzymes, the drug may interact with
ARVs metabolized by these pathways. On the basis of drug interaction studies in healthy volunteers and data
on responses in coinfected patients enrolled in the small clinical trial noted above, telaprevir can be
coadministered with ATV/r and RAL at the standard recommended dose of telaprevir (750 mg every 7–9
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hours) and with EFV at an increased dose of telaprevir (1125 mg every 7–9 hours) (see Table 15b); however,
coadministration of telaprevir with DRV/r, fosamprenavir/ritonavir (FPV/r), or LPV/r is not recommended
because of bidirectional drug interactions. Data on PK interactions of telaprevir with other ARVs including
45
non-nucleoside reverse transcriptase inhibitors (NNRTIs) other than EFV and with maraviroc (MVC) are not
available; therefore, coadministration of telaprevir with other ARVs cannot be recommended.

Following are preliminary recommendations for the use of boceprevir or telaprevir in HIV patients
coinfected with HCV genotype 1 based on current ART use. These recommendations may be modified
as new drug interaction and clinical trial information become available.

Patients not on ART: Use either boceprevir or telaprevir
Patients receiving RAL + 2-NRTI: Use either boceprevir or telaprevir
Patients receiving ATV/r + 2-NRTI: Use telaprevir at standard dose. Do not use boceprevir.
Patients receiving EFV + 2-NRTI: Use telaprevir at increased dose of 1125 mg every 7–9 hours.
Do not use boceprevir.
Patients receiving other ARV regimens:

• If HCV disease is minimal (i.e., no or mild portal fibrosis), consider deferring HCV treatment
given rapidly evolving HCV drug development.

• If good prognostic factors for HCV treatment response are present—IL28B CC genotype or low
HCV RNA level (<400,000 International Unit [IU]/mL)—consider use of PegIFN/RBV without
HCV NS3/4A PI.
• On the basis of ART history and HIV genotype testing results, if possible, consider switching to
the ART regimens listed above to permit the use of boceprevir or telaprevir.
• For patients with complex ART history or resistance to multiple classes of ART, consultation with
experts regarding the optimal strategy to minimize the risk of HIV breakthrough may be needed.
In such patients, telaprevir may be the preferred HCV NS3/4A PI because its duration of use (12
weeks) is shorter than that of boceprevir (24 to 44 weeks).

Summary:
In summary, HCV coinfection and use of PegIFN/RBV with or without HCV NS3/4A PIs (telaprevir or
boceprevir) to treat HCV may impact the treatment of HIV because of increased pill burden, toxicities, and

Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents J-8

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