Trial Outcomes & Findings for A Study to Treat Subjects With Telaprevir, Ribavirin, and Peginterferon Who Are Coinfected With HIV and Hepatitis C Virus (HCV) (NCT NCT01467479)

Last Updated: 2015-03-17

Results Overview

SVR 12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (\<lower limit of quantification) at 12 weeks after last planned dose of study drug. The plasma hepatitis C virus ribonucleic acid (HCV RNA) level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL).

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

185 participants

Primary outcome timeframe

12 weeks after last planned dose of study drug (up to Week 60)

Results posted on

2015-03-17

Participant Flow

Study included Treatment-Naïve (no prior hepatitis C virus \[HCV\] therapy); Prior Relapser (prior HCV treatment with pegylated interferon alfa/ribavirin \[Peg-IFN/RBV\] and experienced viral relapse); and Prior Null/Partial Responder (prior HCV treatment with Peg-IFN/RBV and had null/partial response) participants.

Efficacy analyses were reported as per highly active antiretroviral therapy (HAART) treatment (reporting arms) and also separately as per prior response (in categories) (Treatment-Naive, Prior Relapser, Prior Null Responder, Prior Partial Responder as well as for Total Participants), unless otherwise specified.

Participant milestones

Participant milestones
Measure	T/PR + HAART Regimen (ATV/r-Based) Participants who were receiving atazanavir/ritonavir (ATV/r) based HAART at baseline, received Telaprevir (T)1125 milligram (mg) tablet twice daily for 12 weeks in combination with pegylated interferon alfa 2a (P) (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (R) (RBV) tablet orally twice daily at a dose of 800 milligram per day (mg/day) for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.	T/PR + HAART Regimen (EFV-Based) Participants who were receiving efavirenz (EFV) based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.	T/PR + HAART Regimen (RAL-Based) Participants who were receiving raltegravir (RAL) based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
Overall Study STARTED	55	69	61
Overall Study Treated	54	69	59
Overall Study COMPLETED	46	52	45
Overall Study NOT COMPLETED	9	17	16

Reasons for withdrawal

Reasons for withdrawal
Measure	T/PR + HAART Regimen (ATV/r-Based) Participants who were receiving atazanavir/ritonavir (ATV/r) based HAART at baseline, received Telaprevir (T)1125 milligram (mg) tablet twice daily for 12 weeks in combination with pegylated interferon alfa 2a (P) (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (R) (RBV) tablet orally twice daily at a dose of 800 milligram per day (mg/day) for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.	T/PR + HAART Regimen (EFV-Based) Participants who were receiving efavirenz (EFV) based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.	T/PR + HAART Regimen (RAL-Based) Participants who were receiving raltegravir (RAL) based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
Overall Study No Study Medication	1	0	2
Overall Study Adverse Event	1	2	0
Overall Study Death	0	0	1
Overall Study Lost to Follow-up	2	5	3
Overall Study Withdrawal of Consent	3	7	7
Overall Study Study Terminated by Sponsor	1	3	3
Overall Study Other	1	0	0

Baseline Characteristics

A Study to Treat Subjects With Telaprevir, Ribavirin, and Peginterferon Who Are Coinfected With HIV and Hepatitis C Virus (HCV)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	T/PR + HAART Regimen (ATV/r-Based) n=54 Participants Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.	T/PR + HAART Regimen (EFV-Based) n=69 Participants Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.	T/PR + HAART Regimen (RAL-Based) n=59 Participants Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.	Total n=182 Participants Total of all reporting groups
Age, Continuous	50.4 years STANDARD_DEVIATION 8.81 • n=5 Participants	49.6 years STANDARD_DEVIATION 8.84 • n=7 Participants	48.4 years STANDARD_DEVIATION 9.58 • n=5 Participants	49.5 years STANDARD_DEVIATION 9.06 • n=4 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	9 Participants n=7 Participants	15 Participants n=5 Participants	30 Participants n=4 Participants
Sex: Female, Male Male	48 Participants n=5 Participants	60 Participants n=7 Participants	44 Participants n=5 Participants	152 Participants n=4 Participants

PRIMARY outcome

Timeframe: 12 weeks after last planned dose of study drug (up to Week 60)

Population: Safety Set included all participants who received at least 1 dose of study drug. Here, n = participants evaluable for specified category for each arm, respectively.

Outcome measures

Outcome measures
Measure	T/PR + HAART Regimen (ATV/r-Based) n=54 Participants Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.	T/PR + HAART Regimen (EFV-Based) n=69 Participants Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.	T/PR + HAART Regimen (RAL-Based) n=59 Participants Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
Percentage of Participants With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12) Treatment Naïve (n= 24, 39, 31)	66.7 percentage of participants	59.0 percentage of participants	61.3 percentage of participants
Percentage of Participants With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12) Prior Relapser (n=8, 11, 4)	75.0 percentage of participants	54.5 percentage of participants	100 percentage of participants
Percentage of Participants With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12) Prior Null Responder (n= 15, 11, 15)	40 percentage of participants	36.4 percentage of participants	40 percentage of participants
Percentage of Participants With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12) Prior Partial Responder (n= 7, 8, 9)	14.3 percentage of participants	87.5 percentage of participants	55.6 percentage of participants
Percentage of Participants With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12) Total (n= 54, 69, 59)	53.7 percentage of participants	58.0 percentage of participants	57.6 percentage of participants

SECONDARY outcome

Timeframe: 24 weeks after last planned dose of study drug (up to Week 72)

Population: Safety set. Here number of participants analyzed = participants evaluable for this measure and n = participants evaluable for specified categories, for each arm, respectively.

SVR 24 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (\<lower limit of quantification) at 24 weeks after last planned dose of study drug. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL).

Outcome measures

Outcome measures
Measure	T/PR + HAART Regimen (ATV/r-Based) n=53 Participants Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.	T/PR + HAART Regimen (EFV-Based) n=66 Participants Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.	T/PR + HAART Regimen (RAL-Based) n=56 Participants Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
Percentage of Participants With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR 24) Treatment Naïve (n= 23, 38, 29)	65.2 percentage of participants	57.9 percentage of participants	51.7 percentage of participants
Percentage of Participants With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR 24) Prior Relapser (n=8, 11, 4)	75.0 percentage of participants	54.5 percentage of participants	100 percentage of participants
Percentage of Participants With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR 24) Prior Null Responder (n= 15, 9, 14)	33.3 percentage of participants	22.2 percentage of participants	35.7 percentage of participants
Percentage of Participants With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR 24) Prior Partial Responder (n= 7, 8, 9)	14.3 percentage of participants	75.0 percentage of participants	55.6 percentage of participants
Percentage of Participants With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR 24) Total (n= 53, 66, 56)	50.9 percentage of participants	54.5 percentage of participants	51.8 percentage of participants

SECONDARY outcome

Timeframe: Week 4

Population: Safety set. Here, n = participants evaluable for specified category for each arm, respectively.

The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. RVR was defined as undetectable HCV RNA (\<lower limit of quantification) 4 weeks after the start of study treatment.

Outcome measures

Outcome measures
Measure	T/PR + HAART Regimen (ATV/r-Based) n=54 Participants Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.	T/PR + HAART Regimen (EFV-Based) n=69 Participants Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.	T/PR + HAART Regimen (RAL-Based) n=59 Participants Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
Percentage of Participants With Rapid Viral Response (RVR) Treatment Naïve (n= 24, 39, 31)	50.0 percentage of participants	53.8 percentage of participants	74.2 percentage of participants
Percentage of Participants With Rapid Viral Response (RVR) Prior Relapser (n=8, 11, 4)	62.5 percentage of participants	72.7 percentage of participants	100 percentage of participants
Percentage of Participants With Rapid Viral Response (RVR) Prior Null Responder (n= 15, 11, 15)	26.7 percentage of participants	54.5 percentage of participants	53.3 percentage of participants
Percentage of Participants With Rapid Viral Response (RVR) Prior Partial Responder (n= 7, 8, 9)	42.9 percentage of participants	50.0 percentage of participants	44.4 percentage of participants
Percentage of Participants With Rapid Viral Response (RVR) Total (n= 54, 69, 59)	44.4 percentage of participants	56.5 percentage of participants	66.1 percentage of participants

SECONDARY outcome

Timeframe: Week 4 and Week 12

Population: Safety set. Here, n = participants evaluable for specified category for each arm, respectively.

The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. eRVR was defined as undetectable HCV RNA (\<lower limit of quantification) at both 4 weeks and 12 weeks after the start of study treatment.

Outcome measures

Outcome measures
Measure	T/PR + HAART Regimen (ATV/r-Based) n=54 Participants Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.	T/PR + HAART Regimen (EFV-Based) n=69 Participants Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.	T/PR + HAART Regimen (RAL-Based) n=59 Participants Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
Percentage of Participants With Extended Rapid Viral Response (eRVR) Treatment Naïve (n= 24, 39, 31)	50.0 percentage of participants	53.8 percentage of participants	61.3 percentage of participants
Percentage of Participants With Extended Rapid Viral Response (eRVR) Prior Relapser (n=8, 11, 4)	62.5 percentage of participants	72.7 percentage of participants	100 percentage of participants
Percentage of Participants With Extended Rapid Viral Response (eRVR) Prior Null Responder (n= 15, 11, 15)	26.7 percentage of participants	54.5 percentage of participants	53.3 percentage of participants
Percentage of Participants With Extended Rapid Viral Response (eRVR) Prior Partial Responder (n= 7, 8, 9)	14.3 percentage of participants	50.0 percentage of participants	44.4 percentage of participants
Percentage of Participants With Extended Rapid Viral Response (eRVR) Total (n= 54, 69, 59)	40.7 percentage of participants	56.5 percentage of participants	59.3 percentage of participants

SECONDARY outcome

Timeframe: EOT (up to Week 48)

Population: Full analysis set included all participants who received at least 1 dose of study drug.

The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. Percentage of participants with undetectable HCV RNA (\<lower limit of quantification) at EOT (up to Week 48) are reported. Data for this outcome was not planned to be reported by prior response.

Outcome measures

Outcome measures
Measure	T/PR + HAART Regimen (ATV/r-Based) n=54 Participants Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.	T/PR + HAART Regimen (EFV-Based) n=69 Participants Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.	T/PR + HAART Regimen (RAL-Based) n=59 Participants Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
Percentage of Participants With Undetectable HCV RNA at End of Treatment (EOT)	55.6 percentage of participants	63.8 percentage of participants	61.0 percentage of participants

SECONDARY outcome

Timeframe: Up to Week 52

Population: Safety set.

AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event.

Outcome measures

Outcome measures
Measure	T/PR + HAART Regimen (ATV/r-Based) n=54 Participants Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.	T/PR + HAART Regimen (EFV-Based) n=69 Participants Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.	T/PR + HAART Regimen (RAL-Based) n=59 Participants Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs	100 percentage of participants	95.7 percentage of participants	94.9 percentage of participants
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	13.0 percentage of participants	11.6 percentage of participants	15.3 percentage of participants

SECONDARY outcome

Timeframe: Day -14 to Day -1 and Week 1 for ATV, EFV, and RAL; Week 1 for telaprevir

Population: Full Analysis set.Here, n = participants evaluable for specified category for each arm, respectively.

Cmax, Cmin, and Cavg were reported for atazanavir (ATV), efavirenz (EFV), raltegravir (RAL), and telaprevir.

Outcome measures

SECONDARY outcome

Timeframe: Baseline, follow-up (Week 96)

Population: Full analysis set. Here number of participants analyzed = participants who were evaluable for this measure and n = participants evaluable for specified categories.

Sequence analysis of the HCV NS3-4A region was performed to monitor telaprevir-resistant variants. HCV RNA was isolated from the plasma, amplified by reverse transcription-polymerase chain reaction (RT-PCR), and sequenced (sequencing assay limit of detection HCV RNA \>=1000 IU/mL). Results of this outcome measure were to be reported for overall participants instead of by HAART treatment.

Outcome measures

Outcome measures
Measure	T/PR + HAART Regimen (ATV/r-Based) n=180 Participants Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.	T/PR + HAART Regimen (EFV-Based) Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.	T/PR + HAART Regimen (RAL-Based) Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
Number of Participants With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region Baseline (n = 180)	2 participants	—	—
Number of Participants With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region Follow-up (n = 26)	11 participants	—	—

Adverse Events

T/PR + HAART Regimen (ATV/r-Based)

Serious events: 7 serious events

Other events: 54 other events

Deaths: 0 deaths

T/PR + HAART Regimen (EFV-Based)

Serious events: 8 serious events

Other events: 66 other events

Deaths: 0 deaths

T/PR + HAART Regimen (RAL-Based)

Serious events: 9 serious events

Other events: 56 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Medical Monitor

Vertex Pharmaceuticals Incorporated

Phone: 617-341-6777

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee PI is free to publish results of the study after (1) the first multi-center publication, (2) if the sponsor elects not to publish the results, or (3) 18 months after close of the study, whichever occurs first. Proposed publications are to be submitted to the sponsor for review and comment for a period of at least 45 days (which may be extended under certain circumstances related to protection of intellectual property); the sponsor cannot require changes to the proposed publications.
Publication restrictions are in place

Restriction type: OTHER

Measure	T/PR + HAART Regimen (ATV/r-Based) n=54 Participants Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.	T/PR + HAART Regimen (EFV-Based) n=69 Participants Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.	T/PR + HAART Regimen (RAL-Based) n=59 Participants Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
Maximum (Cmax), Minimum (Cmin), and Average Plasma Concentration (Cavg) Telaprevir: Week 1, Cavg(n=30, 32, 26)	2320 nanogram per milliliter (ng/mL) Standard Deviation 907	2430 nanogram per milliliter (ng/mL) Standard Deviation 1290	2520 nanogram per milliliter (ng/mL) Standard Deviation 643
Maximum (Cmax), Minimum (Cmin), and Average Plasma Concentration (Cavg) ATV: Day -14 to Day -1, Cmax(n=46, 0, 0)	2870 nanogram per milliliter (ng/mL) Standard Deviation 1580	NA nanogram per milliliter (ng/mL) Standard Deviation NA Data not reported as no participant was evaluable for this parameter from this reporting group	NA nanogram per milliliter (ng/mL) Standard Deviation NA Data not reported as no participant was evaluable for this parameter from this reporting group
Maximum (Cmax), Minimum (Cmin), and Average Plasma Concentration (Cavg) ATV: Day -14 to Day -1, Cmin(n=46, 0, 0)	991 nanogram per milliliter (ng/mL) Standard Deviation 635	NA nanogram per milliliter (ng/mL) Standard Deviation NA Data not reported as no participant was evaluable for this parameter from this reporting group	NA nanogram per milliliter (ng/mL) Standard Deviation NA Data not reported as no participant was evaluable for this parameter from this reporting group
Maximum (Cmax), Minimum (Cmin), and Average Plasma Concentration (Cavg) ATV: Day -14 to Day -1, Cavg(n=41, 0, 0)	1100 nanogram per milliliter (ng/mL) Standard Deviation 647	NA nanogram per milliliter (ng/mL) Standard Deviation NA Data not reported as no participant was evaluable for this parameter from this reporting group	NA nanogram per milliliter (ng/mL) Standard Deviation NA Data not reported as no participant was evaluable for this parameter from this reporting group
Maximum (Cmax), Minimum (Cmin), and Average Plasma Concentration (Cavg) ATV: Week 1, Cmax (n=42, 0, 0)	2820 nanogram per milliliter (ng/mL) Standard Deviation 1570	NA nanogram per milliliter (ng/mL) Standard Deviation NA Data not reported as no participant was evaluable for this parameter from this reporting group	NA nanogram per milliliter (ng/mL) Standard Deviation NA Data not reported as no participant was evaluable for this parameter from this reporting group
Maximum (Cmax), Minimum (Cmin), and Average Plasma Concentration (Cavg) ATV: Week 1, Cmin (n=42, 0, 0)	1280 nanogram per milliliter (ng/mL) Standard Deviation 636	NA nanogram per milliliter (ng/mL) Standard Deviation NA Data not reported as no participant was evaluable for this parameter from this reporting group	NA nanogram per milliliter (ng/mL) Standard Deviation NA Data not reported as no participant was evaluable for this parameter from this reporting group
Maximum (Cmax), Minimum (Cmin), and Average Plasma Concentration (Cavg) ATV: Week 1, Cavg (n=30, 0, 0)	1320 nanogram per milliliter (ng/mL) Standard Deviation 685	NA nanogram per milliliter (ng/mL) Standard Deviation NA Data not reported as no participant was evaluable for this parameter from this reporting group	NA nanogram per milliliter (ng/mL) Standard Deviation NA Data not reported as no participant was evaluable for this parameter from this reporting group
Maximum (Cmax), Minimum (Cmin), and Average Plasma Concentration (Cavg) EFV: Day -14 to Day -1, Cmax(n=0, 60, 0)	NA nanogram per milliliter (ng/mL) Standard Deviation NA Data not reported as no participant was evaluable for this parameter from this reporting group	3800 nanogram per milliliter (ng/mL) Standard Deviation 2600	NA nanogram per milliliter (ng/mL) Standard Deviation NA Data not reported as no participant was evaluable for this parameter from this reporting group
Maximum (Cmax), Minimum (Cmin), and Average Plasma Concentration (Cavg) EFV: Day -14 to Day -1, Cmin(n=0, 60, 0)	NA nanogram per milliliter (ng/mL) Standard Deviation NA Data not reported as no participant was evaluable for this parameter from this reporting group	2560 nanogram per milliliter (ng/mL) Standard Deviation 1900	NA nanogram per milliliter (ng/mL) Standard Deviation NA Data not reported as no participant was evaluable for this parameter from this reporting group
Maximum (Cmax), Minimum (Cmin), and Average Plasma Concentration (Cavg) EFV: Day -14 to Day -1, Cavg(n=0, 51, 0)	NA nanogram per milliliter (ng/mL) Standard Deviation NA Data not reported as no participant was evaluable for this parameter from this reporting group	2150 nanogram per milliliter (ng/mL) Standard Deviation 1680	NA nanogram per milliliter (ng/mL) Standard Deviation NA Data not reported as no participant was evaluable for this parameter from this reporting group
Maximum (Cmax), Minimum (Cmin), and Average Plasma Concentration (Cavg) EFV: Week 1, Cmax (n=0, 51, 0)	NA nanogram per milliliter (ng/mL) Standard Deviation NA Data not reported as no participant was evaluable for this parameter from this reporting group	3340 nanogram per milliliter (ng/mL) Standard Deviation 2450	NA nanogram per milliliter (ng/mL) Standard Deviation NA Data not reported as no participant was evaluable for this parameter from this reporting group
Maximum (Cmax), Minimum (Cmin), and Average Plasma Concentration (Cavg) EFV: Week 1, Cmin (n=0, 51, 0)	NA nanogram per milliliter (ng/mL) Standard Deviation NA Data not reported as no participant was evaluable for this parameter from this reporting group	2290 nanogram per milliliter (ng/mL) Standard Deviation 1880	NA nanogram per milliliter (ng/mL) Standard Deviation NA Data not reported as no participant was evaluable for this parameter from this reporting group
Maximum (Cmax), Minimum (Cmin), and Average Plasma Concentration (Cavg) EFV: Week 1, Cavg (n=0, 47, 0)	NA nanogram per milliliter (ng/mL) Standard Deviation NA Data not reported as no participant was evaluable for this parameter from this reporting group	1920 nanogram per milliliter (ng/mL) Standard Deviation 1400	NA nanogram per milliliter (ng/mL) Standard Deviation NA Data not reported as no participant was evaluable for this parameter from this reporting group
Maximum (Cmax), Minimum (Cmin), and Average Plasma Concentration (Cavg) RAL: Day -14 to Day -1, Cmax(n=0, 0, 52)	NA nanogram per milliliter (ng/mL) Standard Deviation NA Data not reported as no participant was evaluable for this parameter from this reporting group	NA nanogram per milliliter (ng/mL) Standard Deviation NA Data not reported as no participant was evaluable for this parameter from this reporting group	1900 nanogram per milliliter (ng/mL) Standard Deviation 1880
Maximum (Cmax), Minimum (Cmin), and Average Plasma Concentration (Cavg) RAL: Day -14 to Day -1, Cmin(n=0, 0, 52)	NA nanogram per milliliter (ng/mL) Standard Deviation NA Data not reported as no participant was evaluable for this parameter from this reporting group	NA nanogram per milliliter (ng/mL) Standard Deviation NA Data not reported as no participant was evaluable for this parameter from this reporting group	196 nanogram per milliliter (ng/mL) Standard Deviation 198
Maximum (Cmax), Minimum (Cmin), and Average Plasma Concentration (Cavg) RAL: Day -14 to Day -1, Cavg(n=0, 0, 35)	NA nanogram per milliliter (ng/mL) Standard Deviation NA Data not reported as no participant was evaluable for this parameter from this reporting group	NA nanogram per milliliter (ng/mL) Standard Deviation NA Data not reported as no participant was evaluable for this parameter from this reporting group	483 nanogram per milliliter (ng/mL) Standard Deviation 429
Maximum (Cmax), Minimum (Cmin), and Average Plasma Concentration (Cavg) RAL: Week 1, Cmax (n=0, 0, 49)	NA nanogram per milliliter (ng/mL) Standard Deviation NA Data not reported as no participant was evaluable for this parameter from this reporting group	NA nanogram per milliliter (ng/mL) Standard Deviation NA Data not reported as no participant was evaluable for this parameter from this reporting group	2320 nanogram per milliliter (ng/mL) Standard Deviation 1970
Maximum (Cmax), Minimum (Cmin), and Average Plasma Concentration (Cavg) RAL: Week 1, Cmin (n=0, 0, 49)	NA nanogram per milliliter (ng/mL) Standard Deviation NA Data not reported as no participant was evaluable for this parameter from this reporting group	NA nanogram per milliliter (ng/mL) Standard Deviation NA Data not reported as no participant was evaluable for this parameter from this reporting group	281 nanogram per milliliter (ng/mL) Standard Deviation 435
Maximum (Cmax), Minimum (Cmin), and Average Plasma Concentration (Cavg) RAL: Week 1, Cavg (n=0, 0, 34)	NA nanogram per milliliter (ng/mL) Standard Deviation NA Data not reported as no participant was evaluable for this parameter from this reporting group	NA nanogram per milliliter (ng/mL) Standard Deviation NA Data not reported as no participant was evaluable for this parameter from this reporting group	643 nanogram per milliliter (ng/mL) Standard Deviation 539
Maximum (Cmax), Minimum (Cmin), and Average Plasma Concentration (Cavg) Telaprevir: Week 1, Cmax(n=49, 59, 54)	3160 nanogram per milliliter (ng/mL) Standard Deviation 1180	3780 nanogram per milliliter (ng/mL) Standard Deviation 1670	3470 nanogram per milliliter (ng/mL) Standard Deviation 868
Maximum (Cmax), Minimum (Cmin), and Average Plasma Concentration (Cavg) Telaprevir: Week 1, Cmin(n=49, 59, 54)	1650 nanogram per milliliter (ng/mL) Standard Deviation 863	1750 nanogram per milliliter (ng/mL) Standard Deviation 961	1840 nanogram per milliliter (ng/mL) Standard Deviation 741

Measure	T/PR + HAART Regimen (ATV/r-Based) n=54 participants at risk Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.	T/PR + HAART Regimen (EFV-Based) n=69 participants at risk Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.	T/PR + HAART Regimen (RAL-Based) n=59 participants at risk Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
Blood and lymphatic system disorders Anaemia	0.00% 0/54 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.	4.3% 3/69 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.	6.8% 4/59 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.
Blood and lymphatic system disorders Neutropenia	1.9% 1/54 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.	1.4% 1/69 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.	1.7% 1/59 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.
Blood and lymphatic system disorders Leukocytosis	1.9% 1/54 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.	0.00% 0/69 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.	0.00% 0/59 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.
Gastrointestinal disorders Diarrhoea	0.00% 0/54 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.	0.00% 0/69 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.	1.7% 1/59 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.
Gastrointestinal disorders Mallory-Weiss syndrome	0.00% 0/54 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.	1.4% 1/69 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.	0.00% 0/59 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/54 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.	0.00% 0/69 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.	1.7% 1/59 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.
Gastrointestinal disorders Vomiting	1.9% 1/54 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.	0.00% 0/69 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.	0.00% 0/59 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.
Infections and infestations Escherichia urinary tract infection	1.9% 1/54 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.	0.00% 0/69 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.	0.00% 0/59 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.
Infections and infestations Pneumonia	0.00% 0/54 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.	1.4% 1/69 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.	0.00% 0/59 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.
Infections and infestations Psoas abscess	1.9% 1/54 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.	0.00% 0/69 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.	0.00% 0/59 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	1.9% 1/54 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.	0.00% 0/69 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.	0.00% 0/59 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis	1.9% 1/54 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.	0.00% 0/69 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.	0.00% 0/59 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/54 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.	0.00% 0/69 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.	1.7% 1/59 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.
General disorders Non-cardiac chest pain	1.9% 1/54 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.	0.00% 0/69 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.	0.00% 0/59 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.
General disorders Pyrexia	0.00% 0/54 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.	0.00% 0/69 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.	1.7% 1/59 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.
Musculoskeletal and connective tissue disorders Flank pain	1.9% 1/54 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.	0.00% 0/69 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.	0.00% 0/59 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	1.9% 1/54 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.	0.00% 0/69 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.	0.00% 0/59 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.
Nervous system disorders Syncope	0.00% 0/54 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.	1.4% 1/69 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.	1.7% 1/59 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.
Renal and urinary disorders Renal cyst	1.9% 1/54 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.	0.00% 0/69 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.	0.00% 0/59 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.
Renal and urinary disorders Renal failure acute	0.00% 0/54 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.	0.00% 0/69 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.	1.7% 1/59 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.
Ear and labyrinth disorders Vertigo	0.00% 0/54 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.	0.00% 0/69 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.	1.7% 1/59 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.
Endocrine disorders Basedow's disease	0.00% 0/54 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.	0.00% 0/69 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.	1.7% 1/59 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.
Eye disorders Retinopathy	0.00% 0/54 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.	1.4% 1/69 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.	0.00% 0/59 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/54 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.	1.4% 1/69 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.	0.00% 0/59 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.
Investigations Hepatic enzyme increased	0.00% 0/54 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.	1.4% 1/69 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.	0.00% 0/59 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.
Metabolism and nutrition disorders Hypokalaemia	1.9% 1/54 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.	0.00% 0/69 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.	0.00% 0/59 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	1.9% 1/54 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.	0.00% 0/69 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.	0.00% 0/59 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.
Psychiatric disorders Anxiety	1.9% 1/54 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.	0.00% 0/69 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.	0.00% 0/59 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.
Skin and subcutaneous tissue disorders Rash	0.00% 0/54 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.	0.00% 0/69 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.	1.7% 1/59 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/54 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.	0.00% 0/69 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.	1.7% 1/59 • Baseline up to Week 52 Adverse events were planned to be reported as per HAART treatment.