Brief HCV/HIV Considerations for Antiretroviral Use in Patients with Coinfections Adult and Adolescent ARV

The Department of Health and Human Services (HHS) Panel on Antiretroviral Guidelines for Adults and Adolescents is accepting nominations for new scientific/clinical members with expertise in HIV medicine, as well as nominations for a community representative. Nominations should be submitted to Alice Pau, Pharm.D., electronically (apau@niaid.nih.gov) by no later than January 10, 2020.

For more information on the scientific/clinical member nomination requirements, please read this news announcement.

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Considerations for Antiretroviral Use in Patients with Coinfections

Hepatitis C Virus/HIV Coinfection

Last Updated: October 25, 2018; Last Reviewed: October 25, 2018

Panel's Recommendations Regarding Hepatitis C Virus/HIV Coinfection
Panel's Recommendations
All people with HIV should be screened for hepatitis C virus (HCV) infection (AIII). Patients at high risk of HCV infection should be screened annually and whenever incident HCV infection is suspected (AIII). Antiretroviral therapy (ART) may slow the progression of liver disease by preserving or restoring immune function and reducing HIV-related immune activation and inflammation. For most persons with HCV/HIV coinfection, including those with cirrhosis, the benefits of ART outweigh concerns regarding drug-induced liver injury. Therefore, ART should be initiated in all patients with HCV/HIV coinfection, regardless of CD4 T lymphocyte cell count (AI). Initial ART regimens that are recommended for most patients with HCV/HIV coinfection are the same as those recommended for individuals without HCV infection. However, when treatment for both HIV and HCV is indicated, the ART and HCV treatment regimens should be selected with special consideration for potential drug-drug interactions and overlapping toxicities (AIII) (see discussion in the text below and in Table 15). All patients with HCV/HIV coinfection should be evaluated for HCV therapy, which includes having their liver fibrosis stage assessed to inform the length of their therapy and subsequent risk of hepatocellular carcinoma and liver disease complications (AIII). Persons with chronic HCV/HIV coinfection should be screened for active and prior hepatitis B virus (HBV) infection by testing for the presence of hepatitis B surface antigen (HBsAg) and antibodies to hepatitis B surface (HBsAb) and core (HBcAb; total or IgG). Persons who are not immune to HBV infection (HBsAb negative) should receive anti-HBV vaccination (AIII). HBV reactivation has been observed in persons with HBV infection during HCV treatment with direct-acting antivirals (DAAs). Accordingly, persons with HCV/HIV coinfection and active HBV infection (HBsAg positive) should receive ART that includes two agents with anti-HBV activity prior to initiating HCV therapy (AIII).
Rating of Recommendations: A = Strong; B = Moderate; C = Optional Rating of Evidence: I = Data from randomized controlled trials; II = Data from well-designed nonrandomized trials or observational cohort studies with long-term clinical outcomes; III = Expert opinion

Table 15. Concomitant Use of Selected Antiretroviral Drugs and Hepatitis C Virus Direct-Acting Antiviral Drugs for Treatment of Hepatitis C Virus in Adults with HIV

The recommendations in this table for concomitant use of selected HIV drugs with FDA-approved HCV DAA drugs are based on available PK interaction data or are predictions based on the known metabolic pathway of the agents. In some cases, there are not enough data to make any recommendations, and these instances are indicated in the table. In all cases where HIV and HCV drugs are used concomitantly, patients should be closely monitored for HIV and HCV virologic efficacy and potential toxicities. As the field of HCV therapy is rapidly evolving, readers should also refer to the latest drug product labels and the HCV Guidance for updated information.

Note: Interactions with FPV, IDV, NFV, and SQV are not included in this table. Please refer to the FDA product labels for information regarding drug interactions with these HIV PIs.

Table 15. Concomitant Use of Selected Antiretroviral Drugs and Hepatitis C Virus Direct-Acting Antiviral Drugs for Treatment of Hepatitis C Virus in Adults with HIV
Selected HIV Drugs	HCV Direct-Acting Antiviral Agents
	NS5A Inhibitor	NS5B Inhibitor	Coformulated
					SHOULD NOT BE USED IN THOSE WITH MODERATE TO SEVERE HEPATIC IMPAIRMENT (Cirrhosis classified as Child Pugh class B or C)
			NS5A/NS5B Inhibitor	NS5A/NS5B Inhibitor	NS5A/NS5B Inhibitor/NS3/4A Protease Inhibitor	NS5A Inhibitor/NS3/4A Protease Inhibitor	NS5A Inhibitor/NS3A/4A Protease Inhibitor	NS5A Inhibitor/NS3A/4A Protease Inhibitor plus NS5B Inhibitor	NS3A/4A Protease Inhibitor^a
	Daclatasvir	Sofosbuvir	Ledipasvir/ Sofosbuvir	Sofosbuvir/ Velpatasvir	Sofosbuvir/ Velpatasvir/ Voxilaprevir	Glecaprevir/ Pibrentasvir	Elbasvir/ Grazoprevir	Ombitasvir/ Paritaprevir/ Ritonavir plus Dasabuvir^a	Simeprevir
NRTIs
3TC	√	√	√	√	√	√	√	√	√
ABC	√	√	√	√	√	√	√	√	√
FTC	√	√	√	√	√	√	√	√	√
TDF	√	√	√ Monitor for TDF toxicity.	√ Monitor for TDF toxicity.	√ Monitor for TDF toxicity.	√	√	√	√
TAF	√	√	√	√	√	√	√	√	√
PIs
Unboosted ATV	√	√	√	√	X	X	X	√^b	X
ATV/r or ATV/c	√ ↓ DCV dose to 30 mg/day	√	√ If a PI/r or PI/c is used with TDF, ↑ TDF concentrations are expected. If coadministration is necessary, monitor for TDF-associated toxicities.^d	√ If a PI/r or PI/c is used with TDF, ↑ TDF concentrations are expected. If coadministration is necessary, monitor for TDF-associated toxicities.^d	X	X	X	√^c	X
DRV/r or DRV/c	√	√			√ If a PI/r is used with TDF, ↑ TDF concentrations. Monitor for TDF-associated toxicities.^d Consider monitoring for hepatotoxicity.^e	X	X	X	X
LPV/r	√	√			X	X	X	X	X
TPV/r	?	X	X	X	X	X	X	X	X
NNRTIs
DOR	√	√	√ If used with TDF, monitor for TDF toxicity.	√	√	√	√	√	√
EFV	√ ↑ DCV dose to 90 mg/day	√		X	X	X	X	X	X
ETR	√ ↑ DCV dose to 90 mg/day	√		X	X	X	X	X	X
NVP	√ ↑ DCV dose to 90 mg/day	√		X	X	X	X	X	X
RPV	√	√		√	√	√	√	X	√
INSTIs
BIC/TAF/FTC	√	√	√	√	√	√	√	√	√
DTG	√	√	√ If used with TDF, monitor for TDF toxicity.	√	√	√	√	√	√
EVG/ c/ TDF/ FTC	√ ↓ DCV dose to 30 mg/day	√	X	√ If used with TDF, monitor for TDF toxicity	√ If used with TDF, monitor for TDF toxicity. Consider monitoring for hepatotoxicity.^e	√ If used with TDF, monitor for TDF toxicity. Consider monitoring for hepatotoxicity.^f	X	X	X
EVG/ c/ TAF/ FTC	√ ↓ DCV dose to 30 mg/day	√	√	√	√ Consider monitoring for hepatotoxicity.^e	√ Consider monitoring for hepatotoxicity.^f	X	X	X
RAL	√	√	√	√	√	√	√	√	√
CCR5 Antagonist
MVC	√	√	√	√	√	√	√	X	√
^a Dasabuvir must be prescribed with ombitasvir/paritaprevir/RTV. ^b Reduce ATV dose to 300 mg and instruct the patient to take it in the morning at same time as ombitasvir/paritaprevir/RTV plus dasabuvir. If RTV cannot be used, choose an alternative HCV regimen. ^c This HCV regimen contains RTV. If ATV is part of the ARV regimen, prescribe ATV 300 mg without COBI or RTV. It should be taken in the morning at the same time as ombitasvir/paritaprevir/RTV plus dasabuvir. Resume RTV or COBI regimen when HCV therapy is completed. ^dConsider using an alternative HCV treatment or ARV regimen to avoid increases in TDF exposure. If co-administration is necessary, monitor patient for TDF-associated adverse reactions. ^e Voxilaprevir exposures can increase when it is coadministered with pharmacologically boosted DRV or EVG. Until more safety data in clinical settings becomes available, patients who are receiving voxilaprevir and pharmacologically boosted DRV or EVG should be monitored for hepatotoxicity. ^f Glecaprevir exposures can increase when it is coadministered with EVG/c. Until more safety data in clinical settings becomes available, patients who are receiving glecaprevir and EVG/c should be monitored for hepatotoxicity. Key to Symbols: √ = ARV agents that can be used concomitantly X = ARV agents not recommended ? = data limited or not available on pharmacokinetic interactions with ARV drug ↑ = increase ↓ = decrease Key to Acronyms: 3TC = lamivudine; ABC = abacavir; ARV = antiretroviral; ATV = atazanavir; ATV/c = atazanavir/cobicistat; ATV/r = atazanavir/ritonavir; BIC = bictegravir; COBI = cobicistat; DAA = direct-acting antiviral agents; DCV = daclatasvir; DOR = doravirine; DRV = darunavir; DRV/c = darunavir/cobicistat; DRV/r = darunavir/ritonavir; DTG = dolutegravir; DSV = dasabuvir; EFV = efavirenz; ETR = etravirine; EVG = elvitegravir; FDA = Food and Drug Administration; EVG/c = elvitegravir/cobicistat; FPV = fosamprenavir; FTC = emtricitabine; HCV = hepatitis C virus; IDV = indinavir; INSTI = integrase strand transfer inhibitor; LPV/r = lopinavir/ritonavir; MVC = maraviroc; NNRTI = non-nucleoside reverse transcriptase inhibitor; NRTI = nucleoside reverse transcriptase inhibitor; NVP = nevirapine; PI = protease inhibitor; PI/c = protease inhibitor/cobicistat; PI/r = protease inhibitor/ritonavir; PK = pharmacokinetic; RAL = raltegravir; RPV = rilpivirine; RTV = ritonavir; SQV = saquinavir; TAF = tenofovir alafenamide; TDF = tenofovir disoproxil fumarate; TPV/r = tipranavir/ritonavir

Table 15. Concomitant Use of Selected Antiretroviral Drugs and Hepatitis C Virus Direct-Acting Antiviral Drugs for Treatment of Hepatitis C Virus in Adults with HIV

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